Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-26 @ 4:46 AM
Study NCT ID:
NCT00974194
Status:
COMPLETED
Last Update Posted:
2018-10-17
First Post:
2009-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Cost-effectiveness Study of Single Port Laparoscopic Cholecystectomies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D041761', 'term': 'Cholecystolithiasis'}], 'ancestors': [{'id': 'D002769', 'term': 'Cholelithiasis'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 268}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-12', 'studyFirstSubmitDate': '2009-09-08', 'studyFirstSubmitQcDate': '2009-09-09', 'lastUpdatePostDateStruct': {'date': '2018-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain (value on a Visual Analog Scale)', 'timeFrame': '1 day', 'description': 'VAS'}, {'measure': 'Pain (value on a Visual Analog Scale)', 'timeFrame': '2 days', 'description': 'VAS'}, {'measure': 'Pain (value on a Visual Analog Scale)', 'timeFrame': '1 month', 'description': 'VAS'}, {'measure': 'Pain (value on a Visual Analog Scale)', 'timeFrame': '3 month', 'description': 'VAS'}, {'measure': 'Pain (value on a Visual Analog Scale)', 'timeFrame': '1 year', 'description': 'VAS'}], 'secondaryOutcomes': [{'measure': 'Complications', 'timeFrame': '1 month', 'description': 'In euro'}, {'measure': 'Operative time', 'timeFrame': 'Operative day', 'description': 'In euro'}, {'measure': 'Cost analysis', 'timeFrame': '1 year', 'description': 'In euro'}, {'measure': 'Cosmetic results', 'timeFrame': '1 month', 'description': 'According to POSAS score'}, {'measure': 'Cosmetic results', 'timeFrame': '3 month', 'description': 'According to POSAS score'}, {'measure': 'Cosmetic results', 'timeFrame': '1 year', 'description': 'According to POSAS score'}, {'measure': 'Complications', 'timeFrame': '3 month', 'description': 'According to Clavien classification and CCI'}, {'measure': 'Complications', 'timeFrame': '1 year', 'description': 'According to Clavien classification and CCI'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cholecystolithiasis', 'Cholecystectomy', 'Laparoscopic surgery', 'Single port'], 'conditions': ['Cholecystolithiasis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.chirurgieviscerale.ch', 'label': 'Internet page of our departement'}]}, 'descriptionModule': {'briefSummary': 'Many feasibility studies have been published on Single Port surgery, but no comparative studies have shown any advantages compared to standard laparoscopy. The purpose of this study is to compare the clinical outcomes and economical issues of laparoscopic cholecystectomies using single port transumbilical approach and three trocars.', 'detailedDescription': 'Design:\n\n* Prospective Randomized Controlled trial\n* Population analysis based on Intention To Treat\n* Patient and data analyzer blinded (double-blind trial)\n\nOutcomes observed:\n\n* Primary: pain\n* Secondaries: overall operative time, complication rate, cost-effectiveness analysis, cosmetic evaluation, quality of life, CO2 consumption\n\nNbr of patients included: 260\n\nPort used: Triport, Olympus'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cholecystolithiasis\n* Age 18 to 75 y.o.\n* BMI \\< 35\n\nExclusion Criteria:\n\n* Immunodeficiency\n* Choledocholithiasis\n* Previous upperGI open surgery'}, 'identificationModule': {'nctId': 'NCT00974194', 'acronym': 'SPoCOT', 'briefTitle': 'Safety and Cost-effectiveness Study of Single Port Laparoscopic Cholecystectomies', 'organization': {'class': 'OTHER', 'fullName': 'University of Lausanne Hospitals'}, 'officialTitle': 'Single Port vs Tree Trocars Laparoscopic Cholecystectomy: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'SPoCOT_2009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SinglePort CCK', 'description': 'CCK using Triport', 'interventionNames': ['Procedure: Single Trocar CCK']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LS CCK', 'description': 'CCK using three or four trocars', 'interventionNames': ['Procedure: Standard CCK']}], 'interventions': [{'name': 'Single Trocar CCK', 'type': 'PROCEDURE', 'description': 'CCK using Triport', 'armGroupLabels': ['SinglePort CCK']}, {'name': 'Standard CCK', 'type': 'PROCEDURE', 'description': 'CCK using three or four ports', 'armGroupLabels': ['LS CCK']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1011', 'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'University Hospital of Lausanne', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'Pierre Allemann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHV/CHUV'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Lausanne Hospitals', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor of surgery', 'investigatorFullName': 'Nicolas DEMARTINES', 'investigatorAffiliation': 'University of Lausanne Hospitals'}}}}