Status:
COMPLETED
What Benefit With a New Stapler Device in the Surgical Treatment of Obstructed Defecation?
Lead Sponsor:
University of Milan
Conditions:
Rectal Prolapse
Eligibility:
All Genders
35-85 years
Phase:
PHASE4
Brief Summary
This randomized study was designed to compare the 2 year clinical and functional results with the STARR procedure using a new curved cutter stapler or the same operation done with 2 traditional circul...
Detailed Description
From January to November 2006, 80 women were selected, with clinical examination, constipation score, colonoscopy, anorectal manometry, and perineography and randomly assigned to 2 groups: 40 patients...
Eligibility Criteria
Inclusion
- Rectal prolapse
- Rectocele
- ODS score \> 15
- Continence score \< 3
- Resting pressure \> 40 mm/Hg
Exclusion
- Previous anorectal surgery
- Ods score \< 15
- Continence score \> 3
- Resting pressure \< 40
- Concomitant pelvic floor diseases
- Psychiatric diseases
- Absolute contraindications to surgery
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00810745
Start Date
January 1 2006
End Date
November 1 2008
Last Update
February 26 2009
Active Locations (2)
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1
First department of general surgery university of milan
Milan, Italy, 20122
2
First Department of General Surgery
Milan, Italy, 20122