Status:
COMPLETED
International Multicenter Prospective Transtar Registry
Lead Sponsor:
Ethicon Endo-Surgery (Europe) GmbH
Conditions:
Constipation
Eligibility:
All Genders
16+ years
Brief Summary
Obstructed Defecation Syndrome (ODS) describes a condition which is characterized by chronic constipation. The symptoms of ODS include abdominal pain or cramping, irregular bowel frequency and the fee...
Detailed Description
A new surgical procedure - Transtar - has been introduced in Europe recently. The goal of this registry is to assess safety, effectiveness and patient quality of life, associated with Transtar for chr...
Eligibility Criteria
Inclusion
- Patients with obstructed defecation, fragmented defecation or incomplete evacuation as a presenting symptom documented by a standardized symptom score
- confirmed internal rectal prolapse or rectocele on dynamic defecography
- adequate external sphincter on rectal digital examination.
Exclusion
- Subjects with any other surgical procedure than STARR for ODS
- Subjects in whom STARR is not performed with the Contour Transtar stapler
- Subjects with a physical or psychological condition which would impair participation in the registry.
Key Trial Info
Start Date :
January 31 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 30 2012
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00909116
Start Date
January 31 2009
End Date
April 30 2012
Last Update
August 11 2017
Active Locations (1)
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1
Andree D'Hoore
Leuven, Belgium, 3000