Trial record 18 of 55 for:
Open Studies | "Endometriosis"
Functional Outcomes of Surgical Management of Deep Endometriosis Infiltrating the Rectum (ENDORE)
This study is currently recruiting participants.
Verified January 2013 by University Hospital, Rouen
Sponsor:
University Hospital, Rouen
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01291576
First received: January 31, 2011
Last updated: January 8, 2013
Last verified: January 2013
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Purpose
The purpose of this study is to determine whether performing colorectal resection in deep endometriosis infiltrating the rectum is responsible for a higher rate of postoperative digestive and urinary dysfunction when compared to rectal nodules excision (conservation of the rectum).
| Condition | Intervention |
|---|---|
|
Endometriosis, Rectum |
Procedure: Rectal/colorectal segmental resection Procedure: Rectal nodule excision |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Trial Comparing Digestive and Urinary Dysfunction Secondary to 2 Surgical Techniques Used in the Management of Deep Endometriosis Infiltrating the Rectum: Colorectal Resection and Rectal Nodules Excision (ENDORE) |
Resource links provided by NLM:
Further study details as provided by University Hospital, Rouen:
Primary Outcome Measures:
- Percentage of women experiencing a postoperative digestive or urinary dysfunction [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
At least one of following symptoms:
- major constipation (< 1 stool/5 days) associated with defecation pain;
- increase of the stool frequency ( >=3 stools/day);
- anal incontinence;
- de novo postoperative dysuria confirmed by urodynamic work up;
- bladder atony requiring daily catheterization.
Secondary Outcome Measures:
- Percentage of women experiencing postoperative pain related to endometriosis [ Time Frame: 24 months ] [ Designated as safety issue: No ]Percentage of women presenting with dysmenorrhea, dyspareunia, chronic pelvic pain
- Percentage of women experiencing a postoperative digestive or urinary dysfunction [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
At least one of following symptoms:
- major constipation (< 1 stool/5 days) associated with defecation pain;
- increase of the stool frequency ( >=3 stools/day);
- anal incontinence;
- de novo postoperative dysuria confirmed by urodynamic work up;
- bladder atony requiring daily catheterization.
- Biberoglu & Behrman score [ Time Frame: 24 months ] [ Designated as safety issue: No ]Evaluation of endometriosis related pain using the above mentioned scale
- SF-36 quality of life scale [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- The Gastrointestinal Quality of Life Index (GIQLI) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- The Knowles-Eccersley-Scott-Symptom Questionnaire (KESS) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- Wexner questionnaire related to anal incontinence [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- percentage of women requiring endoscopic dilatation due to the stenosis of the colorectal anastomosis [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- Percentage of women presenting postoperative rectal fistulae or leakage of rectal suture or colorectal anastomosis [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | March 2015 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Rectal/colorectal segmental resection |
Procedure: Rectal/colorectal segmental resection
Resection of the rectum +/- sigmoid colon involved by the deep infiltrating endometriosis
Other Name: Anterior rectal resection
|
| Active Comparator: Rectal nodule excision |
Procedure: Rectal nodule excision
Either full thickness excision or rectal shaving
Other Name: Conservative sergery of the rectum
|
Detailed Description:
The study compare digestive and urinary functional outcomes following surgical management of rectal endometriosis by either colorectal resection or conservative surgery (shaving or full thickness excision of rectal nodules).
Patients managed for rectal endometriosis are randomized in two arms, and followed up for 24 months. The assessment of digestive and urinary functions is performed at 6, 12, 18 and 24 months using standardized questionnaires. Postoperative complications and improvement of endometriosis related pain are also recorded.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- female
- age >18 and <45
- at least one digestive symptom related to deep endometriosis (pain defecation, either cyclic diarrhea or cyclic constipation, cyclic rectorrhagia)
- preoperative work up revealing a deep endometriosis nodule infiltrating the rectum (either muscular or submucosal layer, on less than 50% of rectal circumference) and measuring at least 20 mm
- affiliation to the National Social Security System
Exclusion Criteria:
- pregnant women or likely to be at the moment of the surgery
- no preoperative hypothesis of rectal involvement
- no intraoperative confirmation of the rectal involvement
- advanced rectal endometriosis involving rectal mucosa or more than 50% of the rectal circumference (preoperative assessment using rectal endoscopy or ultrasonography)
- women unable to give an informed consent (guardianship or trusteeship)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01291576
Contacts
| Contact: Horace Roman, MD PhD | 33 232 888 754 | horace.roman@gmail.com |
Locations
| Belgium | |
| Service de Gynécologie et Obstétrique, CHR La Citadelle, Liège | Active, not recruiting |
| Liège, Belgium | |
| France | |
| University Hospital "Estaing" | Active, not recruiting |
| Clermont Ferrand, France, 63000 | |
| Clinique Gynécologique et Obstétricale, Hôpital Jeanne de Flandre | Active, not recruiting |
| Lille, France, 59037 | |
| Service de Gynécologique-Obstétricale et Reproduction Humaine, Hôpital Tenon, Université Pierre et Marie Curie Paris 6 | Active, not recruiting |
| Paris, France, 75020 | |
| Rouen University Hospital | Recruiting |
| Rouen, France, 76031 | |
| Contact: Horace Roman, MD PhD 33 232 888 754 horace.roman@gmail.com | |
| Contact: Jean Jacques Tuech, MD PhD 33 232 888 754 jean-jacques.Tuech@chu-rouen.fr | |
| Principal Investigator: Horace Roman, MD PhD | |
| Sub-Investigator: Jean-Jacques Tuech, MD PhD | |
Sponsors and Collaborators
University Hospital, Rouen
Investigators
| Principal Investigator: | Horace Roman, MD PhD | Rouen University Hospital, France |
More Information
No publications provided
| Responsible Party: | University Hospital, Rouen |
| ClinicalTrials.gov Identifier: | NCT01291576 History of Changes |
| Other Study ID Numbers: | 2009/069/HP |
| Study First Received: | January 31, 2011 |
| Last Updated: | January 8, 2013 |
| Health Authority: | France: Ministry of Health |
Keywords provided by University Hospital, Rouen:
|
Deep infiltrating endometriosis Rectal endometriosis Colorectal resection Nodule excision |
Rectal shaving Functional outcomes Constipation |
Additional relevant MeSH terms:
|
Endometriosis Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 22, 2013