NCT01413867

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Societa Italiana di Chirurgia ColoRettale · Network
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2011-03-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2011-08-10
• Last updated: 2013-12-11

Locations

1 site across 1 country: Italy