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

NCT ID: NCT03504930

Last Updated: 2021-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

330 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-07

Study Completion Date

2022-12-07

Brief Summary

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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.

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Detailed Description

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Conditions

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Ulcerative Colitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Impact of biotherapy on postoperative morbidity

Impact of biotherapy on postoperative morbidity in ulcerative colitis

Impact of biotherapy on postoperative morbidity in ulcerative colitis

Intervention Type OTHER

Impact of biotherapy on postoperative morbidity, quality of life, sexual function, sexual health in ulcerative colitis

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eddy COTTE, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Quentin DENOST, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

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Centre Hospitalier Universitaire de Besançon

Besançon, , France

Site Status RECRUITING

Centre Hospitalier Universitaire de Caen

Caen, , France

Site Status NOT_YET_RECRUITING

Centre Hospitalier Universitaire de Clermont-Ferrand

Clermont-Ferrand, , France

Site Status NOT_YET_RECRUITING

APHP - Hôpital Beaujon

Clichy, , France

Site Status RECRUITING

Centre Hospitalier Universitaire de Grenoble

La Tronche, , France

Site Status RECRUITING

APHP - Hôpital Kremlin-Bicêtre

Le Kremlin-Bicêtre, , France

Site Status RECRUITING

Centre Hospitalier Universitaire de Lille

Lille, , France

Site Status RECRUITING

APHM - Hôpital Nord

Marseille, , France

Site Status RECRUITING

Centre Hospitalier Universitaire de Nice - Hôpital L'Archet II

Nice, , France

Site Status RECRUITING

APHP - Hôpital Cochin

Paris, , France

Site Status NOT_YET_RECRUITING

APHP - Hôpital Européen Georges Pompidou

Paris, , France

Site Status NOT_YET_RECRUITING

APHP - Hôpital St Antoine

Paris, , France

Site Status RECRUITING

APHP - Hôpital St Louis

Paris, , France

Site Status NOT_YET_RECRUITING

Institut Mutualiste Montsouris

Paris, , France

Site Status NOT_YET_RECRUITING

Hôpital Haut-Lévêque

Pessac, , France

Site Status RECRUITING

Centre Hospitalier Lyon SUD

Pierre-Bénite, , France

Site Status RECRUITING

Centre Hospitalier Universitaire de Rennes

Rennes, , France

Site Status RECRUITING

Centre Hospitalier Universitaire de Rouen

Rouen, , France

Site Status NOT_YET_RECRUITING

Centre Hospitalier Universitaire de Strasbourg

Strasbourg, , France

Site Status RECRUITING

Centre Hospitalier Universitaire de Toulouse

Toulouse, , France

Site Status NOT_YET_RECRUITING

Centre Hospitalier Universitaire de Tours

Tours, , France

Site Status RECRUITING

Centre Hospitalier Universitaire de Nancy

Vandœuvre-lès-Nancy, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Eddy COTTE, MD

Role: CONTACT

[email protected]
04 78 86 23 71 ext. +33

Quentin DENOST, MD

Role: CONTACT

[email protected]
05 56 79 58 10 ext. +33

Facility Contacts

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Zaher LAKKIS, MD

Role: primary

[email protected]

Arnaud ALVES, MD

Role: primary

Role: backup

[email protected]

Anne DUBOIS, MD

Role: primary

[email protected]

Yves PANIS, MD

Role: primary

[email protected]

Jean-Luc FAUCHERON, MD

Role: primary

[email protected]

Antoine BROUQUET, MD

Role: primary

[email protected]

Philippe ZERBIB, MD

Role: primary

[email protected]

Laura BEYER-BERJOT, MD

Role: primary

[email protected]

Amine RAHILI, MD

Role: primary

[email protected]

Mahaut LECONTE, MD

Role: primary

[email protected]

Richard DOUARD, MD

Role: primary

[email protected]

Jérémie LEFEVRE, MD

Role: primary

[email protected]

Hélène CORTE, MD

Role: primary

[email protected]

Christine DENET, MD

Role: primary

[email protected]

Quentin DENOST, MD

Role: primary

[email protected]
05 56 79 58 10 ext. +33

Eddy COTTE, MD

Role: primary

[email protected]
04 78 86 23 71 ext. +33

Véronique DESFOURNEAUX, MD

Role: primary

[email protected]

Jean-Jacques TUECH, MD

Role: primary

[email protected]

Cécile BRIGAND, MD

Role: primary

[email protected]

Jean-Pierre DUFFAS, MD

Role: primary

[email protected]

Mehdi OUAISSI, MD

Role: primary

[email protected]

Adeline GERMAIN, MD

Role: primary

[email protected]

Other Identifiers

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69HCL18_0178

Identifier Type: -

Identifier Source: org_study_id

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