Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-26 @ 6:00 PM
Study NCT ID:
NCT07113704
Status:
COMPLETED
Last Update Posted:
2025-08-11
First Post:
2025-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fundus-First Laparoscopic Cholecystectomy in Difficult Gallbladders: A Safe Alternative Technique
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002769', 'term': 'Cholelithiasis'}], 'ancestors': [{'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-08-02', 'size': 152271, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-08-02T12:43', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-02', 'studyFirstSubmitDate': '2025-07-25', 'studyFirstSubmitQcDate': '2025-08-02', 'lastUpdatePostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Conversion Rate to Open Surgery', 'timeFrame': 'Intraoperative (during surgery)', 'description': 'Rate of conversion from laparoscopic to open cholecystectomy in each group. Measured as number and percentage of patients converted.'}], 'secondaryOutcomes': [{'measure': 'Operative Time', 'timeFrame': 'Intraoperative (during surgery)', 'description': 'Total operative time measured in minutes from skin incision to closure. Comparison between the fundus-first and conventional laparoscopic cholecystectomy groups.'}, {'measure': 'Postoperative Complication Rate', 'timeFrame': 'Within 30 days postoperatively', 'description': 'Includes complications such as wound infection, bile leak, abscess, or any adverse event requiring medical or surgical intervention. Compared between groups'}, {'measure': 'Length of Hospital Stay', 'timeFrame': 'Postoperative hospitalization', 'description': 'Number of days from surgery to discharge. Mean values will be compared between groups.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fundus-first laparoscopic cholecystectomy', 'difficult cholecystectomy', 'Cross-sectional study', 'General surgery', 'Laparoscopic cholecystectomy', 'Tertiary care hospital'], 'conditions': ['Cholelithiasis']}, 'descriptionModule': {'briefSummary': 'This retrospective cross-sectional study evaluated the safety and effectiveness of the fundus-first laparoscopic cholecystectomy (FFLC) technique in patients with difficult gallbladders. A total of 124 patients who underwent FFLC between 2023 and 2024 were reviewed. The study assessed operative time, intraoperative complications, conversion rates, and postoperative outcomes. The results suggest that FFLC is a safe and feasible approach that can reduce the need for conversion to open surgery in complex cases. The study was conducted at a private hospital in Istanbul, Turkey', 'detailedDescription': 'This retrospective study was conducted at a private healthcare institution without a formal IRB. All patient data were anonymised before analysis, and written informed consent was obtained from all patients for the academic use of their clinical data'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study included adult patients (≥18 years) who underwent laparoscopic cholecystectomy for difficult gallbladder (Nassar grade 3-4) at a single tertiary care center between January 2023 and March 2024.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who underwent laparoscopic cholecystectomy at the study center between January 2023 and March 2024\n* Patients diagnosed with difficult gallbladder (Nassar Grade 3-4)\n* Age ≥ 18 years\n* Complete clinical data available for analysis\n\nExclusion Criteria:\n\n* Patients with incomplete medical records\n* Patients undergoing open cholecystectomy from the beginning\n* Patients under 18 years of age'}, 'identificationModule': {'nctId': 'NCT07113704', 'briefTitle': 'Fundus-First Laparoscopic Cholecystectomy in Difficult Gallbladders: A Safe Alternative Technique', 'organization': {'class': 'OTHER', 'fullName': 'Medicana Ataşehir International Hospital'}, 'officialTitle': 'Fundus-First Laparoscopic Cholecystectomy in Difficult Gallbladders: A Retrospective Cross-Sectional Study on a Safe Alternative to Avoid Conversion', 'orgStudyIdInfo': {'id': 'FFLC2025AMSUKI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Conventional Laparoscopic Cholecystectomy', 'description': "Patients who underwent standard laparoscopic cholecystectomy, starting dissection at Calot's triangle. This technique served as the comparator for assessing safety and conversion rates relative to the fundus-first approach.", 'interventionNames': ['Procedure: Conventional Laparoscopic Cholecystectomy']}, {'label': 'Fundus-First Laparoscopic Cholecystectomy', 'description': "Patients with difficult gallbladders (Nassar Grade 3-4) who underwent laparoscopic cholecystectomy using the fundus-first technique. This approach involved starting dissection at the gallbladder fundus and proceeding retrogradely toward Calot's triangle to improve safety in complex cases.", 'interventionNames': ['Procedure: Fundus-First Laparoscopic Cholecystectomy']}], 'interventions': [{'name': 'Conventional Laparoscopic Cholecystectomy', 'type': 'PROCEDURE', 'otherNames': ['Antegrade Laparoscopic Cholecystectomy'], 'description': "Standard laparoscopic cholecystectomy technique starting at Calot's triangle. Used as the comparator group in this study.", 'armGroupLabels': ['Conventional Laparoscopic Cholecystectomy']}, {'name': 'Fundus-First Laparoscopic Cholecystectomy', 'type': 'PROCEDURE', 'otherNames': ['Retrograde laparoscopic cholecystectomy'], 'description': "Laparoscopic cholecystectomy technique initiated at the gallbladder fundus and carried out retrogradely toward Calot's triangle. This method was applied to difficult gallbladders (Nassar Grade 3-4) to improve operative safety and avoid conversion to open surgery.", 'armGroupLabels': ['Fundus-First Laparoscopic Cholecystectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34750', 'city': 'Istanbul', 'state': 'Ataşehir', 'country': 'Turkey (Türkiye)', 'facility': 'Medicana Ataşehir International Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'KANAN ISMAYILZADA, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medicana Ataşehir International Hospital, ISTANBUL.TURKEY'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The study is retrospective in nature, and no plans have been made to share individual participant data with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KANAN ISMAYILZADA, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'General Surgeon', 'investigatorFullName': 'KANAN ISMAYILZADA, MD', 'investigatorAffiliation': 'Medicana Ataşehir International Hospital'}}}}