Safety and Short Term Effectiveness of EEA Versus PPH Stapler for III Degree Hemorrhoids (EEA/PPH2011)

December 10, 2013 updated by: Donato F Altomare, Societa Italiana di Chirurgia ColoRettale

Safety and Short Term Effectiveness of EEA Stapler vs PPH Stapler in the Treatment of III Degree Haemorrhoids. Prospective Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bari, Italy, 70124
        • Dept of Emergency and Organ transplantation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: EEA group
Group of patients with III degree hemorrhoids treated by EEA stapler
Procedure: stapled hemorrhoidopexy
stapled hemorrhoidopexy will be performed using the EEA stapler Covidien
Procedure: stapled hemorrhoidopexy
stapled hemorrhoidopexy will be performed using the PPH01/03 Ethicon EndoSurgery
ACTIVE_COMPARATOR: PPH group
group of patients with III degree hemorrhoids treated by PPH stapler
Procedure: stapled hemorrhoidopexy
stapled hemorrhoidopexy will be performed using the EEA stapler Covidien
Procedure: stapled hemorrhoidopexy
stapled hemorrhoidopexy will be performed using the PPH01/03 Ethicon EndoSurgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quantity of anorectal mucosa resected using two different circular staplers
Time Frame: 1 hour following the end of the operation
The surface (in cm2)of anorectal mucosa resected during stapled hemorrhoidopexy for III degree hemorrhoids, using two different circular staplers will be compared
1 hour following the end of the operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of hemostatic stitches required to get perfect hemostasis using 2 different staplers
Time Frame: 1 hour after each operation
the number of hemostatic sutures required to get perfect hemostasis during stapled hemorrhoidopexy using 2 different staplers for III degree hemorrhoids
1 hour after each operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Societa Italiana di Chirurgia ColoRettale

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

August 8, 2011

First Submitted That Met QC Criteria

August 9, 2011

First Posted (ESTIMATE)

August 10, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

December 11, 2013

Last Update Submitted That Met QC Criteria

December 10, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • No sponsor

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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