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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00939861
Other study ID # 13072009
Secondary ID
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


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
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