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

• Conditions: Ulcerative Colitis
• Interventions: Other: Impact of biotherapy on postoperative morbidity in ulcerative colitis

• Registration Number: NCT03504930
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-12
• Study First Submitted QC: 2018-04-12
• Study First Posted: 2018-04-20
• Study Start: 2018-06-07
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-26
• Last Update Posted: 2021-07-28
• Primary Completion: 2022-06
• Study Completion: 2022-12-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

Age ≥ 13 ans

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Impact of biotherapy on postoperative morbidity	Impact of biotherapy on postoperative morbidity in ulcerative colitis	Impact of biotherapy on postoperative morbidity in ulcerative colitis

Primary Outcome Measures

Name	Time	Method
Infectious complications at D30 postoperative	First month (Day 30) after surgery (Day 0)	Infectious complications during the first month (D30) after surgery (D0)

Trial Locations

Locations (22)

Centre Hospitalier Universitaire de Besançon; 🇫🇷 Besançon, France

Centre Hospitalier Universitaire de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

Centre Hospitalier Universitaire de Caen; 🇫🇷 Caen, France

APHP - Hôpital Beaujon; 🇫🇷 Clichy, France

Centre Hospitalier Universitaire de Grenoble; 🇫🇷 La Tronche, France

APHP - Hôpital Cochin; 🇫🇷 Paris, France

APHM - Hôpital Nord; 🇫🇷 Marseille, France

Centre Hospitalier Universitaire de Lille; 🇫🇷 Lille, France

Centre Hospitalier Universitaire de Nice - Hôpital L'Archet II; 🇫🇷 Nice, 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

Centre Hospitalier Universitaire de Rennes; 🇫🇷 Rennes, France

Hôpital Haut-Lévêque; 🇫🇷 Pessac, 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 Lyon SUD; 🇫🇷 Pierre-Bénite, France

APHP - Hôpital Kremlin-Bicêtre; 🇫🇷 Le Kremlin-Bicêtre, France

Centre Hospitalier Universitaire de Nancy; 🇫🇷 Vandœuvre-lès-Nancy, France