Study Comparing Laparoscopy Versus Laparotomy in the Treatment of Colorectal Endometriosis
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Endometriosis
- Sponsor
- Tenon Hospital, Paris
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Evaluation of dyschesia at 6 months using a visual analogue scale
- Last Updated
- 16 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Evaluation of dyschesia at 6 months using a visual analogue scale
Time Frame: at 6 months
Secondary Outcomes
- 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)