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

NCT01413867 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2013-12-11

No results posted yet for this study

Summary

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.

Conditions

  • III Degree Hemorrhoids

Interventions

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

Sponsors & Collaborators

  • Societa Italiana di Chirurgia ColoRettale

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01413867 on ClinicalTrials.gov