Back to resultsA Study to Investigate the Ileo Neo Rectal Anastomosis Compared to the Ileo Pouch Anal Anastomosis for Patients With Ulcerative Colitis
Primary Purpose
Colitis, Ulcerative, Surgery
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Ileal Neo Rectal Anastomosis
Ileal Pouch Anal Anastomosis
Sponsored by
About this trial
This is an interventional treatment trial for Colitis, Ulcerative focused on measuring Colitis, Ulcerative, Ileo Neo Rectal Anastomosis, Ileal Pouch Anal Anastomosis, Quality of Life, functional results, reconstructive surgery, surgery
Eligibility 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
Sites / Locations
- St Elisabeth Hospital
- University Medical Centre St Radboud
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
INRA
IPAA
Arm Description
Patients treated for medical refractory Ulcerative Colitis
Patients treated for medical refractory Ulcerative Colitis
Outcomes
Primary Outcome Measures
functional outcome
Quality of life and Health Status
Secondary Outcome Measures
histo-pathologic results
endoscopic results
morbidity and mortality
ano-rectal physiology
Full Information
NCT ID
NCT00922103
First Posted
June 12, 2009
Last Updated
September 10, 2010
Sponsor
Elisabeth-TweeSteden Ziekenhuis
Collaborators
Radboud University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00922103
Brief Title
A Study to Investigate the Ileo Neo Rectal Anastomosis Compared to the Ileo Pouch Anal Anastomosis for Patients With Ulcerative Colitis
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 Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Elisabeth-TweeSteden Ziekenhuis
Collaborators
Radboud University Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colitis, Ulcerative, Surgery
Keywords
Colitis, Ulcerative, Ileo Neo Rectal Anastomosis, Ileal Pouch Anal Anastomosis, Quality of Life, functional results, reconstructive surgery, surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
INRA
Arm Type
Experimental
Arm Description
Patients treated for medical refractory Ulcerative Colitis
Arm Title
IPAA
Arm Type
Active Comparator
Arm Description
Patients treated for medical refractory Ulcerative Colitis
Intervention Type
Procedure
Intervention Name(s)
Ileal Neo Rectal Anastomosis
Intervention Description
Comparison of the Ileal Neo Rectal Anastomosis to the Ileal Pouch Anal Anastomosis in patients treated for medical refractory Ulcerative Colitis
Intervention Type
Procedure
Intervention Name(s)
Ileal Pouch Anal Anastomosis
Intervention Description
Comparison of the Ileal Pouch Anal Anastomosis to the Ileal Neo Rectal Anastomosis in patients treated for medical refractory Ulcerative Colitis
Primary Outcome Measure Information:
Title
functional outcome
Time Frame
after surgery: 3 months, 6 months, 12 months and yearly afterwards
Title
Quality of life and Health Status
Time Frame
after surgery: 3 months, 6 months, 12 months and yearly afterwards
Secondary Outcome Measure Information:
Title
histo-pathologic results
Time Frame
after surgery: 3 months, 6 months, 12 months and yearly afterwards
Title
endoscopic results
Time Frame
after surgery: 3 months, 6 months, 12 months and yearly afterwards
Title
morbidity and mortality
Time Frame
after surgery: 3 months, 6 months, 12 months and yearly afterwards
Title
ano-rectal physiology
Time Frame
after surgery: 3 months, 6 months, 12 months and yearly afterwards
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JT Heikens, MD
Organizational Affiliation
St Elisabeth Hospital, Tilburg, The Netherlands
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
D de Jong, MD, PhD
Organizational Affiliation
University Medical Centre St Radboud, Nijmegen, The Netherlands
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
JLJM Teepen, MD, PhD
Organizational Affiliation
St Elisabeth Hospital, Tilburg, The Netherlands
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
JHJM van Krieken, MD, PhD
Organizational Affiliation
University Medical Centre St Radboud, The Netherlands
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
HG Gooszen, MD, PhD
Organizational Affiliation
University Medical Centre St Radboud, Nijmegen, The Netherlands
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
J de Vries, Md, PhD
Organizational Affiliation
St Elisabeth Hospital, Tilburg, The Netherlands
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
CJHM van Laarhoven, MD, PhD
Organizational Affiliation
University Medical Centre St Radboud, The Netherlands
Official's Role
Study Director
Facility Information:
Facility Name
St Elisabeth Hospital
City
Tilburg
State/Province
Brabant
ZIP/Postal Code
5022 GC
Country
Netherlands
Facility Name
University Medical Centre St Radboud
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6500 HB
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
A Study to Investigate the Ileo Neo Rectal Anastomosis Compared to the Ileo Pouch Anal Anastomosis for Patients With Ulcerative Colitis
We'll reach out to this number within 24 hrs