- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00630669
Comparison Between Two Endoscopic Treatments of Bleeding Internal Hemorrhoids:Band Ligation and Electrocoagulation Probe
March 6, 2008 updated by: University of California, Los Angeles
Randomized Study Of Endoscopic Band Ligation Versus Bipolar Probe Electrocoagulation Of Bleeding Internal Hemorrhoids
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- Rome Jutabha,MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Rubber band ligation
|
placing rubber bands around the internal hemorrhoids
|
Active Comparator: 2
Bipolar coagulation
|
using electricity to cauterize
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
treatment success rate
Time Frame: one year
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
treatment complication rate
Time Frame: one year
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 1997
Primary Completion (Actual)
May 1, 2000
Study Completion (Actual)
May 1, 2001
Study Registration Dates
First Submitted
February 27, 2008
First Submitted That Met QC Criteria
March 6, 2008
First Posted (Estimate)
March 7, 2008
Study Record Updates
Last Update Posted (Estimate)
March 7, 2008
Last Update Submitted That Met QC Criteria
March 6, 2008
Last Verified
May 1, 2001
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 97-10-009-03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hemorrhoids
-
Vilnius UniversityBiolitec Pharma Ltd.UnknownHemorrhoids Second Degree | Hemorrhoids Third DegreeLithuania
-
Ventrus Biosciences, IncTerminatedInternal HemorrhoidsUnited States
-
Nivagen Pharmaceuticals Inc.CompletedInternal HemorrhoidsUnited States, India
-
Universidade do PortoCompletedHemorrhoids, InternalPortugal
-
G & W Laboratories Inc.CompletedInternal HemorrhoidsUnited States
-
Kuwait Oil Company Ahmadi HospitalNetherlands: Ministry of Health, Welfare and SportsCompleted
-
Societa Italiana di Chirurgia ColoRettaleSICCR - Gaetano GalloCompletedSecond-degree HemorrhoidsItaly
-
Services Hospital, LahoreCompletedLength of Stay | Operative Time | Hemorrhoidectomy | Third Degree Hemorrhoids | Fourth Degree Hemorrhoids | Postoperative,PainPakistan
-
Medtronic - MITGCompletedHemorrhoids, InternalUnited States
-
The Second Affiliated Hospital of Hunan University...Hunan University of Traditional Chinese Medicine; Zhengfeng Medical Technology...Unknown
Clinical Trials on Rubber band ligation
-
Federal University of AmazonasUnknownSecond-degree HemorrhoidsBrazil
-
Cook Group IncorporatedTerminatedDyspepsia | Gastroesophageal Reflux Disease | Heartburn | RegurgitationUnited States
-
American University of Beirut Medical CenterWithdrawnPain | Bleeding | HemorrhoidsLebanon
-
Universidade do PortoCompletedHemorrhoids, InternalPortugal
-
Tanta UniversityUnknown
-
El Katib HospitalKasr El Aini HospitalNot yet recruiting
-
Johns Hopkins UniversityWithdrawnGERD | Bariatric Surgery | Laparoscopic Sleeve Gastrectomy
-
Universitair Ziekenhuis BrusselNot yet recruiting
-
St. Olavs HospitalEnrolling by invitation