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

Tracking Information
First Received Date ^ICMJE	February 27, 2008
Last Updated Date	March 6, 2008
Start Date ^ICMJE	December 1997
Primary Completion Date	May 2000 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 6, 2008)	treatment success rate [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00630669 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 6, 2008)	treatment complication rate [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Comparison Between Two Endoscopic Treatments of Bleeding Internal Hemorrhoids:Band Ligation and Electrocoagulation Probe
Official Title ^ICMJE	Randomized Study Of Endoscopic Band Ligation Versus Bipolar Probe Electrocoagulation Of Bleeding Internal Hemorrhoids
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.
Detailed Description
Study Type ^ICMJE	Interventional
Study Phase
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Hemorrhoids
Intervention ^ICMJE	Procedure: Rubber band ligation placing rubber bands around the internal hemorrhoids Procedure: Bipolar coagulation using electricity to cauterize
Study Arms	Active Comparator: 1 Rubber band ligation Intervention: Procedure: Rubber band ligation Active Comparator: 2 Bipolar coagulation Intervention: Procedure: Bipolar coagulation
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	45
Completion Date	May 2001
Primary Completion Date	May 2000 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00630669
Other Study ID Numbers ^ICMJE	97-10-009-03
Has Data Monitoring Committee	No
Responsible Party	Rome Jutabha,MD/Associate Professor of Medicine, University of California, Los Angeles
Study Sponsor ^ICMJE	University of California, Los Angeles
Collaborators ^ICMJE	American Society for Gastrointestinal Endoscopy
Investigators ^ICMJE
Information Provided By	University of California, Los Angeles
Verification Date	May 2001
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP