- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02294825
The North-West Inter Regional Female Cohort for Patients With Endometriosis (CIRENDO)
The North-West Inter Regional Female Cohort for Patients With Endometriosi
All women managed for endometriosis are included and followed up through the CIRENDO database.
Information is obtained from surgical and histological records and from self-questionnaires completed before surgery. Standardized gastrointestinal questionnaires (KESS, GIQLI, WEXNER, FIQL and Bristol) are routinely used to assess bowel function. Data recording, patient contact and follow-up are carried out by a clinical research technician. Postoperative follow-up is based on data from the afore-mentioned questionnaires completed at 1, 3, 5 and 7 years.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Horace Roman
- Phone Number: +33 232 888 745
- Email: horace.roman@gmail.com
Study Locations
-
-
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Rouen, France, 76031
- Recruiting
- Clinique Gynécologique et Obstétricale
-
Contact:
- Horace Roman, MD PhD
- Phone Number: +33232888745
- Email: horace.roman@gmail.com
-
Principal Investigator:
- Horace Roman, MD PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Endometriosis revealed on histological specimens
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recurrences
Time Frame: 7 years
|
rate of recurrences at 1,3,5 and 7 years postoperatively
|
7 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Risk factors for endometriosis
Time Frame: 1 year
|
Association of various antecedents with specific localizations of features of the endometriosis
|
1 year
|
Digestive functional outcomes
Time Frame: 7 years
|
Bowel function in patients managed for bowel endometriosis by various procedures
|
7 years
|
Fertility
Time Frame: 7 years
|
Rate of pregnancy at 1, 3, 5, and 7 years postoperatively
|
7 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Horace Roman, University Hospital, Rouen
Publications and helpful links
General Publications
- Roman H, Bubenheim M, Auber M, Marpeau L, Puscasiu L. Antimullerian hormone level and endometrioma ablation using plasma energy. JSLS. 2014 Jul-Sep;18(3):e2014.00002. doi: 10.4293/JSLS.2014.00002.
- Roman H, Auber M, Bourdel N, Martin C, Marpeau L, Puscasiu L. Postoperative recurrence and fertility after endometrioma ablation using plasma energy: retrospective assessment of a 3-year experience. J Minim Invasive Gynecol. 2013 Sep-Oct;20(5):573-82. doi: 10.1016/j.jmig.2013.02.016. Epub 2013 Jun 10.
- Roman H, Ness J, Suciu N, Bridoux V, Gourcerol G, Leroi AM, Tuech JJ, Ducrotte P, Savoye-Collet C, Savoye G. Are digestive symptoms in women presenting with pelvic endometriosis specific to lesion localizations? A preliminary prospective study. Hum Reprod. 2012 Dec;27(12):3440-9. doi: 10.1093/humrep/des322. Epub 2012 Sep 7.
- Rozsnyai F, Roman H, Resch B, Dugardin F, Berrocal J, Descargues G, Schmied R, Boukerrou M, Marpeau L; CIRENDO Study Group. Outcomes of surgical management of deep infiltrating endometriosis of the ureter and urinary bladder. JSLS. 2011 Oct-Dec;15(4):439-47. doi: 10.4293/108680811X13176785203798.
- Bridoux V, Roman H, Kianifard B, Vassilieff M, Marpeau L, Michot F, Tuech JJ. Combined transanal and laparoscopic approach for the treatment of deep endometriosis infiltrating the rectum. Hum Reprod. 2012 Feb;27(2):418-26. doi: 10.1093/humrep/der422. Epub 2011 Dec 8.
- Auber M, Bourdel N, Mokdad C, Martin C, Diguet A, Marpeau L, Roman H. Ultrasound ovarian assessments after endometrioma ablation using plasma energy. Fertil Steril. 2011 Jun 30;95(8):2621-4.e1. doi: 10.1016/j.fertnstert.2011.04.090. Epub 2011 May 31.
- Vassilieff M, Suaud O, Collet-Savoye C, Da Costa C, Marouteau-Pasquier N, Belhiba H, Tuech JJ, Marpeau L, Roman H. [Computed tomography-based virtual colonoscopy: an examination useful for the choice of the surgical management of colorectal endometriosis]. Gynecol Obstet Fertil. 2011 Jun;39(6):339-45. doi: 10.1016/j.gyobfe.2011.04.004. Epub 2011 May 18. French.
- Roman H, Pura I, Tarta O, Mokdad C, Auber M, Bourdel N, Marpeau L, Sabourin JC. Vaporization of ovarian endometrioma using plasma energy: histologic findings of a pilot study. Fertil Steril. 2011 Apr;95(5):1853-6.e1-4. doi: 10.1016/j.fertnstert.2010.11.038. Epub 2010 Dec 17.
- Badescu A, Roman H, Barsan I, Soldea V, Nastasia S, Aziz M, Puscasiu L, Stolnicu S. Patterns of Bowel Invisible Microscopic Endometriosis Reveal the Goal of Surgery: Removal of Visual Lesions Only. J Minim Invasive Gynecol. 2018 Mar-Apr;25(3):522-527.e9. doi: 10.1016/j.jmig.2017.10.026. Epub 2017 Oct 31.
- Darwish B, Stochino-Loi E, Pasquier G, Dugardin F, Defortescu G, Abo C, Roman H. Surgical Outcomes of Urinary Tract Deep Infiltrating Endometriosis. J Minim Invasive Gynecol. 2017 Sep-Oct;24(6):998-1006. doi: 10.1016/j.jmig.2017.06.005. Epub 2017 Jun 15.
- Roman H, Darwish B, Bridoux V, Chati R, Kermiche S, Coget J, Huet E, Tuech JJ. Functional outcomes after disc excision in deep endometriosis of the rectum using transanal staplers: a series of 111 consecutive patients. Fertil Steril. 2017 Apr;107(4):977-986.e2. doi: 10.1016/j.fertnstert.2016.12.030. Epub 2017 Jan 27.
- Roman H, Hennetier C, Darwish B, Badescu A, Csanyi M, Aziz M, Tuech JJ, Abo C. Bowel occult microscopic endometriosis in resection margins in deep colorectal endometriosis specimens has no impact on short-term postoperative outcomes. Fertil Steril. 2016 Feb;105(2):423-9.e7. doi: 10.1016/j.fertnstert.2015.09.030. Epub 2015 Oct 29.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2009-099-HP
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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