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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03504930
Other study ID # 69HCL18_0178
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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