Comparison of Gallbladder Extraction Via Subxiphoid vs Infraumbilical Port in Laparoscopic Cholecystectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorKing Edward Medical University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Intraoperative conversion to open cholecystectomy.
Diagnosed with Diabetes mellitus type 2.
Trial design
Design model
Parallel
Treatments tested in this trial
Subxiphoid Gallbladder Retrieval
Procedure/SurgeryFollowing 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.
Infraumbilical Gallbladder Extraction
Procedure/SurgeryFollowing 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.
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: Group A: Subxiphoid Port ExtractionExperimental treatment 1 intervention
Group B: Group B: Infraumbilical Port ExtractionActive comparator 1 intervention
Trial outcomes
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".
Time frame
At 6, 12, and 24 hours post-surgerySecondary outcomes
1
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)
Time frame
Up to 7 postoperative days2
Incidence of Local Wound-Related Complications
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).
Time frame
Up to 7 postoperative daysSponsors and contacts
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Source ClinicalTrials.gov