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

NCT07672145 | Recruiting

• 1 other identifier: Dr Abdur Rehman
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cholelithiasis (Without Cholecystitis); Cholecystitis, Acute

Keywords

Laparoscopic Cholecystectomy; Gallbladder Extraction; Subxiphoid Port; Infraumbilical Port; Postoperative Pain; Port-Site Infection

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Incidence of Port-Site Infection

  Up to 7 postoperative days

• Incidence of Local Wound-Related Complications

  Up to 7 postoperative days

Study Arms (2)

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.

Procedure: Subxiphoid Gallbladder Retrieval

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.

Procedure: Infraumbilical Gallbladder Extraction

Interventions

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.

Group A: Subxiphoid Port Extraction

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.

Group B: Infraumbilical Port Extraction

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• King Edward Medical University: lead

Study Sites (1)

Department of Surgery ,Mayo Hospital

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (7)

• 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 BACKGROUND

• 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 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.

  PMID: 40053819 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.

  PMID: 37007356 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.

  PMID: 31033631 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.

  PMID: 37868486 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.

  PMID: 37727181 BACKGROUND

MeSH Terms

Conditions

Cholelithiasis; Cholecystitis, Acute; Pain, Postoperative

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases; Cholecystitis; Gallbladder Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Dr Muhammad Zeeshan Sarwar, MBBS,FCPS

  King Edward Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Abdur Rehman, MBBS

CONTACT

+92 331 4344721; oabdurrehmanazad@gmail.com

Dr Muhammad Abdullah, MBBS

CONTACT

+92 315 2480028; oabdullahch@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 26, 2026
• Study Start: May 20, 2026
• Primary Completion: July 15, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)