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

This study has been completed.
Sponsor:
Collaborator:
Radboud University
Information provided by:
St. Elisabeth Hospital, Tilburg, Netherlands
ClinicalTrials.gov Identifier:
NCT00922103
First received: June 12, 2009
Last updated: September 10, 2010
Last verified: September 2010
History of Changes
  Purpose

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.


Condition Intervention
Colitis, Ulcerative
Surgery
 Procedure: Ileal Neo Rectal Anastomosis
Procedure: Ileal Pouch Anal Anastomosis

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St. Elisabeth Hospital, Tilburg, Netherlands:

Primary Outcome Measures:
  • functional outcome [ Time Frame: after surgery: 3 months, 6 months, 12 months and yearly afterwards ] [ Designated as safety issue: No ]
  • Quality of life and Health Status [ Time Frame: after surgery: 3 months, 6 months, 12 months and yearly afterwards ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • histo-pathologic results [ Time Frame: after surgery: 3 months, 6 months, 12 months and yearly afterwards ] [ Designated as safety issue: Yes ]
  • endoscopic results [ Time Frame: after surgery: 3 months, 6 months, 12 months and yearly afterwards ] [ Designated as safety issue: Yes ]
  • morbidity and mortality [ Time Frame: after surgery: 3 months, 6 months, 12 months and yearly afterwards ] [ Designated as safety issue: No ]
  • ano-rectal physiology [ Time Frame: after surgery: 3 months, 6 months, 12 months and yearly afterwards ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2005
Study Completion Date: July 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   15 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00922103

Locations
Netherlands
St Elisabeth Hospital
Tilburg, Brabant, Netherlands, 5022 GC
University Medical Centre St Radboud
Nijmegen, Gelderland, Netherlands, 6500 HB
Sponsors and Collaborators
St. Elisabeth Hospital, Tilburg, Netherlands
Radboud University
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
  More Information

No publications provided

Responsible Party: JT Heikens, MD, St Elisabeth Hospital, Tilburg, The Netherlands
ClinicalTrials.gov Identifier: NCT00922103     History of Changes
Other Study ID Numbers: 0426, AMO nr. 04/074
Study First Received: June 12, 2009
Last Updated: September 10, 2010
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by St. Elisabeth Hospital, Tilburg, Netherlands:
Colitis, Ulcerative
Ileo Neo Rectal Anastomosis
Ileal Pouch Anal Anastomosis
Quality of Life
 functional results
reconstructive surgery
surgery

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013