Towards endoscopic ultrafast laser microsurgery of vocal folds
0747 Transanal Endoscopic Microsurgery (1)...Oct 15, 2019 · Aetna considers transanal endoscopic...
Transcript of 0747 Transanal Endoscopic Microsurgery (1)...Oct 15, 2019 · Aetna considers transanal endoscopic...
(https://www.aetna.com/)
Transanal Endoscopic Microsurgery
Clinical Policy Bulletins Medical Clinical Policy Bulletins
Number: 0747
*Please see amendment for Pennsylvania Medicaid at the end of this CPB.
Aetna considers transanal endoscopic microsurgery (TEM) medically necessary for the following
indications:
Benign rectal tumors (adenomas)
Low-risk Tis and T1 rectal carcinoma
Small rectal carcinoids (less than 2 cm in diameter).
Aetna considers TEM experimental and investigational for all the following indications (not an all-
inclusive list) because its effectiveness for indications other than the ones listed above has not
been established:
Advanced rectal cancer
Anorectal melanoma
Benign rectal strictures
Functional constipation
Giant villous adenoma of rectum
Megacolon
Rectal amyloidoma
Rectal gastro-intestinal stromal tumor (GIST)
Rectal neuroendocrine tumor in advanced stages or with metastasis
Rectal prolapse and diverticula
Last Review
10/15/2019
Effective: 02/08/2008
Next
Review: 08/13/2020
Review
History
Definitions
Additional
Clinical Policy
Bulletin
Notes
www.aetna.com/cpb/medical/data/700_799/0747.html Proprietary 1/34
Rectal ulcer syndrome
Recto-urinary fistula (e.g., recto-urethral fistula)
Recto-vesical fistula
Retro-rectal (pre-sacral) tumors.
Background
Rectal cancers, most of which are adenocarcinomas, affect more than 40,000 people in the
United States each year. Rectal cancers can be classified by the tumor, node, metastasis (TNM)
system, which was introduced by the American Joint Committee on Cancer and the International
Union Against Cancer. The TNM classification is an universal staging system for all
solid tumors, and is based on clinical and pathological information (Cirincione and Cagir, 2007):
Primary Tumor (T):
TX - Primary tumor can not be assessed or depth of penetration not specified
T0 - No evidence of primary tumor
Tis - Carcinoma in-situ (mucosal); intra-epithelial or invasion of the lamina propria
T1 - Tumor invades submucosa
T2 - Tumor invades muscularis propria
T3 - Tumor invades through the muscularis propria into the subserosa or into non
peritonealized peri-colic or peri-rectal tissue
T4 - Tumor directly invades other organs or structures and/or perforates the visceral
peritoneum
Regional Lymph Nodes (N):
NX - Regional lymph nodes can not be assessed
N0 - No regional lymph node metastasis
N1 - Metastasis in 1 to 3 peri-colic or peri-rectal lymph nodes
N2 - Metastasis in 4 or more peri-colic or peri-rectal lymph nodes
N3 - Metastasis in any lymph node along the course of a named vascular trunk
Distant Metastasis (M):
MX - Presence of metastasis can not be assessed
M0 - No distant metastasis
www.aetna.com/cpb/medical/data/700_799/0747.html#dummyLink2 Proprietary 2/34
M1 - Distant metastasis
According to the National Cancer Institute (2007), rectal cancers can also be classified as Stage
0 to Stage IV.
Stage 0: Abnormal cells are found in the innermost lining of the rectum. These abnormal
cells may become cancer and spread into nearby normal tissue. Stage 0 is also called
carcinoma in- situ
Stage I: Cancer has formed and spread beyond the innermost lining of the rectum to the 2nd
and 3rd layers and involves the inside wall of the rectum, but it has not spread to the outer
wall of the rectum or outside the rectum. Stage I rectal cancer is sometimes called Dukes A
rectal cancer.
Stage II: Cancer has spread outside the rectum to nearby tissue, but it has not gone into the
lymph nodes. Stage II rectal cancer is sometimes called Dukes B rectal cancer.
Stage III: Cancer has spread to nearby lymph nodes, but it has not spread to other parts of
the body. Stage III rectal cancer is sometimes called Dukes C rectal cancer.
Stage IV: Cancer has spread to other parts of the body (e.g., the liver, lungs, or ovaries).
Stage IV rectal cancer is sometimes called Dukes D rectal cancer.
Despite recent advances in chemo-radiotherapy, surgery still plays an important role in the
curative treatment for rectal cancers. The choice of surgical intervention depends on the location
of the tumor, depth of rectal wall invasion, as well as clinical stage of the disease. Surgical
options include local excision such as transanal excision and transanal endoscopic microsurgery
(TEM), and radical resection such as low anterior resection, extended low anterior resection with
colo-anal anastomosis, abdomino-perineal resection (APR), as well as pelvic exenteration. If the
cancer is found in a polyp, a polypectomy can be performed. Many considerations (e.g.,
morbidity, sexual and urinary dysfunction, and/or risk of definitive stoma) have led to the
increased popularity of local excision in the management of patients with rectal cancer.
However, its role as a curative treatment is still controversial with oncological long-term results
lower than those obtained by radical resection (Rajput and Bullard Dunn, 2007; Bretagnol et al,
2007a).
Currently, TEM is the only endoscopic technique that uses a natural opening to reach the target
organ, and is a valuable surgical technique with a low complication rate for patients with early
rectal cancer. The main advantage of TEM is preservation of the rectum. Other advantages
include better exposure, magnified stereoscopic view, and greater reach into the middle and
upper rectum. This procedure was introduced in the early 1980s; its first indication was excision
of rectal adenomas. Indication for TEM was later extended to low-risk rectal cancer. Many
www.aetna.com/cpb/medical/data/700_799/0747.html Proprietary 3/34
studies reported that TEM is the optimal procedure to avoid complications for patients with rectal
polyps and low-risk pathological T1 (pT1) rectal tumors (Burghardt and Buess, 2005; Whiteford,
2007).
Araki et al (2003) discussed their experience with video-assisted gasless TEM (V-TEM) as a
means of local excision of rectal cancer. A total of 217 patients, with a mean follow-up of 61
months, underwent V-TEM for adenoma (n = 102), Tis (n = 83), T1 (n = 28), and T2 (n = 4) rectal
tumors, located 3 to 20 cm from the dentate line. The mean size of the tumor was 39 mm, and
the mean duration of the operation was 63 mins including set-up time, and the mean duration of
hospital stay was 5.8 days. Seven (3.2 %) patients underwent conversion to radical resection
owing to T1 with massive invasion or T2 tumors histopathologically. Two (0.9 %) patients had
recurrent disease that was managed by repeat V-TEM. The post-operative course in all patients
was free from any significant complications. Transient fecal soiling was present in 12 (5.5 %)
patients. The authors concluded that V-TEM was a safe, simple and minimally invasive
procedure for benign and early cancer in the proximal rectum.
In a retrospective review, Floyd and Saclarides (2006) reported that TEM treatment of pT1 rectal
cancers is safe and achieved low local recurrence and high survival rates. Patient age, gender,
tumor distance from the anal verge, lesion size, operative time, blood loss, complications,
recurrence, and survival rates were prospectively recorded. A total of 53 patients (26 men and
27 women, average age of 65.6 years, range of 31 to 89 years) were studied. Average tumor
distance from the anal verge was 7 cm (range of 0 to 13 cm); average size was 2.4 cm (range
of 1 to 10 cm). Radiation and/or chemotherapy were not administered. A total of 16 patients had
pT1 lesions removed piecemeal during colonoscopy; there was no residual tumor after TEM of
the polyp site. Mean follow-up was 2.84 years; 51 % of subjects had longer than 2-year follow-
up. For the entire group, there were 4 recurrences (7.5 %) occurring at 9 months, 15 months, 16
months, and 11 years. Two were treated with APR, one with low anterior resection, and one with
fulguration alone. There were no recurrences in the 16 patients who had excision of the
polypectomy site. If excluded, recurrence was 11 % (4/37). Patients were examined at 3-month
intervals for the first 2 years and every 6 months thereafter. There have been no cancer-related
deaths. The authors concluded that TEM of pT1 rectal cancers yielded low recurrence rates.
Lin et al (2006) compared local excision of early rectal tumors by TEM and the conventional
posterior trans-sphincteric approach (Mason's operation). The study group comprised 31
consecutive patients with early rectal tumors (18 villous adenomas, 13 adenocarcinomas) who
underwent TEM. The control group consisted of 51 patients with early rectal tumors (27 villous
adenomas, 24 adenocarcinomas) who underwent the Mason's operation. Outcome measures
included morbidity and mortality, operation time, recurrence rate, and post-operative pathological
staging. Age, sex, as well as pathological staging were similar in both groups. The tumor size,
www.aetna.com/cpb/medical/data/700_799/0747.html Proprietary 4/34
operation time, and blood loss were similar. The m edian distance from the anal verge was
significantly higher in the TEM group (TEM/Mason = 8.0/6.4 cm, p = 0.042). The post-operative
resumption of food intake (TEM/Mason = 1/5 days, p = 0.002) and the median hospital stay
(TEM/Mason = 4/10 days, p = 0.005) were significantly shorter in the TEM group. Analgesic
intake was significantly less in the TEM group (TEM/Mason = 0/100 mg, p = 0.0003). There was
no operation-related mortality and the resection margins were clear in both groups. Two patients
(3.9 %) in the Mason's group developed post-operative wound infection, and 2 patients (3.9 %)
developed fecal fistulae. There was one secondary hemorrhage in the TEM group that required
injection sclerotherapy. On median follow-up of 23 months, there was no tumor recurrence in the
TEM group, whereas 2 patients (3.9 %) in the Mason's group experienced recurrence during a
median follow-up of 30 months. The authors concluded that TEM is as effective as the
conventional Mason's operation for local curative excision of early rectal tumors. It is less
invasive, with shorter hospital stay and fewer complications than the conventional Mason's
operation.
Borschitz and associates (2006) determined the prognostic factors for recurrences and the need
for re-operation in patients who had undergone local excision of early rectal cancer. In 105 of
118 patients with pT1 rectal carcinomas and local excision, recurrence rates as well as 10-year
cancer-free survival rates were studied separately according to different histological criteria (R0,
R1, Rx, R less than or equal to 1 mm, high-risk/low-risk situation), tumor localization (anterior,
posterior, lateral wall, and third of rectum), size, and degree of resection (full-thickness/partial
wall). Patients were grouped into local excision (n = 89) and local excision followed by re-
operation (n = 21). Risk classification was performed by division into "low-risk" carcinomas after
local R0-resection (group A) and unfavorable histological results after local resection (R1, Rx,
R less than or equal to 1 mm, high-risk situation; group B). Local recurrence rate after local R0
resection of low-risk carcinomas (group A) was 6 %, whereas that for patients in group B with
local resection was 39 %. The recurrence risk in those patients was significantly reduced to 6 %
by re-operation (p = 0.015). In addition, the 10-year cancer-free survival rate was 93 % in group
B after re-operation compared with that of 89 % in patients of group A after local excision alone.
The authors concluded that local R0-resection in cases with low-risk pT1 carcinomas represents
an oncologically adequate therapy, which resulted in similar survival rates compared with primary
radical surgery of pT1N0M0 rectal carcinomas. High recurrence rates are observed in tumors
with unfavorable histological result (group B) requiring further treatment. In these cases
immediate re-operation lowered the recurrence rate to 6 %.
On the other hand, the same group of investigators reported that local R0 resection of low-risk
pT2 carcinomas represents an inadequate therapy (Borschitz et al, 2007). These researchers
examined the value of local excision for T2 rectal carcinomas, prognostic factors, and the need
for re-operation. After local excision of 649 patients with rectal tumors, pT2 carcinoma was
www.aetna.com/cpb/medical/data/700_799/0747.html Proprietary 5/34
found in 44 patients. In general, immediate re-operation was recommended; however, 24
patients declined further surgery or were not re-operated because of co-morbidities. Results
were analyzed separately for local R0 resection of low-risk carcinomas and for prognostically
unfavorable criteria (R1/RX/R less than or equal to 1 mm/G3-4/L1/V1). Re-operation was
performed within 4 weeks. Recurrences also were divided by previous local R0 resection of low-
risk tumors as well as by unfavorable results, and were analyzed in a long-term, follow-up study.
Patients with palliative therapy were excluded, and follow-up was obtained in 90 % (20 TEM
alone, 17 TEM and re-operation). Local recurrence rate after local R0 resection alone of low-risk
T2 carcinomas was 29 %, whereas patients with unfavorable criteria developed recurrences in
50 %. After immediate re-operation, the local recurrence risk in patients without lymph node
filiae was significantly reduced to 7 %. The authors concluded that local R0 resection of low-risk
pT2 carcinomas represents an inadequate therapy.
In a prospective study, Maslekar et al (2007) presented their findings of patients with rectal
cancers managed by TEM. A total of 52 patients (22 women and 30 men) underwent TEM
excision of a rectal cancer. Their mean age was 74.3 years (range of 48 to 93 years). The
median diameter of the lesions was 3.44 cm (range of 1.6 to 8.5 cm). The median distance of
the lesions from the anal verge was 8.8 cm (range of 3 to 15 cm), with the tumor more than 10
cm from the anal verge in 36 patients. The median operating time was 90 minutes (range of 20
to 150 minutes), and the median post-operative stay was 2 days. All patients underwent full-
thickness excisions. There were 11 minor complications, 2 major complications, and no deaths.
The mean follow-up period was 40 months (range of 22 to 82 months). None of the pT1 rectal
cancers received adjuvant therapy. Eight patients with pT2 rectal cancer and 2 patients with pT3
rectal cancer received post-operative adjuvant therapy. The overall local rate of recurrence was
14 %, and involved cases of T2 and T3 lesions, with no recurrence after excision of T1 cancers.
Three patients died during the follow-up period, but no cancer-specific deaths occurred. The
authors concluded that TEM is a safe and effective treatment for selected cases of rectal cancer,
with low morbidity and no mortality.
Zacharakis and co-workers (2007) described a single institution's experience in the use of TEM
for rectal tumors. Between 1996 and 2005, TEM was performed in 76 patients (n = 28 for
adenocarcinoma; n = 48 for adenoma). Clear resection margins were achieved in 71 of 74
patients (95.9 %). Overall morbidity was 18.9 % because 14 patients developed minor (n = 10)
or major (n = 4) complications. During follow-up, benign tumor recurrence was detected in 3
patients (6.3 %). The recurrence rates among patients with T1, T2, and T3 malignant tumors
were 7.1 %, 42.8 %, and 66.6 %, respectively. The authors concluded that TEM is a safe and
feasible technique with low incomplete excision rates and may be the preferred method in
patients with benign rectal tumors. However, its role in the management of malignant tumors
should be limited to selected patients with T1 lesions.
www.aetna.com/cpb/medical/data/700_799/0747.html Proprietary 6/34
Bretagnol and colleagues (2007b) ascertained the morbidity and long-term results of rectal
tumors excised by TEM. A total of 200 patients underwent TEM for excision of adenomas (n =
148) or carcinomas (n = 52). The median tumor distance from the anal verge was 8 cm (range
of 1 to 16 cm). Morbidity and mortality rates were 14.0 % and 0.5 %, respectively. At a median
follow-up of 33 months (range of 2 to 133 months), local recurrence had developed in 11 patients
(7.6 %) with an adenoma. Histological examination of carcinomas revealed pT1 in 31 patients,
pT2 in 17 and pT3 in 4. Immediate salvage surgery was performed in 7 patients (13 %). At a
median follow-up of 34 months (range of 1 to 102 months), 8 patients (15 %) with carcinomas
had developed local recurrence. The overall as well as disease-free 5-year survival rates for
patients with carcinomas were 76 % and 65 %, respectively. The authors concluded that TEM is
an appropriate surgical treatment option for benign rectal tumors. For carcinomas, it is
oncologically safe provided that resection margins are clear, but strict patient selection is
needed.
Many reviews, technology assessments, and clinical practice guidelines/parameters have
recommended local excision/TEM in the management of patients with early rectal cancer.
The Australian Medical Services Advisory Committee's assessment on TEM (2003) stated
that this procedure is primarily used for removal of certain lower and upper rectal tumors, such
as adenomas and carcinomas. Patients with small or early benign or early malignant tumors of
the rectum that can not be removed by colonoscopy are candidates for this surgery. The
procedure may also be used on patients who are unwilling or unable to undergo conventional
open surgery.
The American Society of Colon and Rectal Surgeons' practice parameters for the management
of rectal cancer (Tjandra et al, 2005) stated that local excision of rectal cancer is an appropriate
alternative therapy for selected cases of rectal cancer with a low likelihood of nodal metastases.
This probability is dependent on the depth of tumor invasion (T stage), tumor differentiation, and
lympho-vascular invasion. Comparative trials to APR supported transanal local excision with
curative intent for T1, well-differentiated cancers that are less than 3 cm in diameter and occupy
less than 40 % of the circumference of the rectal wall. Furthermore, the tumor must be excised
intact by full-thickness excision with clear margins. It should be orientated and pinned out for
complete pathological examination. If unfavorable features are observed on pathological
examination, a radical resection is warranted.
An assessment by the Canadian Agency for Drugs and Technologies in Health (Keay and
Farrah, 2008) concluded that the evidence suggests that TEM is effective and safe in removing
adenomas and T1 carcinomas when compared to local or radical resection. The
assessment stated that one study noted the local recurrence rate was higher for TEM compared
www.aetna.com/cpb/medical/data/700_799/0747.html Proprietary 7/34
to resection, possibly because of lymphatic involvement; however, there was no difference in
long term survival between TEM and resection. The assessment noted that, overall, the
recurrence rates for adenomas and carcinomas were low, provided the resection margins are
clear and the lesions are not removed in a piecemeal fashion. The assessment found that the
most common complications of TEM include bleeding (which may be related to lesion location
and surgeon experience), urinary retention and temporary incontinences. Two functional quality
studies demonstrated that there was an overall good bowel function response with TEM. The
assessment reported that studies that have examined the costs of TEM have shown it to be a
cost-saving procedure when compared to radical resection, primarily because of the shorter
procedure time and hospital stay.
Serra Aracil et al (2006) stated that TEM-associated morbidity is low and mortality is practically
nil. It is the technique of choice in large rectal adenomas and malignant rectal tumors in stage
pT1 localized in the rectal ampulla. The frequency of recurrence is similar to that in abdominal
surgery. The technique does not cause complications of urinary or sexual dysfunction, and fecal
incontinence is minimal. In more advanced stages of rectal cancer, the results of better patient
selection and future studies on the possible application of neo-adjuvant therapy associated with
TEM are required.
Papagrigoriadis (2006) stated that TEM is an useful minimally invasive technique for the
treatment of certain large or sessile adenomas of the rectum. It can successfully treat those
adenomas that are unamenable to colonoscopic excision and can spare some patients the risks
and adverse effects of major rectal surgery. In case of malignant transformation or recurrence,
TEM can be used as first line treatment since it does not preclude radical resection, and can be
repeated for treating recurrences.
Helgstrand et al (2007) noted that the sue of TEM in the treatment of benign as well as T1
rectum tumors has become more widespread. These researchers presented their findings on 74
patients who underwent this procedure. A total of 49 patients had adenomas; both the
recurrence and complication rate was 6 %. Median follow-up period was 12 months (range of 0
to 57 months). Fifteen patients had a T1 tumor removed; the recurrence rate was 15 %. One
had a serious complication. Median follow-up period was 12 months (range of 3 to 36 months).
Eight had a T2 tumor removed; the recurrence rate was 16 %. One had a serious complication.
Median follow-up period was 21 months (range of 9 to 36 months). Two patients were treated for
a T3 tumor as part of palliation. The authors concluded that their results are comparative to the
largest foreign data. The recurrence rate is on the same level as open as well as laparoscopic
surgery and far less than traditional transanal surgery. The complication risks are on the same
www.aetna.com/cpb/medical/data/700_799/0747.html Proprietary 8/34
level as laparoscopic access and far less than open surgery. However, pre-operative
investigation has to be developed further. Research is needed to clarify if selected patients with
T2 cancer could be treated with TEM in combination with radiotherapy.
Rokke et al (2007) stated that TEM is a safe and suitable method for resection of rectal
adenomas that can not be radically removed by endoscopic methods. It offers lower recurrence
rates and less morbidity than traditional treatment. Selected malignant tumors (e.g., small
carcinoid tumors and early stage [Tis, T1] adencarcinomas) with higer moderate differentiation
may be resected by TEM with the same oncological result as open surgery.
The National Cancer Institute's treatment option overview on rectal cancer (2007) stated that
surgery is the most common treatment for all stages of rectal cancer. Local excision is
recommended if the cancer is found at a very earlystage.
The progress report on the "1st Workshop on Local Excision of Rectal Cancer" that was held in
Germany (Borschitz and Junginger, 2007) noted that local excision of "low-risk" T1 carcinomas
was rated as oncologically adequate therapy with good functional results and low complication
rates. Transanal endoscopic microsurgery was the preferred technique. Pre-requisite for the
achievement of low recurrence rates (5 %) is an R0 resection with a safety margin of at least 1
mm (R less than or equal to 1 mm) without tumor fragmentation, because otherwise possible
tumor cell displacement and RX resection may not allow an assessment of the resection margin.
"High-risk" tumors or T2 carcinomas were not considered an indication for local excision.
The National Comprehensive Cancer Network's practice guideline on rectal cancer (2007) stated
that transanal excision may be appropriate for selected early stage cancers. Small (less than 3
cm), well-to-moderately differentiated T1 tumors that are within 8 cm of the anal verge and
limited to less than 30 % of the rectal circumference, and for which there is no evidence of nodal
involvement can be approached with a full-thickness excision with a 3-mm negative margin. An
alternative technique to full-thickness excision is TEM.
In summary, TEM has been shown to be safe and effective for resecting benign adenomas as
well as selected malignant tumors (e.g., small carcinoid tumors and early stage [Tis, T1]
adencarcinomas).
Baatrup and colleagues (2010) described 6 cases of management of rectal strictures by TEM.
Patients were placed in the lithotomy-Trendelenburg position and the stricture was resected from
4 to 8 o'clock through the entire thickness of the fibrosis. The upper resection edge was
mobilized including all layers of the rectal wall and the defect was sutured along the
www.aetna.com/cpb/medical/data/700_799/0747.html Proprietary 9/34
circumference. Satisfactory anatomical and functional long-term results were obtained in 5 of 6
patients. The authors concluded that TEM resection of benign strictures is feasible in some
patients and should be tested in a randomized study against known procedures.
Rectal carcinoids are often inadequately resected by snare excision during colonoscopy.
Transanal endoscopic microsurgery offers full thickness excision with a low rate of negative
margins. It presents an excellent alternative to radical surgery for mid and proximally located
lesions.
Kinoshita et al (2007) evaluated the effectiveness of TEM in the treatment of rectal carcinoid
tumor. A total of 27 patients with rectal carcinoid tumor underwent TEM, and their clinical data
were reviewed retrospectively. The TEM procedure was performed as a primary excision (n =
14) or as completion surgery after incomplete resection by endoscopic polypectomy (n = 13).
The average size of a primary tumor was 9.1 mm (range of 5 to 13 mm), and the average
distance of the tumor from the anal verge was 8.5 cm. The mean duration of the operation was
51.6 mins. Minor morbidities, transient soilage, and mild dehiscence occurred in 2 cases (7.4
%). Histopathologically, all tumors were localized within the submucosal layer showing typical
histology without lymphatic or vessel infiltration, and both deep and lateral surgical margins were
completely free of tumors. Among 13 cases of completion surgery after endoscopic
polypectomy, 4 (30.8 %) were histologically shown to have a residual tumor in the specimens
obtained by TEM. No additional radical surgery was performed. The mean follow-up period was
70.6 months, and no recurrence was noted. The authors concluded that TEM is a safe,
minimally invasive procedure for the local excision of rectal carcinoid tumors, particularly those in
the proximal rectum. Furthermore, for patients with microscopic positive margins after
endoscopic polypectomy, TEM can be an effective surgical option for complete removal of
residual tumors.
Tsai et al (2010) reviewed their experience with TEM to clarify its role in the treatment of different
types of rectal pathology. A prospective database documented all patients undergoing transanal
endoscopic microsurgery from October 1996 through June 2008. These investigators analyzed
patient and operative factors, complications, and tumor recurrence. For recurrence
analysis, they excluded patients with fewer than 6 months of follow-up, previous excisions,
known metastases at initial presentation, and those who underwent immediate radical resection
following transanal endoscopic microsurgery. A total of 269 patients underwent TEM for benign
(n = 158) and malignant (n = 111) tumors. Procedure-related complications (21 %) included
urinary retention (10.8 %), fecal incontinence (4.1 %), fever (3.8 %), suture line dehiscence (1.5
%), and bleeding (1.5 %). Local recurrence rates for 121 benign and 83 malignant tumors were
5 % for adenomas, 9.8 % for T1 adenocarcinoma, 23.5 % for T2 adenocarcinoma, 100 % for T3
adenocarcinoma, and 0 % for carcinoid tumors. All 6 (100 %) recurrent adenomas were
www.aetna.com/cpb/medical/data/700_799/0747.html Proprietary 10/34
retreated with endoscopic techniques, and 8 of 17 (47 %) recurrent adenocarcinomas underwent
salvage procedures with curative intent. The authors concluded that TEM is a safe and effective
method for excision of benign and malignant rectal tumors. It can be offered for (i) curative
resection of benign tumors, carcinoid tumors, and select T1 adenocarcinomas, (ii)
histopathological staging in indeterminate cases, and (iii) palliative resection in patients
medically unfit or unwilling to undergo radical resection.
Shields et al (2010) described recent experience with rectal carcinoids in European and North
American centers. Rectal carcinoid patients were identified from prospective databases
maintained at 9 institutions between 1999 and 2008. Demographic, clinical, and histological data
were collated. Median follow-up was 5 years (range of 0.5 to 10 years). A total of 202 patients
were identified. The median age was 55 years (range of 31 to 81 years). The majority of tumors
were an incidental finding (n = 115, 56.9 %). The median tumor size was 10 mm (range of 2 to
120 mm). Overall, 93 (49 %) tumors were limited to the mucosa or submucosa, 45 (24 %)
involved the muscularis propria, 29 (15 %) extended into the peri-rectal fat, and 6 (3 %) reached
the visceral peritoneum. The primary treatment modalities were endoscopic resection (n = 86,
43 %) and surgical extirpation (n = 102, 50 %). Forty-one patients (40 %) underwent a high
anterior resection, whereas 45 (44 %) underwent anterior resection with total mesorectal
excision. Seven patients (7 %) underwent Hartman's procedure, 7 (7 %) underwent abdomino
perineal resection, and 6 (6 %) had TEM, whereas 4 (4 %) patients underwent a transanal
excision. Multiple variable logistic regression analysis demonstrated that tumor size greater than
10 mm and lymphovascular invasion were predictors of nodal involvement (p = 0.006 and <
0.001, respectively), whereas the presence of lymph node metastases and lymphovascular
invasion was associated with subsequent development of distant metastases (p = 0.033 and
0.022, respectively). The presence of nodal metastases has a profound effect upon survival,
with a 5-year survival rate of 70 %, and 10-year survival of 60 % for node-positive tumors.
Patients with distant metastases have a 4-year survival of 38 %. The authors concluded that
tumor size greater than 10 mm and lymphovascular invasion are significantly associated with the
presence of nodal disease, rendering mesorectal excision advisable. Transanal excision is
adequate for smaller tumors.
Steinhagen et al (2011) performed a review of a prospectively maintained database of patients
scheduled for TEM. A total of 93 patients underwent 96 procedures for 13 carcinoid tumors, 1
submucosal mass, 46 adenomas, 12 in situ adenocarcinomas, and 21 invasive
adenocarcinomas. Of these cases, 81.2 % was successfully completed. There were 9
complications (11.5 %). Final pathology demonstrated 33 in situ and invasive adenocarcinomas.
The mean follow-up was 25.9 months. The 4 recurrences (12.1 %) occurred in: 1 tubulo-villous
adenoma, 2 in situ carcinomas, and 1 T2 lesion. The authors concluded that TEM is appropriate
www.aetna.com/cpb/medical/data/700_799/0747.html Proprietary 11/34
for benign lesions such as carcinoid tumors and adenomas and can also be curative in carefully
selected patients with early-stage invasive rectal cancer. In cases of invasive adenocarcinoma,
it should be reserved for low-risk cancers in patients who accept the possible increased risk of
recurrence.
Kumar et al (2012) reported the largest American experience in the use of TEM for rectal
carcinoids. Data of patients having undergone TEM for rectal carcinoids were prospectively
collected and retrospectively analyzed. Patient and tumor characteristics, operative and peri
operative details, as well as oncological outcomes were reviewed. Over a 12-year period, 24
patients underwent TEM for rectal carcinoids. Of these, 6 (25 %) were primary surgical
resections and 18 (75 %) were done after incomplete snare excisions during colonoscopy. Three
patients (17 %) undergoing full-thickness resection after snare excision had residual tumor on
histopathological examination. Negative margins were obtained in all cases. No recurrences
were noted. The authors concluded that TEM is safe and effective for the surgical resection of
rectal carcinoids less than 2 cm in diameter, with typical features, and located more than 5 cm
from the anal verge. It can be used for primary resection or resection following inadequate
colonoscopic snare excision.
Ashraf et al (2012) stated that TEM for early rectal cancer (ERC) gives results similar to major
surgery in selected cases. Endorectal ultrasound (ERUS) is an important part of the pre
operative selection process. This study reported its accuracy and impact for patients entered on
the United Kingdom TEM database, which comprises prospectively collected data on 494
patients. This data set was used to determine the prevalence of ERUS in pre-operative staging
and its accuracy by comparing pre-operative T-stage with definitive pathological staging following
TEM. Endorectal ultrasound was performed in 165 of 494 patients who underwent TEM for
rectal cancer. It inaccurately staged rectal cancer in 44.8 % of tumors: 32.7 % were under-
staged and 12.1 % were over-staged. There was no significant difference in the depth of TEM
excision or R1 rate between the patients who underwent ERUS before TEM and those who did
not (p = 0.73). The authors concluded that these findings showed that ERUS is employed in a
minority of patients with rectal cancers undergoing TEM in the United Kingdom and its accuracy
in this "real world" practice is disappointing.
Morino et al (2013) stated that almost 30 years ago, TEM revolutionized the technique and
outcomes of transanal surgery, first becoming the standard of treatment for large rectal
adenomas, then offering a possibly curative treatment for early rectal cancer, and finally
generating discussion on its potential role in combination with neoadjuvant therapies for the
treatment of more invasive cancer. Transanal endoscopic microsurgery afforded the advantage
of combining a less invasive transanal approach with low recurrence rates thanks to enhanced
visualization of the surgical field, which allows more precise dissection. These investigators
www.aetna.com/cpb/medical/data/700_799/0747.html Proprietary 12/34
described the current indications, the pre-operative work-up, the surgical technique (with the aid
of a video), post-operative management and results obtained in an over 20-year long
experience. Designed as an accurate means to allow excision of benign rectal neoplasms with a
very low morbidity rate, TEM today is indicated as a curative treatment of malignant neoplasms
that are histologically confirmed as pT1 sm1 carcinomas. The authors stated that T1 sm2-3 and
T2 lesions should at present be included in prospective trials. Accurate pre-operative staging is
essential for optimal selection of patients. Patients with clear indication for TEM should be
referred to specialized medical centers experienced with thetechnique.
The Standards Practice Task Force of the American Society of Colon and Rectal Surgeons’
practice parameters on “The management of rectal cancer (revised)” (Monson et al, 2013) stated
that “Local excision is an appropriate treatment modality for carefully selected T1 rectal cancers
without high-risk features. Local excision can be performed via transanal excision (Parks-type
excision) or with a transanal endoscopic microsurgery approach. The transanal endoscopic
microsurgery approach appears to be superior to the transanal approach in terms of visualization
and resection of higher lesions”.
Chen and colleagues (2013) compared the surgical and oncological effectiveness as well as
safety of TEMS and laparoscopic lower anterior resection (LAR) in T1-2 rectal cancer patients.
T1-2N0 rectal cancer patients were prospectively and randomly assigned to local excision using
TEMS (n = 30) or radical resection (RR) using LAR (n = 30). The primary outcome measures
were post-operative recovery course. The operative duration of TEMS was significantly shorter
than that of LAR (130.3 ± 16.7 minutes versus 198.7 ± 16.8 minutes, p < 0.01). The TEMS
group re-started bowel movement significantly earlier than the LAR group (51.4 ± 5.4 hours
versus 86.2 ± 8.7 hours, p < 0.01). The post-operative complications were mild and self-limited
in the 2 groups. Local recurrences occurred in 2 T2 patients (2/28, 7.1 %) at 8 months and 16
months following TEMS, respectively; no patient (0/30, 0.0 %) developed local recurrence
following LAR. The authors concluded that TEMS was associated with more rapid post
operative recovery and minimal surgical morbidity in T1-2 rectal cancer patients as compared to
LAR.
Sajid et al (2014) performed a systematic analysis of trials comparing the effectiveness of TEM
with RR for T1 and T2 rectal cancer. An electronic search was carried out of trials reporting the
effectiveness of TEM and RR in the treatment of T1 and T2 rectal cancers. A total of 10 trials
including 942 patients were retrieved. There was a trend toward a higher risk of local recurrence
(odds ratio [OR] 2.78; 95 % confidence interval [CI]: 1.42 to 5.44; z = 2.97; p < 0.003) and overall
recurrence (p < 0.01) following TEMS compared with RR. The risk of distant recurrence, overall
survival (OS) (OR 0.90; 95 % CI: 0.49 to 1.66; z = 0.33; p = 0.74) and mortality was similar.
Transanal endoscopic microsurgery was associated with a shorter operation time and hospital
www.aetna.com/cpb/medical/data/700_799/0747.html Proprietary 13/34
stay and a reduced risk of post-operative complications (p < 0.0001). The included studies,
however, were significantly diverse in stage and grade of rectal cancer and the use of
neoadjuvant chemo-radiotherapy. The authors concluded that TEM appears to have clinically
measurable advantages in patients with early rectal cancer. The studies included in this review
do not allow firm conclusions as to whether TEM is superior to RR in the management of early
rectal cancer. They stated that larger, better designed and executed prospective studies are
needed to answer this question.
In a systematic review and meta-analysis, Arezzo et al (2014) compared the safety and
effectiveness of endoscopic submucosal dissection (ESD) and full-thickness rectal wall excision
by TEM in the treatment of large non-pedunculated rectal lesions pre-operatively assessed as
non-invasive. A systematic review of the literature published between 1984 and 2010 was
conducted (Registration no. CRD42012001882). Data were integrated with those from the
original databases requested from the study authors when needed. Pooled estimates of the
proportions of patients with en-bloc R0 resection, complications, recurrence, and need for further
treatment in the ESD and TEM series were compared using random-effects single-arm meta-
analysis. This review included 11 ESD and 10 TEM series (2,077 patients). The en-bloc
resection rate was 87.8 % (95 % CI: 84.3 to 90.6) for the ESD patients versus 98.7 % (95 % CI:
97.4 to 99.3 %) for the TEM patients (p < 0.001). The R0 resection rate was 74.6 % (95 % CI:
70.4 to 78.4 %) for the ESD patients versus 88.5 % (95 % CI: 85.9 to 90.6 %) for the TEM
patients (p < 0.001). The post-operative complications rate was 8.0 % (95 % CI: 5.4 to 11.8 %)
for the ESD patients versus 8.4 % (95 % CI: 5.2 to 13.4 %) for the TEM patients (p = 0.874).
The recurrence rate was 2.6 % (95 % CI: 1.3 to 5.2 %) for the ESD patients versus 5.2 % (95 %
CI: 4.0 to 6.9 %) for the TEM patients (p < 0.001). Nevertheless, the rate for the overall need of
further abdominal treatment, defined as any type of surgery performed through an abdominal
access, including both complications and pathology indications, was 8.4 % (95 % CI: 4.9 to 13.9
%) for the ESD patients versus 1.8 % (95 % CI: 0.8 to 3.7 %) for the TEM patients (p < 0.001).
The authors concluded that the ESD procedure appears to be a safe technique, but TEM
achieves a higher R0 resection rate when performed in full-thickness fashion, significantly
reducing the need for further abdominal treatment.
Fichera and Allaix (2014) stated that treatment of rectal cancer has dramatically evolved during
the last 3 decades shifting toward a tailored approach based on pre-operative staging and
response to neoadjuvant combined modality therapy (CMT). These investigators performed a
literature search using PubMed/Medline electronic databases. Selected patients with T1 N0
rectal cancer are best treated with local excision by TEM. Satisfactory results have been
reported after CMT and TEM for the treatment of highly selected T2 N0 rectal cancers.
Neoadjuvant CMT followed by rectal resection and total meso-rectal excision is considered the
standard of care for the treatment of locally advanced rectal cancer. However, a subset of stage
www.aetna.com/cpb/medical/data/700_799/0747.html Proprietary 14/34
II and III patients may not require neoadjuvant radiation treatment. Finally, there are mounting
data supporting a "watch and wait" approach or local excision in patients with complete clinical
response after neoadjuvant CMT. The authors concluded that current evidence showed that
selected T1 N0 rectal cancers can be managed by TEM alone, while locally advanced cancers
should be treated by CMT followed by radical surgery. Studies are underway to identify patients
that do not benefit from neoadjuvant radiation therapy. A non-operative approach in case of
complete clinical response must be validated by large prospective studies.
The National Comprehensive Cancer Network’s clinical practice guideline on “Rectal cancer”
(Version 3.2014) indicates that TEMS may be used for transanal excision of rectal cancer when
the following criteria are met:
Less than 30 % circumference of bowel
Less than 3 cm in size
Margin clear (greater than 3 mm)
Mobile, non-fixed
With 8 cm of anal verge
T1 only
Endoscopically removed polyp with cancer or indeterminate pathology
No lympho-vascular invasion or peri-neural invasion
Well to moderately differentiated
No evidence of lymphadenopathy
Cunningham (2014) noted that there is increasing interest in organ-preserving options in the
management of rectal cancer. Excision of small, early stage cancers by TEM is an important part
of this approach. Carefully selected cancers can be treated successfully by TEM with acceptably
low risk of recurrent disease and overall cancer outcomes similar to radical surgery. The impact
of recurrence can be mitigated by early detection of luminal or nodal disease for which a robust
surveillance program is essential. However, patients with high risk features on post-TEM
pathology should be offered completion radical surgery that is associated with good oncological
results. There may be an opportunity to expand the population of patients who can be offered
rectal preservation with the use of radiotherapy in either adjuvant or neo-adjuvant context. Full
thickness excision by TEM may be particularly valuable in those demonstrating a clinical
complete response to radiotherapy, where diagnosis of complete pathological response can be
confirmed. The authors stated that the use of TEM in managing more advanced rectal cancers is
exciting, but must be tested within formal clinical trials before being adopted as routine practice.
www.aetna.com/cpb/medical/data/700_799/0747.html Proprietary 15/34
Heidary et al (2014) stated that rectal adenomas and cancers occur frequently. Small adenomas
can be removed colonoscopically, whereas larger polyps are removed via conventional transanal
excision. Owing to technical difficulties, adenomas of the mid- and upper-rectum require radical
resection. Transanal endoscopic microsurgery was first designed as an alternative treatment for
these lesions. However, since its development, TEM has been also used for a variety of rectal
lesions, including carcinoids, rectal prolapse and diverticula, early stage carcinomas and
palliative resection of rectal cancers. These investigators described the current status of TEM in
the treatment of rectal lesions. Since the 1980s, TEM has advanced substantially. With low
recurrence rates, it is the method of choice for resection of endoscopically unresectable
adenomas. Some studies have shown benefits to its use in treating early T1 rectal cancers
compared with radical surgery in select patients. However, for more advanced rectal cancers
TEM should be considered palliative or experimental. This technique has also been shown to be
safe for the treatment of other uncommon rectal tumors, such as carcinoids.
Althumairi and Gearhart (2015) stated that the goal of treatment for early stage rectal cancer is
to optimize oncologic control while minimizing the long-term impact of treatment on quality of life
(QOL). The standard of care treatment for most stage I and II rectal cancers is radical surgery
alone, specifically total mesorectal excision (TME). For early rectal cancers, this procedure is
usually curative but can have a substantial impact on QOL, including the possibility of permanent
colostomy and the potential for short- and long-term bowel, bladder, and sexual dysfunction.
Given the morbidity associated with radical surgery, alternative approaches to management of
early rectal cancer have been explored, including local excision (LE) via trans-anal excision
(TAE) or TEM and trans-anal minimally invasive surgery (TAMIS). Compared to the gold
standard of radical surgery, local procedures for strictly selected early rectal cancers should lead
to identical oncological results and even better outcomes regarding morbidity, mortality, and
QOL.
Jung and associates (2018) compared the safety and efficacy between ESD and TEM for the
treatment of rectal epithelial tumors, including large adenoma, cancer, and sub-epithelial tumors
(SET). These researchers conducted a retrospective analysis of the medical records of 71
patients with rectal tumors who were treated with ESD (48 patients) or TEM (23 patients) from
January 2013 to December 2015. The patient group comprised 56 patients with epithelial
tumors and 15 patients with SET. Treatment efficacy such as en bloc resection, procedure time,
local recurrence, hospital stay, additional procedure rate, and safety between the treatment
groups were evaluated and analyzed. There were no significant differences in tumor size,
location, macroscopic appearance, and histological depth between ESD and TEM groups. For
ESD compared to TEM in rectal epithelial tumors, en bloc resection rates were 95 % versus 93.7
% and R0 resection rates were 92.5 % versus 87.5 % (p = 0.617); in rectal SET, en bloc
resection rates were 100 % versus 100 % and R0 resection rates were 87 % versus 85 % (p =
www.aetna.com/cpb/medical/data/700_799/0747.html Proprietary 16/34
0.91). The procedure time was 71.5 ± 51.3 mins versus 105.6 ± 28.2 mins (p = 0.016) for
epithelial tumors and 32.13 ± 13.4 mins versus 80.71 ± 18.35 mins (p = 0.00) for SET,
respectively. Hospital stay was 4.3 ± 1.2 days versus 5.8 ± 1.8 days (p = 0.001) for epithelial
tumors and 4.1 ± 4.1 days versus 5.5 ± 2 days (p = 0.42) for rectal SET, respectively. There
were no significant differences between recurrence rates, additional procedure rates, and
complications in the 2 groups. The authors concluded that ESD and TEM were both safe and
effective for the treatment of rectal epithelial tumors and SET because of favorable R0 resection
rates and recurrence rates. However, the ESD group showed shorter procedure times and
hospital stays than the TEM group. Thus, ESD should be considered more preferentially than
TEM in the treatment of large rectal epithelial tumors andSET.
Leijtens and colleagues (2019) stated that TEM is used for the resection of large rectal
adenomas and well or moderately differentiated T1 carcinomas. Due to difficulty in pre-operative
staging, final pathology may reveal a carcinoma not suitable for TEM. Although completion total
mesorectal excision is considered standard of care in T2 or more invasive carcinomas, this
completion surgery is not always performed. These researchers evaluated the outcome of
patients after TEM-only, when completion surgery would be indicated. In this retrospective multi-
center, observational cohort study, outcome after TEM-only (n = 41) and completion surgery (n =
40) following TEM for a pT2-3 rectal adenocarcinoma was compared. Median follow-up was 29
months for the TEM-only group and 31 months for the completion surgery group. Local
recurrence rate was 35 % and 11 % for the TEM-only and completion surgery groups,
respectively. Distant metastasis occurred in 16 % of the patients in both groups . The 3-year OS
was 63 % in the TEM-only group and 91 % in the completion surgery group, respectively; 3-year
disease-specific survival (DSS) was 91 % versus 93 %, respectively. The authors concluded that
although local recurrence after TEM-only for pT2-3 rectal cancer was worse compared to the
recurrence that occurred after completion surgery, DSS was comparable between both groups.
The lower unadjusted OS in the TEM-only group indicated that TEM-only may be a valid
alternative in older and frail patients, especially when high morbidity of completion surgery was
taken into consideration. Nevertheless, completion surgery should always be advised when
curation is intended.
Transanal Endoscopic Microsurgery for Functional Constipation
Zhang and colleagues (2014) examined the feasibility and effectiveness of laparoscopic subtotal
colectomy and modified Duhamel procedure combined with TEM in the treatment of severe
functional constipation (SFC). The clinical data of 10 patients with SFC treated by laparoscopic
surgery combined with TEM between May 2010 and October 2012 were retrospectively
analyzed. The gastro-intestinal QOL index (GIQOLI), Wexner constipation scale and daily
frequency of defecation post-operatively during follow-up were collected. All the 10 operations
www.aetna.com/cpb/medical/data/700_799/0747.html Proprietary 17/34
were successfully accomplished (laparoscopic subtotal colectomy combined with TEM without
abdominal incision). There was no conversion to open procedure. One case had preventive
terminal ileum stoma. The mean operative time was (256 ± 58) minutes. The mean blood loss
was (178 ± 67) ml. The mean time to first flatus was (40 ± 11) hours. There were no ureteric
injury, anastomotic leak, pelvic sepsis and other complications post-operatively. There was 1
case of insufficient small bowel obstruction that was released by conservative treatments. The
patients were discharged from the hospital in (9.0 ± 1.5) days post-operatively. The GIQOLI in 1
year post-operatively was (112 ± 10) points, which indicated good results compared to (75 ± 12)
points pre-operatively (p = 0.000). The Wexner constipation scale was 20.8 ± 2.2 pre-operatively
and decreased to 5.2 ± 1.8 at 1 year follow-up (p = 0.000). The authors concluded that
laparoscopic subtotal colectomy and modified Duhamel procedure combined with TEM provided
SFC patients a safe and feasible minimally invasive surgery. These preliminary findings need to
be validated by well-designed studies.
Transanal Endoscopic Microsurgery for Megacolon
Han and associates (2014) stated that laparoscopic-assisted colonic resection has been well-
described for multiple surgical indications and typically requires an abdominal incision for
specimen removal that is associated with most of the post-operative pain. These investigators
reported the total laparoscopic modified Duhamel operation for megacolon in combination with
TEM for transanal specimen retrieval and anastomosis to avoid the additional abdominal
extraction incision. These researchers presented 2 cases. Case 1 was a 15-year old boy who
presented with intermittent abdominal distention, pain, and constipation for 3 years' duration and
was diagnosed with Hirschsprung disease; and case 2 was a 60-year old man who presented
with repeated attacks of incomplete intestinal obstruction for 2 years' duration and was
diagnosed with adult megacolon. They were treated by the total laparoscopic modified Duhamel
operation without an abdominal extraction incision in combination with TEM. The operations
were successfully accomplished without conversion to open surgery. The patients tolerated the
procedure well, complained of minimal post-operative pain, and did not require narcotics beyond
the day of the operation. No surgical complications occurred. Discharge from the hospital
occurred on the 9th post-operative day in case 1 and the 13th post-operative day in case 2. The
authors concluded that the total laparoscopic modified Duhamel operation in combination with
TEM is a feasible and minimally invasive technique for idiopathic megacolon and adult
megacolon. These preliminary findings need to be validated by well-designed studies.
Transanal Endoscopic Microsurgery for Rectal Prolapse
www.aetna.com/cpb/medical/data/700_799/0747.html Proprietary 18/34
Bordeianou et al (2015) stated that perineal approaches for rectal prolapse repair have low
complication rates but high recurrence rates, while abdominal approaches that include
sigmoidopexy have lower recurrence rates but higher complication rates. To optimize both
recurrence and complication rates, these researchers developed a novel procedure that uses
TEM to perform a sigmoidopexy via a perineal approach. These investigators created a rectal
prolapse model in 6 swine and 2 human cadavers using a previously published technique. The
rectum was mobilized and eviscerated transanally. After marking the planned point of sigmoid
transection, the rectum was returned to the peritoneal cavity. A TEM proctoscope was inserted
transanally alongside the rectum, and the lateral sigmoid colon walls were sutured to the sacrum.
The sigmoid colon was then transected where previously planned, and a primary sigmoid
anastomosis was performed. Total operative time, sigmoidopexy operative time, and suture
security were measured and compared to standard rectosigmoidectomy and abdominal
sigmoidopexy times. No sigmoid colon, iliac vessel, bladder, or ureteral injuries occurred. At least
2 sigmoidopexy sutures were secure on inspection in all animals and human cadavers, with
increasing success of secure suture placement as experience increased. Operative length was
similar to traditional abdominal sigmoidopexy. The authors concluded that TEM sigmoidopexy is
technically feasible. They stated that this approach has the potential to reduce the recurrence
rate associated with perineal approaches alone, but further study is needed to confirm this
hypothesis.
Transanal Endoscopic Microsurgery for Recto-Vesical Fistula
Kanehira et al (2015) stated that recto-vesical fistula is a rare complication following
prostatectomy, associated with significant symptoms such as urinary drainage from anus or
fecaluria. While several surgical procedures have been described to treat this condition, none of
them has been accepted as the universal standard. Transanal endoscopic microsurgery is a
well-established endoluminal procedure for local excision of rectal tumors. But its application to
the repair of recto-vesical fistula has been almost unknown. These researchers performed TEM
as a surgical repair for refractory recto-vesical fistula developing after radical prostatectomy in 10
patients. Under the magnified 3-D view, through the stereoscope, the fistula and the surrounding
rectal mucosa were precisely resected. The defect and the muscle layer of the rectum were
closed by hand-sew technique in 4 layers. Fistula was completely closed in 7 patients, who
eventually underwent enterostomy closure, while in the other 3 patients the fistula recurred. In
the 3 recurrent cases, the fistula was associated with wide, tough scar tissue due to previous
irradiation, high intensity focused ultrasound (HIFU), or repeated surgical repair attempts. The
authors concluded that recto-vesical fistulas associated with wide, tough scar tissue due to multi-
time attempt of surgical repair or any type of energy ablation should not be indicated for repair by
www.aetna.com/cpb/medical/data/700_799/0747.html Proprietary 19/34
TEM. However, for simple fistulas without tough, fibrotic surroundings, TEM can be indicated as
a minimally invasive surgical option with very low morbidity, without any incision in healthy tissue
for approach. These preliminary findings need to be validated by well-designed studies.
Transanal Endoscopic Microsurgery for Anorectal Melanoma
Kong et al (2015) noted that anorectal malignant melanoma (AMM) is an uncommon malignancy
that is thought to arise from melanocytes in the mucosa around the anorectal junction. Anorectal
malignant melanoma is commonly misdiagnosed, and definitive pre-operative diagnosis is often
difficult. The prognosis of AMM is relatively poor. Although radical resection is required for
AMM, there is still no consensus at this moment on which surgical approach is preferred. These
investigators reported a rare case of AMM that was treated by TEM in combination with
radiotherapy, which resulted in complete excision of the lesion without complications. The
authors concluded that the successful treatment for this AMM using TEM emphasized the need
to broaden its application in the treatment of various rectal lesions while preserving organ
function and decreasing recurrence. This was single-case study, and its findings were
confounded by the combinational use of TEM and radiotherapy. The clinical value of TEM in the
treatment of AMM needs to be examined by well-designedstudies.
Transanal Endoscopic Microsurgery for Rectal Amyloidoma
Sharma and George (2015) noted that localized amyloidosis is characterized by amyloid protein
deposition restricted to one organ or tissue without systemic involvement. Gastro-intestinal (GI)
manifestations of localized amyloidoma are unusual, which makes amyloidoma restricted to the
rectum a very rare diagnosis requiring a high index of suspicion. These researchers presented a
rare account for rectal amyloidoma with an unusual presentation of obstructive symptoms and its
treatment using TEM, which resulted in complete excision of the lesion without hospitalization
and complications. The authors concluded that the successful treatment for this rectal
amyloidoma using TEM emphasized the need to broaden its application in the treatment of
various rectal lesions while preserving organ function and decreasing recurrence. This was
single-case study; the clinical value of TEM in the treatment of rectal amyloidoma needs to be
further investigated by well-designed studies.
Transanal Endoscopic Microsurgery for Rectal Ulcer Syndrome
Ihnat et al (2015) stated that solitary rectal ulcer syndrome (SRUS) is an uncommon chronic
disorder with a wide range of endoscopic findings, clinical presentations and characteristic
histopathological features. There is no clear consensus regarding SRUS management, because
of its poorly understood pathogenesis and frequent association with various pelvic floor
www.aetna.com/cpb/medical/data/700_799/0747.html Proprietary 20/34
disorders. Laparoscopic resection rectopexy and TEM were used for the treatment of non-
healing SRUS. These investigators reported a case of non-healing SRUS due to obstructive
defecation syndrome based on combined pelvic floor disorders (rectocele, enterocele, internal
rectal prolapse and dolichosigma) successfully managed by a novel combined mini-invasive
approach that has never been previously reported in the literature (laparoscopic resection
rectopexy and TEM). The authors concluded that this new minimally invasive concept appeared
to be safe and feasible -- laparoscopic resection rectopexy resulted in effective correction of the
obstructive defecation syndrome, while TEM allowed comfortable access for radical resection of
a rectal ulcer. This was single-case study, and its findings were confounded by the
combinational use of TEM and laparoscopic resection rectopexy. The clinical value of TEM in
the treatment of SRUS needs to be examined by well-designed studies.
Transanal Endoscopic Microsurgery for Retro-Rectal (Pre-Sacral) Tumors
Hopper et al (2016) stated that tumors in the retro-rectal space are rare and pathologically
heterogeneous. The roles of imaging and pre-operative biopsy, non-operative management and
the indications for surgical resection are controversial. This study investigated a series of retro-
rectal tumors treated in a single institution with the aim of producing a modern improved
management algorithm. A retrospective analysis was conducted of the management of all retro-
rectal lesions identified between 1998 and 2013 from a radiology database search. Patient
demographics, presenting symptoms, imaging, biopsy, management and the results were
recorded. Descriptive statistics were used and Kaplan-Meier survival analysis was performed. A
total of 69 patients with a confirmed retro-rectal tumor were identified. The median age was 50
years (36 to 67 interquartile range) and 42 (56 %) were female; 20 (29 %) of the tumors were
malignant: 4 of 41 cystic lesions were malignant (12.9 %) versus 16 of 28 solid (or
heterogeneous) lesions (57.1 %) (p < 0.0001). Imaging demonstrated a 95 % sensitivity and 64
% specificity for differentiating benign from malignant tumors. Magnetic resonance imaging
(MRI) was significantly better at distinguishing between benign and malignant tumors than
computed tomography (CT) (94 % versus 64 %, p = 0.03). Percutaneous biopsy was performed
in 16 patients and only 27 underwent resection. There was no evidence of local recurrence
associated with biopsy. Solid lesions were associated with a non-significant decreased OS (p =
0.348). The authors concluded that the findings of this study demonstrated that MRI should be
the investigation of choice for retro-rectal lesions; biopsy of solid lesions is safe and useful for
guiding neoadjuvant and surgical therapy. Cystic lesions without suspicious radiological features
can be followed by serial imaging without resection. Transanal endoscopic microsurgery was not
mentioned as a management option.
www.aetna.com/cpb/medical/data/700_799/0747.html Proprietary 21/34
Toh and Morgan (2016) noted that the management strategy for retro-rectal tumors is complex.
Due to their rarity, few surgeons have expertise in management. These investigators performed
a systematic review using the PubMed database. English language publications in the years
2011 to 2015 that assessed pre-operative management, surgical strategies and chemo
radiotherapy for pre-sacral tumors were included. A total of 251 abstracts were screened of
which 88 met the inclusion criteria. After review of the full text, this resulted in a final list of 42
studies eligible for review. In all, 932 patients (63.2 % female, 36.8 % male; p < 0.01) with a
retro-rectal tumor were identified. Most were benign (65.9 % versus 33.7 %, p < 0.01). Imaging
distinguished benign from malignant lesions in 88.1 % of cases; pre-operative biopsy was
superior to imaging in providing an accurate definitive diagnosis (91.3 % versus 61.4 %, p <
0.05) with negligible seeding risk. Biopsy should be performed in solid tumors. It is useful in
guiding neoadjuvant therapy for GI stromal tumors, sarcomas and desmoid type fibromatosis
and may alter the management strategy in cases of diffuse large B-cell lymphoma and
metastases. Biopsies for cystic lesions are not recommended. The gold standard in imaging is
MRI. The posterior Kraske procedure is the most common surgical approach. Overall, the
reported recurrence rate was 19.7 %. The authors concluded that this review evaluated the
management strategies for retro-rectal tumors. A pre-operative biopsy should be performed for
solid tumors; MRI is the most useful imaging modality. They stated that surgery is the mainstay
of treatment; however, there is limited information on robotic surgery, single-port surgery, TEM,
chemo-radiotherapy and reconstruction.
Ferrer-Marquez and co-workers (2017) stated that TEM was developed as a less aggressive
alternative treatment for rectal lesions (mainly adenomas and adenocarcinomas). However, its
use for other rectal lesions has become more frequent, trying to reduce the morbidity associated
with more invasive techniques. These investigators described their experience in the use of
TEM in other rectal lesions. They performed a retrospective and descriptive study including
patients operated with TEM (from June 2008 to December 2016) for the treatment of rectal
lesions different from adenomas or adenocarcinomas. Among the 138 patients treated by TEM
in the authors’ department, 10 patients were operated on for rectal lesions other than adenomas
or adenocarcinomas. Rectal lesions were 3 neuroendocrine tumors, 1 neuroendocrine tumor
metastasis, 1 rectal stenosis, 1 cloacogenic polyp, 1 endometrioma, 1 retro-rectal tumor, 1 pre
sacral abscess and 1 lesion in the recto-vaginal septum. Mean operative time was 72 minutes
and post-operative stay was 4.2 days. Only 1 patient needed a re-operation, due to rectal
bleeding. The authors concluded that TEM could be a useful tool for the treatment of rectal
lesions different from adenomas or adenocarcinomas, potentially decreasing the morbidity
associated with more aggressive surgical techniques.
Transanal Endoscopic Microsurgery for Rectal Gastro-Intestinal Stromal Tumor
www.aetna.com/cpb/medical/data/700_799/0747.html Proprietary 22/34
Han and colleagues (2017) stated that a multi-modal treatment has been applied for patients
with rectal gastro-intestinal stromal tumor (GIST) that represents 5 % of the total localization.
Meanwhile, TEM offers a minimally invasive method for full-thickness tumor excision with
negative margins and low morbidity. These investigators reported the single most extensive
analysis of data from China to evaluate the feasibility and safety of the procedure combined with
neoadjuvant imatinib therapy to treat patients with rectal GISTs. All the clinical data were
obtained for patients who underwent the procedure in the authors hospital from February 2008 to
May 2015, and the data were retrospectively analyzed. Full-thickness excision by TEM was
performed on 25 patients with rectal GIST by using primary surgical excision, 8 of whom had
received peri-operative chemotherapy after histopathological confirmation under the care of
medical oncologists. No obvious post-operative complications were observed. The average
tumor down-sizing ratio was 14.5 %, which apparently enabled over-sized tumors to be excised
by TEM. The comparative risk did not increase during or after the procedure. These
researchers did not observe recurrence or metastasis in any of the 25 patients during the median
3-year follow-up period after the procedures. The authors concluded that peri-operative imatinib
treatment effectively allowed over-sized rectal GIST tumors to be excised by TEM, and the
procedures did not exhibit an increased risk. They stated that the TEM procedure with
neoadjuvant imatinib therapy is a feasible and safe modality for treating patients with rectal
GISTs. This was a small study (n = 25),and its findings were confounded by the peri-operative
use of imatinib. These preliminary findings need to be validated by well-designed studies.
Liu and associates (2017) reported the initial application of TEM for high-risk GIST after imatinib
mesylate (IM) therapy. A 52-year old woman suffered mild lower abdominal pain and perianal
discomfort. Physical examination found a soft mass 4 cm far away from anal verge. Rectal MRI
and trans-rectal ultrasound (TRUS) showed that there was a 1.9 ×1.6 cm submucosal mass in
the lower rectum. The incisional biopsy was performed and the pathological result reported it
was a high-risk GIST; IM was given for neoadjuvant therapy. Then TEM was adopted to resect
the residual tumor; IM was restored 4 weeks after surgery. The final pathological results
reported the margin was clear. After an 18-month follow-up, no recurrence and metastasis was
found and the patient had a satisfactory anal and urinal functions. The authors concluded that
lower rectal GIST is a rare entity that warrants special attentions of preserving anal and urinal
functions. In this case, TEM in combinations with IM neoadjuvant therapy achieved curative
resection of the tumor, satisfactory anal and urinal function and good long-term prognosis. For
the lower rectal GIST, especially when the tumor was small and responded well to IM, TEM in
combination with IM neoadjuvant therapy could be the initial attempt to achieve simultaneous
radical resection of the tumor and satisfactory anal and urinal function-preserving. Moreover,
these investigators stated that prospective, multi-center studies with a good number of patients
to validate these findings.
www.aetna.com/cpb/medical/data/700_799/0747.html Proprietary 23/34
Furthermore, an UpToDate review on “Local treatment for gastrointestinal stromal tumors,
leiomyomas, and leiomyosarcomas of the gastrointestinal tract” (Morgan and Raut, 2017) does
not mention the use of TEM as a management tool.
Transanal Endoscopic Microsurgery for Recto-Urinary Fistula
D'Ambrosio and colleagues (2016) noted that recto-urinary fistula (RUF) is a rare complication of
pelvic surgery. Different therapeutic approaches have been reported, but a gold standard
treatment has not yet been achieved. These investigators reported the current evidence on RUF
treatment by TEM and suggested some key points for its correct management. After a search of
Medline in PubMed and Scopus databases, 7 papers were eligible for the present review. Data
were reviewed on the basis of the cases reported, patient's characteristics, surgical techniques
and results. A total of 18 cases have been reported in the literature from 1996 to 2005. The
healing success rate was 77.8 %. Fecal and urinary diversion were performed before TEM-
assisted procedure in 83 % and 94 % of cases, respectively. Recurrence occurred in 4 patients
(22 %). These researches stated that a gold standard treatment of RUF should ensure the
complete removal of scar tissue around the fistula, in order to perform a tension-free suture on
healthy margins with adequate vascularization. Pre-operative stoma improved the healing of the
fistula, reducing local inflammation and infections. The authors concluded that there inadequate
evidence to clarify which could be the best treatment; and recurrences treatment has a lower
cure rate if compared to primary lesions. They stated that more studies are needed to confirm
these findings.
In an observational study with prospective data collection, Serra-Aracil and co-workers (2018)
examined the role of transanal endoscopic operation (TEO) or TEM in recto-urethral fistulas
(RUF), which may appear after radical prostatectomy. Their treatment represents a challenge;
many therapies have been proposed, from conservative to aggressive surgical approaches.
Transanal endoscopic surgery (TEO or TEM) is a minimally invasive technique to access the site
of the RUF to perform repair. This trial was conducted between September 2006 and December
2015. All patients were diagnosed with RUF following management of prostatecancer.
Conservative treatment was administered in the form of urinary and fecal diversion with
cystotomy and terminal colostomy, to achieve total urinary and fecal exclusion. If the fistula
persisted, it was treated by TEO or TEM, with or without biological mesh interposition. If this
failed, gracilis muscle was applied as salvage therapy. A total of 10 patients were diagnosed
with RUF. In 1 patient (10 %), the fistula healed with bladder catheterization alone. In another
patient, it resolved after total urinary and fecal exclusion; 8 patients underwent repair by TEO or
TEM, 4 with biological mesh interposition; all 4 presented recurrence. In the other 4 patients
treated via TEO or TEM, 2 had early recurrence, whereas the others had healed at follow-up
visits after 4 to 6 months (2 of 8)-- a success rate of 25 %. The 6 patients who recurred were
www.aetna.com/cpb/medical/data/700_799/0747.html Proprietary 24/34
treated with gracilis muscle interposition via a trans-perineal approach. The authors concluded
that the low rate of positive results obtained by TEO or TEM argued against its use as technique
of choice in RUF, and against the use of biological meshes.
Giant Villous Adenoma of the Rectum
Bains and colleagues (2019) stated that villous adenomas are dubiously benign lesions, which
are difficult to interpret because of their malignant potential. Distal villous adenomas present
with bleeding or mucus discharge. Giant adenomas are not amenable for endoscopic or
transanal resection. Only few isolated cases have been reported by laparoscopic resection.
These researchers presented a case of a circumferential giant villous adenoma of the rectum
managed successfully by laparoscopic ultra-low anterior resection with colo-anal anastomosis
with a review of literature in regard to their malignant potential. A 62-year old woman presented
with complaints of painless bleeding per rectum and a fleshy mass protruding from the anal
canal which on digital rectal examination appeared a large soft velvety flat mass with mucus
discharge. Colonoscopy showed circumferential irregular, friable, edematous mucosa in rectum
extending for 15 cm. Computed tomography showed a large heterogeneously enhancing
polypoid mass lesion in the rectal wall involving the entire rectum. The patient underwent
laparoscopic low anterior resection with colo-anal anastomosis and protecting loop ileostomy.
Histopathological examination of the resected specimen revealed villous adenoma of the rectum
with moderate-to-severe dysplasia. The authors concluded that villous adenomas are sessile
growths lined by dysplastic glandular epithelium, whose risk of malignancy is especially high up
to 50 % when greater than 2 cm in size. Large size, villous content, and distal location are all
associated with severe dysplasia in colorectal adenomas. Large villous rectal tumors,
particularly of circumferential type pose a great challenge for endoscopic or transanal removal.
Thus, open or laparoscopic surgery is needed for these cases. These investigators stated that
giant rectal villous polyps are usually unresectable by endoscopic methods or transanal
endoscopic microsurgery and are associated with a high rate of unsuspected cancer which
requires a formal radical oncologic resection. As per current data, the combined risk of
dysplasia/malignancy is about 83 % with 50 % risk of dysplasia and frank malignancy in 33 % of
cases of giant rectal villous adenomas of more than 8 cm in size. Laparoscopic colorectal
resection is safe and effective.
Rectal Neuroendocrine Tumor in Advanced Stages or With Metastasis
Xu and colleagues (2017) noted that rectal neuroendocrine tumor (NET) is a relatively rare
tumor. Well-differentiated NETs (G1 and G2) rarely display distant metastasis at initial diagnosis.
Currently, treatment for the primary lesions of rectal NETs with liver metastasis remains
controversial. The liver metastasis was resected in local hospital; TEM has emerged as an
www.aetna.com/cpb/medical/data/700_799/0747.html Proprietary 25/34
effective minimally invasive surgery for local resection of lower rectal lesions. These
investigators reported the initial application of TEM to remove the rectal primary lesion in patients
with low rectal NETs (G2) with giant liver metastases. A 45-year old woman was diagnosed with
hepato-cellular carcinoma (HCC) and underwent curative resection of a giant liver lesion in a
local hospital. Nevertheless, the post-operative pathologic examination revealed that the lesion
was an NET (G2). The colonoscopy then showed a nodule of 1.4 cm in diameter, 4 cm above the
anal verge, located on the anterior wall of the rectum. The biopsy revealed that the nodule was
also an NET (G2). However, the patient did not consent to abdomino-perineal resection based
on concerns for QOL. The patient underwent curative resection of liver metastasis; and TEM
was adopted to resect the primary tumor in rectum. The patient has been disease-free for 2
years with a good QOL and presented no local recurrence in the rectum. The authors concluded
that TEM was an appropriate palliative operation for therapy of rectal NETs with distant
metastases, especially for primary rectal NETs located in low rectal. Moreover, these
researchers stated that long-term outcomes still need to be determined using a larger series of
patients. They noted that with further intensive study of targeted therapy and high-quality
combination therapy, it is possible that the prognosis and QOL of rectal NETs patients in
advanced stages or with metastasis may be improved in thefuture.
CPT Codes / HCPCS Codes / ICD-10 Codes
Information in the [brackets] below has been added for clarification purposes. Codes requiring a 7th character are represented by "+":
Code Code Description
CPT codes covered if selection criteria are met:
0184T Excision of rectal tumor, transanal endoscopic microsurgical approach (ie, TEMS),
including muscularis propria (ie, full thickness)
ICD-10 codes covered if selection criteria are met:
C20 Malignant neoplasm of rectum [low-risk] [not covered for advanced rectal cancer]
[giant villous adenoma]
C7a.026 Malignant carcinoid tumor of the rectum [rectal neuroendocrine tumor]
D01.1 - D01.2 Carcinoma in situ of rectosigmoid junction and rectum [low-risk]
D12.7 - D12.9 Benign neoplasm of rectosigmoid junction, rectum and anus and an al canal
[including giant villous adenoma]
D3A.026 Benign carcinoid tumor of the rectum [rectal neuroendocrine tumor]
ICD-10 codes not covered for indications listed in the CPB (not all inclusive):
www.aetna.com/cpb/medical/data/700_799/0747.html Proprietary 26/34
Code Code Description
B57.32 Megacolon in Chagas' disease
C43.51 Malignant melanoma of anal skin
C49.A0 - C49.A9 Gastrointestinal stromal tumor [rectal gastro-intestinal stromal tumor]
K57.00 - K57.93 Diverticular disease of intestine
K59.31 - K59.39 Megacolon, not elsewhere classified
K59.00 - K59.09 Constipation
K62.3 Rectal prolapse
K62.4 Stenosis of anus and rectum
K62.6 Ulcer of anus and rectum
K62.89 Other specified diseases of anus and rectum [rectal amyloidoma]
N32.8 Other specified disorders of bladder
N36.0 Urethral fistula [recto-urinary fistula]
Q42.1 Congenital absence, atresia and stenosis of rectum without fistula
The above policy is based on the following references:
1. Araki Y, Isomoto H, Shirouzu K. Video-assisted gasless transanal endoscopic
microsurgery: A review of 217 cases of rectal tumors over the past 10 years. Dig Surg.
2003;20(1):48-52.
2. Medical Services Advisory Committee (MSAC). Transanal endoscopic microsurgery.
MSAC Assessment Report. MSAC Reference 15. Canberra, ACT: MSAC; March 2003.
3. Middleton PF, Sutherland LM, Maddern GJ. Transanal endoscopic microsurgery: A
systematic review. Dis Colon Rectum. 2005;48(2):270-284.
4. Burghardt J, Buess G. Transanal endoscopic microsurgery (TEM): A new technique and
development during a time period of 20 years. Surg Technol Int. 2005;14:131-137.
5. Tjandra JJ, Kilkenny JW, Buie WD, et al. Practice parameters for the management of rectal
cancer (revised). Dis Colon Rectum 2005;48(3):411-323.
6. Floyd ND, Saclarides TJ. Transanal endoscopic microsurgical resection of pT1 rectal
tumors. Dis Colon Rectum. 2006;49(2):164-168.
7. Lin GL, Meng WC, Lau PY, et al. Local resection for early rectal tumours: Comparative
study of transanal endoscopic microsurgery (TEM) versus posterior trans-sphincteric
approach (Mason's operation). Asian J Surg. 2006;29(4):227-232.
www.aetna.com/cpb/medical/data/700_799/0747.html Proprietary 27/34
8. Borschitz T, Heintz A, Junginger T. The influence of histopathologic criteria on the long
term prognosis of locally excised pT1 rectal carcinomas: Results of local excision
(transanal endoscopic microsurgery) and immediate reoperation. Dis Colon Rectum.
2006;49(10):1492-1506; discussion 1500-1505.
9. Serra Aracil X, Bombardó Junca J, Mora López L, et al. Transanal endoscopic microsurgery
(TEM). Current situation and future expectations. Cir Esp. 2006;80(3):123-132.
10. Papagrigoriadis S. Transanal endoscopic micro-surgery (TEMS) for the management of
large or sessile rectal adenomas: A review of the technique and indications. Int Semin Surg
Oncol. 2006; 3:13.
11. Rajput A, Bullard Dunn K. Surgical management of rectal cancer. Semin Oncol.
2007;34(3):241-249.
12. Cirincione E, Cagir B. Rectal cancer. eMedicine Medicine Topic 1994. Omaha, NE:
eMedicine.com; 2007. .
13. National Cancer Institute (NCI). Stages of rectal cancer. Rectal Cancer Treatment (PDQ).
Patient Version. Bethesda, MD: NCI; updated June 18,2008.
14. Whiteford MH. Transanal endoscopic microsurgery (TEM) resection of rectal tumors. J
Gastrointest Surg. 2007;11(2):155-157.
15. National Cancer Institute (NCI). Treatment option overview. Rectal Cancer Treatment
(PDQ). Patient Version. Bethesda, MD: NCI; updated June 18, 2008.
16. Bretagnol F, Rullier E, George B, et al. Local therapy for rectal cancer: Still controversial?
Dis Colon Rectum. 2007a;50(4):523-533.
17. Bretagnol F, Merrie A, George B, et al. Local excision of rectal tumours by transanal
endoscopic microsurgery. Br J Surg. 2007b;94(5):627-633.
18. Maslekar S, Pillinger SH, Monson JR. Transanal endoscopic microsurgery for carcinoma of
the rectum. Surg Endosc. 2007;21(1):97-102.
19. Zacharakis E, Freilich S, Rekhraj S, et al. Transanal endoscopic microsurgery for rectal
tumors: The St. Mary's experience. Am J Surg.2007;194(5):694-698.
20. Borschitz T, Heintz A, Junginger T. Transanal endoscopic microsurgical excision of pT2
rectal cancer: Results and possible indications. Dis Colon Rectum. 2007;50(3):292-301.
21. Helgstrand F, Iversen E, Bech K. Transanal endoscopic microsurgery. The latest 5 years'
experience in Roskilde County. Ugeskr Laeger.2007;169(19):1784-1788.
22. Røkke O, Færden AE, Øvrebø K. Transanal endoscopic microsurgery for tumours in
rectum. Tidsskr Nor Laegeforen. 2007;127(22):2954-2958.
23. Borschitz T, Junginger T. Progress report about the 1st Workshop on Local Excision of
Rectal Cancer. Zentralbl Chir. 2007;132(2):99-105.
24. National Comprehensive Cancer Network (NCCN). Rectal cancer. Clinical Practice
Guidelines in Oncology v.1.2008. Jenkintown, PA: NCCN; September 2007.
www.aetna.com/cpb/medical/data/700_799/0747.html Proprietary 28/34
25. Vallejo Godoy S, Marquez Calderon S. Outcomes of transanal endoscopic surgery in
patients with rectal tumours. Report. Sevilla, Spain: Andalusian Agency for Health
Technology Assessment (AETSA); 2007.
26. Guerrieri M, Baldarelli M, Organetti L, et al. Transanal endoscopic microsurgery for the
treatment of selected patients with distal rectal cancer: 15 years experience. Surg
Endosc. 2008;22(9):2030-2035.
27. Serra-Aracil X, Vallverdú H, Bombardó-Junca J, et al. Long-term follow-up of local rectal
cancer surgery by transanal endoscopic microsurgery. World J Surg. 2008;32(6):1162-
1167.
28. Baatrup G, Breum B, Qvist N, et al. Transanal endoscopic microsurgery in 143
consecutive patients with rectal adenocarcinoma. Results from a Danish multicenter
study. Colorectal Dis. 2009;11(3):270-275.
29. Southern Health Technology/Clinical Practice Committee. Transanal endoscopic
microsurgery (TEM). Application No. 09003N. Clayton, VIC: Centre for Clinical
Effectiveness, Monash University Institute for Health Services Research; March 27,
2009.
30. Palma P, Horisberger K, Joos A, et al. Local excision of early rectal cancer: Is transanal
endoscopic microsurgery an alternative to radical surgery? Rev Esp Enferm Dig.
2009;101(3):172-178.
31. Bach SP, Hill J, Monson JR, et al; Association of Coloproctology of Great Britain and
Ireland Transanal Endoscopic Microsurgery (TEM) Collaboration. A predictive model for
local recurrence after transanal endoscopic microsurgery for rectal cancer. Br J Surg.
2009;96(3):280-290.
32. Keay E, Farrah K. Transanal endoscopic microsurgery for rectal cancer: A clinical and
cost effectiveness review. Health Technology Inquiry Service (HTIS). Ottawa, ON:
Canadian Agency for Drugs and Technologies in Health (CADTH); April 3, 2008.
33. National Working Group on Gastrointestinal Cancers. Rectal cancer. Cancer Clinical
Practice Guidelines Version 2.0. Amsterdam, The Netherlands: Association of
Comprehensive Cancer Centres (ACCC); October 14, 2008.
34. Dias AR, Nahas CS, Marques CF, et al. Transanal endoscopic microsurgery: Indications,
results and controversies. Tech Coloproctol. 2009;13(2):105-111.
35. Casadesus D. Surgical resection of rectal adenoma: A rapid review. World J
Gastroenterol. 2009;15(31):3851-3854.
36. De Graaf EJ, Doornebosch PG, Tollenaar RA, et al. Transanal endoscopic microsurgery
versus total mesorectal excision of T1 rectal adenocarcinomas with curative intention.
Eur J Surg Oncol. 2009;35(12):1280-1285.
37. Baatrup G, Svensen R, Ellensen VS. Benign rectal strictures managed with transanal
resection -- a novel application for transanal endoscopic microsurgery. Colorectal Dis.
2010;12(2):144-146.
www.aetna.com/cpb/medical/data/700_799/0747.html Proprietary 29/34
38. Kinoshita T, Kanehira E, Omura K, et al. Transanal endoscopic microsurgery in the
treatment of rectal carcinoid tumor. Surg Endosc. 2007;21(6):970-974.
39. Tsai BM, Finne CO, Nordenstam JF, et al. Transanal endoscopic microsurgery resection
of rectal tumors: Outcomes and recommendations. Dis Colon Rectum. 2010;53(1):16-
23.
40. Shields CJ, Tiret E, Winter DC; International Rectal Carcinoid Study Group. Carcinoid
tumors of the rectum: A multi-institutional international collaboration. Ann Surg.
2010;252(5):750-755.
41. Steinhagen E, Chang G, Guillem JG. Initial experience with transanal endoscopic
microsurgery: The need for understanding the limitations. J Gastrointest Surg.
2011;15(6):958-962.
42. Kumar AS, Sidani SM, Kolli K, et al. Transanal endoscopic microsurgery for rectal
carcinoids: The largest reported U.S. experience. Colorectal Dis. 2012;14(5):562-566
43. Gracia JA, Ramirez JM, Callejo D, et al. Efficiency and outcomes of harmonic device in
transanal endoscopic microsurgery compared with monopolar scalpel. Surg Endosc.
2011;25(10):3209-3213.
44. Ashraf S, Hompes R, Slater A, et al; Association of Coloproctology of Great Britain and
Ireland Transanal Endoscopic Microsurgery (TEM) Collaboration. A critical appraisal of
endorectal ultrasound and transanal endoscopic microsurgery and decision-making in
early rectal cancer. Colorectal Dis. 2012;14(7):821-826.
45. Lezoche G, Paganini AM, Campagnacci R, et al. Treatment of rectal cancer by transanal
endoscopic microsurgery: Review of the literature. Minerva Chir. 2013;68(1):1-9.
46. Morino M, Arezzo A, Allaix ME. Transanal endoscopic microsurgery. Tech Coloproctol.
2013;17 Suppl 1:S55-S61.
47. Monson JR, Weiser MR, Buie WD, et al; Standards Practice Task Force of the American
Society of Colon and Rectal Surgeons. Practice parameters for the management of
rectal cancer (revised). Dis Colon Rectum. 2013;56(5):535-550.
48. Chen YY, Liu ZH, Zhu K, et al. Transanal endoscopic microsurgery versus laparoscopic
lower anterior resection for the treatment of T1-2 rectal cancers.
Hepatogastroenterology. 2013;60(124):727-732.
49. Sajid MS, Farag S, Leung P, et al. Systematic review and meta-analysis of published
trials comparing the effectiveness of transanal endoscopic microsurgery and radical
resection in the management of early rectal cancer. Colorectal Dis. 2014;16(1):2-14.
50. Arezzo A, Passera R, Saito Y, et al. Systematic review and meta-analysis of endoscopic
submucosal dissection versus transanal endoscopic microsurgery for large noninvasive
rectal lesions. Surg Endosc. 2014;28(2):427-438.
51. Fichera A, Allaix ME. Paradigm-shifting new evidence for treatment of rectal cancer. J
Gastrointest Surg. 2014;18(2):391-397.
www.aetna.com/cpb/medical/data/700_799/0747.html Proprietary 30/34
52. National Comprehensive Cancer Network (NCCN). Rectal cancer. NCCN Clinical Practice
Guidelines in Oncology, version.3.2014. Fort Washington, PA: NCCN; 2014.
53. Cunningham C. Transanal endoscopic microsurgery. Recent Results Cancer Res.
2014;203:31-38.
54. Heidary B, Phang TP, Raval MJ, Brown CJ. Transanal endoscopic microsurgery: A review.
Can J Surg. 2014;57(2):127-138.
55. Zhang Z, Zhang Y, Li A, et al. Laparoscopy assisted with transanal endoscopic
microsurgery in the treatment of severe functional constipation. Zhonghua Wei Chang
Wai Ke Za Zhi. 2014;17(12):1179-1182.
56. Han Y, Lin MB, Zhang YJ, Yin L. Total laparoscopic modified Duhamel operation in
combination with transanal endoscopic microsurgery. JSLS. 2014;18(1):128-131.
57. Kidane B, Chadi SA, Kanters S, et al. Local resection compared with radical resection in
the treatment of T1N0M0 rectal adenocarcinoma: A systematic review and meta-
analysis. Dis Colon Rectum. 2015;58(1):122-140.
58. Clancy C, Burke JP, Albert MR, et al. Transanal endoscopic microsurgery versus
standard transanal excision for the removal of rectal neoplasms: A systematic review
and meta-analysis. Dis Colon Rectum. 2015;58(2):254-261.
59. Althumairi AA, Gearhart SL. Local excision for early rectal cancer: Transanal endoscopic
microsurgery and beyond. J Gastrointest Oncol. 2015;6(3):296-306.
60. Bordeianou L, Sylla P, Kinnier CV, Rattner D. Perineal sigmoidopexy utilizing transanal
endoscopic microsurgery (TEM) to treat full thickness rectal prolapse: A feasibility trial
in porcine and human cadaver models. Surg Endosc. 2015;29(3):686-691.
61. Kanehira E, Tanida T, Kamei A, et al. Transanal endoscopic microsurgery for surgical
repair of rectovesical fistula following radical prostatectomy. Surg Endosc.
2015;29(4):851-855.
62. Kong X, Liu Q, Lin G, et al. The first attempt in local excision of anorectal malignant
melanoma using transanal endoscopic microsurgery. Int J Clin Exp Pathol.
2015;8(9):11735-11740.
63. Sharma R, George VV. Transanal endoscopic microsurgery: The first attempt in
treatment of rectal amyloidoma. World J Gastroenterol. 2015;21(4):1324-1328.
64. Ihnat P, Martinek L, Vavra P, Zonca P. Novel combined approach in the management of
non-healing solitary rectal ulcer syndrome -- laparoscopic resection rectopexy and
transanal endoscopic microsurgery. Wideochir Inne Tech Maloinwazyjne.
2015;10(2):295-298.
65. Stornes T, Wibe A, Nesbakken A, et al. National early rectal cancer treatment revisited.
Dis Colon Rectum. 2016;59(7):623-629.
66. Hopper L, Eglinton TW, Wakeman C, et al. Progress in the management of retrorectal
tumours. Colorectal Dis. 2016;18(4):410-417.
www.aetna.com/cpb/medical/data/700_799/0747.html Proprietary 31/34
67. Toh JW, Morgan M. Management approach and surgical strategies for retrorectal
tumours: A systematic review. Colorectal Dis.2016;18(4):337-350.
68. Chiniah M, Ganganah O, Cheng Y, Sah SK. Transanal endoscopic microsurgery is an
oncologically safe alternative to total mesorectal excision for stage I rectal cancer:
Results of a meta-analysis of randomized controlled trials. Int J Colorectal Dis.
2016;31(8):1501-1504.
69. Allaix ME, Arezzo A, Morino M. Transanal endoscopic microsurgery for rectal cancer: T1
and beyond? An evidence-based review. Surg Endosc. 2016;30(11):4841-4852.
70. D'Ambrosio G, Intini G, Balla A, et al. Recto-urinary fistula (RUF) treated by transanal
endoscopic microsurgery (TEM). Review of the literature and surgical technique. Ann
Ital Chir. 2016;87:356-361.
71. Ferrer-Marquez M, Rubio-Gil F, Ortega-Ruiz S, et al. Transanal endoscopic microsurgery
for the treatment of uncommon rectal lesions. Cir Esp. 2017;95(6):335-341.
72. Veereman G, Vlayen J, Robays J, et al. Systematic review and meta-analysis of local
resection or transanal endoscopic microsurgery versus radical resection in stage i
rectal cancer: A real standard? Crit Rev Oncol Hematol. 2017;114:43-52.
73. Han X, Xu J, Qiu H, Lin G. A novel curative treatment strategy for patients with lower
grade rectal gastrointestinal stromal tumor: Chemoreduction combined with transanal
endoscopic microsurgery. J Laparoendosc Adv Surg Tech A. 2017;27(6):579-585.
74. Morgan J, Raut CP. Local treatment for gastrointestinal stromal tumors, leiomyomas,
and leiomyosarcomas of the gastrointestinal tract. UpToDate [online serial]. Waltham,
MA: UpToDate; reviewed June 2017.
75. Liu Q, Zhong G, Zhou W, Lin G. Initial application of transanal endoscopic microsurgery
for high-risk lower rectal gastrointestinal stromal tumor after imatinib mesylate
neoadjuvant chemotherapy: A case report. Medicine (Baltimore). 2017;96(29):e7538.
76. Xu ZS, Cheng H, Xiao Y, et al. Comparison of transanal endoscopic microsurgery with or
without neoadjuvant therapy and standard total mesorectal excision in the treatment
of clinical T2 low rectal cancer: A meta-analysis. Oncotarget. 2017;8(70):115681-115690.
77. Jung Y, Lee J, Cho JY, et al. Comparison of efficacy and safety between endoscopic
submucosal dissection and transanal endoscopic microsurgery for the treatment of
rectal tumor. Saudi J Gastroenterol. 2018;24(2):115-121.
78. Serra-Aracil X, Labro-Ciurans M, Mora-Lopez L, et al. The place of transanal endoscopic
surgery in the treatment of uectourethral fistula. Urology. 2018;111:139-144.
79. Leijtens JWA, Koedam TWA, Borstlap WAA, et al. Transanal endoscopic microsurgery
with or without completion total mesorectal excision for T2 and T3 rectal carcinoma.
Dig Surg. 2019;36(1):76-82.
80. Xu G, Wang P, Xiao Y, et al. Local resection of rectal neuroendocrine tumor with first
clinical manifestation of giant liver metastasis by transanal endoscopic microsurgery: A
case report. Medicine (Baltimore). 2017;96(50):e9153.
www.aetna.com/cpb/medical/data/700_799/0747.html Proprietary 32/34
81. Kane WJ, Friel CM. Diagnosis and treatment of rectal gastrointestinal stromal tumors.
Dis Colon Rectum. 2019;62(5):537-540.
82. Bains L, Lal P, Vindal A, Singh M. Giant villous adenoma of rectum - what is the
malignant potential and what is the optimal treatment? A case and review of literature.
World J Surg Oncol. 2019;17(1):109.
83. de Jong GM, Hugen N. Minimally invasive transanal surgery is safe after incomplete
polypectomy of low risk T1 rectal cancer: A systematic review. Colorectal Dis. 2019 May
10 [Epub ahead of print].
www.aetna.com/cpb/medical/data/700_799/0747.html Proprietary 33/34
Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and
constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or
program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any
results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna
or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be
updated and therefore is subject to change.
Copyright © 2001-2019 Aetna Inc.
www.aetna.com/cpb/medical/data/700_799/0747.html Proprietary 34/34
AETNA BETTER HEALTH® OF PENNSYLVANIA
Amendment to Aetna Clinical PolicyBulletin Number: 0747
Transanal Endoscopic Microsurgery
There are no amendments for Medicaid.
www.aetnabetterhealth.com/pennsylvania revised 10/10/2019
Proprietary