Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2025-12-27 @ 1:30 AM
Study NCT ID:
NCT01097759
Status:
COMPLETED
Last Update Posted:
2010-04-02
First Post:
2010-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LigaSure Hemorrhoidectomy Versus Stapled Hemorrhoidopexy
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-01', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-04-01', 'studyFirstSubmitDate': '2010-04-01', 'studyFirstSubmitQcDate': '2010-04-01', 'lastUpdatePostDateStruct': {'date': '2010-04-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of postoperative pain', 'timeFrame': '12 months', 'description': 'Postoperative pain was assessed using the visual analogue scale (VAS)'}], 'secondaryOutcomes': [{'measure': 'Assessment of postoperative complications', 'timeFrame': '12 months', 'description': 'Postoperative complications and their management were compared between both groups during the followup visits for 12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hemorrhoids', 'prolapsed', 'hemorrhoidectomy', 'Hemorrhoidopexy', 'LigaSure', 'Stapled'], 'conditions': ['Prolapsed Hemorrhoids']}, 'descriptionModule': {'briefSummary': 'This study was designed to compare the outcome of LigaSure hemorrhoidectomy and stapled hemorrhoidopexy for prolapsed hemorrhoids.', 'detailedDescription': 'The study was designed as a single-blind, prospective, randomized controlled trial and was approved by the Ethics Committee of Ahmadi Hospital, Kuwait. Patients were randomly assigned to undergo either hemorrhoidectomy with the LigaSure device or stapled hemorrhoidopexy. Patients were blinded as to the type of procedure perform. Candidates for the study were consecutive patients with symptomatic grade III or IV hemorrhoids admitted to the Ahmadi Hospital (secondary care hospital), Kuwait, from January 2006 through July 2007.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'A total of 68 patients with symptomatic grade III or grade IV hemorrhoids entered the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (above 18 years)\n* With prolapsed hemorrhoids (grades III or IV)\n\nExclusion Criteria:\n\n* Complicated hemorrhoid\n* Coexisting perianal disease\n* Previous perianal surgery\n* Unfit for general anesthesia\n* Pregnancy\n* History of bleeding tendency'}, 'identificationModule': {'nctId': 'NCT01097759', 'briefTitle': 'LigaSure Hemorrhoidectomy Versus Stapled Hemorrhoidopexy', 'organization': {'class': 'OTHER', 'fullName': 'Kuwait Oil Company Ahmadi Hospital'}, 'officialTitle': 'LigaSure Hemorrhoidectomy vs Stapled Hemorrhoidopexy: a Prospective Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '58061302393'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'LigaSure', 'description': 'LigaSure is a vascular sealing device that can seal the hemorrhoidal plexus during hemorrhoidectomy (surgery)', 'interventionNames': ['Procedure: Surgery']}, {'label': 'Stapler', 'description': 'Circular stapler that removes excess loose tissue above the anus and interrupts the blood supply during hemorrhoidal surgery', 'interventionNames': ['Procedure: Surgery']}], 'interventions': [{'name': 'Surgery', 'type': 'PROCEDURE', 'description': 'Hemorrhoidectomy using the LigaSure sealing device or hemorrhoidopexy using the stapler', 'armGroupLabels': ['LigaSure', 'Stapler']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61008', 'city': 'Al Ahmadi', 'state': 'Al Ahmadi', 'country': 'Kuwait', 'facility': 'Ahmadi Hospital', 'geoPoint': {'lat': 29.07694, 'lon': 48.08389}}], 'overallOfficials': [{'name': 'Mahmoud F Sakr, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of Surgery, Faculty of Medicine, Alexandria University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kuwait Oil Company Ahmadi Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Netherlands: Ministry of Health, Welfare and Sports', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Mohamed Moussa', 'oldOrganization': 'Ahmadi Hospital'}}}}