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

NCT ID: NCT00810745

Last Updated: 2009-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-11-30

Brief Summary

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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

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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.

Conditions

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Rectal Prolapse

Keywords

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ODS stapled transanal rectal resection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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rectal resection

Group Type EXPERIMENTAL

starr

Intervention Type PROCEDURE

stapled transanal rectal resection

Interventions

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starr

stapled transanal rectal resection

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Milan

OTHER

Sponsor Role lead

Responsible Party

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university of milan

Principal Investigators

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paolo boccasanta, md

Role: PRINCIPAL_INVESTIGATOR

1 department of general surgery

Locations

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First department of general surgery university of milan

Milan, , Italy

Site Status

First Department of General Surgery

Milan, , Italy

Site Status

Countries

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Italy

Other Identifiers

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starr

Identifier Type: -

Identifier Source: org_study_id