Laparoscopy Versus Laparotomy for Colorectal Endometriosis

Phase 3

• Conditions: Endometriosis
• Interventions: Procedure: laparoscopy; Procedure: laparotomy

• Registration Number: NCT00939861
• Lead Sponsor: Tenon Hospital, Paris

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.

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2009-05
• Status Verified: 2009-07
• Study First Submitted: 2009-07-14
• Study First Submitted QC: 2009-07-14
• Last Update Submitted: 2009-07-14
• Study First Posted: 2009-07-15
• Last Update Posted: 2009-07-15
• Study Completion: 2009-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	laparoscopy	laparoscopy
2	laparotomy	laparotomy

Primary Outcome Measures

Name	Time	Method
Evaluation of dyschesia at 6 months using a visual analogue scale	at 6 months

Secondary Outcome Measures

Name	Time	Method
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	at 6 months
Evaluation of quality of life at 6 months using SF-36 questionnaire	at 6 months
Morbidity	During 6 months
Postoperative fertility	during the study

Trial Locations

Locations (1)

Tenon Hospital, Departement of Obstetrics and Gynecology; 🇫🇷 Paris, France