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

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ClinicalTrials.gov Identifier: NCT02294825
Recruitment Status : Recruiting
First Posted : November 19, 2014
Last Update Posted : May 16, 2018
Sponsor:
Collaborators:
University Hospital, Lille
University Hospital, Caen
Amiens University Hospital
Information provided by (Responsible Party):
University Hospital, Rouen

Brief 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.


Condition or disease Intervention/treatment
Endometriosis Procedure: various surgical procedures in endometriosis

Detailed 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).

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 7 Years
Official Title: The North-West Inter Regional Female Cohort for Patients With Endometriosi
Study Start Date : June 2009
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis


Intervention Details:
  • 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


Primary Outcome Measures :
  1. Recurrences [ Time Frame: 7 years ]
    rate of recurrences at 1,3,5 and 7 years postoperatively


Secondary Outcome Measures :
  1. Risk factors for endometriosis [ Time Frame: 1 year ]
    Association of various antecedents with specific localizations of features of the endometriosis

  2. Digestive functional outcomes [ Time Frame: 7 years ]
    Bowel function in patients managed for bowel endometriosis by various procedures

  3. Fertility [ Time Frame: 7 years ]
    Rate of pregnancy at 1, 3, 5, and 7 years postoperatively



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients surgically managed for endometriosis in one of centers involved in the study
Criteria

Inclusion Criteria:

  • Endometriosis revealed on histological specimens

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02294825


Contacts
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Contact: Horace Roman +33 232 888 745 horace.roman@gmail.com

Locations
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France
Clinique Gynécologique et Obstétricale Recruiting
Rouen, France, 76031
Contact: Horace Roman, MD PhD    +33232888745    horace.roman@gmail.com   
Principal Investigator: Horace Roman, MD PhD         
Sponsors and Collaborators
University Hospital, Rouen
University Hospital, Lille
University Hospital, Caen
Amiens University Hospital
Investigators
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Principal Investigator: Horace Roman University Hospital, Rouen

Additional Information:

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT02294825     History of Changes
Other Study ID Numbers: 2009-099-HP
First Posted: November 19, 2014    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018

Keywords provided by University Hospital, Rouen:
deep endometriosis;
colorectal endometriosis
surgery
medical treatment
fertility

Additional relevant MeSH terms:
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Endometriosis
Genital Diseases, Female