NCT00922103

A Study to Investigate the Ileo Neo Rectal Anastomosis Compared to the Ileo Pouch Anal Anastomosis for Patients With Ulcerative Colitis

A Historical Cohort Study, to Investigate Morbidity, Functional and Physiological Outcome, as Well as Endoscopic and Histological Aspects and the Quality of Life, of the Ileo Neo Rectal Anastomosis (INRA) Compared to the Ileo Pouch Anal Anastomosis (IPAA), for Patients With Ulcerative Colitis (UC)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Elisabeth-TweeSteden Ziekenhuis · Academic / Other
• Sex: All
• Age: 15 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

For patients with ulcerative colitis, eligible for surgical treatment, which restorative surgical procedure: the standard ileo pouch anal anastomosis or the alternative ileo neo rectal anastomosis is the best in terms of complications, functional outcome and health status and quality of life.

Detailed description

This research is designed to answer questions from the medical profession and patients´ community (Crohn en Colitis Ulcerosa Society, the Netherlands) whether the new INRA technique needs further development on a broader scale or not. The research project will be conducted in the two institutes where INRA procedures have been carried out and in the UMCN to recruit matched control IPAA patients. There is a large experience with the IPAA procedure in this latter institute. The University of Tilburg will participate to work on health status and quality of life aspects. They have a large experience with quality of life research in general and have participated in QOL research in this topic before. The aim of this historical cohort study is to establish the value of INRA, compared to IPAA, for patients with ulcerative colitis.

Conditions

• Colitis, Ulcerative
• Surgery

Interventions

Type	Name	Description
PROCEDURE	Ileal Neo Rectal Anastomosis	Comparison of the Ileal Neo Rectal Anastomosis to the Ileal Pouch Anal Anastomosis in patients treated for medical refractory Ulcerative Colitis
PROCEDURE	Ileal Pouch Anal Anastomosis	Comparison of the Ileal Pouch Anal Anastomosis to the Ileal Neo Rectal Anastomosis in patients treated for medical refractory Ulcerative Colitis

Timeline

• Start date: 2005-06-01
• Primary completion: 2009-12-01
• Completion: 2010-07-01
• First posted: 2009-06-17
• Last updated: 2010-09-13

Locations

2 sites across 1 country: Netherlands