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

Primary Purpose

Hemorrhoids

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Rubber band ligation

Bipolar coagulation

About this trial

This is an interventional treatment trial for Hemorrhoids focused on measuring Internal hemorrhoids, Rubber band ligation, Bipolar coagulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Rome Jutabha,MD

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

Rubber band ligation

Bipolar coagulation

Outcomes

Primary Outcome Measures

treatment success rate

Secondary Outcome Measures

treatment complication rate

Full Information

NCT ID

NCT00630669

First Posted

February 27, 2008

Last Updated

March 6, 2008

Sponsor

University of California, Los Angeles

Collaborators

American Society for Gastrointestinal Endoscopy

1. Study Identification

Unique Protocol Identification Number

NCT00630669

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2001

Overall Recruitment Status

Completed

Study Start Date

December 1997 (undefined)

Primary Completion Date

May 2000 (Actual)

Study Completion Date

May 2001 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of California, Los Angeles

Collaborators

American Society for Gastrointestinal Endoscopy

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemorrhoids

Keywords

Internal hemorrhoids, Rubber band ligation, Bipolar coagulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Rubber band ligation

Arm Title

Arm Type

Active Comparator

Arm Description

Bipolar coagulation

Intervention Type

Procedure

Intervention Name(s)

Rubber band ligation

Intervention Description

placing rubber bands around the internal hemorrhoids

Intervention Type

Procedure

Intervention Name(s)

Bipolar coagulation

Intervention Description

using electricity to cauterize

Primary Outcome Measure Information:

Title

treatment success rate

Time Frame

one year

Secondary Outcome Measure Information:

Title

treatment complication rate

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Rome Jutabha,MD

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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