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NCT00521872 Clinical Trial

Stapled Trans Anal Rectal Resection (STARR) for Outlet Obstruction: Functional and Morphological Outcome

Surgery Clinical Trial

Official title:
Stapled Trans Anal Rectal Resection (STARR) for Outlet Obstruction: Functional and Morphological Outcome

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00521872
Other study ID # 33-2006
Secondary ID
Status Completed
Phase Phase 4
First received August 27, 2007
Last updated June 25, 2008
Start date April 2004
Est. completion date October 2007

Study information
Verified date August 2007
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority Switzerland: Swissmedic
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date October 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Procedure:
• STARR Operation

Locations
Country Name City State
Switzerland UniversitätsSpital Zürich Zurich

Sponsors (1)
Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pathomorphological changes of the pelvis (by MRI): intussuception, rectocele, defecation angles
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