Laparoscopy Versus Laparotomy for Colorectal Endometriosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2009-09-30

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.

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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.

Conditions

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Endometriosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

laparoscopy

Group Type EXPERIMENTAL

laparoscopy

Intervention Type PROCEDURE

colorectal resection

2

laparotomy

Group Type EXPERIMENTAL

laparotomy

Intervention Type PROCEDURE

colorectal resection

Interventions

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laparoscopy

colorectal resection

Intervention Type PROCEDURE

laparotomy

colorectal resection

Intervention Type PROCEDURE

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