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LigaSure Hemorrhoidectomy Versus Stapled Hemorrhoidopexy

This study has been completed.
Sponsor:
Collaborator:
Netherlands: Ministry of Health, Welfare and Sports
Information provided by:
Kuwait Oil Company Ahmadi Hospital
ClinicalTrials.gov Identifier:
NCT01097759
First received: April 1, 2010
Last updated: NA
Last verified: January 2006
History: No changes posted
  Purpose

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


Condition Intervention
Prolapsed Hemorrhoids
 Procedure: Surgery

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: LigaSure Hemorrhoidectomy vs Stapled Hemorrhoidopexy: a Prospective Randomized Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Hemorrhoids
U.S. FDA Resources

Further study details as provided by Kuwait Oil Company Ahmadi Hospital:

Primary Outcome Measures:
  • Assessment of postoperative pain [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Postoperative pain was assessed using the visual analogue scale (VAS)


Secondary Outcome Measures:
  • Assessment of postoperative complications [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Postoperative complications and their management were compared between both groups during the followup visits for 12 months


Enrollment: 115
Study Start Date: January 2006
Study Completion Date: July 2008
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
LigaSure
LigaSure is a vascular sealing device that can seal the hemorrhoidal plexus during hemorrhoidectomy (surgery)
 Procedure: Surgery
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
 Procedure: Surgery
Hemorrhoidectomy using the LigaSure sealing device or hemorrhoidopexy using the stapler

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

A total of 68 patients with symptomatic grade III or grade IV hemorrhoids entered the study.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01097759

Locations
Kuwait
Ahmadi Hospital
Ahmadi, Kuwait, 61008
Sponsors and Collaborators
Kuwait Oil Company Ahmadi Hospital
Netherlands: Ministry of Health, Welfare and Sports
Investigators
Principal Investigator: Mahmoud F Sakr, MD, PhD Professor of Surgery, Faculty of Medicine, Alexandria University
  More Information

No publications provided

Responsible Party: Mohamed Moussa, Ahmadi Hospital
ClinicalTrials.gov Identifier: NCT01097759     History of Changes
Other Study ID Numbers: 58061302393
Study First Received: April 1, 2010
Last Updated: April 1, 2010
Health Authority: Kuwait: Ministry of Health

Keywords provided by Kuwait Oil Company Ahmadi Hospital:
hemorrhoids
prolapsed
hemorrhoidectomy
 Hemorrhoidopexy
LigaSure
Stapled

Additional relevant MeSH terms:
Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013