A Historical Cohort Study, to Investigate Morbidity, Functional and Physiological Outcome, as Well as Endoscopic and Histological Aspects and the Quality of Life, of the Ileo Neo Rectal Anastomosis (INRA) Compared to the Ileo Pouch Anal Anastomosis (IPAA), for Patients With Ulcerative Colitis (UC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- functional outcome
研究概览
简要总结
For patients with ulcerative colitis, eligible for surgical treatment, which restorative surgical procedure: the standard ileo pouch anal anastomosis or the alternative ileo neo rectal anastomosis is the best in terms of complications, functional outcome and health status and quality of life.
详细描述
This research is designed to answer questions from the medical profession and patients´ community (Crohn en Colitis Ulcerosa Society, the Netherlands) whether the new INRA technique needs further development on a broader scale or not.
The research project will be conducted in the two institutes where INRA procedures have been carried out and in the UMCN to recruit matched control IPAA patients. There is a large experience with the IPAA procedure in this latter institute. The University of Tilburg will participate to work on health status and quality of life aspects. They have a large experience with quality of life research in general and have participated in QOL research in this topic before.
The aim of this historical cohort study is to establish the value of INRA, compared to IPAA, for patients with ulcerative colitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •UC patients with INRA procedure
- •Age, sex and disease specific matched group of UC-IPAA patients with temporary diverting ileostomy from the same period
- •Written informed consent
排除标准
- •Pregnancy
- •Malignancy (apart from basalioma or carcinoma-in-situ of cervix)
- •Psychiatric disease or inability to assess follow up
结局指标
主要结局
functional outcome
时间窗: after surgery: 3 months, 6 months, 12 months and yearly afterwards
Quality of life and Health Status
时间窗: after surgery: 3 months, 6 months, 12 months and yearly afterwards
次要结局
- histo-pathologic results(after surgery: 3 months, 6 months, 12 months and yearly afterwards)
- endoscopic results(after surgery: 3 months, 6 months, 12 months and yearly afterwards)
- morbidity and mortality(after surgery: 3 months, 6 months, 12 months and yearly afterwards)
- ano-rectal physiology(after surgery: 3 months, 6 months, 12 months and yearly afterwards)