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

June 23, 2026 updated by: King Edward Medical University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54000
        • Recruiting
        • Department of Surgery ,Mayo Hospital
        • Contact:
        • Principal Investigator:
          • Muhammad Zeeshan Sarwar, MBBS,FCPS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A: Subxiphoid Port Extraction
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
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.
Active Comparator: Group B: Infraumbilical Port Extraction
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 primary camera port site at the infraumbilical incision under direct laparoscopic visualization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Postoperative Pain Score
Time Frame: At 6, 12, and 24 hours post-surgery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Port-Site Infection
Time Frame: Up to 7 postoperative days
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
Time Frame: Up to 7 postoperative days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Edward Medical University

Investigators

  • Principal Investigator: Dr Muhammad Zeeshan Sarwar, MBBS,FCPS, King Edward Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2026

Primary Completion (Estimated)

July 15, 2026

Study Completion (Estimated)

August 15, 2026

Study Registration Dates

First Submitted

June 15, 2026

First Submitted That Met QC Criteria

June 23, 2026

First Posted (Actual)

June 26, 2026

Study Record Updates

Last Update Posted (Actual)

June 26, 2026

Last Update Submitted That Met QC Criteria

June 23, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dr Abdur Rehman

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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