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

University of Milan80 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Rectal Prolapse

Interventions

starrPROCEDURE

stapled transanal rectal resection

Eligibility

Sex: ALLMin age: 35 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (2)

First department of general surgery university of milan

Milan, Italy

First Department of General Surgery

Milan, Italy

Outcomes

Primary Outcomes

incidence of recurrences

Time frame: 2 years

Secondary Outcomes

outcomes on symptoms and defecography

Time frame: 2 years

Data from ClinicalTrials.gov

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