Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2026-02-27 @ 4:08 PM
Study NCT ID:
NCT06498492
Status:
COMPLETED
Last Update Posted:
2024-07-12
First Post:
2024-07-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Versus Delayed Laparoscopic Cholecystectomy For Acute Mild Biliary Pancreatitis: A Prospective Comparative Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}, 'targetDuration': '4 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2021-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-05', 'studyFirstSubmitDate': '2024-07-05', 'studyFirstSubmitQcDate': '2024-07-05', 'lastUpdatePostDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total duration of hospital stay among early cholecystectomy group vs delayed cholecystectomy group', 'timeFrame': '4 weeks', 'description': 'In the early group, the time interval between admission to the day of discharge following laparoscopic cholecystectomy was taken into account. In the delayed group, total duration of hospital stay in conservative management period as well as for laparoscopic cholecystectomy was taken into account.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Biliary Acute Pancreatitis', 'Laparoscopic Cholecystectomy', 'Outcomes'], 'conditions': ['Biliary Acute Pancreatitis']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to evaluate the outcomes of early versus delayed cholecystectomy following mild biliary pancreatitis in Nepalese patients.', 'detailedDescription': 'This was a hospital-based prospective observational study performed at a tertiary academic center from September 2020 to August 2021.\n\nPatients diagnosed with acute mild biliary pancreatitis according to the Revised Atlanta classification 2012 were enrolled from the Emergency/Outpatient Department. Detailed history taking and thorough general and systemic examinations were conducted. Eligible patients were informed about treatment options (early vs. delayed LC) and provided informed written consent. Randomization into "early" or "delayed" groups was performed, and detailed investigations were conducted. To avoid bias, randomization was accomplished by lottery method. In the early group, laparoscopic cholecystectomy was performed during the same admission, while delayed group patients underwent surgery after symptom resolution and readmission. Surgeries were performed under general anesthesia with standard laparoscopic techniques with surgeons of equivalent qualifications. Postoperative care included analgesics and antibiotics, with follow-up examinations and histopathological assessments conducted at specified intervals. Oral intake and pain management protocols were implemented postoperatively, with patients monitored for recovery and instructed to return to normal activities after staple removal. Patients were asked to complete a visual analog pain score (VAS) from 0 (no pain) to 10 (intolerable pain) on the seventh postoperative day.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with acute mild biliary pancreatitis according to the Revised Atlanta classification 2012 were enrolled from the Emergency/Outpatient Department.Eligible patients were informed about treatment options (early vs. delayed LC) and provided informed written consent. Randomization into "early" or "delayed" groups was performed, and detailed investigations were conducted. To avoid bias, randomization was accomplished by lottery method. In the early group, laparoscopic cholecystectomy was performed during the same admission, while delayed group patients underwent surgery after symptom resolution and readmission.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients (\\>18 years of age) who presented with the diagnosis of acute mild biliary pancreatitis in our hospital were included after obtaining written consent\n\nExclusion Criteria:\n\n* patients with severe sepsis, acute moderate and severe pancreatitis, immunocompromised conditions, biliary peritonitis, cholangitis, pregnancy, admission to the intensive care unit (ICU) or high dependency unit (HDU) and those who declined to provide consent.'}, 'identificationModule': {'nctId': 'NCT06498492', 'briefTitle': 'Early Versus Delayed Laparoscopic Cholecystectomy For Acute Mild Biliary Pancreatitis: A Prospective Comparative Study', 'organization': {'class': 'OTHER', 'fullName': 'Tribhuvan University Teaching Hospital, Institute Of Medicine.'}, 'officialTitle': 'Early Versus Delayed Laparoscopic Cholecystectomy For Acute Mild Biliary Pancreatitis: A Prospective Comparative Study', 'orgStudyIdInfo': {'id': '180(6-11)E2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Early cholecystectomy group', 'description': 'For group division patients were asked to select a paper randomly from a box, offering them the choice between early or delayed laparoscopic cholecystectomy although the ultimate decision was influenced by patient preference. Those patients whose paper came early underwent early laparoscopic cholecystectomy within index hospital.', 'interventionNames': ['Procedure: Laparoscopic Cholecystectomy']}, {'label': 'Late cholecystectomy group', 'description': 'Those patients whose paper came delayed were discharged after symptoms subside and were readmitted after 6 weeks to undergo laparoscopic cholecystectomy.', 'interventionNames': ['Procedure: Laparoscopic Cholecystectomy']}], 'interventions': [{'name': 'Laparoscopic Cholecystectomy', 'type': 'PROCEDURE', 'description': 'Laparoscopic cholecystectomy (LC) has been established as the gold standard of treatment for acute mild biliary pancreatitis.', 'armGroupLabels': ['Early cholecystectomy group', 'Late cholecystectomy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44600', 'city': 'Kathmandu', 'country': 'Nepal', 'facility': 'Ishwor Thapaliya', 'geoPoint': {'lat': 27.70169, 'lon': 85.3206}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will be available for a period of 1 year.', 'ipdSharing': 'YES', 'description': 'Types of IPD to be Shared:\n\nDemographic data of the participants (age, gender, comorbidities). Data on the severity of biliary pancreatitis. Surgical outcomes, including the length of hospital stay, duration of surgery, and conversion rate to open cholecystectomy.\n\nData on recurrent biliary events and perioperative complications.\n\nGroups and Time Frame:\n\nThe study divided participants into two groups:\n\nEarly Cholecystectomy Group:\n\nIntervention: Underwent laparoscopic cholecystectomy within a short period after diagnosis of acute mild biliary pancreatitis.\n\nTime Frame: Mean hospital stay of 5.42 ± 1.01 days.\n\nDelayed Cholecystectomy Group:\n\nIntervention: Underwent laparoscopic cholecystectomy after an extended period following the initial diagnosis.\n\nTime Frame: Mean hospital stay of 9.36 ± 1.53 days.\n\nData Sharing Mechanism:\n\nData will be available upon reasonable request from the corresponding author.', 'accessCriteria': 'Researchers must provide a clear scientific rationale for requesting the data. Data will be shared upon reasonable request to the corresponding author. Requests must detail the intended use of the data and ensure it aligns with the ethical guidelines, ensuring patient confidentiality.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tribhuvan University Teaching Hospital, Institute Of Medicine.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Mr.', 'investigatorFullName': 'Ishwor Thapaliya', 'investigatorAffiliation': 'Tribhuvan University Teaching Hospital, Institute Of Medicine.'}}}}