Comparison Between Two Endoscopic Treatments of Bleeding Internal Hemorrhoids:Band Ligation and Electrocoagulation Probe

March 6, 2008 updated by: University of California, Los Angeles

Randomized Study Of Endoscopic Band Ligation Versus Bipolar Probe Electrocoagulation Of Bleeding Internal Hemorrhoids

The purpose of this study is to determine which treatment, band ligation (placing rubber bands around the hemorrhoids) or BICAP electrocoagulation (using electricity to cauterize) is safer and more effective endoscopic treatment for bleeding internal hemorrhoids.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Los Angeles, California, United States, 90095
        • Rome Jutabha,MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Grade II or III internal hemorrhoids with chronic rectal bleeding, which failed at least 8 weeks of intensive medical therapy.
  2. Age over 18 years
  3. A life expectancy of at least 24 months
  4. A signed written informed consent

Exclusion Criteria:

  1. The patient was uncooperative or could not return for routine outpatient follow-up
  2. Severe or end-stage co-morbid illness
  3. Prior endoscopic or surgical treatment of hemorrhoids within the past 6 months
  4. Ongoing need for anticoagulation therapy or high doses of aspirin or non-steroidal antiinflammatory agents
  5. Presence of severe rectal pain
  6. Recently thrombosed internal or external hemorrhoids
  7. Anal stricture,fissure, fistula,or abscess
  8. Rectal carcinoma or bleeding distal colonic polyp
  9. Rectal varices
  10. Acute or chronic colitis
  11. Rectal prolapse
  12. Radiation telangiectasia of the rectum
  13. Prothrombin time >3 seconds over control
  14. Platelet count <75,000

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Rubber band ligation
placing rubber bands around the internal hemorrhoids
Active Comparator: 2
Bipolar coagulation
using electricity to cauterize

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
treatment success rate
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
treatment complication rate
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1997

Primary Completion (Actual)

May 1, 2000

Study Completion (Actual)

May 1, 2001

Study Registration Dates

First Submitted

February 27, 2008

First Submitted That Met QC Criteria

March 6, 2008

First Posted (Estimate)

March 7, 2008

Study Record Updates

Last Update Posted (Estimate)

March 7, 2008

Last Update Submitted That Met QC Criteria

March 6, 2008

Last Verified

May 1, 2001

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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