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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospices Civils de Lyon

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 7, 2018

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 7, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 28, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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