COLISURG : Exploratory Analysis of Sexual Function and the Impact of Biotherapies on Postoperative Morbidity.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Impact of biotherapy on postoperative morbidity Impact of biotherapy on postoperative morbidity in ulcerative colitis |
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
|
Outcome Measures
Primary Outcome Measures
- Infectious complications at D30 postoperative [First month (Day 30) after surgery (Day 0)]
Infectious complications during the first month (D30) after surgery (D0)
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre Hospitalier Universitaire de Besançon | Besançon | France | ||
| 2 | Centre Hospitalier Universitaire de Caen | Caen | France | ||
| 3 | Centre Hospitalier Universitaire de Clermont-Ferrand | Clermont-Ferrand | France | ||
| 4 | APHP - Hôpital Beaujon | Clichy | France | ||
| 5 | Centre Hospitalier Universitaire de Grenoble | La Tronche | France | ||
| 6 | APHP - Hôpital Kremlin-Bicêtre | Le Kremlin-Bicêtre | France | ||
| 7 | Centre Hospitalier Universitaire de Lille | Lille | France | ||
| 8 | APHM - Hôpital Nord | Marseille | France | ||
| 9 | Centre Hospitalier Universitaire de Nice - Hôpital L'Archet II | Nice | France | ||
| 10 | APHP - Hôpital Cochin | Paris | France | ||
| 11 | APHP - Hôpital Européen Georges Pompidou | Paris | France | ||
| 12 | APHP - Hôpital St Antoine | Paris | France | ||
| 13 | APHP - Hôpital St Louis | Paris | France | ||
| 14 | Institut Mutualiste Montsouris | Paris | France | ||
| 15 | Hôpital Haut-Lévêque | Pessac | France | ||
| 16 | Centre Hospitalier Lyon SUD | Pierre-Bénite | France | ||
| 17 | Centre Hospitalier Universitaire de Rennes | Rennes | France | ||
| 18 | Centre Hospitalier Universitaire de Rouen | Rouen | France | ||
| 19 | Centre Hospitalier Universitaire de Strasbourg | Strasbourg | France | ||
| 20 | Centre Hospitalier Universitaire de Toulouse | Toulouse | France | ||
| 21 | Centre Hospitalier Universitaire de Tours | Tours | France | ||
| 22 | Centre Hospitalier Universitaire de Nancy | Vandœuvre-lès-Nancy | France |
Sponsors and Collaborators
- Hospices Civils de Lyon
Investigators
- Principal Investigator: Eddy COTTE, MD, Hospices Civils de Lyon
- Principal Investigator: Quentin DENOST, MD, CHU Bordeaux
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 69HCL18_0178