Laparoscopy Versus Laparotomy for Colorectal Endometriosis
Primary Purpose
Endometriosis
Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
laparoscopy
laparotomy
Sponsored by
About this trial
This is an interventional treatment trial for Endometriosis focused on measuring colorectal endometriosis, laparoscopy, laparotomy, gynecologic and digestive symptoms, quality of life (SF-36 questionnaire), morbidity, fertility
Eligibility Criteria
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
Sites / Locations
- Tenon Hospital, Departement of Obstetrics and Gynecology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
laparoscopy
laparotomy
Outcomes
Primary Outcome Measures
Evaluation of dyschesia at 6 months using a visual analogue scale
Secondary Outcome Measures
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
Evaluation of quality of life at 6 months using SF-36 questionnaire
Morbidity
Postoperative fertility
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00939861
Brief Title
Laparoscopy Versus Laparotomy for Colorectal Endometriosis
Official Title
Study Comparing Laparoscopy Versus Laparotomy in the Treatment of Colorectal Endometriosis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2006 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
September 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Tenon Hospital, Paris
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
colorectal endometriosis, laparoscopy, laparotomy, gynecologic and digestive symptoms, quality of life (SF-36 questionnaire), morbidity, fertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
laparoscopy
Arm Title
2
Arm Type
Experimental
Arm Description
laparotomy
Intervention Type
Procedure
Intervention Name(s)
laparoscopy
Intervention Description
colorectal resection
Intervention Type
Procedure
Intervention Name(s)
laparotomy
Intervention Description
colorectal resection
Primary Outcome Measure Information:
Title
Evaluation of dyschesia at 6 months using a visual analogue scale
Time Frame
at 6 months
Secondary Outcome Measure Information:
Title
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
Title
Evaluation of quality of life at 6 months using SF-36 questionnaire
Time Frame
at 6 months
Title
Morbidity
Time Frame
During 6 months
Title
Postoperative fertility
Time Frame
during the study
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
emile Daraï, MD,PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tenon Hospital, Departement of Obstetrics and Gynecology
City
Paris
ZIP/Postal Code
75020
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
25294552
Citation
Touboul C, Ballester M, Dubernard G, Zilberman S, Thomin A, Darai E. Long-term symptoms, quality of life, and fertility after colorectal resection for endometriosis: extended analysis of a randomized controlled trial comparing laparoscopically assisted to open surgery. Surg Endosc. 2015 Jul;29(7):1879-87. doi: 10.1007/s00464-014-3880-4. Epub 2014 Oct 8.
Results Reference
derived
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Laparoscopy Versus Laparotomy for Colorectal Endometriosis
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