Ileal Pouch-Anal Anastomosis Registry | oneFAPvoice

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terminated

Ileal Pouch-Anal Anastomosis Registry

study id #: NCT01026480

condition: Ileal Pouch-Anal Anastomosis

status: Terminated

purpose:

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 17, 2017

phase of development: Not Available

size / enrollment: 936

study design:
Observational Model: Cohort
Time Perspective: Prospective

study description:
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.

primary outcomes:

  • 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.

secondary outcomes:

  • 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.

inclusion criteria:
- 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

exclusion criteria:
- 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

sponsor: Boston Medical Center

contacts:
Lauren A Howard, MPH; 617.414.8013; lauren.howard@bmc.org
Jennifer A Coukos, BS; 617.638.8668; jennifer.coukos@bmc.org

investigators:
James M Becker, MD
Study Director: Francis A Farraye, MD
Study Director: Arthur F Stucchi, PhD

locations: United States