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

Elisabeth-TweeSteden Ziekenhuis

Status: Completed

Conditions: Colitis, Ulcerative; Surgery

Treatments: Procedure: Ileal Pouch Anal Anastomosis; Procedure: Ileal Neo Rectal Anastomosis

Study type: Interventional

Funder types: Other

Identifiers

NCT00922103

0426

AMO nr. 04/074

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 15 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

INRA

Experimental group

Description:

Patients treated for medical refractory Ulcerative Colitis

Treatment:

Procedure: Ileal Neo Rectal Anastomosis

IPAA

Active Comparator group

Description:

Patients treated for medical refractory Ulcerative Colitis

Treatment:

Procedure: Ileal Pouch Anal Anastomosis