Laparoscopy Versus Laparotomy for Colorectal Endometriosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Study Comparing Laparoscopy Versus Laparotomy in the Treatment of Colorectal Endometriosis

Conditions
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Endometriosis

Intervention / Treatment
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* Procedure: laparoscopy
* Procedure: laparotomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>laparoscopy | Procedure: laparoscopy<br>* colorectal resection<br>|
| Experimental: 2<br>laparotomy | Procedure: laparotomy<br>* colorectal resection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of dyschesia at 6 months using a visual analogue scale |  | at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal endometriosis, laparoscopy, laparotomy, gynecologic and digestive symptoms, quality of life (SF-36 questionnaire), morbidity, fertility