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