Laparoscopy Versus Laparotomy for Colorectal Endometriosis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 laparoscopy |
Procedure: laparoscopy
colorectal resection
|
| Experimental: 2 laparotomy |
Procedure: laparotomy
colorectal resection
|
Outcome Measures
Primary Outcome Measures
- Evaluation of dyschesia at 6 months using a visual analogue scale [at 6 months]
Secondary Outcome Measures
- 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]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tenon Hospital, Departement of Obstetrics and Gynecology | Paris | France | 75020 |
Sponsors and Collaborators
- Tenon Hospital, Paris
Investigators
- Principal Investigator: emile Daraï, MD,PhD, Assistance Publique - Hôpitaux de Paris
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 13072009