LigaSure Hemorrhoidectomy Versus Stapled Hemorrhoidopexy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

115 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-07-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Prolapsed Hemorrhoids

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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LigaSure

LigaSure is a vascular sealing device that can seal the hemorrhoidal plexus during hemorrhoidectomy (surgery)

Surgery

Intervention Type PROCEDURE

Hemorrhoidectomy using the LigaSure sealing device or hemorrhoidopexy using the stapler

Stapler

Circular stapler that removes excess loose tissue above the anus and interrupts the blood supply during hemorrhoidal surgery

Surgery

Intervention Type PROCEDURE

Hemorrhoidectomy using the LigaSure sealing device or hemorrhoidopexy using the stapler

Interventions

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Surgery

Hemorrhoidectomy using the LigaSure sealing device or hemorrhoidopexy using the stapler

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No