Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2026-03-02 @ 9:46 AM
Study NCT ID:
NCT01272505
Status:
UNKNOWN
Last Update Posted:
2011-01-07
First Post:
2011-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Conventional SILS vs Harmonic Scalpel SILS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 137}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'lastUpdateSubmitDate': '2011-01-06', 'studyFirstSubmitDate': '2011-01-06', 'studyFirstSubmitQcDate': '2011-01-06', 'lastUpdatePostDateStruct': {'date': '2011-01-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'operative time'}], 'secondaryOutcomes': [{'measure': 'complications'}]}, 'conditionsModule': {'conditions': ['Gallbladde Stones']}, 'descriptionModule': {'briefSummary': 'Single incision laparoscopic cholecystectomy is gaining widespread acceptance. there are some obstacles making this procedure more complex than conventional laparoscopic cholecystectomy. The use of harmonic scalpel may aid in solving some of these issues that may allow simplification of the technique. The investigators will compare the ordinary method of single incision laparoscopic cholecystectomy versus harmonic scalpel single incision laparoscopic cholecystectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with symptomatic gallbladder stones\n\nExclusion Criteria:\n\n* acute cholecystitis cbd stones contraindications for laparoscopy'}, 'identificationModule': {'nctId': 'NCT01272505', 'acronym': 'SILS', 'briefTitle': 'Conventional SILS vs Harmonic Scalpel SILS', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'orgStudyIdInfo': {'id': 'HSSILSVSCSILS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'conventional SILC', 'description': 'Conventional method of single incision laparoscopic cholecystectomy', 'interventionNames': ['Procedure: converntional SILC', 'Procedure: Harmonic scalpel Single incision laparoscopic cholecystectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HS-SILC', 'interventionNames': ['Procedure: Harmonic scalpel Single incision laparoscopic cholecystectomy']}], 'interventions': [{'name': 'converntional SILC', 'type': 'PROCEDURE', 'armGroupLabels': ['conventional SILC']}, {'name': 'Harmonic scalpel Single incision laparoscopic cholecystectomy', 'type': 'PROCEDURE', 'armGroupLabels': ['HS-SILC', 'conventional SILC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'ahmed a elgeidie, md', 'role': 'CONTACT', 'email': 'ahmedraoaf@mans.edu.eg', 'phone': '0020105290111', 'phoneExt': '0'}, {'name': 'ahmed a elgeidie, md', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mansoura Gastroenterology Surgical Center', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'centralContacts': [{'name': 'ahmed a elgeidie, md', 'role': 'CONTACT', 'email': 'ahmedraoaf@mans.edu.eg', 'phone': '0020105290111', 'phoneExt': '0'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}}}}