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

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ClinicalTrials.gov Identifier: NCT00630669
Recruitment Status : Completed
First Posted : March 7, 2008
Last Update Posted : March 7, 2008
Sponsor:
Collaborator:
American Society for Gastrointestinal Endoscopy
Information provided by:
University of California, Los Angeles

Brief Summary:
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 or disease Intervention/treatment Phase
Hemorrhoids Procedure: Rubber band ligation Procedure: Bipolar coagulation Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Study Of Endoscopic Band Ligation Versus Bipolar Probe Electrocoagulation Of Bleeding Internal Hemorrhoids
Study Start Date : December 1997
Actual Primary Completion Date : May 2000
Actual Study Completion Date : May 2001

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. treatment success rate [ Time Frame: one year ]

Secondary Outcome Measures :
  1. treatment complication rate [ Time Frame: one year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: March 7, 2008    Key Record Dates
Last Update Posted: March 7, 2008
Last Verified: May 2001

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

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