COLISURG Prospective, Multicentric Cohort

Study Purpose

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.#46; 10%, p <0.001). In a dedicated cohort to the RCH, the same author found a risk of increased pelvic abscess (31.3% vs.#46;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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Adult (≥18 years) - Patients with ulcerative colitis requiring surgical treatment with ileal pouch-anal anastomosis

Exclusion Criteria:

- Age <18 years - Under any administrative or legal supervision

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03504930
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Hospices Civils de Lyon
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Eddy COTTE, MDQuentin DENOST, MD
Principal Investigator Affiliation Hospices Civils de LyonCHU Bordeaux
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Ulcerative Colitis
Arms & Interventions

Arms

: Impact of biotherapy on postoperative morbidity

Impact of biotherapy on postoperative morbidity in ulcerative colitis

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Besançon, France

Status

Address

Centre Hospitalier Universitaire de Besançon

Besançon, ,

Site Contact

Zaher LAKKIS, MD

zlakkis@chu-besancon.fr

04 78 86 23 71

Centre Hospitalier Universitaire de Caen, Caen, France

Status

Address

Centre Hospitalier Universitaire de Caen

Caen, ,

Site Contact

Arnaud ALVES, MD

eddy.cotte@chu-lyon.fr

04 78 86 23 71

Clermont-Ferrand, France

Status

Address

Centre Hospitalier Universitaire de Clermont-Ferrand

Clermont-Ferrand, ,

Site Contact

Anne DUBOIS, MD

a_dubois@chu-clermontferrand.fr

04 78 86 23 71

APHP - Hôpital Beaujon, Clichy, France

Status

Address

APHP - Hôpital Beaujon

Clichy, ,

Site Contact

Yves PANIS, MD

yves.panis@aphp.fr

04 78 86 23 71

La Tronche, France

Status

Address

Centre Hospitalier Universitaire de Grenoble

La Tronche, ,

Site Contact

Jean-Luc FAUCHERON, MD

JLFaucheron@chu-grenoble.fr

04 78 86 23 71

APHP - Hôpital Kremlin-Bicêtre, Le Kremlin-Bicêtre, France

Status

Address

APHP - Hôpital Kremlin-Bicêtre

Le Kremlin-Bicêtre, ,

Site Contact

Antoine BROUQUET, MD

antoine.brouquet@aphp.fr

04 78 86 23 71

Lille, France

Status

Address

Centre Hospitalier Universitaire de Lille

Lille, ,

Site Contact

Philippe ZERBIB, MD

Philippe.ZERBIB@CHRU-LILLE.FR

04 78 86 23 71

APHM - Hôpital Nord, Marseille, France

Status

Address

APHM - Hôpital Nord

Marseille, ,

Site Contact

Laura BEYER-BERJOT, MD

Laura.BEYER@ap-hm.fr

04 78 86 23 71

Nice, France

Status

Address

Centre Hospitalier Universitaire de Nice - Hôpital L'Archet II

Nice, ,

Site Contact

Amine RAHILI, MD

rahili.ma@chu-nice.fr

04 78 86 23 71

APHP - Hôpital Cochin, Paris, France

Status

Address

APHP - Hôpital Cochin

Paris, ,

Site Contact

Mahaut LECONTE, MD

mahaut.leconte@aphp.fr

04 78 86 23 71

APHP - Hôpital Européen Georges Pompidou, Paris, France

Status

Address

APHP - Hôpital Européen Georges Pompidou

Paris, ,

Site Contact

Richard DOUARD, MD

richard.douard@aphp.fr

04 78 86 23 71

APHP - Hôpital St Antoine, Paris, France

Status

Address

APHP - Hôpital St Antoine

Paris, ,

Site Contact

Jérémie LEFEVRE, MD

jeremie.lefevre@aphp.fr

04 78 86 23 71

APHP - Hôpital St Louis, Paris, France

Status

Address

APHP - Hôpital St Louis

Paris, ,

Site Contact

Hélène CORTE, MD

helenecorte@hotmail.com

04 78 86 23 71

Institut Mutualiste Montsouris, Paris, France

Status

Address

Institut Mutualiste Montsouris

Paris, ,

Site Contact

Christine DENET, MD

Christine.Denet@imm.fr

04 78 86 23 71

Hôpital Haut-Lévêque, Pessac, France

Status

Address

Hôpital Haut-Lévêque

Pessac, ,

Site Contact

Quentin DENOST, MD

quentin.denost@chu-bordeaux.fr

05 56 79 58 10 #+33

Centre Hospitalier Lyon SUD, Pierre-Bénite, France

Status

Address

Centre Hospitalier Lyon SUD

Pierre-Bénite, ,

Site Contact

Eddy COTTE, MD

eddy.cotte@chu-lyon.fr

04 78 86 23 71 #+33

Rennes, France

Status

Address

Centre Hospitalier Universitaire de Rennes

Rennes, ,

Site Contact

Véronique DESFOURNEAUX, MD

Veronique.DESFOURNEAUX-DENIS@chu-rennes.fr

04 78 86 23 71

Rouen, France

Status

Address

Centre Hospitalier Universitaire de Rouen

Rouen, ,

Site Contact

Jean-Jacques TUECH, MD

jean-jacques.tuech@chu-rouen.fr

04 78 86 23 71

Strasbourg, France

Status

Address

Centre Hospitalier Universitaire de Strasbourg

Strasbourg, ,

Site Contact

Cécile BRIGAND, MD

Cecile.BRIGAND@chru-strasbourg.fr

04 78 86 23 71

Toulouse, France

Status

Address

Centre Hospitalier Universitaire de Toulouse

Toulouse, ,

Site Contact

Jean-Pierre DUFFAS, MD

duffas.jp@chu-toulouse.fr

04 78 86 23 71

Tours, France

Status

Address

Centre Hospitalier Universitaire de Tours

Tours, ,

Site Contact

Mehdi OUAISSI, MD

M.OUAISSI@chu-tours.fr

04 78 86 23 71

Vandœuvre-lès-Nancy, France

Status

Address

Centre Hospitalier Universitaire de Nancy

Vandœuvre-lès-Nancy, ,

Site Contact

Adeline GERMAIN, MD

a.germain@chru-nancy.fr

04 78 86 23 71

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. For a full description of terms please refer to our Terms, Conditions & Privacy.