What Benefit With a New Stapler Device in the Surgical Treatment of Obstructed Defecation?
- Conditions
- Rectal Prolapse
- Registration Number
- NCT00810745
- Lead Sponsor
- University of Milan
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- Rectal prolapse
- Rectocele
- ODS score > 15
- Continence score < 3
- Resting pressure > 40 mm/Hg
- Previous anorectal surgery
- Ods score < 15
- Continence score > 3
- Resting pressure < 40
- Concomitant pelvic floor diseases
- Psychiatric diseases
- Absolute contraindications to surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method incidence of recurrences 2 years
- Secondary Outcome Measures
Name Time Method outcomes on symptoms and defecography 2 years
Trial Locations
- Locations (2)
First department of general surgery university of milan
🇮🇹Milan, Italy
First Department of General Surgery
🇮🇹Milan, Italy
First department of general surgery university of milan🇮🇹Milan, Italy