LigaSure Hemorrhoidectomy Versus Stapled Hemorrhoidopexy

Completed

• Conditions: Prolapsed Hemorrhoids
• Interventions: Procedure: Surgery

• Registration Number: NCT01097759
• Lead Sponsor: Kuwait Oil Company Ahmadi Hospital

Brief Summary

This study was designed to compare the outcome of LigaSure hemorrhoidectomy and stapled hemorrhoidopexy for prolapsed hemorrhoids.

Detailed Description

The study was designed as a single-blind, prospective, randomized controlled trial and was approved by the Ethics Committee of Ahmadi Hospital, Kuwait. Patients were randomly assigned to undergo either hemorrhoidectomy with the LigaSure device or stapled hemorrhoidopexy. Patients were blinded as to the type of procedure perform. Candidates for the study were consecutive patients with symptomatic grade III or IV hemorrhoids admitted to the Ahmadi Hospital (secondary care hospital), Kuwait, from January 2006 through July 2007.

Study Timeline

• Status Verified: 2006-01
• Study Start: 2006-01
• Primary Completion: 2007-07
• Study Completion: 2008-07
• Study First Submitted: 2010-04-01
• Study First Submitted QC: 2010-04-01
• Last Update Submitted: 2010-04-01
• Study First Posted: 2010-04-02
• Last Update Posted: 2010-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 115

Inclusion Criteria

• Adult (above 18 years)
• With prolapsed hemorrhoids (grades III or IV)

Exclusion Criteria

• Complicated hemorrhoid
• Coexisting perianal disease
• Previous perianal surgery
• Unfit for general anesthesia
• Pregnancy
• History of bleeding tendency

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stapler	Surgery	Circular stapler that removes excess loose tissue above the anus and interrupts the blood supply during hemorrhoidal surgery
LigaSure	Surgery	LigaSure is a vascular sealing device that can seal the hemorrhoidal plexus during hemorrhoidectomy (surgery)

Primary Outcome Measures

Name	Time	Method
Assessment of postoperative pain	12 months	Postoperative pain was assessed using the visual analogue scale (VAS)

Secondary Outcome Measures

Name	Time	Method
Assessment of postoperative complications	12 months	Postoperative complications and their management were compared between both groups during the followup visits for 12 months

Trial Locations

Locations (1)

Ahmadi Hospital; 🇰🇼 Ahmadi, Kuwait