This trial is active, not recruiting.

Condition endometriosis
Treatments laparoscopy, laparotomy
Phase phase 3
Sponsor Tenon Hospital, Paris
Start date January 2006
End date May 2009
Trial size 52 participants
Trial identifier NCT00939861, 13072009


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
colorectal resection
colorectal resection

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
time frame: at 6 months
Evaluation of quality of life at 6 months using SF-36 questionnaire
time frame: at 6 months
time frame: During 6 months
Postoperative fertility
time frame: during the study

Eligibility Criteria

Female participants from 18 years up to 50 years old.

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

Additional Information

Official title Study Comparing Laparoscopy Versus Laparotomy in the Treatment of Colorectal Endometriosis
Principal investigator emile Daraï, MD,PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2009.
Information provided to ClinicalTrials.gov by Tenon Hospital, Paris.