Endometriosis Clinical Trial
— CIRENDOOfficial title:
The North-West Inter Regional Female Cohort for Patients With Endometriosi
NCT number | NCT02294825 |
Other study ID # | 2009-099-HP |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 2009 |
Est. completion date | June 2022 |
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.
Status | Recruiting |
Enrollment | 1500 |
Est. completion date | June 2022 |
Est. primary completion date | June 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Endometriosis revealed on histological specimens Exclusion Criteria: - None |
Country | Name | City | State |
---|---|---|---|
France | Clinique Gynécologique et Obstétricale | Rouen |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Rouen | Amiens University Hospital, University Hospital, Caen, University Hospital, Lille |
France,
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. — View Citation
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 — View Citation
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 — View Citation
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). pii: e2014.00002. doi: 10.4293/JSLS.2014.00002. — View Citation
Roman H, Ness J, Suciu N, Bridoux V, Gourcerol G, Leroi AM, Tuech JJ, Ducrotté 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 — View Citation
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.2010.11.03 — View Citation
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- — View Citation
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] — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recurrences | rate of recurrences at 1,3,5 and 7 years postoperatively | 7 years | |
Secondary | Risk factors for endometriosis | Association of various antecedents with specific localizations of features of the endometriosis | 1 year | |
Secondary | Digestive functional outcomes | Bowel function in patients managed for bowel endometriosis by various procedures | 7 years | |
Secondary | Fertility | Rate of pregnancy at 1, 3, 5, and 7 years postoperatively | 7 years |
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