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

Civil Hospices of Lyon

Status: Unknown

Conditions: Ulcerative Colitis

Treatments: Other: Impact of biotherapy on postoperative morbidity in ulcerative colitis

Study type: Observational

Funder types: Other

Identifiers

NCT03504930

69HCL18_0178

Details and patient eligibility

About

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.

Enrollment: 330 estimated patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

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

Trial design

330 participants in 1 patient group

Impact of biotherapy on postoperative morbidity

Description:

Impact of biotherapy on postoperative morbidity in ulcerative colitis

Treatment:

Other: Impact of biotherapy on postoperative morbidity in ulcerative colitis