Surgery Clinical Trial
Official title:
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)
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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