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Stapled TransAnal Rectal Resection (STARR): Clinical and Radiological Outcome

This study has been completed.

Sponsored by: University of Zurich
Information provided by: University of Zurich
ClinicalTrials.gov Identifier: NCT00587080
  Purpose

To evaluate the correlation between clinical and radiological outcome after Stapled TransAnal Rectal Resection (STARR)


Condition
Obstructed Defecation Syndrome (ODS)

U.S. FDA Resources

Study Type:   Observational
Study Design:   Cohort, Prospective
Official Title:   Stapled TransAnal Rectal Resection (STARR): Correlation Between Clinical and Radiological Outcome

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Clinical and radiological outcome as assessed by closed-configuration MR defecography [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Morbidity and Mortality after STARR [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Enrollment:   24
Study Start Date:   January 2004
Study Completion Date:   August 2007
Primary Completion Date:   July 2007 (Final data collection date for primary outcome measure)

  Eligibility
Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Study Population

Patients with ODS and diagnosis of rectal redundancy (intussusception/rectoceles) in MR defecography


Criteria

Inclusion Criteria:

  • > 18 years
  • clinical signs of ODS with prior not effective conservative treatment
  • anterior rectoceles and/or intussusceptions in MR-defecography

Exclusion Criteria:

  • < 18 years
  • fixed enteroceles
  • severe fecal incontinence
  • external rectal prolapse
  • anismus
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00587080

Locations
Switzerland
University Hospital, Clinic for Visceral and Transplantation Surgery    
      Zurich, Switzerland, 8091

Sponsors and Collaborators
University of Zurich

Investigators
Principal Investigator:     Daniel Dindo, MD     University of Zurich    
  More Information

Responsible Party:   University Hospital Zurich ( Daniel Dindo, MD )
Study ID Numbers:   StV 33-2006
First Received:   December 21, 2007
Last Updated:   December 21, 2007
ClinicalTrials.gov Identifier:   NCT00587080
Health Authority:   Switzerland: Federal Office of Public Health

ClinicalTrials.gov processed this record on August 20, 2008

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