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

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.

Study Overview

• Status: Completed
• Conditions: Rectal Prolapse
• Intervention / Treatment: Procedure: starr

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20122
    • First department of general surgery university of milan
  • Milan, Italy, 20122
    • First Department of General Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 33 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
incidence of recurrences	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
outcomes on symptoms and defecography	2 years

Collaborators and Investigators

• Sponsor: University of Milan
• Investigators: Principal Investigator: paolo boccasanta, md, 1 department of general surgery

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: December 17, 2008
• First Submitted That Met QC Criteria: December 17, 2008
• First Posted (Estimate): December 18, 2008

Study Record Updates

• Last Update Posted (Estimate): February 26, 2009
• Last Update Submitted That Met QC Criteria: February 25, 2009
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Keywords: ODS; stapled transanal rectal resection
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Pelvic Organ Prolapse; Prolapse; Rectal Prolapse
• Other Study ID Numbers: STARR