EndoTHeF - Endovascular Treatment of Hemorrhoids with Foam - UIP Boston, 2013
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Transcript of EndoTHeF - Endovascular Treatment of Hemorrhoids with Foam - UIP Boston, 2013
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EndoTHeF: Endovascular Treatment of
Hemorrhoids with Foam
M. Ronconi, M.D.
E. Cervi, M.D.
A. Frullini, M.D.
XVII°World Meeting
of the
Union Internationale de Phlébologie
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Polidocanol foam as referred to in this talk
has not been approved for use by the
Federal Drug Administration (FDA).
Disclosure of
conflicts of interest
I do not have any relevant financial relationships with any commercial interests.
Disclosure of non-FDA
approved drugs
Maurizio Ronconi, M.D.
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• Haemorrhoids are normal anatomical structures present in healthy
people from birth, recognizable even in uterine life.
• When these vascular cushions generate symptoms, we erroneously
speak of “haemorrhoids”
When we use the term “haemorroids” we
generally refer to the symptoms caused by
haemorrhoids
Misunderstanding
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• Bleeding, anemization
• Prolapse
» ulceration
»sepsis
»strangulation
• Pain
• Thromboflebitis
• Pruritus
Most frequent symptoms
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Epidemiology
Western countries:
- 5% of the whole population is affected by haemorrhoids
USA:
- 10 million people complained of haemorrhoids, leading to
a prevalence rate of
4.4% (National Center for Health Statistics)
Italy
- there are 1,000,000 new cases per year
(2% of the population)
- every year 35,000 operations are carried out to
treat
haemorrhoidal diseases
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Classification of internal hemorrhoids
• 1st grade : venous ectasies which bleed, but do not prolapse
• 2nd grade: haemorrhoidal prolapse during defecation, spontaneously reductable
• 3rd grade: haemorrhoidal prolapse during defecation, reductable only manually
• 4th grade: permanent external haemorrhoidal prolapse, non reductable
Goligher, 1975
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Option therapy
medical topical medication
orally administered medication
surgical
Milligan-Morgan haemorrhoidectomy
Ferguson haemorrhoidectomy
haemorrhoidopexy using a stapler
Transanal Haemorrhoidal Dearterization (THD)
rubber band ligation
diathermal coagulation
sclerotherapy
outpatient care
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Mean volume per knot:
•0.93 ml (first session)
•0.5 ml (others sessions)
abandoned for the high
number of relapses
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2nd European Consensus Meeting on Foam Sclerotherapy -Tegernsee, Germany
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F. X. Breu et al., Supplement 71, February 2008, 3 VASA 2008; S/71: 3–29
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Monitoring of the vital functions using an oxypulsemeter
Technique
Patient in left lateral position
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• Rectal exploration
• Introduction of the endoscope into the rectum
• “retroversion” (or inversion) manoeuvre
• Visualization of the hemorrhoidal plexus origin
• puncure into the haemorroid with a 25g needle
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Injecting the 3% Polidocanol foam, prepared in according to Tessari
method:
- two luer-lock syringes (10 and 5 cc)
- 3-way cock
- gas (air)/liquid 4:1
- 20 passages using 2 syringes alternatively.
max 3 cc. foam / each globe
max 8 cc foam /session
new session after 3 weeks
usually at least 3 sessions
Protocol
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EndoTHeFEndovascular Treatment of Hemorrhoids with Foam
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Average duration
8 minutes (range 5-12).
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Direct injection
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Direct injection of hemorrhoids
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CasesJanuary 2009 – June 2013
290 patients rectal bleeding
No. %
males 122 58,1
females 88 41,9
80 exluded for other causes of bleeding
210 enrolled
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No. %
1st grade 5 2.5
2nd grade 108 51.4
3rd grade 86 40.9
4th grade 11 5.2
12 patients, already operated on:
6 - Longo
5 - Milligan-Morgan
1 - double Millogan-Morgan + Longo.
32 patients (12,7%)
severe hypocromic microcytic anaemia
( Hgb < 8 g/dL, MCV < 70)
Characteristics of the patients according to the Goligher
classification
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Results
765 procedures in 210 patients( means: 3.6 sessions per patient)
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Follow-up
12 cases (4,8%) : more than five sessions due to persistant bleeding
2 cases: patients opted for surgical haemorrhoidectomy.
32 patients suffering from severe anaemia
- 3 transfusion of two units of autologous blood
- 29 normalization of haematocrit within 30 days after the 1st treatment
Disappearance of rectal bleeding in
83% of the cases
after the first session
176 patients available
(means: 12 months)
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4 patients (1.6 %): local itching
6 patients (1.8 %): local heaviness for a week after
treatment
Adverse effect
No major complications
No major side-effects
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Score
4 3 2 1
Bleeding > 1 episode/week < 1 episode/week <1 episode/month never
VAS* 10-8 7-5 4-2 1-0
Discomfort alwais > 7 days/month < 7 days/month <3 days/month
Information obtained insufficient sufficient exhaustive
reasons for recommending the method
Before the first procedure
Before the first procedure and after the last procedure
Questionnaire
After the last procedure
*VAS : visual analogue scale for pain
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insufficient sufficient exhaustive
Information obtained - 2.4% 97.6%
Answers to the questionnaire
Reason for recommending the method
Stop the bleeding 98.8%
Absence of pain 98.3%
Get back to usual activities within a day 94.7%
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Answers to the questionnaire
proctorragy VAS discomfort
P< 0,0015
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Conclusions
• simple, feasable and safe procedure
• painless procedure
• good control of symptoms
Foam endoscopic sclerotherapy:
Recurrence rate
Prospective, randomized, multicentric study needed
?
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2. What’s the recurrence rate of hemorrhoids after
hemorroidectomy?
1. Wich are complications after
hemorroidectomy?
Open questions
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1. Wich are complications after hemorroidectomy?
2. What’s the recurrence rate of hemorrhoids
after hemorroidectomy?
Open questions
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To cure or to operate hemorrhoids…
… that is the question