NCT07473388

Clipless Versus Conventional Laparoscopic Cholecystectomy Using Harmonic Scalpel

Clipless Versus Conventional Laparoscopic Cholecystectomy Using Harmonic Scalpel: A Randomized Controlled Trial From a Tertiary Care Centre in Pakistan

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 158 (actual)
• Sponsor: Services Hospital, Lahore · Other Government
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This randomized controlled trial compares the operative outcomes of clipless laparoscopic cholecystectomy using a harmonic scalpel (HS) versus conventional clip-based laparoscopic cholecystectomy (CLC) in patients with gallstone disease. The primary goals are to determine if the clipless HS technique reduces operative time and intraoperative blood loss. Secondary outcomes include the length of postoperative hospital stay and the rate of port-site infections.

Detailed description

Conventional laparoscopic cholecystectomy (CLC) uses metal clips to control the cystic duct and artery. Potential complications include clip slippage, which can lead to bleeding or bile leak, and clips acting as a nidus for future stone formation. The harmonic scalpel (HS) uses ultrasonic energy to simultaneously cut and coagulate tissue, allowing for dissection and sealing of vessels without clips. This single-center randomized controlled trial, conducted at Services Hospital, Lahore, Pakistan, enrolled 158 adults scheduled for elective laparoscopic cholecystectomy. Participants were randomly assigned to either undergo a clipless cholecystectomy with a harmonic scalpel (Group A) or a conventional clip-based cholecystectomy with monopolar electrocautery (Group B). All procedures were performed by the same experienced surgical team. The study aims to provide evidence on the safety and efficiency of the clipless HS technique in a high-volume public hospital setting.

Conditions

• Cholecystectomy, Laparoscopic
• Cholecystitis
• Gall Stones (& [Calculus - Gall Bladder])

Interventions

Type	Name	Description
PROCEDURE	Clipless Laparoscopic Cholecystectomy with Harmonic Scalpel	Patients in this arm undergo a clipless laparoscopic cholecystectomy using a harmonic scalpel. Dissection of Calot's triangle is performed with the harmonic scalpel. The cystic duct and cystic artery are occluded and divided using the harmonic shear without the application of any metal clips. The harmonic scalpel is used on power setting 2 for closure and division of the cystic pedicle. The gallbladder is dissected from the liver bed using the harmonic scalpel on power setting 5 to achieve hemostasis.
PROCEDURE	Conventional Laparoscopic Cholecystectomy	Patients in this arm undergo a conventional laparoscopic cholecystectomy. Calot's triangle is dissected using standard instruments and monopolar electrocautery. The cystic duct and cystic artery are individually controlled with metal clips (two clips applied proximally toward the common bile duct / hepatic artery side and one clip distally on the specimen side) and divided with laparoscopic scissors. The gallbladder is dissected from the liver bed using a monopolar hook

Timeline

• Start date: 2020-02-01
• Primary completion: 2025-06-15
• Completion: 2025-12-01
• First posted: 2026-03-16
• Last updated: 2026-03-16

Locations

1 site across 1 country: Pakistan