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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary:
Sponsor: Societa Italiana di Chirurgia ColoRettale

Current Primary Outcome: quantity of anorectal mucosa resected using two different circular staplers [ Time Frame: 1 hour following the end of the operation ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Number of hemostatic stitches required to get perfect hemostasis using 2 different staplers [ Time Frame: 1 hour after each operation ]

Original Secondary Outcome: Same as current

Information By: Societa Italiana di Chirurgia ColoRettale

Dates:
Date Received: August 8, 2011
Date Started: March 2011
Date Completion:
Last Updated: December 10, 2013
Last Verified: December 2013