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

Ulcerative Colitis Clinical Trial

— COLISURG  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03504930
• Other study ID #: 69HCL18_0178
• Status: Recruiting
• Start date: June 7, 2018
• Est. completion date: December 7, 2022

Study information

• Verified date: July 2021
• Source: Hospices Civils de Lyon
• Contact: Eddy COTTE, MD
• Phone: 04 78 86 23 71
• Email: eddy.cotte[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: December 7, 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

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

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infectious complications at D30 postoperative	Infectious complications during the first month (D30) after surgery (D0)	First month (Day 30) after surgery (Day 0)