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

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ClinicalTrials.gov Identifier: NCT03504930
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : July 28, 2021
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.
Actual Study Start Date : June 7, 2018
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : December 7, 2022

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 (Day 30) after surgery (Day 0) ]
    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:   13 Years and older   (Child, 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

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

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

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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

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Sponsors and Collaborators
Hospices Civils de Lyon
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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    
Other Study ID Numbers: 69HCL18_0178
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: July 28, 2021
Last Verified: July 2021

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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:
Ileal pouch-anal anastomosis
Additional relevant MeSH terms:
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Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases