The North-West Inter Regional Female Cohort for Patients With Endometriosis

Endometriosis Clinical Trial

— CIRENDO  

Official title:

The North-West Inter Regional Female Cohort for Patients With Endometriosi

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02294825
• Other study ID #: 2009-099-HP
• Status: Recruiting
• Start date: June 2009
• Est. completion date: June 2022

Study information

• Verified date: October 2019
• Source: University Hospital, Rouen
• Contact: Horace Roman
• Phone: +33 232 888 745
• Email: horace.roman[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

All women managed for endometriosis are included and followed up through the CIRENDO database (the North-West Inter Regional Female Cohort for Patients with Endometriosis), a prospective cohort financed by the G4 Group (The University Hospitals of Rouen, Lille, Amiens and Caen), and coordinated by the principal investigator (H.R.). 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. Women are included in the CIRENDO database only when endometriosis is confirmed by both surgical exploration and biopsy. Postoperative follow-up is based on data from the afore-mentioned questionnaires completed at 1, 3, 5 and 7 years. Prospective data recording and analysis were approved by the French authorities CNIL (Commission Nationale de l'Informatique et des Libertés) and CCTIRS (Comité Consultatif pour le Traitement de l'Information en matière de Recherche dans le domaine de la Santé).

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Endometriosis

Intervention

Procedure:
• various surgical procedures in endometriosis
Shaving, disc excision and colorectal resection; ureterolysis or ureter resection; bladder resection; ablation of endometriomas using plasma energy; excision and ablation of deep and superficial lesions

Locations

Country	Name	City	State
France	Clinique Gynécologique et Obstétricale	Rouen

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Rouen	Amiens University Hospital, University Hospital, Caen, University Hospital, Lille

Country where clinical trial is conducted

France, 

References & Publications (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. — 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

Outcome

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