Clinical trial NCT03504930: COLISURG : Exploratory Analysis of Sexual Function and the Impact of Biotherapies on Postoperative Morbidity.
Official title: COLISURG Prospective, Multicentric Cohort of Ulcerative Colitis Requiring Surgical Treatment With Ileal Pouch-anal Anastomosis. Impact of Biotherapies on Sexual Function and Postoperative Morbidity.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ulcerative Colitis
Keywords: Surgical
Ileal pouch-anal anastomosis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-04-20
Enrollment: 330
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with ulcerative colitis requiring surgical treatment with ileal pouch-anal anastomosis

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.


Eligibility criteria: 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

Primary outcomes:
measure: Infectious complications at D30 postoperative
timeFrame: First month (Day 30) after surgery (Day 0)
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: Centre Hospitalier Universitaire de Besançon
city: Caen
country: France
facility: Centre Hospitalier Universitaire de Caen
city: Clermont-Ferrand
country: France
facility: Centre Hospitalier Universitaire de Clermont-Ferrand
city: Clichy
country: France
facility: APHP - Hôpital Beaujon
city: La Tronche
country: France
facility: Centre Hospitalier Universitaire de Grenoble
city: Le Kremlin-Bicêtre
country: France
facility: APHP - Hôpital Kremlin-Bicêtre
city: Lille
country: France
facility: Centre Hospitalier Universitaire de Lille
city: Marseille
country: France
facility: APHM - Hôpital Nord
city: Nice
country: France
facility: Centre Hospitalier Universitaire de Nice - Hôpital L'Archet II
city: Paris
country: France
facility: APHP - Hôpital Cochin
city: Paris
country: France
facility: APHP - Hôpital Européen Georges Pompidou
city: Paris
country: France
facility: APHP - Hôpital St Antoine
city: Paris
country: France
facility: APHP - Hôpital St Louis
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Pessac
country: France
facility: Hôpital Haut-Lévêque
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon SUD
city: Rennes
country: France
facility: Centre Hospitalier Universitaire de Rennes
city: Rouen
country: France
facility: Centre Hospitalier Universitaire de Rouen
city: Strasbourg
country: France
facility: Centre Hospitalier Universitaire de Strasbourg
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire de Toulouse
city: Tours
country: France
facility: Centre Hospitalier Universitaire de Tours
city: Vandœuvre-lès-Nancy
country: France
facility: Centre Hospitalier Universitaire de Nancy
Study officials:
affiliation: Hospices Civils de Lyon
name: Eddy COTTE, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: Quentin DENOST, MD
role: PRINCIPAL_INVESTIGATOR
References: