Clinical Outcome After Close Rectal Ileo Pouch Anal Anastomosis for Colitis Ulcerosa(CU)
CR-IPAA
1 other identifier
interventional
90
1 country
1
Brief Summary
The purpose of this study is to investigate a new technique: Close Rectal Dissection (CRD) as restorative surgery for Ulcerative Colitis patients: the Close Rectal Ileo Pouch Anal Anastomosis (CR-IPAA). Clinical outcome and quality of life will be compared to the conventional Ileo Pouch Anal Anastomosis (C-IPAA) and the Ileo Neo Rectal Anastomosis (INRA).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 26, 2010
CompletedFirst Posted
Study publicly available on registry
April 27, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedApril 27, 2010
January 1, 2010
3 years
April 26, 2010
April 26, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
To determine the clinical outcome (functional outcome and morbidity) after CR-IPAA compared to C-IPAA and INRA and to compare quality of life in these three different groups.
1 year
Secondary Outcomes (1)
Secondary objectives are the inflammatory responses (pouchitis), ano-rectal function, meso-rectal development on MRI, endoscopy results and histopathology.
1 year
Study Arms (3)
Close Rectal-Ileo Pouch Anal Anastomosis
EXPERIMENTALConventional Ileo Pouch Anal Anastomosis
ACTIVE COMPARATORIleo Neo Rectal Anastomosis
ACTIVE COMPARATORInterventions
Comparison between conventional IPAA and Close Rectal IPAA and INRA after (sub)total proctocolectomy for Ulcerative colitis
Eligibility Criteria
You may qualify if:
- UC patients with the CRD procedure with written informed consent.
- Age, sex and disease specific matched control group op UC-IPAA patients with written informed consent.
You may not qualify if:
- Pregnancy
- Malignancy
- Psychiatric disease or inability to assess follow-up
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universitair Medical Centre St. Radboud
Nijmegen, Gelderland, 6500HB, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kees v Laarhoven, prof. dr.
Radboud University Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 26, 2010
First Posted
April 27, 2010
Study Start
April 1, 2010
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
April 27, 2010
Record last verified: 2010-01