Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-28 @ 12:08 AM
Study NCT ID:
NCT05912894
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2023-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anatomical Variation in Rouvière's Sulcus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-02', 'studyFirstSubmitDate': '2023-06-10', 'studyFirstSubmitQcDate': '2023-06-10', 'lastUpdatePostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Prevalence of Rouvière's Sulcus", 'timeFrame': '2 years'}, {'measure': "Anatomical variations in Rouvière's Sulcus", 'timeFrame': '2 years', 'description': "The variants of the Rouvière's Sulcus are catheghorized by the classification of Singh e Prasad."}], 'secondaryOutcomes': [{'measure': 'Operative time', 'timeFrame': '2 years', 'description': 'Time expressed in minutes'}, {'measure': 'Biliary tract injuries', 'timeFrame': '2 years', 'description': "Biliary tract injuries according to Stewart's classification."}, {'measure': 'Vascular injuries', 'timeFrame': '2 years', 'description': 'Vascular injuries.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Prevalence Rouvière's Sulcus", "Anatomical variations Rouvière's Sulcus"], 'conditions': ["Rouvière's Sulcus"]}, 'referencesModule': {'references': [{'pmid': '28281470', 'type': 'BACKGROUND', 'citation': "Singh M, Prasad N. The anatomy of Rouviere's sulcus as seen during laparoscopic cholecystectomy: A proposed classification. J Minim Access Surg. 2017 Apr-Jun;13(2):89-95. doi: 10.4103/0972-9941.201731."}, {'pmid': '24679422', 'type': 'BACKGROUND', 'citation': 'Stewart L. Iatrogenic biliary injuries: identification, classification, and management. Surg Clin North Am. 2014 Apr;94(2):297-310. doi: 10.1016/j.suc.2014.01.008.'}, {'pmid': '37032796', 'type': 'BACKGROUND', 'citation': 'Pesce A, Fabbri N, Feo CV. Vascular injury during laparoscopic cholecystectomy: An often-overlooked complication. World J Gastrointest Surg. 2023 Mar 27;15(3):338-345. doi: 10.4240/wjgs.v15.i3.338.'}]}, 'descriptionModule': {'briefSummary': "Rouvière's sulcus is a 2-5 cm fissure lying on the lower face of the liver, between the right lobe and caudate process. Due to its extrabiliary location, Rouvière's Sulcus could be used as an anatomical landmark for safe laparoscopic cholecystectomy. In literature there's an high variability about Rouvière Sulcus prevalence and its anatomical variants.", 'detailedDescription': "The goal of this observational study is to evaluate the presence of Rouvière Sulcus in patients underwent laparoscopic cholecystectomy. The main questions it aims to answer are the prevalence and the anatomical variations of Rouvière's Sulcus and the variants of Rouvière's Sulcus which are catheghorized according to Singh and Prasad criteria.\n\nThe following were considered secondary outcome: operative time expressed in minutes, biliary tract injuries according to Stewart's classification and Vascular injuries."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Laparoscopic cholecystectomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing videolaparoscopic cholecystectomy\n\nExclusion Criteria:\n\n* If the lower face of the right hepatic lobe and the main elements of the biliary tract cannot be clearly analyzed patients will be excluded.'}, 'identificationModule': {'nctId': 'NCT05912894', 'briefTitle': "Anatomical Variation in Rouvière's Sulcus", 'organization': {'class': 'OTHER', 'fullName': 'University Of Perugia'}, 'officialTitle': "Anatomical Variation in Rouvière's Sulcus: a Cross-sectional Study", 'orgStudyIdInfo': {'id': 'AVRS1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Videolaparoscopic cholecystectomy', 'description': 'Patients undergoing Videolaparoscopic cholecystectomy', 'interventionNames': ['Procedure: Videolaparoscopic cholecystectomy']}], 'interventions': [{'name': 'Videolaparoscopic cholecystectomy', 'type': 'PROCEDURE', 'description': "Evaluation of Rouvière's Sulcus Anatomical Variation.", 'armGroupLabels': ['Videolaparoscopic cholecystectomy']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Of Perugia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Giovanni Domenico Tebala', 'class': 'UNKNOWN'}, {'name': 'Luca Properzi', 'class': 'UNKNOWN'}, {'name': 'Nereo Vettoretto', 'class': 'UNKNOWN'}, {'name': 'Matteo Matteucci', 'class': 'UNKNOWN'}, {'name': 'Antonio Pesce', 'class': 'UNKNOWN'}, {'name': 'Carlo Boselli', 'class': 'UNKNOWN'}, {'name': 'Antonia Rizzuto', 'class': 'UNKNOWN'}, {'name': 'Augusto Lauro', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor in General Surgery', 'investigatorFullName': 'Roberto Cirocchi', 'investigatorAffiliation': 'University Of Perugia'}}}}