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EndometriosisCIRENDONCT02294825

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

An observational study of Endometriosis, run by University Hospital, Rouen at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 50 years, women only
Conditions the study is for
Endometriosis
What is being tested?
various surgical procedures in endometriosis
Type of treatment
Surgery or procedure
How many people
1,500 participants
Where
1 siteFrance
Study dates
Jun 2009to Jun 2022
How long will I take part?
7 Years
Phase
Observational
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 50 years
  • Women only
  • No healthy volunteers
  • Adult

Study population: Patients surgically managed for endometriosis in one of centers involved in the study

Who may be able to join

  • Endometriosis revealed on histological specimens

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

Horace Roman contact

+33 232 888 745

horace.roman@gmail.com

France1 site, 1 recruiting

  • Clinique Gynécologique et Obstétricale

    Rouen, 76031

    Horace Roman, MD PhD, +33232888745, horace.roman@gmail.com

    Horace Roman, MD PhD

    Recruiting

Other trials in France

About this study

Official title: 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.

Read the 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).

Conditions
Endometriosis
Being tested
various surgical procedures in endometriosis
Keywords
deep endometriosis;, colorectal endometriosis, surgery, medical treatment, fertility
Medical subject headings
Endometriosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • various surgical procedures in endometriosisProcedure or surgery

    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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recurrences

    rate of recurrences at 1,3,5 and 7 years postoperatively

    Measured: 7 years

Secondary outcomes (3)

  1. Risk factors for endometriosis

    Association of various antecedents with specific localizations of features of the endometriosis

    Measured: 1 year

  2. Digestive functional outcomes

    Bowel function in patients managed for bowel endometriosis by various procedures

    Measured: 7 years

  3. Fertility

    Rate of pregnancy at 1, 3, 5, and 7 years postoperatively

    Measured: 7 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2014 (estimated)
  2. Study startJun 2009
  3. Primary completionJun 2022 (estimated)
  4. Study completionJun 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,500 participants (estimated)
Target duration
7 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02294825
Sponsor's protocol ID
2009-099-HP
Acronym
CIRENDO
Status last verified
Oct 2019
First submitted
16 Nov 2014
Last updated
24 Oct 2019
Results posted
No
Data monitoring committee
No

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.

    PubMed 25392649

  • 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.

    PubMed 23759693

  • 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.

    PubMed 22962316

  • 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.

    PubMed 22643496

  • 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.

    PubMed 22158086

  • 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.

    PubMed 21621773

  • 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.

    PubMed 21596608

  • 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.

    PubMed 21168130

  • Roman H, Braund S, Hennetier C, Celhay O, Pasquier G, Kade S, Dennis T, Merlot B. Combined Cystoscopic-Abdominal Versus Abdominal-Only Route for Complete Excision of Large Deep Endometriosis Nodules Infiltrating the Supratrigonal Area of the Bladder: A Comparative Study. J Minim Invasive Gynecol. 2024 Apr;31(4):295-303. doi: 10.1016/j.jmig.2024.01.007. Epub 2024 Jan 18.

    PubMed 38244721

  • 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.

    PubMed 29097234

  • 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.

    PubMed 28624664

  • 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.

    PubMed 28139235

  • 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.

    PubMed 26474734

Questions about this trial

What is this clinical trial studying?

An observational study of Endometriosis, run by University Hospital, Rouen at 1 site 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Horace Roman (+33 232 888 745, horace.roman@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrences (time frame: 7 years). 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 NCT02294825, which also lists 13 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 24 Oct 2019.

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