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

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00922103
• Other study ID #: 0426
• Secondary ID: AMO nr. 04/074
• Status: Completed
• Phase: N/A
• First received: June 12, 2009
• Last updated: September 10, 2010
• Start date: June 2005
• Est. completion date: July 2010

Study information

• Verified date: September 2010
• Source: Elisabeth-TweeSteden Ziekenhuis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Surgery
• Ulcer

Intervention

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

Locations

Country	Name	City	State
Netherlands	University Medical Centre St Radboud	Nijmegen	Gelderland
Netherlands	St Elisabeth Hospital	Tilburg	Brabant

Sponsors (2)

Lead Sponsor	Collaborator
Elisabeth-TweeSteden Ziekenhuis	Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	functional outcome		after surgery: 3 months, 6 months, 12 months and yearly afterwards	No
Primary	Quality of life and Health Status		after surgery: 3 months, 6 months, 12 months and yearly afterwards	No
Secondary	histo-pathologic results		after surgery: 3 months, 6 months, 12 months and yearly afterwards	Yes
Secondary	endoscopic results		after surgery: 3 months, 6 months, 12 months and yearly afterwards	Yes
Secondary	morbidity and mortality		after surgery: 3 months, 6 months, 12 months and yearly afterwards	No
Secondary	ano-rectal physiology		after surgery: 3 months, 6 months, 12 months and yearly afterwards	No