NCT00810745

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: University of Milan · Academic / Other
• Sex: All
• Age: 35 Years – 85 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Rectal Prolapse

Interventions

Type	Name	Description
PROCEDURE	starr	stapled transanal rectal resection

Timeline

• Start date: 2006-01-01
• Primary completion: 2008-09-01
• Completion: 2008-11-01
• First posted: 2008-12-18
• Last updated: 2009-02-26

Locations

2 sites across 1 country: Italy