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 Details — Status: Completed

Administrative data

• NCT number: NCT00810745
• Other study ID #: starr
• Status: Completed
• Phase: Phase 4
• First received: December 17, 2008
• Last updated: February 25, 2009
• Start date: January 2006
• Est. completion date: November 2008

Study information

• Verified date: February 2009
• Source: University of Milan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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 information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 85 Years

Eligibility

Inclusion Criteria:

• Rectal prolapse

• Rectocele

• ODS score > 15

• Continence score < 3

• Resting pressure > 40 mm/Hg

Exclusion Criteria:

• Previous anorectal surgery

• Ods score < 15

• Continence score > 3

• Resting pressure < 40

• Concomitant pelvic floor diseases

• Psychiatric diseases

• Absolute contraindications to surgery

Related Conditions & MeSH terms

• Prolapse
• Rectal Prolapse

Intervention

Procedure:
• starr
stapled transanal rectal resection

Locations

Country	Name	City	State
Italy	First Department of General Surgery	Milan
Italy	First department of general surgery university of milan	Milan

Sponsors (1)

Lead Sponsor	Collaborator
University of Milan

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of recurrences		2 years
Secondary	outcomes on symptoms and defecography		2 years