Ileal Pouch-Anal Anastomosis (IPAA) Registry
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 936
- 试验地点
- 1
- 主要终点
- Pouch status: functional pouch or non-functional pouch (diverted or excised)
研究概览
简要总结
Little is known about the factors that predispose patients to complications after an ileal pouch-anal anastomosis procedure (IPAA). Our goal is to establish a registry that prospectively captures pre- and post-surgical data from participants. Retrospective studies concerning IPAA outcomes and will be conducted using these data.
详细描述
In order to better understand the long-term outcomes following IPAA, a registry that collects pertinent information about the underlying disease and its treatments and complications in an organized manner must be established. Establishing this Registry will allow us to follow patients who have an IPAA and organize retrospective medical information into a meaningful system.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with one of the following: Ulcerative colitis, Crohn's disease, Indeterminate colitis, Familial adenomatous polyposis, Hereditary nonpolyposis colorectal cancer, Lynch syndrome I or II, or Gardners' syndrome
- •Treated by a Center for Digestive Disorders physician
- •Scheduled for, or has undergone, ileal pouch-anal anastomosis procedure
排除标准
- •Patients who do not speak a language for which the IRB has approved an Informed Consent Form or Short Form
- •Patients who are currently incarcerated
结局指标
主要结局
Pouch status: functional pouch or non-functional pouch (diverted or excised)
时间窗: Once per year for duration of the study
Participants will be queried once per year as to the status of their intestinal pouch. Patients will have either a functional pouch or a non-functional pouch. A pouch will be considered functional if patient is not temporarily or permanently diverted to an ileostomy.
次要结局
- Quality of life(Once per year for duration of the study)
- Health status(Once per year for duration of the study)
研究者
Francis Farraye, MD
Faculty member
Boston Medical Center