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

Not Applicable

Completed

• Conditions: Colitis, Ulcerative; Surgery
• Interventions: Procedure: Ileal Neo Rectal Anastomosis; Procedure: Ileal Pouch Anal Anastomosis

• Registration Number: NCT00922103
• Lead Sponsor: Elisabeth-TweeSteden Ziekenhuis

Brief 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.

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2009-06-12
• Study First Submitted QC: 2009-06-15
• Study First Posted: 2009-06-17
• Primary Completion: 2009-12
• Study Completion: 2010-07
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-10
• Last Update Posted: 2010-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• UC patients with INRA procedure
• Age, sex and disease specific matched group of UC-IPAA patients with temporary diverting ileostomy from the same period
• Written informed consent

Exclusion criteria

• Pregnancy
• Malignancy (apart from basalioma or carcinoma-in-situ of cervix)
• Psychiatric disease or inability to assess follow up

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
INRA	Ileal Neo Rectal Anastomosis	Patients treated for medical refractory Ulcerative Colitis
IPAA	Ileal Pouch Anal Anastomosis	Patients treated for medical refractory Ulcerative Colitis

Primary Outcome Measures

Name	Time	Method
functional outcome	after surgery: 3 months, 6 months, 12 months and yearly afterwards
Quality of life and Health Status	after surgery: 3 months, 6 months, 12 months and yearly afterwards

Secondary Outcome Measures

Name	Time	Method
histo-pathologic results	after surgery: 3 months, 6 months, 12 months and yearly afterwards
endoscopic results	after surgery: 3 months, 6 months, 12 months and yearly afterwards
morbidity and mortality	after surgery: 3 months, 6 months, 12 months and yearly afterwards
ano-rectal physiology	after surgery: 3 months, 6 months, 12 months and yearly afterwards

Trial Locations

Locations (2)

St Elisabeth Hospital; 🇳🇱 Tilburg, Brabant, Netherlands

University Medical Centre St Radboud; 🇳🇱 Nijmegen, Gelderland, Netherlands