COLISURG : Exploratory Analysis of Sexual Function and the Impact of Biotherapies on Postoperative Morbidity. (COLISURG)

July 26, 2021 updated by: Hospices Civils de Lyon

COLISURG Prospective, Multicentric Cohort of Ulcerative Colitis Requiring Surgical Treatment With Ileal Pouch-anal Anastomosis. Impact of Biotherapies on Sexual Function and Postoperative Morbidity.

The surgical treatment of the ulcerative colitis (UC) remains associate to a significant morbidity (up to 60%). Anastomotic fistula and pelvic sepsis are the most severe complications which could dramatically compromise the surgical issue and functional status. Thanks to the current therapeutic arsenal and the evolution of health care paradigms, the quality of life of patients plays a key role in the modern global management of these medical conditions. Biotherapies (e.g anti-TNF) are widely used to treat patients with UC. Anti-TNF and anti-integrins have an effect on the immune response and can theoretically aggravate the infectious disease. Their potential impact on postoperative complications after ileo anal anastomosis (AIA) remains debated. Very few studies have looked at other biotherapies including vedolizumab. All studies are retrospective series with small sample size. Here again the conclusion remain contradictory. Lightner et al. showed an increased risk of surgical site infection for patients preoperatively exposed to vedolizumab (37% vs. 10%, p <0.001). In a dedicated cohort to the RCH, the same author found a risk of increased pelvic abscess (31.3% vs 5.9%, NS) but the difference was not statistically significant probably for lack of power. Other studies did not find any impact of vedolizumab on the risk of postoperative complications. To clearly determine within a large prospective cohort the impact of anti-TNF agents and biotherapies on the postoperative complications seems to be essential in order to adapt and to optimize the therapeutic strategy, especially the surgical sequences, in patients with UCR whom benefit a surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

330

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Besançon, France
      • Caen, France
        • Not yet recruiting
        • Centre Hospitalier Universitaire de Caen
        • Contact:
          • Arnaud ALVES, MD
        • Contact:
        • Principal Investigator:
          • Arnaud ALVES, MD
      • Clermont-Ferrand, France
        • Not yet recruiting
        • Centre Hospitalier Universitaire de Clermont-Ferrand
        • Contact:
        • Principal Investigator:
          • Anne Dubois, MD
        • Sub-Investigator:
          • Denis PEZET, MD
      • Clichy, France
        • Recruiting
        • APHP - Hôpital Beaujon
        • Contact:
        • Principal Investigator:
          • Yves PANIS, MD
        • Sub-Investigator:
          • Léon MAGGIORI, MD
      • La Tronche, France
        • Recruiting
        • Centre Hospitalier Universitaire de Grenoble
        • Principal Investigator:
          • Jean-Luc FAUCHERON, MD
        • Contact:
        • Sub-Investigator:
          • Bertrand TRILLING, MD
        • Sub-Investigator:
          • Pierre-Yves SAGE, MD
      • Le Kremlin-Bicêtre, France
        • Recruiting
        • APHP - Hôpital Kremlin-Bicêtre
        • Contact:
        • Sub-Investigator:
          • Stéphane BENOIST, MD
      • Lille, France
        • Recruiting
        • Centre Hospitalier Universitaire De Lille
        • Contact:
        • Principal Investigator:
          • Philippe ZERBIB, MD
      • Marseille, France
        • Recruiting
        • APHM - Hopital Nord
        • Contact:
        • Principal Investigator:
          • Laura Beyer-Berjot, MD
        • Sub-Investigator:
          • Stéphane BERDAH, MD
      • Nice, France
        • Recruiting
        • Centre Hospitalier Universitaire de Nice - Hôpital L'Archet II
        • Contact:
        • Principal Investigator:
          • Amine RAHILI, MD
      • Paris, France
        • Not yet recruiting
        • Institut Mutualiste Montsouris
        • Contact:
        • Principal Investigator:
          • Christine DENET, MD
      • Paris, France
        • Not yet recruiting
        • APHP - Hôpital Européen Georges Pompidou
        • Contact:
        • Principal Investigator:
          • Richard DOUARD, MD
      • Paris, France
        • Not yet recruiting
        • APHP - Hopital Cochin
        • Contact:
        • Principal Investigator:
          • Mahaut LECONTE, MD
      • Paris, France
        • Recruiting
        • APHP - Hôpital St Antoine
        • Contact:
        • Sub-Investigator:
          • Yann PARC, MD
      • Paris, France
        • Not yet recruiting
        • APHP - Hôpital St Louis
        • Contact:
        • Principal Investigator:
          • Hélène Corte, MD
      • Pessac, France
        • Recruiting
        • Hôpital Haut-Lévêque
        • Contact:
        • Sub-Investigator:
          • Eric RULLIER, MD
      • Pierre-Bénite, France
        • Recruiting
        • Centre Hospitalier Lyon Sud
        • Contact:
        • Sub-Investigator:
          • Yves FRANCOIS, MD
      • Rennes, France
      • Rouen, France
        • Not yet recruiting
        • Centre Hospitalier Universitaire de Rouen
        • Contact:
        • Sub-Investigator:
          • Valérie BRIDOUX, MD
      • Strasbourg, France
        • Recruiting
        • Centre Hospitalier Universitaire de Strasbourg
        • Contact:
        • Sub-Investigator:
          • Benoît ROMAIN, MD
      • Toulouse, France
        • Not yet recruiting
        • Centre Hospitalier Universitaire de Toulouse
        • Contact:
        • Principal Investigator:
          • Jean-Pierre DUFFAS, MD
      • Tours, France
        • Recruiting
        • Centre Hospitalier Universitaire de Tours
        • Contact:
        • Principal Investigator:
          • Mehdi OUAISSI, MD
      • Vandœuvre-lès-Nancy, France
        • Recruiting
        • Centre hospitalier universitaire de NANCY
        • Contact:
        • Sub-Investigator:
          • Laurent BRESLER, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with ulcerative colitis requiring surgical treatment with ileal pouch-anal anastomosis

Description

Inclusion Criteria:

Age ≥ 13 ans

- Patients with ulcerative colitis requiring surgical treatment with ileal pouch-anal anastomosis

Exclusion Criteria:

  • Age < 13 ans
  • Under any administrative or legal supervision

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Impact of biotherapy on postoperative morbidity
Impact of biotherapy on postoperative morbidity in ulcerative colitis
Other: Impact of biotherapy on postoperative morbidity in ulcerative colitis
Impact of biotherapy on postoperative morbidity, quality of life, sexual function, sexual health in ulcerative colitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infectious complications at D30 postoperative
Time Frame: First month (Day 30) after surgery (Day 0)
Infectious complications during the first month (D30) after surgery (D0)
First month (Day 30) after surgery (Day 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Eddy COTTE, MD, Hospices Civils de Lyon
  • Principal Investigator: Quentin DENOST, MD, CHU Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 7, 2018

Primary Completion (ANTICIPATED)

June 1, 2022

Study Completion (ANTICIPATED)

December 7, 2022

Study Registration Dates

First Submitted

April 12, 2018

First Submitted That Met QC Criteria

April 12, 2018

First Posted (ACTUAL)

April 20, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 28, 2021

Last Update Submitted That Met QC Criteria

July 26, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL18_0178

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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