NCT06538402招募中不适用
Ileal Reservoir Length and Functional Outcome in Ileal Pouch-anal Anastomosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Pouch dysfunction score
研究概览
简要总结
The aim of this randomized controlled trial is to compare outcome after construction of an ileal (J-shaped) reservoir of 10 versus 15 centimeters in primary ileal pouch-anal anastomosis surgery.
详细描述
The primary aim of this randomized controlled trial is to compare functional outcome in terms of bowel function correlated with quality of life for patients who undergo primary ileal pouch-anal anastomosis surgery with an ileal (J-shaped) reservoir length of either 10 cm or 15 cm.
Secondary aims include health-related quality of life measures and postoperative complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing ileal pouch-anal anastomosis (IPAA) for ulcerative colitis or familial adenomatous polyposis (FAP) (implying a normal sphincter function as judged by history and clinical examination)
- •Signed informed consent
- •Able to perform both a small (10 cm) and medium-size (15 cm) pouch with adequate reach and no tension as determined subjectively by the surgeon intraoperatively
排除标准
- 未提供
结局指标
主要结局
Pouch dysfunction score
时间窗: 1, 3, 5 and 10 years after surgery
Ranges from 0 to 7.5, where a low score indicates good bowel function will little to no impact on quality of life
次要结局
- Short Inflammatory Bowel Disease Questionnaire(1, 3, 5 and 10 years after surgery)
- Short-form (SF)-36(1, 3, 5 and 10 years after surgery)
- Postoperative complications using the Comprehensive Complication Index (CCI)(90 days after surgery)
- Pouch failure(1, 3, 5 and 10 years after surgery)
- Short Inflammatory Bowel Disease Questionnaire(1, 3, 5 and 10 years after surgery)
- Short-form (SF)-36(1, 3, 5 and 10 years after surgery)
- Postoperative complications using the Comprehensive Complication Index (CCI)(90 days after surgery)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
MOWOOT Device Treatment for Adults With Chronic ConstipationConstipation - FunctionalConstipation-predominant Irritable Bowel SyndromeConstipation Chronic IdiopathicConstipationNeurogenic ConstipationNCT04666155usMIMA S.L.86
撤回
3 期
Pilot Study to Investigate the Effect of Teduglutide on Temporary Ileostomy Function and ComplicationsIleostomy - StomaNCT03953170Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Unknown
4 期
Prophylaxis of Ileostomy Closure Site Hernia by Placing MeshLoop Ileostomy ClosureNCT02226887Hospital Universitari Vall d'Hebron Research Institute120
已完成
不适用
The Effects of Temporary Ileostomy on Outcome in Patients With Rectal CancerColorectal CancerNCT06391385Tishreen University47
已完成
不适用
Quality of Life in Patients That Undergo J Pouch or Side to End Coloanal Anastomosis for Rectal CancerRectal CancerNCT01182116The Cleveland Clinic46