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

Hemorrhoids Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00630669
• Other study ID #: 97-10-009-03
• Status: Completed
• Phase: N/A
• First received: February 27, 2008
• Last updated: March 6, 2008
• Start date: December 1997
• Est. completion date: May 2001

Study information

• Verified date: May 2001
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: May 2001
• Est. primary completion date: May 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhoids

Intervention

Procedure:
• Rubber band ligation
placing rubber bands around the internal hemorrhoids
• Bipolar coagulation
using electricity to cauterize

Locations

Country	Name	City	State
United States	Rome Jutabha,MD	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	American Society for Gastrointestinal Endoscopy

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	treatment success rate		one year	Yes
Secondary	treatment complication rate		one year	Yes