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

Phase 3

Completed

• Conditions: III Degree Hemorrhoids
• Interventions: Procedure: stapled hemorrhoidopexy

• Registration Number: NCT01413867
• Lead Sponsor: Societa Italiana di Chirurgia ColoRettale

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 Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-08-08
• Study First Submitted QC: 2011-08-09
• Study First Posted: 2011-08-10
• Status Verified: 2013-12
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Last Update Submitted: 2013-12-10
• Last Update Posted: 2013-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EEA group	stapled hemorrhoidopexy	Group of patients with III degree hemorrhoids treated by EEA stapler
PPH group	stapled hemorrhoidopexy	group of patients with III degree hemorrhoids treated by PPH stapler

Primary Outcome Measures

Name	Time	Method
quantity of anorectal mucosa resected using two different circular staplers	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

Secondary Outcome Measures

Name	Time	Method
Number of hemostatic stitches required to get perfect hemostasis using 2 different staplers	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

Trial Locations

Locations (1)

Dept of Emergency and Organ transplantation; 🇮🇹 Bari, Italy