NCT01097759

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2010

Completed
Last Updated

April 2, 2010

Status Verified

January 1, 2006

Enrollment Period

1.5 years

First QC Date

April 1, 2010

Last Update Submit

April 1, 2010

Conditions

Prolapsed Hemorrhoids

Keywords

hemorrhoidsprolapsedhemorrhoidectomyHemorrhoidopexyLigaSureStapled

Outcome Measures

Primary Outcomes (1)

  • Assessment of postoperative pain

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

    12 months

Secondary Outcomes (1)

  • Assessment of postoperative complications

    12 months

Study Arms (2)

LigaSure

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

Procedure: Surgery

Stapler

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

Procedure: Surgery

Interventions

SurgeryPROCEDURE

Hemorrhoidectomy using the LigaSure sealing device or hemorrhoidopexy using the stapler

LigaSureStapler

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmadi Hospital

Al Ahmadi, Al Ahmadi, 61008, Kuwait

Location

MeSH Terms

Conditions

Hemorrhoids

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Mahmoud F Sakr, MD, PhD

    Professor of Surgery, Faculty of Medicine, Alexandria University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 1, 2010

First Posted

April 2, 2010

Study Start

January 1, 2006

Primary Completion

July 1, 2007

Study Completion

July 1, 2008

Last Updated

April 2, 2010

Record last verified: 2006-01

Locations

KU(1)