Informations générales (source: ClinicalTrials.gov)
COLISURG Prospective, Multicentric Cohort of Ulcerative Colitis Requiring Surgical Treatment With Ileal Pouch-anal Anastomosis. Impact of Biotherapies on Sexual Function and Postoperative Morbidity. (COLISURG)
Observational
Hospices Civils de Lyon (Voir sur ClinicalTrials)
juin 2018
décembre 2022
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Beaujon | Yves PANIS, MD | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Cochin | Mahaut LECONTE, MD | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Europeen Georges Pompidou | Richard DOUARD, MD | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Saint Antoine | Jérémie LEFEVRE, MD | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| APHM - Hôpital Nord - Marseille - France | Laura BEYER-BERJOT, MD | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire de Nice - Hôpital L'Archet II - Nice - France | Amine RAHILI, MD | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire de Rennes - Rennes - France | Véronique DESFOURNEAUX, MD | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire de Rouen - Rouen - France | Jean-Jacques TUECH, MD | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire de Strasbourg - Strasbourg - France | Cécile BRIGAND, MD | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire de Toulouse - Toulouse - France | Jean-Pierre DUFFAS, MD | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire de Tours - Tours - France | Mehdi OUAISSI, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| APHP - Hôpital Kremlin-Bicêtre - Le Kremlin-Bicêtre - France | Antoine BROUQUET, MD | Contact (sur clinicalTrials) | |||
| APHP - Hôpital St Louis - Paris - France | Hélène CORTE, MD | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Lyon SUD - Pierre-Bénite - France | Eddy COTTE, MD | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire de Besançon - Besançon - France | Zaher LAKKIS, MD | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire de Caen - Caen - France | Arnaud ALVES, MD | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire de Clermont-Ferrand - Clermont-Ferrand - France | Anne DUBOIS, MD | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire de Grenoble - La Tronche - France | Jean-Luc FAUCHERON, MD | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire de Lille - Lille - France | Philippe ZERBIB, MD | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Universitaire de Nancy - Vandœuvre-lès-Nancy - France | Adeline GERMAIN, MD | Contact (sur clinicalTrials) | |||
| Hôpital Haut-Lévêque - Pessac - France | Quentin DENOST, MD | Contact (sur clinicalTrials) | |||
| Institut Mutualiste Montsouris - Paris - France | Christine DENET, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
Age ≥ 13 ans
- Patients with ulcerative colitis requiring surgical treatment with ileal pouch-anal
anastomosis
Age ≥ 13 ans
- Patients with ulcerative colitis requiring surgical treatment with ileal pouch-anal
anastomosis
- Age < 13 ans
- Under any administrative or legal supervision