Cholecystectomy, LaparoscopicNCT07473388
Clipless Versus Conventional Laparoscopic Cholecystectomy Using Harmonic Scalpel
A study testing Clipless Laparoscopic Cholecystectomy with Harmonic Scalpel and Conventional Laparoscopic Cholecystectomy in people with Cholecystectomy, Laparoscopic and Cholecystitis, run by Services Hospital, Lahore at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Cholecystectomy, Laparoscopic, Cholecystitis, Gall Stones (& [Calculus - Gall Bladder])
- What is being tested?
- Clipless Laparoscopic Cholecystectomy with Harmonic Scalpel and Conventional Laparoscopic Cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2020to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 20-70 years.
- Diagnosis of gallstone disease confined to the gallbladder.
- Scheduled for elective laparoscopic cholecystectomy.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Services Institute of Medical Sciences
Lahore, Punjab Province, 54000
About this study
Official title: 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.
Read the 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.
- Being tested
- Clipless Laparoscopic Cholecystectomy with Harmonic Scalpel, Conventional Laparoscopic Cholecystectomy
- Keywords
- laparoscopic cholecystectomy, clipless cholecystectomy, harmonic scalpel
- Medical subject headings
- Cholecystitis, Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clipless Laparoscopic Cholecystectomy with Harmonic ScalpelProcedure or surgery
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 CholecystectomyProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Conventional Laparoscopic Cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative Time in minutes
Defined as the time from skin incision to the completion of skin closure, measured in minutes.
Measured: 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.
Measured: 120 minutes
Secondary outcomes (2)
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.
Measured: 6 days
Port-Site Infection Rate
Defined as the presence of fever (>100°F) with pain and purulent discharge from any port site.
Measured: 7-10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 Feb 2020
- Primary completion15 Jun 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholecystectomy, LaparoscopicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Services Hospital, Lahore
- Sponsor type
- Other government
- Collaborators
- Services Institute of Medical Sciences, Pakistan
- Responsible party
- Principal investigator, Dr. SamiUllah, Services Hospital, Lahore
- Investigators
- Awais Amjad, MBBS, FCPS, Study director, Services Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07473388
- Sponsor's protocol ID
- RCT24SIMS
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clipless Versus Conventional Laparoscopic Cholecystectomy Using Harmonic Scalpel: A Randomized Controlled Trial From a Tertiary Care Centre in Pakistan
- ClinicalTrials.gov ID
- NCT07473388
- Acronym / sponsor ID
- RCT24SIMS
- Keywords
- laparoscopic cholecystectomy, clipless cholecystectomy, harmonic scalpel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Services Hospital, LahoreOther government
- Collaborators
- Services Institute of Medical Sciences, Pakistan
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clipless Harmonic Scalpel Cholecystectomy | Experimental | Procedure: Clipless Laparoscopic Cholecystectomy with Harmonic ScalpelPatients 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. |
| Conventional Clip-Based Cholecystectomy | Active comparator | Procedure: Conventional Laparoscopic CholecystectomyPatients 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. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 20-70 years.
- Diagnosis of gallstone disease confined to the gallbladder.
- Scheduled for elective laparoscopic cholecystectomy.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clipless Laparoscopic Cholecystectomy with Harmonic ScalpelPatients 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 or surgery | Clipless Harmonic Scalpel Cholecystectomy |
| Conventional Laparoscopic CholecystectomyPatients 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 | Procedure or surgery | Conventional Clip-Based Cholecystectomy |
Primary outcome
Operative Time in minutes
Time frame: 120 minutes
Defined as the time from skin incision to the completion of skin closure, measured in minutes.
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.
2 secondary outcomes
Length of Postoperative Hospital Stay in days
Time frame: 6 days
Port-Site Infection Rate
Time frame: 7-10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Awais Amjad, MBBS, FCPS study director
Services Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clipless Laparoscopic Cholecystectomy with Harmonic Scalpel and Conventional Laparoscopic Cholecystectomy in people with Cholecystectomy, Laparoscopic and Cholecystitis, run by Services Hospital, Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative Time in minutes (time frame: 120 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.