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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00922103

Enrollment

100

Registered

2009-06-17

Start date

2005-06-30

Completion date

2010-07-31

Last updated

2010-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colitis, Ulcerative, Surgery

Keywords

Colitis, Ulcerative, Ileo Neo Rectal Anastomosis, Ileal Pouch Anal Anastomosis, Quality of Life, functional results, reconstructive surgery, surgery

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.

Interventions

PROCEDUREIleal Neo Rectal Anastomosis

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

PROCEDUREIleal Pouch Anal Anastomosis

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026