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

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.

Study Overview

• Status: Completed
• Conditions: Cholecystitis; Cholecystectomy, Laparoscopic; Gall Stones (& [Calculus - Gall Bladder])
• Intervention / Treatment: Procedure: Clipless Laparoscopic Cholecystectomy with Harmonic Scalpel; Procedure: Conventional Laparoscopic Cholecystectomy

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.

• Study Type: Interventional
• Enrollment (Actual): 158
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan, 54000
      • Services Institute of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 20-70 years.
• Diagnosis of gallstone disease confined to the gallbladder.
• Scheduled for elective laparoscopic cholecystectomy.

Exclusion Criteria:

• ASA (American Society of Anesthesiologists) physical status class III or IV.
• Renal dysfunction (serum creatinine > 2.0 mg/dL).
• Coagulopathy (PT >1 s above control, aPTT >33 s, INR >1.5).
• Pregnancy.
• Presence of common bile duct stones.
• Previous upper abdominal surgery or laparotomy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Clipless Harmonic Scalpel 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. 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 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.
Active Comparator: Conventional Clip-Based 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. 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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative Time in minutes	Defined as the time from skin incision to the completion of skin closure, measured in minutes.	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.	120 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 days
Port-Site Infection Rate	Defined as the presence of fever (>100°F) with pain and purulent discharge from any port site.	7-10 days

Collaborators and Investigators

• Sponsor: Services Hospital, Lahore
• Collaborators: Services Institute of Medical Sciences, Pakistan
• Investigators: Study Director: Awais Amjad, MBBS, FCPS, Services Institute of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): June 15, 2025
• Study Completion (Actual): December 1, 2025

Study Registration Dates

• First Submitted: March 11, 2026
• First Submitted That Met QC Criteria: March 11, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: laparoscopic cholecystectomy; harmonic scalpel; clipless cholecystectomy
• Additional Relevant MeSH Terms: Calculi; Pathological Conditions, Anatomical; Digestive System Diseases; Biliary Tract Diseases; Gallbladder Diseases; Cholelithiasis; Cholecystolithiasis; Pathological Conditions, Signs and Symptoms; Cholecystitis; Gallstones
• Other Study ID Numbers: RCT24SIMS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No