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Ileal Pouch-Anal Anastomosis Registry
study id #: NCT01026480
condition: Ileal Pouch-Anal Anastomosis
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.
start date: November 2009
estimated completion: March 16, 2017
last updated: March 16, 2017
phase of development: Not Available
size / enrollment: 936
Observational Model: Cohort
Time Perspective: Prospective
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.
- Pouch status: Functional pouch or non-functional pouch (diverted or excised) [ Time Frame:Once per year for duration of the study ] [ Designated as safety issue: No ]
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.
- Quality of life [ Time Frame:Once per year for duration of the study ] [ Designated as safety issue:No ]
Participants will be queried once per year as to their quality of life using the IBDQ-10.
Health status [ Time Frame:Once per year for duration of the study ] [ Designated as safety issue: No ]
Participants will be queried once per year regarding health issues with pouch such as pouchitis, stricture and fistula. Participants will also be asked about presence of co-morbidities such as hypertension, diabetes and arthritis.
- 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
- 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
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