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

• Sponsor: University of Milan (Other)
• Overall Status: Completed
• CT.gov ID: NCT00810745
• Collaborator: (none)
• Enrollment: 80
• Locations: 2
• Arm: 1
• Duration (Months): 34
• Patients Per Site: 40
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rectal Prolapse	Procedure: starr	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: What Benefit With a New Stapler Device in the Surgical Treatment of Obstructed Defecation? Two-Year Outcomes From a Randomized Controlled Trial
• Study Start Date: Jan 1, 2006
• Actual Primary Completion Date: Sep 1, 2008
• Actual Study Completion Date: Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: rectal resection	Procedure: starr; stapled transanal rectal resection

Outcome Measures

Primary Outcome Measures

1. incidence of recurrences [2 years]

Secondary Outcome Measures

1. outcomes on symptoms and defecography [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First department of general surgery university of milan	Milan		Italy	20122
2	First Department of General Surgery	Milan		Italy	20122

Sponsors and Collaborators

• University of Milan

Investigators

• Principal Investigator: paolo boccasanta, md, 1 department of general surgery

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00810745
• Other Study ID Numbers: starr
• First Posted: Dec 18, 2008
• Last Update Posted: Feb 26, 2009
• Last Verified: Feb 1, 2009

• Keywords provided by , ,: ODS; stapled transanal rectal resection
• Additional relevant MeSH terms: Rectal Prolapse; Prolapse

Study Results

No Results Posted as of Feb 26, 2009