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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subxiphoid Gallbladder Retrieval | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Incidence of Local Wound-Related Complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Abdur Rehman, MBBS | Contact | +92 331 4344721 | oabdurrehmanazad@gmail.com | |
| Dr Muhammad Abdullah, MBBS | Contact | +92 315 2480028 | oabdullahch@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Dr Muhammad Zeeshan Sarwar, MBBS,FCPS | King Edward Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery ,Mayo Hospital | Recruiting | Lahore | Punjab Province | 54000 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30302147 | Background | Li M, Cao B, Gong R, Sun D, Zhang P, Jiang X, Sheng Y. Randomized trial of umbilical incisional hernia in high-risk patients: extraction of gallbladder through subxiphoid port vs. umbilical port after laparoscopic cholecystectomy. Wideochir Inne Tech Maloinwazyjne. 2018 Sep;13(3):342-349. doi: 10.5114/wiitm.2018.76001. Epub 2018 May 25. | |
| 26488021 |
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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.
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|
| Infraumbilical Gallbladder Extraction | Procedure | 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. |
|
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). |
| Up to 7 postoperative days |
| Sasmal PK, Mishra TS, Rath S, Meher S, Mohapatra D. Port site infection in laparoscopic surgery: A review of its management. World J Clin Cases. 2015 Oct 16;3(10):864-71. doi: 10.12998/wjcc.v3.i10.864. |
| 40053819 | Background | Ye X, Niu X, Bai D, Cao Y, Mao Y, Liu H, Luo Y, Fuyu-Li, Cheng N, You Z. Comparison of gallbladder extraction via the subxiphoid port and the supraumbilical port during laparoscopic cholecystectomy: a prospective randomized clinical trial. Int J Surg. 2025 Jan 1;111(1):628-634. doi: 10.1097/JS9.0000000000001932. |
| 37007356 | Background | Mohamed HK, Albendary M, Wuheb AA, Ali O, Mohammed MJ, Osman M, Elshikhawoda MSM, Mohamedahmed AY. A Systematic Review and Meta-Analysis of Bag Extraction Versus Direct Extraction for Retrieval of Gallbladder After Laparoscopic Cholecystectomy. Cureus. 2023 Feb 26;15(2):e35493. doi: 10.7759/cureus.35493. eCollection 2023 Feb. |
| 31033631 | Background | Hajibandeh S, Hajibandeh S, Clark MC, Barratt OA, Taktak S, Subar D, Henley N. Retrieval of Gallbladder Via Umbilical Versus Epigastric Port Site During Laparoscopic Cholecystectomy: A Systematic Review and Meta-Analysis. Surg Laparosc Endosc Percutan Tech. 2019 Oct;29(5):321-327. doi: 10.1097/SLE.0000000000000662. |
| 37868486 | Background | Mannam R, Sankara Narayanan R, Bansal A, Yanamaladoddi VR, Sarvepalli SS, Vemula SL, Aramadaka S. Laparoscopic Cholecystectomy Versus Open Cholecystectomy in Acute Cholecystitis: A Literature Review. Cureus. 2023 Sep 21;15(9):e45704. doi: 10.7759/cureus.45704. eCollection 2023 Sep. |
| 37727181 | Background | Khalid A, Khalil K, Mehmood Qadri H, Ahmad CZ, Fatima W, Raza A, Asif MA, Luqman MS, Jawariah, Nizami MFK. Comparison of Postoperative Complications of Open Versus Laparoscopic Cholecystectomy According to the Modified Clavien-Dindo Classification System. Cureus. 2023 Aug 17;15(8):e43642. doi: 10.7759/cureus.43642. eCollection 2023 Aug. |
| ID | Term |
|---|---|
| D002769 | Cholelithiasis |
| D041881 | Cholecystitis, Acute |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D002764 | Cholecystitis |
| D005705 | Gallbladder Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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