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

Not Applicable

Completed

• Conditions: Hemorrhoids
• Interventions: Procedure: Rubber band ligation; Procedure: Bipolar coagulation

• Registration Number: NCT00630669
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 1997-12
• Primary Completion: 2000-05
• Status Verified: 2001-05
• Study Completion: 2001-05
• Study First Submitted: 2008-02-27
• Study First Submitted QC: 2008-03-06
• Last Update Submitted: 2008-03-06
• Study First Posted: 2008-03-07
• Last Update Posted: 2008-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Rubber band ligation	Rubber band ligation
2	Bipolar coagulation	Bipolar coagulation

Primary Outcome Measures

Name	Time	Method
treatment success rate	one year

Secondary Outcome Measures

Name	Time	Method
treatment complication rate	one year

Trial Locations

Locations (1)

Rome Jutabha,MD; 🇺🇸 Los Angeles, California, United States