Approaching thirty years from the fisrt total laparoscopic hysterectomy

(T.L.H.)

Vincenzo Giambanco

Palermo - Italy

Overview of presentation topics

Historical background and technical definition

Benefits, advantages, disadvantages of LPS vs vaginal/abdominal route

Clinical indication to hysterectomy

Scientific guidelines

Scientific awareness

Take home messagges.....

1984 Semm LAVH1989 Reich TLH

1991 Semm CASCH

1929 Richardson adominal total hysterectomy

1843 Clay abdominal

subtotal hysterectomy

1800 Baudeloque: vaginal

hysterectomy

Historical background 1

1901: Kelling (Hamburg) for the first time a new technique of peritoneal cavity visualization in a dog. A cystoscope is used and pneumoperitoneum was obtained trhough air injections

1901: Kelling (Hamburg) for the first time a new technique of peritoneal cavity visualization in a dog. A cystoscope is used and pneumoperitoneum was obtained trhough air injections

1910: H Cristian Jacobeus

laparoscopy and thoracoscopy in human beings.

1910: H Cristian Jacobeus

laparoscopy and thoracoscopy in human beings.

1929: Kalk made a new lents system (135°). Suggested a double entry in abdomen fot hepatic biopsy

1929: Kalk made a new lents system (135°). Suggested a double entry in abdomen fot hepatic biopsy

1934: Ruddock for the first time used monopolar forceps1934: Ruddock for the first time used monopolar forceps

HISTORICAL BACKGROUND 2

1938: Verres invented the needle for creation of pneumoperitoneum1938: Verres invented the needle for creation of pneumoperitoneum

1970 Kurt Semm first automatic insufflator, start of LPS with multiple trocars

1970 Kurt Semm first automatic insufflator, start of LPS with multiple trocars( giynaecologist

and engineer)( giynaecologist and engineer)

1986 videolaparoscopy: everyone of the OR can see the surgey1986 videolaparoscopy: everyone of the OR can see the surgey

1987 Philippe Mouret first laparoscopic cholecystectomy on a man. Since that year LPS represents first choice for cholecistectomy

1987 Philippe Mouret first laparoscopic cholecystectomy on a man. Since that year LPS represents first choice for cholecistectomy

HISTORICAL BACKGROUND 3

- fast recovery - fast bowel recovery - fast feeding - less postsurgical pain - less complications due to comorbidity - less wound infections - less immune stress:

less blood loss, less surgical trauma (?)

- fast recovery - fast bowel recovery - fast feeding - less postsurgical pain - less complications due to comorbidity - less wound infections - less immune stress:

less blood loss, less surgical trauma (?)

Common advantages

laparoscopy

TLH includes laparoscopically detaching the entire uterine cervix and body from the surrounding supporting structures and suturing the vaginal cuff. It includes bivalving, coring, or morcellating the excised tissues, as required. The uterus is then removed through the vagina or abdomen.

LAVH includes laparoscopically detaching the uterine body from the surrounding upper supporting structures. The vaginal portion of the procedure is then performed. The vaginal apex is entered and the cervix and uterus are detached from the remaining supporting structures. The uterus is then removed through the vagina.

LSH includes laparoscopically detaching the body of the uterus down to the uterine arteries. The uterine body is then separated from the cervix, hemostasis of the cervical stump is achieved, and the endocervical canal is coagulated. The uterine body is then abdominally removed by bivalving, coring, or morcellating, as required.

Lps hysterectomy

Classification of the “Lap hyster”

Stage Laparoscopic component

0 Dx lap only

1 Lap adhesiolysis or Rx endometriosis

2 One or both adnexae freed laparoscopically (LAVH)

3 Bladder dissected from uterus laparoscopically (LAVH)

4 Uterine arteries/ veins transected laparoscopically

5 Vault opened and closed laparoscopically (TLH)

Richardson RE, Bournas N, Magos AL. Is laparoscopic hysterectomy a a waste of time? Lancet 1995;345-6 8

Laparoscopic hysterectomy

• Firstly performed by Reich in 1988 - Reich H, DeCaprio J, McGlynn F. Laparoscopic hysterectomy. J Gynecol Surg 1989; 5:213-216.

• LPS vs LPT: a randomized trial showed less complications and faster recovery , but longer operative time : 160 vs 102 - Nezhat F, Nezhat C, Gordon S, Wilkins E. Laparoscopic versus abdominal hysterectomy. J Reprod Med 1992; 37:247-250.

• Data collected between 1989 -1995 confirmed longer operative time (115 vs 89) and shorter hospital stay (49 hours vs 79 hs) for LAVH

• LPS surgical complications 4% - Meikle SF, Nugent EW, Orleans M. Complications and recovery from laparoscopy-assisted vaginal hysterectomy compared with abdominal and vaginal hysterectomy. Obstet Gynecol 1997; 89:304-11.

TAH

LH

VH

WORLDWAR...

LAVH vs Vaginal route

• Many authors reported longer operative times for LAVH (120 vs 65) - Summitt RL, Stovall TG, Lipscomb GH, Ling FW. Randomized comparison of laparoscopically-assisted vaginal hysterectomy with standard vaginal hysterectomy in an outpatient setting. Obstet Gynecol 1992; 80:895-901. - Richardson RE, Bournas N, Magos AL. Is laparoscopic hysterectomy a waste of time? Lancet 1995; 345:36-41.

• LVH is more expensive- Ransom SB, McNeeley SG, White C, Diamond MP. A cost analysis of endometrial ablation, abdominal hysterectomy, and laparoscopic-assisted vaginal hysterectomy in the treatment of primary menorrhagia. J Am Assoc Gynecol Laparoscopists 1996; 4:29-32.

• Some Author choose lps route if endometriosis or adherence or ovarian masses are present. - Minelli L, Angiolillo M, Caione C, Palmara V. Laparoscopically assisted vaginal hysterectomy. Endoscopy 1991; 23:64-6.

b Müller A, Thiel FC, Renner SP, Winkler M, Häberle L, Beckmann MW (2010). "Hysterectomy-a comparison of approaches.". Dtsch Arztebl Int 107 (20): 353–9.

Technique Benefits DisadvantagesAbdominal hysterectomy •No limitation by the size of

the uterus•Combination with reduction and incontinence surgery possible

•Longest duration of hospital treatment•Highest rate of complications•Longest recovery period

Vaginal hysterectomy •Shortest operation time•Short recovery period•Combination with reduction operations are possible

•Limitation by the size of the uterus and previous surgery•Highest blood loss•Limited ability to evaluate the fallopian tubes and ovaries

Laparoscopic supracervical hysterectomy

•Low risk of complication•Less blood loss•Short inpatient treatment duration

•10-17% of patients continue to have minimal menstrual bleeding

Laparoscopic-assisted vaginal hysterectomy

•Possible even with larger uterus and after previous surgery•Combination with reduction operations are possible

•Long operation time•High instrumental costs by changing the access pathway

Total laparoscopic hysterectomy

•Less blood loss•Short inpatient treatment duration

Advantages and disadvantages of different hysterectomy techniques

VH/ LH Cochrane database, 2009

LH / VH LH more common urological

injuries

costs, operative time

VH represents gold standard

• Gendy R. et al. , A.J.O.G., 2011

LH: postoperative painHospital stay

operative time

Better surgical field visualization

(magnification)Useful for treating gynecological

comorbidities

LH works better!!!!

Johns, 1995: retrospective evaluation of 2563 hysterectomies

Uterine weight HCT reduction Costs $ Op time min. Hospital stay (hours)

TAH 216 gr 5.35 % 6552 82 68

LAVH 113 gr 5.19 % 6431 102 44

VH 129 gr 6 % 5879 63 44

Complications Fever Blood trasfusion

Bowel injuries Uretheral injuries

Bladder injuries

TAH 9.1 % 2.5 % 1 %

LAVH 2 % 0.06 % 0.9 %

VH 3.2 % 1 % 1 %

Table 3 Comparison of costs between laparoscopic and standard hysterectomy (1999-2000 prices)Vaginal trial Abdominal trialLaparoscopy (n=324) Vaginal (n=163) Laparoscopy (n=573) Abdominal (286)Theatre cost 807 635 (513-919) 396 362 (309-420) 788 646 (523-890) 453 431 (381-489)Hospital “hotel” cost 589 542 (407-678) 591 542 (407-678) 548 542 (407-678) 692 678 (542-813)Other postoperative cost 14 0 (0-0) 18 0 (0-0) 21 0 (0-0) 13 0 (0-0)Follow up cost at six weeks 144 46 (0-108) 89 46 (0-108) 193 46 (0-108) 128 46 (0-108)Follow up cost at four months 37 0 (0-46) 47 0 (0-46) 39 0 (0-46) 88 0 (0-46)Follow up cost at one year 64 46 (0-46) 112 46 (0-46) 115 46 (0-46) 146 46 (0-46) Total cost 1654 1253 1706 1520

Vaginal route is the champion!

Dısposable trocar80-90euroNot disposable trocar 638 10mm 530 5mm

Costs.....

Not Disposable Morcellator >800 Euros Disposable morcellator >100 EWashing/suction device 112 euroMonopolar scissors160 euroLigasure 600 euroEnseal 600 euroDisposable bipolar forceps 600 euro

1200 euro lavh2000 euro lh

...... costs (Bijen C. et al. , PloSONE 2009; Jonsdottir G.H., Obstet. Gynecol., 2011)

surgical costs (direct costs) general costs : hospital stay complications and reoperationShorter hospital stay and less rate of complications for LPS route

in comparison to higher direct costs ....

LH/AH comparable costs LH/ VH more expensive

Vaginal cuff....

ABDOMINAL, VAGINAL, LAPAROSCOPIC APPROACHES AND DEHISCENCE……..

CONCLUSIONS:

Postoperative chemotherapy, brachytherapy, and early resumption of sexual activities are risk factors for vaginal vault dehiscence. Surgical technique, particularly the use of delayed absorbable sutures, deserves further evaluation.

Int J Gynecol Cancer. 2013 Jun;23(5):943-50. Vaginal vault dehiscence after robotic hysterectomy for gynecologic cancers: search for risk factors and literature review.Drudi L, Press JZ, Lau S, Gotlieb R, How J, Eniu I, Drummond N, Brin S, Deland C, Gotlieb WH.

CONCLUSION:

Current evidence indicates that transvaginal colporraphy after total laparoscopic hysterectomy is associated with a 3- and 9-fold reduction in risk of vaginal cuff dehiscence compared with laparoscopic and robotic suture, respectively

Am J Obstet Gynecol. 2011 Aug;205(2):22.Vaginal cuff closure after minimally invasive hysterectomy: our experience and systematic review of the literature.Uccella S, Ghezzi F, Mariani A, Cromi A, Bogani G, Serati M, Bolis P

Vaginal cuff suture

• complexity

• Highrate of post surgical complications:– infection– Fever– cellulite – Pelvic abscess– Blood loss,

– dehiscence

• Bipolar or monopolar hook– longer healing time

AAGL (2010) e ACOG (2012)

• Mininvasive surgical approaches are reccomended when an hysterectomy is needed, such as vaginal and laparoscopic route

• Laparoscopic hysterectomy is as effective as laparotomic hysterectomy, and is reccomended as an alternative to abdominal approach when vaginal route is contraindicated

• Laparotomy should be reserved only in patients where vaginal and laparosocpic route are contrainidcated

Medicare data- route of hysterectomy(*no specific item number for TLH)

2000-01 2008-09

Abdominal 8498(50%) 5919(38%)

Vaginal 6015(35%) 5558(36%)

All “laparoscopic” * 2477(15%) 3901(26%)

TOTAL 16990 15378

(Molloy, D, O&G 2010, 12:1, 30-31) 24

Indications for hysterectomyIndication Abdominal Vaginal

Leiomyomata 40% 17%

Endometriosis 12% Not reported

Cancer/preinvasive disease

12.6% Not reported

Abnormal bleeding

9.5% Not reported

Prolapse 3% 44%

• Various others– Adenomyosis– PID– Chronic pain– PPH– Cornual ectopics– Sterilisation

Farquar and Steiner Obstet Gynaecol 2002;99:229 25

Gynecological Oncology• Daniel Dargent was the first to perform retroperitoneal linphadenectomy in laparoscopy, opening

the route to gynecological oncology. - Dargent D, Salvat J. Envahissement ganglionnaire pelvien: place de la pelviscopy retroperitoneale. Paris: Medsi/McGraw-Hill; 1989.

• Following his exemple Querleu performed the transperitoneal linphadenectomy, the most used today. - Querleu D, Leblanc E, Catelain B. Laparoscopic lymphadenectomy in the staging of early carcinoma of the cervix. Am J Obstet Gynecol 1991; 164:579-581.

• In the 90’s was then described the radical laparoscopyc hysterectomy.• -Canis M, Mage G, Wattiez A. Vaginally assisted laparoscopic radical hysterectomy . J Gynecol

Surg 1992; 8:103-105. – come pure la Shauta laparoassistita - Querleu D. Laparoscopic management od cervical cancer. 22nd Annual Meeting of the American Association of Gynecologic Laparoscopists. November 1993. San Francisco, California

• LPS second look in ovarian cancer: false negatives 18 – 55% - Lacey CG, Morrow CP, DiSaia PJ & Lucas WE. Laparoscopy in the evaluation of gynecologic cancer. Obstet Gynecol 1978; 52:708-712. - Ozols RF, Fisher RI & Anderson T. Peritoneoscopy in the management of ovarian carcinoma. Am J Obstet Gynecol 1981;140:611-623.

• 19 cases of metastasis at the port site- Wang PH, Yen MS, Yuan CC, Chao KC, Ng HT, Lee WL, et al. Port site metastasis after laparoscopic assisted vaginal hysterectomy for endometrial cancer: possible mechanisms and prevention. Gynecol Oncol 1997; 66:151-155.

Role of prophylactic oophorectomyPre-menopausal subjects

Perceived risk of ovarian carcinomaLifetime risk

Avoidance further gynae proceduresResidual ovary syndromeIncidence

119 trials, one controlled with 362 pp , no RCT; no meta-analysis possibleevidence of very low quality of a positive effect on

psychological well-being for both groups at one year follow up. No significant differences were found between the groups of women studied regarding any aspect of their sexuality.

Orozco LJ, Salazar A, Clarke J, Tristán M. Hysterectomy versus hysterectomy plus oophorectomy for premenopausal women. Cochrane Database of

Systematic Reviews 2008, Issue 3. 27

Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication

Date Issued: April 17, 2014

Purpose:

When used for hysterectomy or myomectomy in women with uterine fibroids, laparoscopic power morcellation poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus. Health care providers and patients should carefully consider available alternative treatment options for symptomatic uterine fibroids. Based on currently available information, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival. For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids.

Recommendations for Health Care Providers:•Be aware that based on currently available information, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for the treatment of women with uterine fibroids.

 Inform patients that their fibroid(s) may contain unexpected cancerous tissue and that laparoscopic power morcellation may spread the cancer, significantly worsening their prognosis.Be aware that some clinicians and medical institutions now advocate using a specimen “bag” during morcellation in an attempt to contain the uterine tissue and minimize the risk of spread in the abdomen and pelvis.

Recommendations for Women:•If laparoscopic hysterectomy or myomectomy is recommended, ask your health care provider if power morcellation will be performed during your procedure, and to explain why he or she believes it is the best treatment option for you.

FDA Actions:•Instructed manufacturers of power morcellators used during laparoscopic hysterectomy and myomectomy to review their current product labeling for accurate risk information for patients and providers;.

)

•Be aware that based on currently available information, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for the treatment of women with uterine fibroids.

FDA News ReleaseFDA warns against using laparoscopic power morcellators to treat uterine fibroidsAgency recommends adding important safety information to product labelsFor Immediate ReleaseNovember 24, 2014

A comparison of vaginal, L.A.V.H. and minilap. hysterect. for enlarged myomatous uteri ( Sesti F. et al., Int.J. Obstet. Gynecol., 103,227,2008)

VH LAVH MLPT

TIME 70’ 125’ 133’

Blood loss (ml) 18 351 474

Canalisation (h.) 18 28 32

Lps. vs. Minilap.

From aestethic To risks

Body habitus is another important factor that may determine the best surgical route. The vaginal and laparoscopic routes are associated with faster recovery after the surgery and, therefore, would, in general, be preferred. A very high BMI (>35-40 kg/m2), however, may not render these approaches the safest for the patient.

This study showed that the abdominal procedure was associated with the longest hospital stay, highest risk for postoperative infections, and need for readmission within 30 days after surgery. Essentially all complications studied were more common with all three approaches as the BMI increased.

Higher perioperative risks associated with increased BMI.

vaginal and laparoscopic procedures carry an overall lower risk for overweight and obese women. The information could be useful for insurance companies covering the expenses of the treatment and hospital stay as they may offer better conditions for the laparoscopic and vaginal procedures. They may also decide to charge the patients more for the modifiable risk factors such as high BMI.

How Does BMI Affect the Best Route for Hysterectomy?Peter Kovacs, March 27, 2015

Surg Endosc. 2012 Jan;26.Total laparoendoscopic single-site surgery (LESS) hysterectomy in low-risk early endometrial cancer: a pilot study.Fanfani F, Rossitto C, Gagliardi ML, Gallotta V, Gueli Alletti S, Scambia G, Fagotti A.

METHODS:Between July 2009 and May 2010, 20 consecutive low-risk early endometrial cancer patients were enrolled in this single institution prospective cohort trial.RESULTS:The median age of the patients was 57 years (range = 42-68) and median body mass index was 24 kg/m(2) (range = 21-30). Median operative time was 105 min (range = 85-155) and median estimated blood loss was 20 ml (range = 10-180). The larger skin and fascial incision required for the single-port approach was 2.5 cm (median = 2.2 cm; range = 2.0-2.5). No laparoscopic/laparotomic conversion was registered, and no insertion of additional ports was necessary. Median ileus was 16 h (range = 12-20) and median time to discharge was 1 day (range = 1-2). All patients were completely satisfied with the cosmetic results and postoperative pain control.CONCLUSIONS:Laparoendoscopic single-site surgery could represent a surgical option for extra-fascial hysterectomy in early-stage endometrial cancer patients, with the potential to further decrease invasiveness of the conventional laparoscopic approach.

CONCLUSIONS:Laparoendoscopic single-site surgery could represent a surgical option for extra-fascial hysterectomy in early-stage endometrial cancer patients, with the potential to further decrease invasiveness of the conventional laparoscopic approach.

The robotic lps

AbstractSince the introduction of robotic technology, there have been significant changes to the field of gynecology. The number of minimally invasive procedures has drastically increased, with robotic procedures rising remarkably. To date several authors have published cost analyses demonstrating that robotic hysterectomy for benign and oncologic indications is more costly compared to the laparoscopic approach. Despite being more expensive than laparoscopy, other studies have found robotics to be less expensive and more effective than laparotomy. In this review, controversies surrounding cost-effectiveness studies are explored.

J Obstet Gynaecol Res. 2014 Jan;40(1):12-7. doi: 10.1111/jog.12197. Epub 2013 Oct 11.

Cost and robotic surgery in gynecology

Date of download: 5/3/2015Copyright © 2015 American Medical Association.

All rights reserved.

From: Robotically Assisted vs Laparoscopic Hysterectomy Among Women With Benign Gynecologic Disease

JAMA. 2013;309(7):689-698. doi:10.1001/jama.2013.186

Gynecol Oncol. 2013 Apr 10.]Robotic single-site hysterectomy (RSS-H) vs. laparoendoscopic single-site hysterectomy (LESS-H) in early endometrial cancer: A double-institution case-control study.Fagotti A, Corrado G, Fanfani F, Mancini M, Paglia A, Vizzielli G, Sindico S, Scambia G, Vizza E.

RESULTS:19 women underwent RSS-H (cases) and 38 patients were submitted to LESS-H (controls) for early endometrial cancer. Pre-surgical procedures (port placement and docking) required a median time of 8min in the RSS-H group and a median time of 2min in the LESS-H group (p=0.0001). The median estimated blood loss was 75ml in the cases and 30ml in the controls (p=0.005). The median operative time, calculated from the beginning of intraperitoneal procedures to the skin closure, was 90min in the cases and 107ml in the controls (p=ns). The median time to discharge from the hospital was postoperative day two for both techniques.CONCLUSIONS:The few differences we registered do not seem clinically relevant, thus making the two procedures comparable

The few differences we registered do not seem clinically relevant, thus making the two procedures comparable

J Minim Invasive Gynecol. 2014 Mar-Apr;21(2):223-7. doi: 10.1016/j.jmig.2013.08.709. Epub 2013 Sep 4.

Disparities in use of laparoscopic hysterectomies: a nationwide analysis

MAIN RESULTS:A total of 32 436 patients were included in this study. Of these, 32% patients underwent laparoscopic hysterectomies, and 67% underwent abdominal hysterectomies. With regard to patient characteristics, women younger than 35 years old were more likely to undergo laparoscopic hysterectomy when compared with each of the other age categories (p < .001). White women were more likely to undergo laparoscopic hysterectomy than black women, Hispanic women, or women classified as "other" races (p < .001 for all comparisons). With regard to median income, patients from the lowest national quartile were less likely to undergo laparoscopic hysterectomy when compared with each of the other 3 national quartiles for income (p = .01, p < .001, p = .001, respectively). Payment by private insurance was associated with laparoscopic hysterectomy when compared with payment by Medicare or payment by insurance category "other" (p < .001 for both). With regard to hospital characteristics, hospitals in the Northeast were more likely to have laparoscopic hysterectomies than hospitals in the Midwest or South (p < .001 for both comparisons); urban hospitals were more likely than rural hospitals (p < .001); teaching hospitals were more likely than nonteaching hospitals (p < .001); and government-owned hospitals were less likely than private, nonprofit or private, investor owned (p < .001 for both comparisons).CONCLUSIONS:Despite the increased popularity of and training in laparoscopic hysterectomies, there remains an obvious disparity in its delivery with regard to patient and hospital characteristics.

Payment by private insurance was associated with laparoscopic hysterectomy when compared with payment by Medicare or payment by

insurance category "other" (p < .001 for both). With regard to hospital characteristics, hospitals in the Northeast were more likely to have

laparoscopic hysterectomies than hospitals in the Midwest or South (p < .001 for both comparisons);

the American Association of Gynae Laparoscopists (AAGL) has recently published a position statement on route of hysterectomy. It states that “when hysterectomy is needed, the demonstrated safety, efficacy and cost effectiveness of vag hyst and laparoscopic hyst make these the procedures of choice” (AAGL Vol18:1, 2011).

between clinical evidence and clinical practice

o Surgery effectiveness depends strongly on surgeon’s experience

o Randomized clinical study could erase clinical bias but not surgeon’s expertise bias

o Lackness of statistical difference doesn’t mean no difference...such as lackness of evidences doesn’t mean no evidence...

The QUESTION isn’t: is it feasible by LAPAROSCOPY?

But.......are there advantages fot women and for society from mininvasive gynecological surgery?

To think about

In 2011 in Italy 228 women/100.000 underwent hysterectomy (range from 144 to 368) Source: OCSE report 2014n

Nearly 1 in 5 women who undergo hysterectomy may not need the procedure

Nearly two in five women under 40 (38%) had pathologic findings that did not support undergoing a hysterectomy versus those aged 40-50 (12%) and over 50 years (7.5%). The frequency of unsupportive pathology was highest among women with endometriosis or chronic pain.

“Use of Other Treatments before Hysterectomy for Benign Conditions in a Statewide Hospital Collaborative,” American Journal of Obstetrics & Gynecology, January, 2015.

- To perform surgery in the best route, for the best indications and in the best patient’s safety

Clear and honest informed consent

The advances in minimally invasive approaches to gynecologic surgery over the past 30 years have been staggering.

The goal is clearly to make minimally invasive surgery the norm, not the exception.

Clinical and Health AffairsThe Evolution of Minimally Invasive Gynecologic SurgeryBy Jon S. Nielsen 2012