Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2026-02-21 @ 11:36 PM
Study NCT ID:
NCT02947256
Status:
COMPLETED
Last Update Posted:
2016-11-01
First Post:
2016-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laparoscopic Cholecystectomy With Retro-infundibular Approach
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D042882', 'term': 'Gallstones'}], 'ancestors': [{'id': 'D002769', 'term': 'Cholelithiasis'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D041761', 'term': 'Cholecystolithiasis'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D002137', 'term': 'Calculi'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-29', 'studyFirstSubmitDate': '2016-10-22', 'studyFirstSubmitQcDate': '2016-10-26', 'lastUpdatePostDateStruct': {'date': '2016-11-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'conversion to open', 'timeFrame': '24 hours', 'description': 'the incidence of conversion to open'}, {'measure': 'biliary injury', 'timeFrame': '2 weeks', 'description': 'the incidence of biliary injury'}], 'secondaryOutcomes': [{'measure': 'operative time', 'timeFrame': '24 hours', 'description': 'time from skin opening to skin closure'}, {'measure': 'hospital stay', 'timeFrame': '6 weeks', 'description': 'time of hospital stay'}, {'measure': 'mortality', 'timeFrame': '6 weeks', 'description': 'incidence of operative related mortality'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Gallstones']}, 'descriptionModule': {'briefSummary': "Aimed to evaluate laparoscopic cholecystectomy by retro-infundibular (RI) approach compared to standard laparoscopic cholecystectomy (SLC) in difficult cases with scarred chole-cystohepatic (Calot's) triangle.", 'detailedDescription': "This study is a prospective cohort study, conducted in Minia university hospital and Minia insurance hospital in the period from July 2013 to January 2016, where 597 patients with gallstones were admitted for laparoscopic cholecystectomy and were done by the same surgeon. Based on the preoperative scoring system to predict the degree of difficulty in laparoscopic cholecystectomy, patients that had the score \\> 6 and were fit for laparoscopic surgery were included in the study. Only 125 met these criteria and agreed to share in the study and gave their informed consent. 60 patients were operated by SLC (Group 1).This included the classic dissection of Calot's triangle to achieve the CVS, with separate clipping and division of cystic duct and artery. While, 65 patients were operated by laparoscopic cholecystectomy using RI approach (Group 2). This included separation of the lower third of GB from its bed down to its pedicle (artery and duct) with mass ligation of both.\n\nOperative procedure of by RI approach:\n\nThe site of trocars was the same as for the standard cholecystectomy. After dissection of adhesion masking the GB, if present, to reach the Hartmann pouch, at this point Calot's triangle usually was scarred and frozen, the surgeon never tried to dissect it and instead the surgeon continued as follow :\n\n1. De-shouldering of GB: by incising the serosal covering on either side of the infundibulum and lower part of the body.\n2. This followed by dissection and separation of the lower third of GB body from its bed, using suction-irrigation probe or hook dissector. Dissection continued downward till the GB pedicle (duct and artery).\n3. Mass ligation of cystic artery and duct, using intracorporeal note by vicryl number 1 suture.\n4. Then the surgeon cut above the ligature using diathermy on scissor or ultrasound sealing device. During this step the cut end of the GB was grasped by forceps trying to prevent spillage of its content, if happened, stones were collected in a bag and extracted.\n5. Then GB was dissected from its bed as usual and extracted in a bag. In cases where the GB was hugely distended, it was aspirated firstly to facilitate its grasping. Also in cases of Mirizzi syndrome the GB was opened direct on the stone to remove it, to facilitate grasping of GB then we continued as described above"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient with gallstones\n* score difficulty according to Gupta et al 2013 \\> 6\n* patient fit for laparoscopic surgery\n\nExclusion Criteria:\n\n* score difficulty according to Gupta et al 2013 \\> 6\n* patient unfit for laparoscopic surgery\n* refusal to share in the study'}, 'identificationModule': {'nctId': 'NCT02947256', 'briefTitle': 'Laparoscopic Cholecystectomy With Retro-infundibular Approach', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': "Laparoscopic Cholecystectomy With Retro-infundibular Approach Versus Standard Laparoscopic Cholecystectomy in Difficult Cases, Where Calot's Triangle is Unsafe to be Dissected", 'orgStudyIdInfo': {'id': 'fac.med.011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'standard laparoscopic cholecystectomy', 'description': "This included the classic dissection of Calot's triangle to achieve the CVS, with separate clipping and division of cystic duct and artery.", 'interventionNames': ['Procedure: standard laparoscopic cholecystectomy']}, {'type': 'EXPERIMENTAL', 'label': 'RI approach', 'description': 'Retroinfundibular laparoscopic cholecystectomy: This included separation of the lower third of GB from its bed down to its pedicle (artery and duct) with mass ligation of both.\n\nOperative procedure of by RI approach:', 'interventionNames': ['Procedure: RI approach']}], 'interventions': [{'name': 'standard laparoscopic cholecystectomy', 'type': 'PROCEDURE', 'otherNames': ['SLC'], 'description': "which included the classic dissection of Calot's triangle to achieve the CVS, with separate clipping and division of cystic duct and artery", 'armGroupLabels': ['standard laparoscopic cholecystectomy']}, {'name': 'RI approach', 'type': 'PROCEDURE', 'description': 'which included separation of the lower third of GB from its bed down to its pedicle (artery and duct) with mass ligation of both.', 'armGroupLabels': ['RI approach']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61511', 'city': 'Minya', 'country': 'Egypt', 'facility': 'Faculty of medicine', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}, {'zip': '61511', 'city': 'Minya', 'country': 'Egypt', 'facility': 'Minia University Hospital', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}], 'overallOfficials': [{'name': 'Alaa M Sewefy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lecturer & consultant of general surgery, Department of surgery, Minia university hospital, Egypt.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Lecturer & consultant of general surgery, Department of surgery, Minia university hospital, Egypt', 'investigatorFullName': 'Alaa Mstafa Hassan Sewefy', 'investigatorAffiliation': 'Minia University'}}}}