Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-31 @ 8:22 AM
Study NCT ID:
NCT05736003
Status:
COMPLETED
Last Update Posted:
2023-06-06
First Post:
2023-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prolonged Versus Delayed Laparoscopic Cholecystectomy for Acute Cholecystitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D041881', 'term': 'Cholecystitis, Acute'}], 'ancestors': [{'id': 'D002764', 'term': 'Cholecystitis'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, '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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 437}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-03', 'studyFirstSubmitDate': '2023-02-09', 'studyFirstSubmitQcDate': '2023-02-09', 'lastUpdatePostDateStruct': {'date': '2023-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall morbidity', 'timeFrame': '30 days', 'description': 'The overall morbidity included failure of initial conservative treatment, emergency consultation, unplanned hospital readmission for recurrent attacks of AC or gallstone-related complications, subtotal cholecystectomy, and intra- and postoperative complications'}], 'secondaryOutcomes': [{'measure': 'Morbidity', 'timeFrame': '30 days', 'description': 'All intra and postoperative complications'}, {'measure': 'Mortality', 'timeFrame': '30 days', 'description': 'Death'}, {'measure': 'Total length of hospital saty', 'timeFrame': '3 years', 'description': 'Duration of hospitalization'}, {'measure': 'Total Cost', 'timeFrame': '3 years', 'description': 'The total cost includes the surgical and medical costs'}, {'measure': 'Total antibiotic duration', 'timeFrame': '3 years', 'description': 'Duration of antibiotic therapy'}, {'measure': 'conversion rate', 'timeFrame': '3 years', 'description': 'conversion from laparoscopic cholecystectomy to open cholecystectomy'}, {'measure': 'Operative time', 'timeFrame': '3 hours', 'description': 'duration from first trocar incision to last stitch'}, {'measure': 'Lost days of work', 'timeFrame': '3 years', 'description': 'Lost days of work'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Cholecystitis']}, 'descriptionModule': {'briefSummary': 'Gallbladder stone affects 10-15% of the adult population, and about 15-25% of these patients presented with acute cholecystitis (AC). Laparoscopic cholecystectomy (LC) is considered the treatment of choice for patients with AC, and recent studies suggest that early laparoscopic cholecystectomy (ELC) is preferable. However, the optimal time for ELC in AC is still controversial.\n\nEarly laparoscopic cholecystectomy (ELC) was advised for patients presented within 72 hours, while conservative treatment and planned delayed laparoscopic cholecystectomy (DLC) after six weeks was recommended for patients presented after 72 hours. Surgeons almost always encounter patients with AC lasting more than 72 hours and these patients consistently refuse conservative treatment and postpone for the DLC.', 'detailedDescription': 'Gallbladder stone affects 10-15% of the adult population, and about 15-25% of these patients presented with acute cholecystitis (AC). Laparoscopic cholecystectomy (LC) is considered the treatment of choice for patients with AC, and recent studies suggest that early laparoscopic cholecystectomy (ELC) is preferable. However, the optimal time for ELC in AC is still controversial.\n\nEarly laparoscopic cholecystectomy (ELC) was advised for patients presented within 72 hours, while conservative treatment and planned delayed laparoscopic cholecystectomy (DLC) after six weeks was recommended for patients presented after 72 hours. ELC might be associated with a significant reduction in morbidity and mortality rates, comparable conversion rates, shorter hospital stays, lower costs, and higher patient satisfaction.\n\nSurgeons almost always encounter patients with AC lasting more than 72 hours and these patients consistently refuse conservative treatment and postpone the DLC. Additionally, 15% of patients do not respond to the conservative treatment and still need an emergency cholecystectomy and another 25% of patients require re-hospitalization for recurrent attacks of AC and biliary colic, biliary pancreatitis, cholangitis, and calcular obstructive jaundice during the interval waiting for the DLC. Furthermore, DLC has a higher cost and is time-consuming.\n\nProlonged LC (PLC) for AC after 3 days from onset of symptoms was thought to be more technically difficult and dangerous because of altered anatomo-pathology where suppurative and subsequently necrotizing cholecystitis develops after edematous cholecystitis during the first 2 to 4 days of symptoms, and this may be associated with increased perioperative complications and conversion rate. On the contrary, others believed that hyperemia and edema may help the dissection. All the studies in the literature focus on the ELC and DLC with little data regarding the safety and feasibility of LC for acute cholecystitis beyond 72 hours of symptoms.\n\nMore clinical trials are needed for the optimal management of acute cholecystitis after 72 hours of symptoms. The aim of this study was to compare the clinical outcomes of prolonged and delayed LC in patients with acute cholecystitis more than 72 hours of symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients diagnosed with acute cholecystitis beyond 72 hours of symptoms onset,\n2. American Society of Anesthesiologists (ASA) scores I - III,\n3. Aged 20-70 years,\n4. Agreement to complete the study\n\nExclusion Criteria:\n\n1. Gallbladder polyp,\n2. common bile duct stones,\n3. acute biliary pancreatitis,\n4. cholangitis,\n5. perforated cholecystitis,\n6. biliary peritonitis,\n7. pregnancy'}, 'identificationModule': {'nctId': 'NCT05736003', 'briefTitle': 'Prolonged Versus Delayed Laparoscopic Cholecystectomy for Acute Cholecystitis', 'organization': {'class': 'OTHER', 'fullName': 'South Valley University'}, 'officialTitle': 'Prolonged Versus Delayed Laparoscopic Cholecystectomy for Acute Cholecystitis: Time to Change the Concept - A Multicenter Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'SVU/MED/SUR011/4/23/4/611'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prolonged laparoscpic cholecystectomy', 'description': 'Patients received laparoscopic cholecystectomy for acute cholecystitis after 27 hours of symptoms', 'interventionNames': ['Procedure: Laparoscopic cholecystectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Delayed laparoscpic cholecystectomy', 'description': 'Patients received laparoscopic cholecystectomy for acute cholecystitis after 6 weeks of symptoms', 'interventionNames': ['Procedure: Laparoscopic cholecystectomy']}], 'interventions': [{'name': 'Laparoscopic cholecystectomy', 'type': 'PROCEDURE', 'description': 'Removal of gallbladder laparoscopically', 'armGroupLabels': ['Delayed laparoscpic cholecystectomy', 'Prolonged laparoscpic cholecystectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '83523', 'city': 'Luxor', 'country': 'Egypt', 'facility': 'Mohammed Ahmed Omar', 'geoPoint': {'lat': 25.69893, 'lon': 32.6421}}], 'overallOfficials': [{'name': 'Mohammed A Omar, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'General Surgery Department, Faculty of Medicine, South Valley University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'For 1 year', 'ipdSharing': 'YES', 'description': 'After publication', 'accessCriteria': 'After publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'South Valley University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor of surgery', 'investigatorFullName': 'Mohammed Ahmed Omar, MD', 'investigatorAffiliation': 'South Valley University'}}}}