An interventional study of Clipless Laparoscopic Cholecystectomy with Harmonic Scalpel and Conventional Laparoscopic Cholecystectomy in Cholecystectomy, Laparoscopic, Cholecystitis and Gall Stones (& [Calculus - Gall Bladder]), sponsored by Services Hospital, Lahore. Completed at 1 site in Pakistan. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-03-16.
Sponsored by Services Hospital, Lahore · Not applicable, Interventional, and Treatment
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.
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.
266 studies on the registry are indexed under Cholecystitis; 46 are open to participants now.
This study's enrollment of 158 is above the median of 86 across 167 interventional studies indexed under Cholecystitis.
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Exclusion Criteria:
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. An abdominal drain is placed in Morrison's pouch at the end of the procedure according to unit protocol.
Procedure: Clipless Laparoscopic Cholecystectomy with Harmonic Scalpel
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. An abdominal drain is placed in Morrison's pouch at the end of the procedure according to unit protocol.
Procedure: Conventional Laparoscopic Cholecystectomy
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.
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
Operative Time in minutes
Defined as the time from skin incision to the completion of skin closure, measured in minutes.
Time frame: 120 minutes
Intraoperative Blood Loss in ml
Defined as the total volume of blood collected in suction canisters after subtracting the volume of irrigation fluid used, measured in milliliters.
Time frame: 120 minutes
Length of Postoperative Hospital Stay in days
Defined as the number of days from operation to discharge when the patient can tolerate oral intake and pain is well-controlled with oral medication.
Time frame: 6 days
Port-Site Infection Rate
Defined as the presence of fever (\>100°F) with pain and purulent discharge from any port site.
Time frame: 7-10 days
Plan to share: No — The study was conducted in a single public sector institution in Pakistan. Data sharing policies are often strict and require specific prior approval, which was not indicated.
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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Services Hospital, Lahore