An interventional study of Ileal Neo Rectal Anastomosis and Ileal Pouch Anal Anastomosis in Colitis, Ulcerative and Surgery, sponsored by Elisabeth-TweeSteden Ziekenhuis. Completed at 2 sites in Netherlands. Open to participants aged 15 Years to 80 Years. Per ClinicalTrials.gov, last updated 2010-09-13.
Sponsored by Elisabeth-TweeSteden Ziekenhuis · Not applicable, Interventional, and Treatment
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.
1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 771 interventional studies indexed under Colitis.
Browse Colitis studies →Elisabeth-TweeSteden Ziekenhuis is the lead sponsor of 11 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria
Patients treated for medical refractory Ulcerative Colitis
Procedure: Ileal Neo Rectal Anastomosis
Patients treated for medical refractory Ulcerative Colitis
Procedure: Ileal Pouch Anal Anastomosis
Comparison of the Ileal Neo Rectal Anastomosis to the Ileal Pouch Anal Anastomosis in patients treated for medical refractory Ulcerative Colitis
Comparison of the Ileal Pouch Anal Anastomosis to the Ileal Neo Rectal Anastomosis in patients treated for medical refractory Ulcerative Colitis
functional outcome
Time frame: after surgery: 3 months, 6 months, 12 months and yearly afterwards
Quality of life and Health Status
Time frame: after surgery: 3 months, 6 months, 12 months and yearly afterwards
histo-pathologic results
Time frame: after surgery: 3 months, 6 months, 12 months and yearly afterwards
endoscopic results
Time frame: after surgery: 3 months, 6 months, 12 months and yearly afterwards
morbidity and mortality
Time frame: after surgery: 3 months, 6 months, 12 months and yearly afterwards
ano-rectal physiology
Time frame: after surgery: 3 months, 6 months, 12 months and yearly afterwards
This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.
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Elisabeth-TweeSteden Ziekenhuis