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

NCT ID: NCT00630669

Last Updated: 2008-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-12-31

Study Completion Date

2001-05-31

Brief Summary

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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

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Conditions

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Hemorrhoids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Rubber band ligation

Group Type ACTIVE_COMPARATOR

Rubber band ligation

Intervention Type PROCEDURE

placing rubber bands around the internal hemorrhoids

2

Bipolar coagulation

Group Type ACTIVE_COMPARATOR

Bipolar coagulation

Intervention Type PROCEDURE

using electricity to cauterize

Interventions

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Rubber band ligation

placing rubber bands around the internal hemorrhoids

Intervention Type PROCEDURE

Bipolar coagulation

using electricity to cauterize

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Society for Gastrointestinal Endoscopy

OTHER

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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University of California, Los Angeles

Locations

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Rome Jutabha,MD

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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97-10-009-03

Identifier Type: -

Identifier Source: org_study_id

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