Clinical trial NCT00939861: Laparoscopy Versus Laparotomy for Colorectal Endometriosis
Official title: Study Comparing Laparoscopy Versus Laparotomy in the Treatment of Colorectal Endometriosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Endometriosis
Keywords: colorectal endometriosis, laparoscopy, laparotomy
gynecologic and digestive symptoms
quality of life (SF-36 questionnaire)
morbidity
fertility
Lead sponsor: Tenon Hospital, Paris
Sponsor class: OTHER
First posted: 2009-07-15
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study hypothesis: equivalency of laparoscopic compared to laparotomic colorectal resection for endometriosis on digestive, gynaecologic, general symptoms and quality of life. Morbidity and fertility outcomes will also be evaluated.Primary purpose of the protocol is the evaluation of dyschesia.

Detailed description: For all patients, colorectal endometriosis will be confirmed preoperatively by clinical examination, transvaginal sonography, rectal endoscopic sonography and magnetic resonance imaging.Among patients with an indication of surgery, the intensity of dyschesia and other gynecological or digestive disorders will be evaluated pre-operatively using a visual analogue scale. Quality of life will be assessed using the SF-36 questionnaire. The allocation of the surgical route will be conducted by lottery the day before surgery. Patients will be reviewed postoperatively at 1 month and a new assessment of symptoms will be made at 6 months. The duration of the study will be 7 months for the patient and 24 months in total.If considering the two surgical routes as equivalent, with a delta score (after-before surgery) = ±2, standard deviation = 1.55, risk α=2.5%, risk β=10%, and taking into account that prevalence of dyschesia in the study population is 63%, 52 patients will be included.

Eligibility criteria: Inclusion Criteria:

* patients over 18 years old
* patients with colorectal endometriosis
* patients affiliated to the French Health Care system
* patients having signed the inform consent.
* patients who can speak and read French

Exclusion Criteria:

* patients with prior colorectal surgery
* patients with a contraindication to laparoscopy

Primary outcomes:
measure: Evaluation of dyschesia at 6 months using a visual analogue scale
timeFrame: at 6 months
Secondary outcomes:
measure: Evaluation of gynaecologic symptoms (dysmenorrhea, dyspareunia), digestive symptoms (diarrhea, constipation , intestinal cramps) and general symptoms (asthenia, back pain) at 6 months using visual analogue scale
timeFrame: at 6 months
measure: Evaluation of quality of life at 6 months using SF-36 questionnaire
timeFrame: at 6 months
measure: Morbidity
timeFrame: During 6 months
measure: Postoperative fertility
timeFrame: during the study
Other outcomes:
Locations:
city: Paris
country: France
facility: Tenon Hospital, Departement of Obstetrics and Gynecology
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: emile Daraï, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Touboul C, Ballester M, Dubernard G, Zilberman S, Thomin A, Darai E. Long-term symptoms, quality of life, and fertility after colorectal resection for endometriosis: extended analysis of a randomized controlled trial comparing laparoscopically assisted to open surgery. Surg Endosc. 2015 Jul;29(7):1879-87. doi: 10.1007/s00464-014-3880-4. Epub 2014 Oct 8.