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

University of California, Los Angeles (UCLA)

Status: Completed

Conditions: Hemorrhoids

Treatments: Procedure: Rubber band ligation; Procedure: Bipolar coagulation

Study type: Interventional

Funder types: Other

Identifiers

NCT00630669

97-10-009-03

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

1

Active Comparator group

Description:

Rubber band ligation

Treatment:

Procedure: Rubber band ligation

2

Active Comparator group

Description:

Bipolar coagulation

Treatment:

Procedure: Bipolar coagulation