Clipless Versus Conventional Laparoscopic Cholecystectomy Using Harmonic Scalpel

NCT07473388 | Completed DMC

• 1 other identifier: RCT24SIMS
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

laparoscopic cholecystectomy; clipless cholecystectomy; harmonic scalpel

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Length of Postoperative Hospital Stay in days

  6 days

• Port-Site Infection Rate

  7-10 days

Study Arms (2)

Clipless Harmonic Scalpel Cholecystectomy

EXPERIMENTAL

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

Conventional Clip-Based Cholecystectomy

ACTIVE COMPARATOR

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

Interventions

Clipless Laparoscopic Cholecystectomy with Harmonic Scalpel PROCEDURE

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.

Clipless Harmonic Scalpel Cholecystectomy

Conventional Laparoscopic Cholecystectomy PROCEDURE

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

Conventional Clip-Based Cholecystectomy

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Services Hospital, Lahore: lead
• Services Institute of Medical Sciences, Pakistan: collaborator

Study Sites (1)

Services Institute of Medical Sciences

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Cholecystitis; Gallstones

Condition Hierarchy (Ancestors)

Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Cholelithiasis; Cholecystolithiasis; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Awais Amjad, MBBS, FCPS

  Services Institute of Medical Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 16, 2026
• Study Start: February 1, 2020
• Primary Completion: June 15, 2025
• Study Completion: December 1, 2025
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)