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Stapled TransAnal Rectal Resection (STARR) With Contour® TranstarTM

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
F. Hetzer, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier:
NCT00673400
First received: May 5, 2008
Last updated: October 1, 2012
Last verified: October 2012
History of Changes
Results First Received: July 16, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Obstructed Defecation Syndrome
Rectocele
Intussusception
SNS
Intervention: Procedure: Stapled transanal rectum resection

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Stapled TransAnal Rectal Resection patients were operated by stapled transanal rectal resection

Participant Flow:   Overall Study
    Stapled TransAnal Rectal Resection  
STARTED     52  
COMPLETED     52  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
Stapled TransAnal Rectal Resection patients were operated by stapled transanal rectal resection

Baseline Measures
    Stapled TransAnal Rectal Resection  
Number of Participants  
[units: participants]
 		  52  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     29  
>=65 years     23  
Age  
[units: years]
Mean ± Standard Deviation 		  63.2  ± 12.9  
Gender  
[units: participants]
 		 
Female     52  
Male     0  
Region of Enrollment  
[units: participants]
 		 
Switzerland     52  



  Outcome Measures
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1.  Primary:   Quality of Life   [ Time Frame: 6 months after intervention ]
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2.  Secondary:   Morbidity   [ Time Frame: 1 year ]
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3.  Secondary:   Hospitalization   [ Time Frame: 1 day to 1 year (until release from hospital) ]
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4.  Other Pre-specified:   Severity of Symptoms Score   [ Time Frame: before surgery - 6 weeks - 3 months - 6 months ]
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5.  Other Pre-specified:   Obstructive Defecation Syndrome Score   [ Time Frame: before surgery - 6 weeks -3 months - 6 months ]
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6.  Other Pre-specified:   SF36 Component Summary Scores   [ Time Frame: Before surgery - 6 months ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Ulrich Beutner PhD
Organization: Cantonal Hospital St. Gallen, Department of Surgery
phone: +41 71 494 1111
e-mail: ulrich.beutner@kssg.ch


Publications of Results:


Responsible Party: F. Hetzer, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier: NCT00673400     History of Changes
Other Study ID Numbers: STARR
Study First Received: May 5, 2008
Results First Received: July 16, 2012
Last Updated: October 1, 2012
Health Authority: Switzerland: Ethikkommission