跳至主要内容
临床试验/NCT03504930
NCT03504930Unknown不适用

COLISURG Prospective, Multicentric Cohort of Ulcerative Colitis Requiring Surgical Treatment With Ileal Pouch-anal Anastomosis. Impact of Biotherapies on Sexual Function and Postoperative Morbidity.

Hospices Civils de Lyon22 个研究点 分布在 1 个国家目标入组 330 人开始时间: 2018年6月7日最近更新:
适应症

试验速览

阶段
不适用
入组人数
330
试验地点
22
主要终点
Infectious complications at D30 postoperative

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
13 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 13 ans
  • Patients with ulcerative colitis requiring surgical treatment with ileal pouch-anal anastomosis

排除标准

  • Age < 13 ans
  • Under any administrative or legal supervision

结局指标

主要结局

Infectious complications at D30 postoperative

时间窗: First month (Day 30) after surgery (Day 0)

Infectious complications during the first month (D30) after surgery (D0)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (22)

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