COLISURG : Exploratory Analysis of Sexual Function and the Impact of Biotherapies on Postoperative Morbidity. (COLISURG)
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| ClinicalTrials.gov Identifier: NCT03504930 |
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Recruitment Status :
Recruiting
First Posted : April 20, 2018
Last Update Posted : July 28, 2021
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Sponsor:
Hospices Civils de Lyon
Information provided by (Responsible Party):
Hospices Civils de Lyon
| Tracking Information | |||||||||
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| First Submitted Date | April 12, 2018 | ||||||||
| First Posted Date | April 20, 2018 | ||||||||
| Last Update Posted Date | July 28, 2021 | ||||||||
| Actual Study Start Date | June 7, 2018 | ||||||||
| Estimated Primary Completion Date | June 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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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| Original Primary Outcome Measures |
Infectious complications at D30 postoperative [ Time Frame: First month (D30) after surgery (D0) ] Infectious complications during the first month (D30) after surgery (D0)
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| Change History | |||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | COLISURG : Exploratory Analysis of Sexual Function and the Impact of Biotherapies on Postoperative Morbidity. | ||||||||
| 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. | ||||||||
| 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. | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | Patients with ulcerative colitis requiring surgical treatment with ileal pouch-anal anastomosis | ||||||||
| Condition | Ulcerative Colitis | ||||||||
| Intervention | 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
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| Study Groups/Cohorts | Impact of biotherapy on postoperative morbidity
Impact of biotherapy on postoperative morbidity in ulcerative colitis
Intervention: Other: Impact of biotherapy on postoperative morbidity in ulcerative colitis
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
330 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | December 7, 2022 | ||||||||
| Estimated Primary Completion Date | June 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria | Inclusion Criteria: Age ≥ 13 ans - Patients with ulcerative colitis requiring surgical treatment with ileal pouch-anal anastomosis Exclusion Criteria:
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| Sex/Gender |
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| Ages | 13 Years and older (Child, Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | France | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03504930 | ||||||||
| Other Study ID Numbers | 69HCL18_0178 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||||||
| Current Responsible Party | Hospices Civils de Lyon | ||||||||
| Original Responsible Party | Same as current | ||||||||
| Current Study Sponsor | Hospices Civils de Lyon | ||||||||
| Original Study Sponsor | Same as current | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | Hospices Civils de Lyon | ||||||||
| Verification Date | July 2021 | ||||||||