A Study to Investigate the Ileo Neo Rectal Anastomosis Compared to the Ileo Pouch Anal Anastomosis for Patients With Ulcerative Colitis
NCT ID: NCT00922103
Last Updated: 2010-09-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2005-06-30
2010-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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INRA
Patients treated for medical refractory Ulcerative Colitis
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
IPAA
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Age, sex and disease specific matched group of UC-IPAA patients with temporary diverting ileostomy from the same period
* Written informed consent
Exclusion Criteria
* Malignancy (apart from basalioma or carcinoma-in-situ of cervix)
* Psychiatric disease or inability to assess follow up
15 Years
80 Years
ALL
No
Sponsors
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Radboud University Medical Center
OTHER
Elisabeth-TweeSteden Ziekenhuis
OTHER
Responsible Party
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St Elisabeth Hospital, Tilburg, The Netherlands
Principal Investigators
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JT Heikens, MD
Role: PRINCIPAL_INVESTIGATOR
St Elisabeth Hospital, Tilburg, The Netherlands
D de Jong, MD, PhD
Role: STUDY_CHAIR
University Medical Centre St Radboud, Nijmegen, The Netherlands
JLJM Teepen, MD, PhD
Role: STUDY_CHAIR
St Elisabeth Hospital, Tilburg, The Netherlands
JHJM van Krieken, MD, PhD
Role: STUDY_CHAIR
University Medical Centre St Radboud, The Netherlands
HG Gooszen, MD, PhD
Role: STUDY_CHAIR
University Medical Centre St Radboud, Nijmegen, The Netherlands
J de Vries, Md, PhD
Role: STUDY_CHAIR
St Elisabeth Hospital, Tilburg, The Netherlands
CJHM van Laarhoven, MD, PhD
Role: STUDY_DIRECTOR
University Medical Centre St Radboud, The Netherlands
Locations
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University Medical Centre St Radboud
Nijmegen, Gelderland, Netherlands
St Elisabeth Hospital
Tilburg, North Brabant, Netherlands
Countries
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Other Identifiers
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AMO nr. 04/074
Identifier Type: -
Identifier Source: secondary_id
0426
Identifier Type: -
Identifier Source: org_study_id