Laparoscopy Versus Laparotomy for Colorectal Endometriosis

Endometriosis Clinical Trial

Official title:

Study Comparing Laparoscopy Versus Laparotomy in the Treatment of Colorectal Endometriosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00939861
• Other study ID #: 13072009
• Status: Active, not recruiting
• Phase: Phase 3
• First received: July 14, 2009
• Last updated: July 14, 2009
• Start date: January 2006
• Est. completion date: September 2009

Study information

• Verified date: July 2009
• Source: Tenon Hospital, Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: French Data Protection Authority
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 52
• Est. completion date: September 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometriosis

Intervention

Procedure:
• laparoscopy
colorectal resection
• laparotomy
colorectal resection

Locations

Country	Name	City	State
France	Tenon Hospital, Departement of Obstetrics and Gynecology	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Tenon Hospital, Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of dyschesia at 6 months using a visual analogue scale		at 6 months	Yes
Secondary	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	Yes
Secondary	Evaluation of quality of life at 6 months using SF-36 questionnaire		at 6 months	Yes
Secondary	Morbidity		During 6 months	Yes
Secondary	Postoperative fertility		during the study	Yes