An interventional study of Subxiphoid Gallbladder Retrieval and Infraumbilical Gallbladder Extraction in Cholelithiasis (Without Cholecystitis) and Cholecystitis, Acute, sponsored by King Edward Medical University. Recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by King Edward Medical University · Not applicable, Interventional, and Treatment
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.
Traditionally, 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.
This 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.
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.
Eligible 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.
Patients will then be dynamically allocated via a computer-generated randomization system into one of two surgical groups:
Postoperatively, 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.
Statistical analyses will be executed using SPSS, utilizing independent t-tests for quantitative variables and Chi-square testing for qualitative categorical outcomes to evaluate significance.
189 studies on the registry are indexed under Cholelithiasis; 42 are open to participants now.
This study's planned enrollment of 66 is below the median of 90 across 135 interventional studies indexed under Cholelithiasis.
Browse Cholelithiasis studies →King Edward Medical University is the lead sponsor of 82 studies on the registry; 27 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Subxiphoid Gallbladder Retrieval
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.
Procedure: 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 subxiphoid port site under direct laparoscopic visualization to minimize bile spillage and abdominal wall contamination.
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.
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".
Time frame: At 6, 12, and 24 hours post-surgery
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)
Time frame: Up to 7 postoperative days
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).
Time frame: Up to 7 postoperative days
Plan to share: No — Individual participant data will not be shared outside of the primary research team to maintain strict patient confidentiality, as mandated by the Institutional Review Board (IRB) and the Advanced Studies \& Research Board (ASRB) of King Edward Medical University, Lahore. According to the signed institutional data protection affidavit and the informed patient consent protocol, all collected clinical data are strictly restricted for use within this specific postgraduate master's thesis project.
Started May 2026 (actual). Primary completion is estimated for Jul 2026, 1 month after the start.
Of 54 non-industry interventional studies with no phase under Cholelithiasis, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 27. This study's planned 1 month is below that.
Counting every sponsor, half of 58 studies reached it within 15 months; a quarter within 6 and three quarters within 24.
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