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Safety and Short Term Effectiveness of EEA Versus PPH Stapler for III Degree Hemorrhoids

NCT ID: NCT01413867

Last Updated: 2013-12-11

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

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-12-31

Brief Summary

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Stapled hemorrhoidopexy has gained wide acceptability among colorectal surgeons because of less postoperative pain compared with excisional surgery, however a still relevant percentage of postoperative bleedings and long-term hemorrhoid recurrence are reported. A new stapler device has been designed to overcome these drawbacks by modifying the stapled sutures and by increasing the space for mucosal resection in the case of the stapler.

This randomized controlled study was aimed to demonstrate whether the new EEA stapler Covidien was able to resect more quantity of prolapsed mucosa than the traditional PPH 01/03 Ethicol Endosurgery by measuring the surface of the resected specimen and to demonstrate if the modified stapled sutures can ensure better intraoperative hemostasis by measuring the number of overstitches required to get perfect hemostasis during the operation.

Detailed Description

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Conditions

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III Degree Hemorrhoids

Keywords

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hemorrhoids circular staplers mucosal resection hemostatic suture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EEA group

Group of patients with III degree hemorrhoids treated by EEA stapler

Group Type EXPERIMENTAL

stapled hemorrhoidopexy

Intervention Type PROCEDURE

stapled hemorrhoidopexy will be performed using the EEA stapler Covidien

PPH group

group of patients with III degree hemorrhoids treated by PPH stapler

Group Type ACTIVE_COMPARATOR

stapled hemorrhoidopexy

Intervention Type PROCEDURE

stapled hemorrhoidopexy will be performed using the PPH01/03 Ethicon EndoSurgery

Interventions

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stapled hemorrhoidopexy

stapled hemorrhoidopexy will be performed using the EEA stapler Covidien

Intervention Type PROCEDURE

stapled hemorrhoidopexy

stapled hemorrhoidopexy will be performed using the PPH01/03 Ethicon EndoSurgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* III degree Hemorrhoids
* written informed consent
* mental ability to understand the procedure

Exclusion Criteria

* Previous treatments for hemorrhoids or other proctological diseases
* Fecal Incontinence
* Chronic inflammatory bowel disease
* Anal sphincter lesions
* coagulative defects
* obstructed defecation
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Societa Italiana di Chirurgia ColoRettale

NETWORK

Sponsor Role lead

Responsible Party

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Donato F Altomare

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dept of Emergency and Organ transplantation

Bari, , Italy

Site Status

Countries

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Italy

Other Identifiers

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No sponsor

Identifier Type: -

Identifier Source: org_study_id