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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03504930
Acronym
COLISURG
Enrollment
330
Registered
2018-04-20
Start date
2018-06-07
Completion date
2022-12-07
Last updated
2021-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

Keywords

Surgical, 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.

Interventions

OTHERImpact of biotherapy on postoperative morbidity in ulcerative colitis

Impact of biotherapy on postoperative morbidity, quality of life, sexual function, sexual health in ulcerative colitis

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Infectious complications at D30 postoperativeFirst month (Day 30) after surgery (Day 0)Infectious complications during the first month (D30) after surgery (D0)

Countries

France

Contacts

Primary ContactEddy COTTE, MD
eddy.cotte@chu-lyon.fr04 78 86 23 71
Backup ContactQuentin DENOST, MD
quentin.denost@chu-bordeaux.fr05 56 79 58 10

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026