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

This study has been completed.
Sponsor:
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00587080
First received: December 21, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  Purpose

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


Condition
Obstructed Defecation Syndrome (ODS)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: 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 ]

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

No publications provided

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

ClinicalTrials.gov processed this record on April 20, 2014