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Completed

NCT Number: NCT01097759

LigaSure Hemorrhoidectomy Versus Stapled Hemorrhoidopexy

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

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Key information

Conditions

Prolapsed Hemorrhoids Cardiovascular Diseases Digestive System Diseases Gastrointestinal Diseases Hemorrhoids Intestinal Diseases Rectal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ahmadi Hospital

Al Ahmadi, 61008, Kuwait

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgery

Procedure

Hemorrhoidectomy using the LigaSure sealing device or hemorrhoidopexy using the stapler

Primary outcomes

  1. Assessment of postoperative pain

    Time frame: 12 months

    Postoperative pain was assessed using the visual analogue scale (VAS)

Secondary outcomes

  1. Assessment of postoperative complications

    Time frame: 12 months

    Postoperative complications and their management were compared between both groups during the followup visits for 12 months

Sponsors and collaborators

Lead sponsor

Kuwait Oil Company Ahmadi Hospital

Other

Collaborators

  • Netherlands: Ministry of Health, Welfare and Sports

Registry information

Official study title

LigaSure Hemorrhoidectomy vs Stapled Hemorrhoidopexy: a Prospective Randomized Clinical Trial

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Apr 2, 2010
Registry last updated
Apr 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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