Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-30 @ 4:36 PM
Study NCT ID:
NCT06280404
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-28
First Post:
2024-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Body First Approach in Lap Cholecystectomy in Cases With Obscure Calot's Triangle
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002764', 'term': 'Cholecystitis'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}], 'ancestors': [{'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-03-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-08-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-26', 'studyFirstSubmitDate': '2024-02-20', 'studyFirstSubmitQcDate': '2024-02-26', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safe laparoscopic cholecystectomy.', 'timeFrame': 'Baseline', 'description': 'To achieve critical view of safety during lap cholecystectomy'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the body first approach technique', 'timeFrame': 'Baseline', 'description': "evaluate the body first approach on the rate of conversion to open technique \\& VBI in patients with obscure calot's triangle."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cholecystitis, Chronic']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://ales.amegroups.org/article/view/5242/html', 'label': 'Laparoscopic cholecystectomy: semi-top-down technique'}, {'url': 'http://pubmed.ncbi.nlm.nih.gov/34159732/', 'label': 'Postoperative analgesic effect of ultrasound-guided rectus sheath block and local anesthetic infiltration after laparoscopic cholecystectomy: Results of a prospective randomized controlled trial'}, {'url': 'http://pubmed.ncbi.nlm.nih.gov/34748289/', 'label': 'Application of a novel surgical difficulty grading system during laparoscopic cholecystectomy'}, {'url': 'http://pubmed.ncbi.nlm.nih.gov/29266752/', 'label': 'Randomized controlled trial comparing the effects of usual gas release, active aspiration, and passive-valve release on abdominal distension in patients who have undergone laparoscopic cholecystectomy'}, {'url': 'http://pubmed.ncbi.nlm.nih.gov/36650019/', 'label': 'Body-first approach of laparoscopic cholecystectomy for minimizing vasculobiliary injury: Initial experience'}, {'url': 'http://www.ncbi.nlm.nih.gov/books/NBK448145/', 'label': 'Laparoscopic Cholecystectomy'}, {'url': 'http://pubmed.ncbi.nlm.nih.gov/30828991/', 'label': 'A three-step conceptual roadmap for avoiding bile duct injury in laparoscopic cholecystectomy: an invited perspective review'}]}, 'descriptionModule': {'briefSummary': "The aim of this study is to evaluate the body first approach on the rate of conversion to open technique \\& VBI in patients with obscure calot's triangle.", 'detailedDescription': 'Gallbladder disease is one of the most common reasons patients are referred to a general surgeon. Laparoscopic cholecystectomy (LC) is the current standard of care for symptomatic cholelithiasis. Despite being considered a low-risk surgery, bile duct injuries (BDIs) have occurred at a constant rate in the last 30 years, leaving devastating consequences on the affected patients. However vasculobiliary injury (VBI) is a rare but critical complication of (LC). So we need to follow critical view of safety. The critical view of safety (CVS) described by Strasberg is considered as the one of the most important critical factors for overall safety during LC. The CVS consists of three essential component or steps: 1) dissection of the hepatocystic triangle (HCT); 2) exposure of at least lower one third of the cystic plate (CP); and 3) demonstration of only two tubular structures (cystic duct and cystic artery) that remain attached to the gallbladder (after components 1 and 2 are achieved). All these three steps must be completed before considering that CVS has been achieved. However in some cases Calot\'s triangle can\'t be demonstrated due to dense adhesions. Conversion with retrograde approach (fundus first) was an option for these cases. However a retrograde approach can be achieved laparoscopically by starting dissection by body to use the fundus attachment for retraction which is called (the "body-first approach") that may decrease the possibility of VBI. Recent studies deficient in evaluation of outcome of (body first approach). So the interest of our study is to evaluate the outcome of body first approach in difficult cases and cases with obscure Calot\'s triangle in (LC) and to evaluate its feasibility and safety in (LC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "All adult patients aging above 18 years old fit for (LC), who presented with symptomatic gall stones by clinical examination and detected by preoperative imaging and intra-operatively have obscure Calot's triangle.", 'eligibilityCriteria': "Inclusion Criteria:\n\n\\- All adult patients aging above 18 years old fit for (LC), who presented with symptomatic gall stones by clinical examination and detected by preoperative imaging and intra-operatively have obscure Calot's triangle.\n\nExclusion Criteria:\n\n* unfit patients.\n* Patients with calcular obstructive jaundice."}, 'identificationModule': {'nctId': 'NCT06280404', 'briefTitle': "Body First Approach in Lap Cholecystectomy in Cases With Obscure Calot's Triangle", 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': "Body First Approach in Laparoscopic Cholecystectomy in Cases With Obscure Calot's Triangle", 'orgStudyIdInfo': {'id': 'Body first in lap chole'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Lap cholecystectomy', 'type': 'DEVICE', 'description': "Body first approach in laparoscopic cholecystectomy in cases with obscure Calot's triangle"}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Abdelrahman Abdullah Badawy, Resident', 'role': 'CONTACT', 'email': 'abdobadawy28.ab@gmail.com', 'phone': '01010016178'}, {'name': 'Samir Ahmed Ammar, Professor', 'role': 'CONTACT', 'email': 'Samirahmed22@aun.edu.eg', 'phone': '01141459567'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Abdelrahman Abdullah Badawy', 'investigatorAffiliation': 'Assiut University'}}}}