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COLISURG Prospective, Multicentric Cohort (COLISURG)

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ClinicalTrials.gov Identifier: NCT03504930
Recruitment Status : Not yet recruiting
First Posted : April 20, 2018
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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
Ulcerative Colitis Other: Impact of biotherapy on postoperative morbidity in ulcerative colitis

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Study Type : Observational
Estimated Enrollment : 330 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: COLISURG Prospective, Multicentric Cohort of Ulcerative Colitis Requiring Surgical Treatment With Ileal Pouch-anal Anastomosis. Impact of Biotherapies on Sexual Function and Postoperative Morbidity.
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Group/Cohort 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




Primary Outcome Measures :
  1. Infectious complications at D30 postoperative [ Time Frame: First month (D30) after surgery (D0) ]
    Infectious complications during the first month (D30) after surgery (D0)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with ulcerative colitis requiring surgical treatment with ileal pouch-anal anastomosis
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504930


Contacts
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Contact: Eddy COTTE, MD 04 78 86 23 71 ext +33 eddy.cotte@chu-lyon.fr
Contact: Quentin DENOST, MD 05 56 79 58 10 ext +33 quentin.denost@chu-bordeaux.fr

Locations
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France
Centre Hospitalier Universitaire de Besançon Not yet recruiting
Besançon, France
Contact: Zaher LAKKIS, MD       zlakkis@chu-besancon.fr   
Principal Investigator: Zaher LAKKIS, MD         
Centre Hospitalier Universitaire de Caen Not yet recruiting
Caen, France
Contact: Arnaud ALVES, MD         
Contact       alves-a@chu-caen.fr   
Principal Investigator: Arnaud ALVES, MD         
Centre Hospitalier Universitaire de Clermont-Ferrand Not yet recruiting
Clermont-Ferrand, France
Contact: Anne DUBOIS, MD       a_dubois@chu-clermontferrand.fr   
Principal Investigator: Anne DUBOIS, MD         
Sub-Investigator: Adnan ABOUKASSEM, MD         
Sub-Investigator: Denis PEZET, MD         
APHP - Hôpital Beaujon Not yet recruiting
Clichy, France
Contact: Yves PANIS, MD       yves.panis@aphp.fr   
Principal Investigator: Yves PANIS, MD         
Sub-Investigator: Léon MAGGIORI, MD         
Centre Hospitalier Universitaire de Grenoble Not yet recruiting
La Tronche, France
Contact: Jean-Luc FAUCHERON, MD       JLFaucheron@chu-grenoble.fr   
Principal Investigator: Jean-Luc FAUCHERON, MD         
Sub-Investigator: Bertrand TRILLING, MD         
Sub-Investigator: Pierre-Yves SAGE, MD         
APHP - Hôpital Kremlin-Bicêtre Not yet recruiting
Le Kremlin-Bicêtre, France
Contact: Antoine BROUQUET, MD       antoine.brouquet@aphp.fr   
Principal Investigator: Antoine BROUQUET, MD         
Sub-Investigator: Stéphane BENOIST, MD         
Centre Hospitalier Universitaire de Lille Not yet recruiting
Lille, France
Contact: Philippe ZERBIB, MD       Philippe.ZERBIB@CHRU-LILLE.FR   
Principal Investigator: Philippe ZERBIB, MD         
APHM - Hôpital Nord Not yet recruiting
Marseille, France
Contact: Laura BEYER-BERJOT, MD       Laura.BEYER@ap-hm.fr   
Principal Investigator: Laura BEYER-BERJOT, MD         
Sub-Investigator: Stéphane BERDAH, MD         
Centre Hospitalier Universitaire de Nice - Hôpital L'Archet II Not yet recruiting
Nice, France
Contact: Amine RAHILI, MD       rahili.ma@chu-nice.fr   
Principal Investigator: Amine RAHILI, MD         
APHP - Hôpital Cochin Not yet recruiting
Paris, France
Contact: Mahaut LECONTE, MD       mahaut.leconte@aphp.fr   
Principal Investigator: Mahaut LECONTE, MD         
APHP - Hôpital Européen Georges Pompidou Not yet recruiting
Paris, France
Contact: Richard DOUARD, MD       richard.douard@aphp.fr   
Principal Investigator: Richard DOUARD, MD         
APHP - Hôpital St Antoine Not yet recruiting
Paris, France
Contact: Jérémie LEFEVRE, MD       jeremie.lefevre@aphp.fr   
Principal Investigator: Jérémie LEFEVRE, MD         
Sub-Investigator: Yann PARC, MD         
APHP - Hôpital St Louis Not yet recruiting
Paris, France
Contact: Hélène CORTE, MD       helenecorte@hotmail.com   
Principal Investigator: Hélène CORTE, MD         
Institut Mutualiste Montsouris Not yet recruiting
Paris, France
Contact: Christine DENET, MD       Christine.Denet@imm.fr   
Principal Investigator: Christine DENET, MD         
Hôpital Haut-Lévêque Not yet recruiting
Pessac, France
Contact: Quentin DENOST, MD    05 56 79 58 10 ext +33    quentin.denost@chu-bordeaux.fr   
Principal Investigator: Quentin DENOST, MD         
Sub-Investigator: Eric RULLIER, MD         
Centre Hospitalier Lyon SUD Not yet recruiting
Pierre-Bénite, France
Contact: Eddy COTTE, MD    04 78 86 23 71 ext +33    eddy.cotte@chu-lyon.fr   
Principal Investigator: Eddy COTTE, MD         
Sub-Investigator: Yves FRANCOIS, MD         
Centre Hospitalier Universitaire de Rennes Not yet recruiting
Rennes, France
Contact: Véronique DESFOURNEAUX, MD       Veronique.DESFOURNEAUX-DENIS@chu-rennes.fr   
Principal Investigator: Véronique DESFOURNEAUX, MD         
Centre Hospitalier Universitaire de Rouen Not yet recruiting
Rouen, France
Contact: Jean-Jacques TUECH, MD       jean-jacques.tuech@chu-rouen.fr   
Principal Investigator: Jean-Jacques TUECH, MD         
Sub-Investigator: Valérie BRIDOUX, MD         
Centre Hospitalier Universitaire de Strasbourg Not yet recruiting
Strasbourg, France
Contact: Cécile BRIGAND, MD       Cecile.BRIGAND@chru-strasbourg.fr   
Principal Investigator: Cécile BRIGAND, MD         
Sub-Investigator: Serge ROHR, MD         
Sub-Investigator: Benoît ROMAIN, MD         
Centre Hospitalier Universitaire de Toulouse Not yet recruiting
Toulouse, France
Contact: Jean-Pierre DUFFAS, MD       duffas.jp@chu-toulouse.fr   
Principal Investigator: Jean-Pierre DUFFAS, MD         
Centre Hospitalier Universitaire de Tours Not yet recruiting
Tours, France
Contact: Mehdi OUAISSI, MD       M.OUAISSI@chu-tours.fr   
Principal Investigator: Mehdi OUAISSI, MD         
Centre Hospitalier Universitaire de Nancy Not yet recruiting
Vandœuvre-lès-Nancy, France
Contact: Adeline GERMAIN, MD       a.germain@chru-nancy.fr   
Principal Investigator: Adeline GERMAIN, MD         
Sub-Investigator: Laurent BRESLER, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Eddy COTTE, MD Hospices Civils de Lyon
Principal Investigator: Quentin DENOST, MD CHU Bordeaux

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03504930     History of Changes
Other Study ID Numbers: 69HCL18_0178
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospices Civils de Lyon:
Surgical
Ileal pouch-anal anastomosis

Additional relevant MeSH terms:
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Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases