Ileal Pouch-Anal Anastomosis Registry (IPAA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01026480|
Recruitment Status : Terminated (Researchers leading this study have left BMC)
First Posted : December 4, 2009
Last Update Posted : March 17, 2017
|Condition or disease|
|Ileal Pouch-Anal Anastomosis|
|Study Type :||Observational|
|Actual Enrollment :||936 participants|
|Official Title:||Ileal Pouch-Anal Anastomosis (IPAA) Registry|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||March 16, 2017|
|Actual Study Completion Date :||March 16, 2017|
Patients who have had their IPAA procedures performed by Dr. Becker
- Pouch status: functional pouch or non-functional pouch (diverted or excised) [ Time Frame: 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.
- Quality of life [ Time Frame: Once per year for duration of the study ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01026480
|United States, Massachusetts|
|Boston Medical Center|
|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|