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NCT Number: NCT07473388

Clipless Versus Conventional Laparoscopic Cholecystectomy Using Harmonic Scalpel

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.

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Key information

Conditions

Cholecystectomy, Laparoscopic Biliary Tract Diseases Calculi Cholecystitis Cholecystolithiasis Cholelithiasis Digestive System Diseases Gall Stones (& [Calculus - Gall Bladder]) Gallbladder Diseases Gallstones Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Services Institute of Medical Sciences

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

Primary outcomes

  1. Operative Time in minutes

    Time frame: 120 minutes

    Defined as the time from skin incision to the completion of skin closure, measured in minutes.

  2. Intraoperative Blood Loss in ml

    Time frame: 120 minutes

    Defined as the total volume of blood collected in suction canisters after subtracting the volume of irrigation fluid used, measured in milliliters.

Secondary outcomes

  1. Length of Postoperative Hospital Stay in days

    Time frame: 6 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.

  2. Port-Site Infection Rate

    Time frame: 7-10 days

    Defined as the presence of fever (>100°F) with pain and purulent discharge from any port site.

Sponsors and collaborators

Lead sponsor

Services Hospital, Lahore

Other Gov

Collaborators

  • Services Institute of Medical Sciences, Pakistan

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Mar 16, 2026
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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