LigaSure Hemorrhoidectomy Versus Stapled Hemorrhoidopexy

Prolapsed Hemorrhoids Clinical Trial

Official title:

LigaSure Hemorrhoidectomy vs Stapled Hemorrhoidopexy: a Prospective Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01097759
• Other study ID #: 58061302393
• Status: Completed
• Phase: N/A
• First received: April 1, 2010
• Last updated: April 1, 2010
• Start date: January 2006
• Est. completion date: July 2008

Study information

• Verified date: January 2006
• Source: Kuwait Oil Company Ahmadi Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Kuwait: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: July 2008
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Hemorrhoids
• Prolapsed Hemorrhoids

Intervention

Procedure:
• Surgery
Hemorrhoidectomy using the LigaSure sealing device or hemorrhoidopexy using the stapler

Locations

Country	Name	City	State
Kuwait	Ahmadi Hospital	Ahmadi

Sponsors (2)

Lead Sponsor	Collaborator
Kuwait Oil Company Ahmadi Hospital	Netherlands: Ministry of Health, Welfare and Sports

Country where clinical trial is conducted

Kuwait, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of postoperative pain	Postoperative pain was assessed using the visual analogue scale (VAS)	12 months	No
Secondary	Assessment of postoperative complications	Postoperative complications and their management were compared between both groups during the followup visits for 12 months	12 months	Yes