- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00939861
Laparoscopy Versus Laparotomy for Colorectal Endometriosis
July 14, 2009 updated by: Tenon Hospital, Paris
Study Comparing Laparoscopy Versus Laparotomy in the Treatment of Colorectal Endometriosis
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
52
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Paris, France, 75020
- Tenon Hospital, Departement of Obstetrics and Gynecology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
laparoscopy
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colorectal resection
|
Experimental: 2
laparotomy
|
colorectal resection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluation of dyschesia at 6 months using a visual analogue scale
Time Frame: at 6 months
|
at 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
at 6 months
|
Evaluation of quality of life at 6 months using SF-36 questionnaire
Time Frame: at 6 months
|
at 6 months
|
Morbidity
Time Frame: During 6 months
|
During 6 months
|
Postoperative fertility
Time Frame: during the study
|
during the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: emile Daraï, MD,PhD, Assistance Publique - Hôpitaux de Paris
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2006
Primary Completion (Actual)
May 1, 2009
Study Completion (Anticipated)
September 1, 2009
Study Registration Dates
First Submitted
July 14, 2009
First Submitted That Met QC Criteria
July 14, 2009
First Posted (Estimate)
July 15, 2009
Study Record Updates
Last Update Posted (Estimate)
July 15, 2009
Last Update Submitted That Met QC Criteria
July 14, 2009
Last Verified
July 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13072009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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