COLISURG : Exploratory Analysis of Sexual Function and the Impact of Biotherapies on Postoperative Morbidity.
COLISURG
COLISURG Prospective, Multicentric Cohort of Ulcerative Colitis Requiring Surgical Treatment With Ileal Pouch-anal Anastomosis. Impact of Biotherapies on Sexual Function and Postoperative Morbidity.
1 other identifier
observational
330
1 country
22
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2018
Longer than P75 for all trials
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2018
CompletedFirst Posted
Study publicly available on registry
April 20, 2018
CompletedStudy Start
First participant enrolled
June 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 7, 2022
CompletedJuly 28, 2021
July 1, 2021
4 years
April 12, 2018
July 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Infectious complications at D30 postoperative
Infectious complications during the first month (D30) after surgery (D0)
First month (Day 30) after surgery (Day 0)
Study Arms (1)
Impact of biotherapy on postoperative morbidity
Impact of biotherapy on postoperative morbidity in ulcerative colitis
Interventions
Impact of biotherapy on postoperative morbidity, quality of life, sexual function, sexual health in ulcerative colitis
Eligibility Criteria
Patients with ulcerative colitis requiring surgical treatment with ileal pouch-anal anastomosis
You may qualify if:
- Age ≥ 13 ans
- \- Patients with ulcerative colitis requiring surgical treatment with ileal pouch-anal anastomosis
You may not qualify if:
- Age \< 13 ans
- Under any administrative or legal supervision
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Centre Hospitalier Universitaire de Besançon
Besançon, France
Centre Hospitalier Universitaire de Caen
Caen, France
Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand, France
APHP - Hôpital Beaujon
Clichy, France
Centre Hospitalier Universitaire de Grenoble
La Tronche, France
APHP - Hôpital Kremlin-Bicêtre
Le Kremlin-Bicêtre, France
Centre Hospitalier Universitaire de Lille
Lille, France
APHM - Hôpital Nord
Marseille, France
Centre Hospitalier Universitaire de Nice - Hôpital L'Archet II
Nice, France
APHP - Hôpital Cochin
Paris, France
APHP - Hôpital Européen Georges Pompidou
Paris, France
APHP - Hôpital St Antoine
Paris, France
APHP - Hôpital St Louis
Paris, France
Institut Mutualiste Montsouris
Paris, France
Hôpital Haut-Lévêque
Pessac, France
Centre Hospitalier Lyon SUD
Pierre-Bénite, France
Centre Hospitalier Universitaire de Rennes
Rennes, France
Centre Hospitalier Universitaire de Rouen
Rouen, France
Centre Hospitalier Universitaire de Strasbourg
Strasbourg, France
Centre Hospitalier Universitaire de Toulouse
Toulouse, France
Centre Hospitalier Universitaire de Tours
Tours, France
Centre Hospitalier Universitaire de Nancy
Vandœuvre-lès-Nancy, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eddy COTTE, MD
Hospices Civils de Lyon
- PRINCIPAL INVESTIGATOR
Quentin DENOST, MD
University Hospital, Bordeaux
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2018
First Posted
April 20, 2018
Study Start
June 7, 2018
Primary Completion
June 1, 2022
Study Completion
December 7, 2022
Last Updated
July 28, 2021
Record last verified: 2021-07