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OpenTrials
Completed

NCT Number: NCT00630669

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rome Jutabha,MD

Los Angeles, California, 90095, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Rubber Band Ligation

Procedure

placing rubber bands around the internal hemorrhoids

Bipolar coagulation

Procedure

using electricity to cauterize

Primary outcomes

  1. treatment success rate

    Time frame: one year

Secondary outcomes

  1. treatment complication rate

    Time frame: one year

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • American Society for Gastrointestinal Endoscopy

Registry information

Official study title

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

Important dates

Study start
1997
Primary completion
2000
Study completion
2001
First posted
Mar 7, 2008
Registry last updated
Mar 7, 2008

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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