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

This study has been completed.
Sponsor:
Collaborator:
American Society for Gastrointestinal Endoscopy
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00630669
First received: February 27, 2008
Last updated: March 6, 2008
Last verified: May 2001
  Purpose

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.


Condition Intervention
Hemorrhoids
Procedure: Rubber band ligation
Procedure: Bipolar coagulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Study Of Endoscopic Band Ligation Versus Bipolar Probe Electrocoagulation Of Bleeding Internal Hemorrhoids

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • treatment success rate [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • treatment complication rate [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Enrollment: 45
Study Start Date: December 1997
Study Completion Date: May 2001
Primary Completion Date: May 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Rubber band ligation
Procedure: Rubber band ligation
placing rubber bands around the internal hemorrhoids
Active Comparator: 2
Bipolar coagulation
Procedure: Bipolar coagulation
using electricity to cauterize

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00630669

Locations
United States, California
Rome Jutabha,MD
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
American Society for Gastrointestinal Endoscopy
  More Information

No publications provided

Responsible Party: Rome Jutabha,MD/Associate Professor of Medicine, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00630669     History of Changes
Other Study ID Numbers: 97-10-009-03
Study First Received: February 27, 2008
Last Updated: March 6, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Internal hemorrhoids
Rubber band ligation
Bipolar coagulation

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

ClinicalTrials.gov processed this record on August 18, 2014