Clinical Outcome After Close Rectal Ileo Pouch Anal Anastomosis for Colitis Ulcerosa(CU) (CR-IPAA)
Primary Purpose
Ulcerative Colitis
Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Close Rectal Dissection - IPAA
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Pregnancy
- Malignancy
- Psychiatric disease or inability to assess follow-up
Sites / Locations
- Universitair Medical Centre St. RadboudRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Close Rectal-Ileo Pouch Anal Anastomosis
Conventional Ileo Pouch Anal Anastomosis
Ileo Neo Rectal Anastomosis
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Secondary objectives are the inflammatory responses (pouchitis), ano-rectal function, meso-rectal development on MRI, endoscopy results and histopathology.
Full Information
NCT ID
NCT01111708
First Posted
April 26, 2010
Last Updated
April 26, 2010
Sponsor
University Medical Center Nijmegen
1. Study Identification
Unique Protocol Identification Number
NCT01111708
Brief Title
Clinical Outcome After Close Rectal Ileo Pouch Anal Anastomosis for Colitis Ulcerosa(CU)
Acronym
CR-IPAA
Official Title
Clinical Outcome After Close Rectal Ileo Pouch Anal Anastomosis for Colitis Ulcerosa Compared to the Ileo Neo Rectal Anastomosis and the Ileo Pouch Anal Anastomosis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Unknown status
Study Start Date
April 2010 (undefined)
Primary Completion Date
April 2013 (Anticipated)
Study Completion Date
April 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University Medical Center Nijmegen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
Detailed Description
Ulcerative colitis (UC) is characterized by recurring episodes of inflammation limited to the mucosal layer of the colon. The surgery rate after 10 years is 30%. After (sub)total colectomy with end ileostoma patients have a choice for restorative surgery. The conventional ileo pouch anal anastomosis (C-IPAA) is the gold standard of reconstructive surgery. This is al well established technique, but still carries a significant morbidity-rate. The recent studied ileo neo rectal anastomosis (INRA) has shown to reduce reservoir-related complications with a similar functional outcome, but is a very laborious technique. Therefore, we want to investigate an alternative technique: the Close Rectal Ileo Pouch Anal Anastomosis (CR-IPAA). The CR-IPAA is conducted in the nonanatomic perimuscular plane, resulting in a reduction of reservoir-related complications. After the close rectal dissection an ileo-anal pouch anastomosis will be constructed in a similar way. The close rectal dissection (CRD) is very laborious and has therefore never been developed extensively. But recent technical development of electrothermal bipolar vessel sealer (EBVS ) and ultrasound dissection have enhanced the CRD technique enormously. This brought along new interest in the CRD and justifies the research of its application.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Close Rectal-Ileo Pouch Anal Anastomosis
Arm Type
Experimental
Arm Title
Conventional Ileo Pouch Anal Anastomosis
Arm Type
Active Comparator
Arm Title
Ileo Neo Rectal Anastomosis
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Close Rectal Dissection - IPAA
Other Intervention Name(s)
INRA, IPAA, restorative surgery
Intervention Description
Comparison between conventional IPAA and Close Rectal IPAA and INRA after (sub)total proctocolectomy for Ulcerative colitis
Primary Outcome Measure Information:
Title
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Secondary objectives are the inflammatory responses (pouchitis), ano-rectal function, meso-rectal development on MRI, endoscopy results and histopathology.
Time Frame
1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Pregnancy
Malignancy
Psychiatric disease or inability to assess follow-up
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sharonne de Zeeuw, Drs
Phone
+31-24-3616421
Email
s.dezeeuw@chir.umcn.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kees v Laarhoven, prof. dr.
Organizational Affiliation
Radboud University Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Universitair Medical Centre St. Radboud
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6500HB
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharonne de Zeeuw, Drs
Phone
0031-24-3616421
Email
s.dezeeuw@chir.umcn.nl
First Name & Middle Initial & Last Name & Degree
Sharonne de Zeeuw, Drs
12. IPD Sharing Statement
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Clinical Outcome After Close Rectal Ileo Pouch Anal Anastomosis for Colitis Ulcerosa(CU)
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