Ileal Pouch-Anal Anastomosis Registry (IPAA)
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.
Ileal Pouch-Anal Anastomosis
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Ileal Pouch-Anal Anastomosis (IPAA) Registry|
- 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.
|Study Start Date:||November 2009|
|Estimated Study Completion Date:||December 2050|
|Estimated Primary Completion Date:||December 2050 (Final data collection date for primary outcome measure)|
Patients who have had their IPAA procedures performed by Dr. Becker
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01026480
|Contact: Lauren A Howard, MPHfirstname.lastname@example.org|
|Contact: Jennifer A Coukos, BSemail@example.com|
|United States, Massachusetts|
|Boston Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||James M Becker, MD||Boston Medical Center|
|Study Director:||Francis A Farraye, MD||Boston Medical Center|
|Study Director:||Arthur F Stucchi, PhD||Boston University|