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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 30, 2014