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

Study Overview
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Brief Summary
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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.

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

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Other: Impact of biotherapy on postoperative morbidity in ulcerative colitis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Impact of biotherapy on postoperative morbidity<br>Impact of biotherapy on postoperative morbidity in ulcerative colitis | Other: Impact of biotherapy on postoperative morbidity in ulcerative colitis<br>* Impact of biotherapy on postoperative morbidity, quality of life, sexual function, sexual health in ulcerative colitis<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgical, Ileal pouch-anal anastomosis