NCT00630669

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 1997

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1997

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2000

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2001

Completed
6.8 years until next milestone

First Submitted

Initial submission to the registry

February 27, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 7, 2008

Completed
Last Updated

March 7, 2008

Status Verified

May 1, 2001

Enrollment Period

2.4 years

First QC Date

February 27, 2008

Last Update Submit

March 6, 2008

Conditions

Hemorrhoids

Keywords

Internal hemorrhoidsRubber band ligationBipolar coagulation

Outcome Measures

Primary Outcomes (1)

  • treatment success rate

    one year

Secondary Outcomes (1)

  • treatment complication rate

    one year

Study Arms (2)

1

ACTIVE COMPARATOR

Rubber band ligation

Procedure: Rubber band ligation

2

ACTIVE COMPARATOR

Bipolar coagulation

Procedure: Bipolar coagulation

Interventions

Rubber band ligationPROCEDURE

placing rubber bands around the internal hemorrhoids

1
Bipolar coagulationPROCEDURE

using electricity to cauterize

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rome Jutabha,MD

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Hemorrhoids

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 27, 2008

First Posted

March 7, 2008

Study Start

December 1, 1997

Primary Completion

May 1, 2000

Study Completion

May 1, 2001

Last Updated

March 7, 2008

Record last verified: 2001-05

Locations

US(1)