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
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Condition or disease | Intervention/treatment |
---|---|
Ulcerative Colitis | Other: Impact of biotherapy on postoperative morbidity in ulcerative colitis |
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 |

Group/Cohort | Intervention/treatment |
---|---|
Impact of biotherapy on postoperative morbidity
Impact of biotherapy on postoperative morbidity in ulcerative colitis
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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 |
- 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)

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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 |
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

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
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 |

Principal Investigator: | Eddy COTTE, MD | Hospices Civils de Lyon | |
Principal Investigator: | Quentin DENOST, MD | CHU Bordeaux |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Surgical Ileal pouch-anal anastomosis |
Colitis Colitis, Ulcerative Ulcer Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Colonic Diseases Intestinal Diseases Pathologic Processes Inflammatory Bowel Diseases |