Comparison of Gallbladder Extraction Via Subxiphoid vs Infraumbilical Port in Laparoscopic Cholecystectomy

Official title

Comparison of Gallbladder Extraction Via the Subxiphoid Port and the Infraumbilical Port During Laparoscopic Cholecystectomy: A Prospective Randomized Clinical Trial

Overview

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.

Detailed description

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:

* Group A (Experimental Arm): The endo-bag containing the gallbladder is carefully retrieved through the subxiphoid port site under direct vision. * Group B (Active Comparator Arm): The endo-bag containing the gallbladder is retrieved through the primary infraumbilical camera port site under direct vision.

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.

Interventions

• 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.
• 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 primary camera port site at the infraumbilical incision under direct laparoscopic visualization.

Primary outcome measures

• Mean Postoperative Pain Score [Time frame: At 6, 12, and 24 hours post-surgery]

Secondary outcome measures (2)

• Incidence of Port-Site Infection [Time frame: Up to 7 postoperative days]
• Incidence of Local Wound-Related Complications [Time frame: Up to 7 postoperative days]

Eligibility criteria

Inclusion criteria

• Patients aged between 18 to 60 years.
• Diagnosed with symptomatic gallstones on ultrasonography.
• American Society of Anesthesiologists (ASA) physical status I-II.
• Scheduled for elective laparoscopic cholecystectomy.
• Presence of acute or empyematous cholecystitis

Exclusion criteria

• Intraoperative conversion to open cholecystectomy.
• Diagnosed with Diabetes mellitus type 2.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Pakistan · 1 center

• Department of Surgery ,Mayo Hospital — Lahore

Publications

• 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. PMID 30302147
• 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. PMID 26488021
• 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. PMID 40053819
• 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. PMID 37007356
• 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. PMID 31033631
• 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. PMID 37868486
• 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. PMID 37727181

Identifiers

NCT: NCT07672145 · Dr Abdur Rehman

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗