Back to resultsStapled Trans Anal Rectal Resection (STARR) for Outlet Obstruction: Functional and Morphological Outcome
Primary Purpose
Surgery, Constipation
Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
STARR Operation
Sponsored by
About this trial
This is an interventional diagnostic trial for Surgery focused on measuring surgery (STARR operation)
Eligibility Criteria
Inclusion criteria:
- All patients at our institution treated with the STARR operation
Exclusion criteria:
- Age under 18,
- Chronic or acute inflammatory disease of the bowel or rectum
Sites / Locations
- UniversitätsSpital Zürich
Outcomes
Primary Outcome Measures
Pathomorphological changes of the pelvis (by MRI): intussuception, rectocele, defecation angles
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00521872
Brief Title
Stapled Trans Anal Rectal Resection (STARR) for Outlet Obstruction: Functional and Morphological Outcome
Official Title
Stapled Trans Anal Rectal Resection (STARR) for Outlet Obstruction: Functional and Morphological Outcome
Study Type
Interventional
2. Study Status
Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Zurich
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study compares pre- and postoperative (at 6 month) quality of life and pathomorphology of the pelvis (by MRI defecation) after a STARR procedure for outlet obstruction.
Trial with surgical intervention
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery, Constipation
Keywords
surgery (STARR operation)
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
STARR Operation
Primary Outcome Measure Information:
Title
Pathomorphological changes of the pelvis (by MRI): intussuception, rectocele, defecation angles
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
All patients at our institution treated with the STARR operation
Exclusion criteria:
Age under 18,
Chronic or acute inflammatory disease of the bowel or rectum
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
01 Studienregister MasterAdmins
Organizational Affiliation
UniversitaetsSpital Zuerich
Official's Role
Study Director
Facility Information:
Facility Name
UniversitätsSpital Zürich
City
Zurich
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Stapled Trans Anal Rectal Resection (STARR) for Outlet Obstruction: Functional and Morphological Outcome
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