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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07672145
Enrollment
66
Registered
2026-06-26
Start date
2026-05-20
Completion date
2026-08-15
Last updated
2026-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholecystitis, Acute, Cholelithiasis (Without Cholecystitis)

Keywords

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

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.

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

PROCEDURESubxiphoid 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.

PROCEDUREInfraumbilical 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.

Sponsors

King Edward Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Mean Postoperative Pain ScoreAt 6, 12, and 24 hours post-surgeryPostoperative 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".

Secondary

MeasureTime frameDescription
Incidence of Port-Site InfectionUp to 7 postoperative daysThe 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)
Incidence of Local Wound-Related ComplicationsUp to 7 postoperative daysThe 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).

Countries

Pakistan

Contacts

CONTACTDr Abdur Rehman, MBBS
oabdurrehmanazad@gmail.com+92 331 4344721
CONTACTDr Muhammad Abdullah, MBBS
oabdullahch@gmail.com+92 315 2480028
PRINCIPAL_INVESTIGATORDr Muhammad Zeeshan Sarwar, MBBS,FCPS

King Edward Medical University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 27, 2026