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)

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.

Study Overview

• Status: Completed
• Conditions: Surgery; Colitis, Ulcerative
• Intervention / Treatment: Procedure: Ileal Neo Rectal Anastomosis; Procedure: Ileal Pouch Anal Anastomosis

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Brabant
    • Tilburg, Brabant, Netherlands, 5022 GC
      • St Elisabeth hospital
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6500 HB
      • University Medical Centre St Radboud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: INRA; Patients treated for medical refractory Ulcerative Colitis	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
Active Comparator: IPAA; Patients treated for medical refractory Ulcerative Colitis	Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Elisabeth-TweeSteden Ziekenhuis
• Collaborators: Radboud University Medical Center
• Investigators: Principal Investigator: JT Heikens, MD, St Elisabeth Hospital, Tilburg, The Netherlands; Study Chair: D de Jong, MD, PhD, University Medical Centre St Radboud, Nijmegen, The Netherlands; Study Chair: JLJM Teepen, MD, PhD, St Elisabeth Hospital, Tilburg, The Netherlands; Study Chair: JHJM van Krieken, MD, PhD, University Medical Centre St Radboud, The Netherlands; Study Chair: HG Gooszen, MD, PhD, University Medical Centre St Radboud, Nijmegen, The Netherlands; Study Chair: J de Vries, Md, PhD, St Elisabeth Hospital, Tilburg, The Netherlands; Study Director: CJHM van Laarhoven, MD, PhD, University Medical Centre St Radboud, The Netherlands

Study record dates

Study Major Dates

• Study Start: June 1, 2005
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: June 12, 2009
• First Submitted That Met QC Criteria: June 15, 2009
• First Posted (Estimate): June 17, 2009

Study Record Updates

• Last Update Posted (Estimate): September 13, 2010
• Last Update Submitted That Met QC Criteria: September 10, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: Quality of Life; surgery; Colitis, Ulcerative; reconstructive surgery; Ileo Neo Rectal Anastomosis; Ileal Pouch Anal Anastomosis; functional results
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: 0426; AMO nr. 04/074