Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-26 @ 4:49 PM
Study NCT ID:
NCT00630669
Status:
COMPLETED
Last Update Posted:
2008-03-07
First Post:
2008-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Two Endoscopic Treatments of Bleeding Internal Hemorrhoids:Band Ligation and Electrocoagulation Probe
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006484', 'term': 'Hemorrhoids'}], 'ancestors': [{'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1997-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2001-05', 'completionDateStruct': {'date': '2001-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-03-06', 'studyFirstSubmitDate': '2008-02-27', 'studyFirstSubmitQcDate': '2008-03-06', 'lastUpdatePostDateStruct': {'date': '2008-03-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2000-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'treatment success rate', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'treatment complication rate', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Internal hemorrhoids', 'Rubber band ligation', 'Bipolar coagulation'], 'conditions': ['Hemorrhoids']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Grade II or III internal hemorrhoids with chronic rectal bleeding, which failed at least 8 weeks of intensive medical therapy.\n2. Age over 18 years\n3. A life expectancy of at least 24 months\n4. A signed written informed consent\n\nExclusion Criteria:\n\n1. The patient was uncooperative or could not return for routine outpatient follow-up\n2. Severe or end-stage co-morbid illness\n3. Prior endoscopic or surgical treatment of hemorrhoids within the past 6 months\n4. Ongoing need for anticoagulation therapy or high doses of aspirin or non-steroidal antiinflammatory agents\n5. Presence of severe rectal pain\n6. Recently thrombosed internal or external hemorrhoids\n7. Anal stricture,fissure, fistula,or abscess\n8. Rectal carcinoma or bleeding distal colonic polyp\n9. Rectal varices\n10. Acute or chronic colitis\n11. Rectal prolapse\n12. Radiation telangiectasia of the rectum\n13. Prothrombin time \\>3 seconds over control\n14. Platelet count \\<75,000'}, 'identificationModule': {'nctId': 'NCT00630669', 'briefTitle': 'Comparison Between Two Endoscopic Treatments of Bleeding Internal Hemorrhoids:Band Ligation and Electrocoagulation Probe', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'Randomized Study Of Endoscopic Band Ligation Versus Bipolar Probe Electrocoagulation Of Bleeding Internal Hemorrhoids', 'orgStudyIdInfo': {'id': '97-10-009-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Rubber band ligation', 'interventionNames': ['Procedure: Rubber band ligation']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Bipolar coagulation', 'interventionNames': ['Procedure: Bipolar coagulation']}], 'interventions': [{'name': 'Rubber band ligation', 'type': 'PROCEDURE', 'description': 'placing rubber bands around the internal hemorrhoids', 'armGroupLabels': ['1']}, {'name': 'Bipolar coagulation', 'type': 'PROCEDURE', 'description': 'using electricity to cauterize', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Rome Jutabha,MD', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Society for Gastrointestinal Endoscopy', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Rome Jutabha,MD/Associate Professor of Medicine', 'oldOrganization': 'University of California, Los Angeles'}}}}