Endometriosis, RectumENDORENCT01291576
Functional Outcomes of Surgical Management of Deep Endometriosis Infiltrating the Rectum
A study testing Rectal/colorectal segmental resection and Rectal nodule excision in people with Endometriosis, Rectum, run by University Hospital, Rouen at 3 sites in France.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis, Rectum
- What is being tested?
- Rectal/colorectal segmental resection and Rectal nodule excision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesFrance
- Study dates
- Mar 2011to 22 Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country.
France3 sites
Service de Gynécologie et Obstétrique, CHU Jean de Flandre
Lille, 59000
Service de Gynécologique-Obstétricale et Reproduction Humaine, Hôpital Tenon, Université Pierre et Marie Curie Paris 6
Paris, 75020
Rouen University Hospital
Rouen, 76031
About this study
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)
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).
Read the 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.
- Conditions
- Endometriosis, Rectum
- Being tested
- Rectal/colorectal segmental resection, Rectal nodule excision
- Keywords
- Deep infiltrating endometriosis, Rectal endometriosis, Colorectal resection, Nodule excision, Rectal shaving, Functional outcomes, Constipation
- Medical subject headings
- Endometriosis, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectal/colorectal segmental resectionProcedure or surgery
Also called Anterior rectal resection
Resection of the rectum +/- sigmoid colon involved by the deep infiltrating endometriosis
Rectal nodule excisionProcedure or surgery
Also called Conservative sergery of the rectum
Either full thickness excision or rectal shaving
| Study group | Role | What they receive |
|---|---|---|
| Rectal/colorectal segmental resection | Active comparator | Not described Receives: Procedure: Rectal/colorectal segmental resection |
| Rectal nodule excision | Active comparator | Not described Receives: Procedure: Rectal nodule excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of women experiencing a postoperative digestive or urinary dysfunction
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.
Measured: 24 months
Secondary outcomes (9)
Percentage of women experiencing postoperative pain related to endometriosis
Percentage of women presenting with dysmenorrhea, dyspareunia, chronic pelvic pain
Measured: 24 months
Percentage of women experiencing a postoperative digestive or urinary dysfunction
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.
Measured: 12 months
Biberoglu & Behrman score
Evaluation of endometriosis related pain using the above mentioned scale
Measured: 24 months
SF-36 quality of life scale
Measured: 24 months
The Gastrointestinal Quality of Life Index (GIQLI)
Measured: 24 months
The Knowles-Eccersley-Scott-Symptom Questionnaire (KESS)
Measured: 24 months
Wexner questionnaire related to anal incontinence
Measured: 24 months
percentage of women requiring endoscopic dilatation due to the stenosis of the colorectal anastomosis
Measured: 24 months
Percentage of women presenting postoperative rectal fistulae or leakage of rectal suture or colorectal anastomosis
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2011 (estimated)
- Study startMar 2011
- Primary completionSep 2013
- Study completion22 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Endometriosis, RectumStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Horace Roman, MD PhD, Principal investigator, Rouen University Hospital, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01291576
- Sponsor's protocol ID
- 2009/069/HP
- Acronym
- ENDORE
- Status last verified
- Oct 2025
- First submitted
- 31 Jan 2011
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Roman H, Tuech JJ, Huet E, Bridoux V, Khalil H, Hennetier C, Bubenheim M, Branduse LA. Excision versus colorectal resection in deep endometriosis infiltrating the rectum: 5-year follow-up of patients enrolled in a randomized controlled trial. Hum Reprod. 2019 Dec 1;34(12):2362-2371. doi: 10.1093/humrep/dez217.
PubMed 31820806Roman H, Chanavaz-Lacheray I, Ballester M, Bendifallah S, Touleimat S, Tuech JJ, Farella M, Merlot B. High postoperative fertility rate following surgical management of colorectal endometriosis. Hum Reprod. 2018 Sep 1;33(9):1669-1676. doi: 10.1093/humrep/dey146.
PubMed 30052994
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01291576
- Acronym / sponsor ID
- ENDORE / 2009/069/HP
- Conditions
- Endometriosis, Rectum
- Keywords
- Deep infiltrating endometriosis, Rectal endometriosis, Colorectal resection, Nodule excision, Rectal shaving, Functional outcomes, Constipation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Mar 2011 (actual)
- Primary completion
- Sep 2013 (actual)
- Study completion
- 22 Sep 2015 (actual)
- First posted
- 8 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rectal/colorectal segmental resection | Active comparator | Procedure: Rectal/colorectal segmental resection |
| Rectal nodule excision | Active comparator | Procedure: Rectal nodule excision |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rectal/colorectal segmental resectionAlso: Anterior rectal resectionResection of the rectum +/- sigmoid colon involved by the deep infiltrating endometriosis | Procedure or surgery | Rectal/colorectal segmental resection |
| Rectal nodule excisionAlso: Conservative sergery of the rectumEither full thickness excision or rectal shaving | Procedure or surgery | Rectal nodule excision |
Primary outcome
Percentage of women experiencing a postoperative digestive or urinary dysfunction
Time frame: 24 months
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.
9 secondary outcomes
Percentage of women experiencing postoperative pain related to endometriosis
Time frame: 24 months
Percentage of women experiencing a postoperative digestive or urinary dysfunction
Time frame: 12 months
Biberoglu & Behrman score
Time frame: 24 months
SF-36 quality of life scale
Time frame: 24 months
The Gastrointestinal Quality of Life Index (GIQLI)
Time frame: 24 months
The Knowles-Eccersley-Scott-Symptom Questionnaire (KESS)
Time frame: 24 months
Wexner questionnaire related to anal incontinence
Time frame: 24 months
percentage of women requiring endoscopic dilatation due to the stenosis of the colorectal anastomosis
Time frame: 24 months
Percentage of women presenting postoperative rectal fistulae or leakage of rectal suture or colorectal anastomosis
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Derived from this study: PubMed 31820806Roman H, Tuech JJ, Huet E, Bridoux V, Khalil H, Hennetier C, Bubenheim M, Branduse LA. Excision versus colorectal resection in deep endometriosis infiltrating the rectum: 5-year follow-up of patients enrolled in a randomized controlled trial. Hum Reprod. 2019 Dec 1;34(12):2362-2371. doi: 10.1093/humrep/dez217.
- Derived from this study: PubMed 30052994Roman H, Chanavaz-Lacheray I, Ballester M, Bendifallah S, Touleimat S, Tuech JJ, Farella M, Merlot B. High postoperative fertility rate following surgical management of colorectal endometriosis. Hum Reprod. 2018 Sep 1;33(9):1669-1676. doi: 10.1093/humrep/dey146.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Horace Roman, MD PhD principal investigator
Rouen University Hospital, France
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rectal/colorectal segmental resection and Rectal nodule excision in people with Endometriosis, Rectum, run by University Hospital, Rouen at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of women experiencing a postoperative digestive or urinary dysfunction (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01291576, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.