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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

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ClinicalTrials.gov Identifier: NCT00922103
Recruitment Status : Completed
First Posted : June 17, 2009
Last Update Posted : September 13, 2010
Sponsor:
Collaborator:
Radboud University
Information provided by:
Elisabeth-TweeSteden Ziekenhuis

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.

Condition or disease Intervention/treatment Phase
Colitis, Ulcerative Surgery Procedure: Ileal Neo Rectal Anastomosis Procedure: Ileal Pouch Anal Anastomosis Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : June 2005
Actual Primary Completion Date : December 2009
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. functional outcome [ Time Frame: after surgery: 3 months, 6 months, 12 months and yearly afterwards ]
  2. Quality of life and Health Status [ Time Frame: after surgery: 3 months, 6 months, 12 months and yearly afterwards ]

Secondary Outcome Measures :
  1. histo-pathologic results [ Time Frame: after surgery: 3 months, 6 months, 12 months and yearly afterwards ]
  2. endoscopic results [ Time Frame: after surgery: 3 months, 6 months, 12 months and yearly afterwards ]
  3. morbidity and mortality [ Time Frame: after surgery: 3 months, 6 months, 12 months and yearly afterwards ]
  4. ano-rectal physiology [ Time Frame: after surgery: 3 months, 6 months, 12 months and yearly afterwards ]


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Ages Eligible for Study:   15 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00922103


Locations
Netherlands
St Elisabeth Hospital
Tilburg, Brabant, Netherlands, 5022 GC
University Medical Centre St Radboud
Nijmegen, Gelderland, Netherlands, 6500 HB
Sponsors and Collaborators
Elisabeth-TweeSteden Ziekenhuis
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

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
First Posted: June 17, 2009    Key Record Dates
Last Update Posted: September 13, 2010
Last Verified: September 2010

Keywords provided by Elisabeth-TweeSteden Ziekenhuis:
Colitis, Ulcerative
Ileo Neo Rectal Anastomosis
Ileal Pouch Anal Anastomosis
Quality of Life
functional results
reconstructive surgery
surgery

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