[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644547":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":30,"studyPopulation":21,"armGroups":31,"interventions":44,"overallOfficials":54,"centralContacts":58,"locations":68,"responsibleParty":90,"collaborators":21,"id":92,"slug":21,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":21,"eligibilityCriteria":97,"healthyVolunteers":93,"sex":98,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":21,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":111,"overallStatus":71,"whyStopped":21,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"King Edward Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"Mean Postoperative Pain Score","Postoperative pain intensity will be assessed while the patient is at rest using a 10-point Visual Analogue Scale (VAS), where 0 represents \"No Pain\" and 10 represents \"Worst Possible Pain\".","At 6, 12, and 24 hours post-surgery",[14,18],{"measure":15,"description":16,"timeFrame":17},"Incidence of Port-Site Infection","The presence and severity of port-site infections will be evaluated and graded according to the objective criteria of the Southampton Wound Classification System (Grades 0 to V)","Up to 7 postoperative days",{"measure":19,"description":20,"timeFrame":17},"Incidence of Local Wound-Related Complications","The development of local wound site complications, specifically tracking the presence or absence of a clinically or ultrasonographically confirmed seroma (clear fluid collection) or hematoma (localized blood collection).",null,{"allocation":23,"interventionModel":24,"interventionModelDescription":21,"primaryPurpose":25,"observationalModel":21,"timePerspective":21,"maskingInfo":26},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":27,"maskingDescription":21,"whoMasked":28},"SINGLE",[29],"PARTICIPANT","This study is structured as a parallel-group randomized controlled trial conducted at Mayo Hospital, Lahore, to evaluate the optimal retrieval site for specimen extraction during elective laparoscopic cholecystectomy.\n\nEligible patients aged 18 to 60 years diagnosed with symptomatic gallstone disease who meet all predefined inclusion criteria will be invited to participate. All surgical procedures will be standardized and performed under general anesthesia by a senior consultant surgeon using a conventional four-port technique. Following the successful mobilization of the gallbladder, the specimen will be enclosed safely inside a sterile endo-bag to control potential bile contamination.\n\nPatients will then be dynamically allocated via a computer-generated randomization system into one of two surgical groups:\n\n* Group A (Experimental Arm): The endo-bag containing the gallbladder is carefully retrieved through the subxiphoid port site under direct vision.\n* Group B (Active Comparator Arm): The endo-bag containing the gallbladder is retrieved through the primary infraumbilical camera port site under direct vision.\n\nPostoperatively, all participating patients will be systematically tracked for primary and secondary outcomes. Postoperative physical distress will be quantified while the patient is at rest using a 10-point Visual Analogue Scale (VAS) at regular intervals of 6, 12, and 24 hours. Additionally, specialized clinical assessments will be performed through the first 7 postoperative days to monitor and log the occurrence of port-site infections, staged using the Southampton Wound Classification system, alongside local complications including seroma or hematoma formation.\n\nStatistical analyses will be executed using SPSS, utilizing independent t-tests for quantitative variables and Chi-square testing for qualitative categorical outcomes to evaluate significance.",[32,38],{"label":33,"type":34,"description":35,"interventionNames":36},"Group A: Subxiphoid Port Extraction","EXPERIMENTAL","Patients undergoing standard four-port laparoscopic cholecystectomy where the gallbladder specimen is placed in a sterile endo-bag and extracted through the subxiphoid port site under direct vision to minimize bile spillage.",[37],"Procedure: Subxiphoid Gallbladder Retrieval",{"label":39,"type":40,"description":41,"interventionNames":42},"Group B: Infraumbilical Port Extraction","ACTIVE_COMPARATOR","Patients undergoing standard four-port laparoscopic cholecystectomy where the gallbladder specimen is placed in a sterile endo-bag and extracted through the primary infraumbilical (camera) port site under direct vision.",[43],"Procedure: Infraumbilical Gallbladder Extraction",[45,50],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":21},"PROCEDURE","Subxiphoid Gallbladder Retrieval","Following standard four-port laparoscopic cholecystectomy, the cystic duct and artery are clipped and divided. The gallbladder specimen is then placed within a sterile endo-bag and extracted through the subxiphoid port site under direct laparoscopic visualization to minimize bile spillage and abdominal wall contamination.",[33],{"type":46,"name":51,"description":52,"armGroupLabels":53,"otherNames":21},"Infraumbilical Gallbladder Extraction","Following standard four-port laparoscopic cholecystectomy, the cystic duct and artery are clipped and divided. The gallbladder specimen is then placed within a sterile endo-bag and extracted through the primary camera port site at the infraumbilical incision under direct laparoscopic visualization.",[39],[55],{"name":56,"affiliation":5,"role":57},"Dr Muhammad Zeeshan Sarwar, MBBS,FCPS","PRINCIPAL_INVESTIGATOR",[59,64],{"name":60,"role":61,"phone":62,"phoneExt":21,"email":63},"Dr Abdur Rehman, MBBS","CONTACT","+92 331 4344721","oabdurrehmanazad@gmail.com",{"name":65,"role":61,"phone":66,"phoneExt":21,"email":67},"Dr Muhammad Abdullah, MBBS","+92 315 2480028","oabdullahch@gmail.com",[69],{"facility":70,"status":71,"city":72,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"Department of Surgery ,Mayo Hospital","RECRUITING","Lahore","Punjab Province","54000","Pakistan","PK",{"type":78,"coordinates":79},"Point",[80,81],74.35071,31.558,{"lat":81,"lon":80},[84,88],{"name":85,"role":61,"phone":86,"phoneExt":21,"email":87},"Dr. Abdur Rehman, MBBS","+92 331 4344 721","Oabdurrehmanazad@gmail.com",{"name":89,"role":57,"phone":21,"phoneExt":21,"email":21},"Muhammad Zeeshan Sarwar, MBBS,FCPS",{"type":91,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100644547",false,"NCT07672145","Comparison of Gallbladder Extraction Via Subxiphoid vs Infraumbilical Port in Laparoscopic Cholecystectomy","Comparison of Gallbladder Extraction Via the Subxiphoid Port and the Infraumbilical Port During Laparoscopic Cholecystectomy: A Prospective Randomized Clinical Trial","Inclusion Criteria:\n\n* Patients aged between 18 to 60 years.\n* Diagnosed with symptomatic gallstones on ultrasonography.\n* American Society of Anesthesiologists (ASA) physical status I-II.\n* Scheduled for elective laparoscopic cholecystectomy.\n* Presence of acute or empyematous cholecystitis\n\nExclusion Criteria:\n\n* Intraoperative conversion to open cholecystectomy.\n* Diagnosed with Diabetes mellitus type 2.","ALL","18 Years","60 Years",{"count":102,"type":103},66,"ESTIMATED","INTERVENTIONAL",[106],"NA","Laparoscopic cholecystectomy is the standard surgical treatment for symptomatic gallstone disease due to its advantages in reducing postoperative pain and recovery times. However, surgeons continue to debate the optimal port site for retrieving the gallbladder specimen from the abdominal cavity, as this choice can influence wound-related morbidity.\n\nTraditionally, the gallbladder is extracted through the infraumbilical port site. While effective, this route is associated with a potential risk of port-site infections due to bacterial colonization within the umbilicus and risk of contamination during specimen extraction. Retrieving the gallbladder through the subxiphoid port has been proposed as an alternative technique that may utilize a cleaner surgical site, potentially reducing patient pain scores and regional wound complications.\n\nThis prospective randomized clinical trial aims to directly compare the clinical outcomes of extracting the gallbladder through the subxiphoid port versus the traditional infraumbilical port. The study will evaluate and compare mean postoperative pain intensity within the first 24 hours, as well as the regional development of port-site infections, seromas, or hematomas within 7 days following elective laparoscopic surgery.",[109,110],"Cholelithiasis (Without Cholecystitis)","Cholecystitis, Acute",[112,113,114,115,116,117],"Laparoscopic Cholecystectomy","Gallbladder Extraction","Subxiphoid Port","Infraumbilical Port","Postoperative Pain","Port-Site Infection","2026-06-23",{"date":120,"type":121},"2026-06-26","ACTUAL",{"date":123,"type":121},"2026-05-20",{"date":125,"type":103},"2026-08-15",{"name":5,"class":6},1]