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What Benefit With a New Stapler Device in the Surgical Treatment of Obstructed Defecation?

Rectal Prolapse Clinical Trial

Official title:
What Benefit With a New Stapler Device in the Surgical Treatment of Obstructed Defecation? Two-Year Outcomes From a Randomized Controlled Trial

Clinical Trial 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 circular staplers.

Clinical Trial 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 underwent stapled transanal rectal resection with two staplers PPH-01 (Ethicon Endosurgery Inc, Pomezia, Italy) (STARR group) and 40 had the same operation with new, curved multi-fire stapler Contour R Transtar TM (TRANSTAR group). Patients were followed up with clinical examination, constipation score, and perineography. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00810745
Study type Interventional
Source University of Milan
Contact
Status Completed
Phase Phase 4
Start date January 2006
Completion date November 2008
View Details
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