Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT05366920
Status:
UNKNOWN
Last Update Posted:
2022-12-28
First Post:
2022-04-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cholecystectomy Blunt Dissection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D041761', 'term': 'Cholecystolithiasis'}, {'id': 'D002769', 'term': 'Cholelithiasis'}, {'id': 'D042882', 'term': 'Gallstones'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D002137', 'term': 'Calculi'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}], 'ancestors': [{'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017081', 'term': 'Cholecystectomy, Laparoscopic'}], 'ancestors': [{'id': 'D002763', 'term': 'Cholecystectomy'}, {'id': 'D001662', 'term': 'Biliary Tract Surgical Procedures'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D010535', 'term': 'Laparoscopy'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Single (Participant)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2023-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-24', 'studyFirstSubmitDate': '2022-04-17', 'studyFirstSubmitQcDate': '2022-05-05', 'lastUpdatePostDateStruct': {'date': '2022-12-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of days for discharge after surgery', 'timeFrame': '30 days'}, {'measure': 'operative time', 'timeFrame': '30 days'}, {'measure': 'intraoperative bleeding amount', 'timeFrame': '30 days', 'description': 'bleeding which require suction or draining'}], 'secondaryOutcomes': [{'measure': 'type of analgesic and dose', 'timeFrame': '30 days'}, {'measure': 'number of events of postoperative nausea and vomiting which require anti emetic drug', 'timeFrame': '30 day'}, {'measure': 'number of days after surgery when readmission is required', 'timeFrame': '30 days'}, {'measure': 'presence of a morbidity', 'timeFrame': '30days', 'description': 'number of days needed for discharge from service'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cholecystolithiasis', 'Cholelithiasis', 'Gallstones', 'Biliary Tract Diseases', 'Digestive System Diseases', 'Gallbladder Diseases', 'Calculi', 'Pathological Conditions, Anatomical'], 'conditions': ['Laparoscopic Cholecystectomy']}, 'descriptionModule': {'briefSummary': 'Day case laparoscopic cholecystectomy can be made with conventional diathermy hook starting at triangle of Calot´s. 5mm suction irrigation blunt dissection starting from the gallbladder fundus is another option. The aim is to test the hypothesis that with 5mm suction irrigation blunt dissection technique a better same day discharge and a shorter operative time can be achieved.', 'detailedDescription': 'After initiation of general anaesthesia patients are randomized either to conventional(cautery) or 5mm suction irrigation blunt dissection group. The patients and recovery room personnel are blinded to the operative technique used.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I-II\n* BMI under 35\n* normal liver enzymes\n* no bile duct dilatation in ultrasound\n* cholecystolithiasis\n\nExclusion Criteria:\n\n* NSAID allergy\n* previous upper gi-surgery\n* common bile duct stones in preoperative imaging\n* history of severe acute pancreatitis'}, 'identificationModule': {'nctId': 'NCT05366920', 'briefTitle': 'Cholecystectomy Blunt Dissection', 'organization': {'class': 'OTHER', 'fullName': 'Imam Mohammad ibn Saud Islamic University'}, 'officialTitle': 'Day-care Laparoscopic Cholecystectomy With Diathermy Hook Versus 5mm Suction Irrigation Blunt Dissection: a Randomized Study', 'orgStudyIdInfo': {'id': 'CHOLECYSTECTOMY BLUNT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'conventional diathermy hook', 'description': 'Laparoscopic cholecystectomy made with diathermy hook starting from Calot´s triangle Intervention: Procedure: dissection of gallbladder in laparoscopic cholecystectomy', 'interventionNames': ['Procedure: dissection of gallbladder in laparoscopic cholecystectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': '5 mm suction irrigation blunt dissection', 'description': 'Laparoscopic cholecystectomy made with 5mm suction irrigation blunt dissection starting from gallbladder fundus Intervention: Procedure: dissection of gallbladder in laparoscopic cholecystectomy', 'interventionNames': ['Procedure: dissection of gallbladder in laparoscopic cholecystectomy']}], 'interventions': [{'name': 'dissection of gallbladder in laparoscopic cholecystectomy', 'type': 'PROCEDURE', 'description': 'Laparoscopic cholecystectomy with diathermy hook starting from triangle of Calot', 'armGroupLabels': ['5 mm suction irrigation blunt dissection', 'conventional diathermy hook']}, {'name': 'dissection of gallbladder in laparoscopic cholecystectomy', 'type': 'PROCEDURE', 'description': 'laparoscopic cholecystectomy with 5mm suction irrigation blunt dissection starting from fundus', 'armGroupLabels': ['5 mm suction irrigation blunt dissection', 'conventional diathermy hook']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hail', 'country': 'Saudi Arabia', 'facility': 'Central fourth Health Cluster'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imam Mohammad ibn Saud Islamic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'mohammad bukhetan alharbi', 'investigatorAffiliation': 'Imam Mohammad ibn Saud Islamic University'}}}}