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CholelithiasisNCT06873594

Comparison of Three Ports and Four Ports Laparoscopic Cholecystectomy

A study testing three-ports laparoscopic cholecystectomy and four-port laparoscopic cholecystectomy in people with Cholelithiasis and Laparoscopic Cholecystectomy, run by Khyber Medical College, Peshawar.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Laparoscopic cholecystectomy is done traditionally with four ports. It has been observed that the same could be achieved using three ports. In this study we will study the outcomes of laparoscopic cholecystectomy done with both techniques. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Cholelithiasis, Laparoscopic Cholecystectomy
What is being tested?
three-ports laparoscopic cholecystectomy and four-port laparoscopic cholecystectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
No sites listed yet
Study dates
1 Jul 2025to 31 Mar 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients diagnosed with cholelithiasis, scheduled for elective laparoscopic cholecystectomy
  • both genders

Who cannot join

  • conversion to open cholecystectomy
  • patients requiring other bail-out procedures
  • lactating and pregnant women

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Nisar Ahmed, MBBS, FCPS contact

+92 321 511 3569

nisar.ahmed@kmc.edu.pk

About this study

Official title: Comparison of the Outcomes of Three Port and Four Port Laparoscopic Cholecystectomy in Patients Presenting to Tertiary Care Hospital: A Randomized Controlled Trial

Laparoscopic cholecystectomy is done traditionally with four ports. It has been observed that the same could be achieved using three ports. In this study we will study the outcomes of laparoscopic cholecystectomy done with both techniques.

Read the detailed description

The gallbladder functions include the storage, concentration, and release of bile into the gut through synchronous contraction. Gallbladder disease is the predominant digestive disorder that may necessitate hospitalization. Gallbladder stones (cholelithiasis) are prevalent in adults, with a prevalence rate of 4.3% in India. The prevalence of gallstones, or cholelithiasis, in the adult population of ranges from 10% to 20% 1, 2.

In cases of chronic and acute calculus cholecystitis, complications arising from cholelithiasis, the preferred treatment is laparoscopic cholecystectomy, which offers diminished post-operative morbidity, lower complication rates, and expedited recovery, albeit with a slight elevation in conversion rates. Therefore, the preferred treatment for high-risk silent cholelithiasis, symptomatic cholelithiasis, persistent calculus cholelithiasis, as well as acute calculus cholelithiasis involves laparoscopic cholecystectomy 3, 4.

This method typically involves the creation of four small incisions in the abdomen, allowing for the introduction of a camera and surgical instruments to facilitate the dissection and removal of the gallbladder. The four-port technique offers several advantages, including improved visualization and maneuverability, which can be particularly beneficial in complex cases or when there are anatomical variations 5, 6. However, as surgical techniques evolve, the three-port laparoscopic cholecystectomy has emerged as a viable alternative, offering the potential for even less invasiveness and quicker recovery times. Proponents of the three-port technique argue that it results in less postoperative pain, reduced narcotic use, and faster recovery due to fewer incisions and reduced tissue trauma. It is observed that experienced surgeons have implemented numerous changes in laparoscopic cholecystectomy, including a reduction in port size. A cholecystectomy can be performed successfully without the utilization of four ports 7-9. A study compared the outcomes of three-port and four-port laparoscopic cholecystectomy i.e Mean pain score (2.19 + 1.06, and 2.91 + 1.20), Return to normal activity (4.9 + 0.85, and 5.8 + 1.95 ), and Post-operative hospital stay (1.19 + 0.06, and 1.44 + 0.17) 10.

As the three-port approach gains popularity due to its potential benefits, it comprehensive comparisons with the traditional four-port technique is essential to determine which technique is more clinically significant. As no such study is available on this subject locally, that is why the goal of this study is to compare the outcomes of three-port and four-port laparoscopic cholecystectomy at our health facility. Understanding the differences in overall patient outcomes can provide valuable insights for surgeons and patients alike, enabling informed decisions about the most appropriate surgical method based on individual patient conditions and the complexity of their gallbladder disease. This study will be helpful to bridge the knowledge gap regarding the efficacy and safety of both techniques, ultimately guiding clinical practice and enhancing patient care in laparoscopic cholecystectomy.

Being tested
three-ports laparoscopic cholecystectomy, four-port laparoscopic cholecystectomy
Keywords
Three-port, Four-port, Laparoscopic Cholecystectomy
Medical subject headings
Cholelithiasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • three-ports laparoscopic cholecystectomyProcedure or surgery

    in this arm, laparoscopic cholecystectomy will be done with three ports

  • four-port laparoscopic cholecystectomyProcedure or surgery

    in this arm, laparoscopic cholecystectomy will be done with four ports

Study groups in NCT06873594
Study groupRoleWhat they receive
four-ports laparoscopic cholecystectomyActive comparatorin this arm, laparoscopic cholecystectomy will be done with three ports
Receives: Procedure: four-port laparoscopic cholecystectomy
Three-port Laparoscopic cholecystectomyExperimentalin this arm, laparoscopic cholecystectomy will be done with three ports
Receives: Procedure: three-ports laparoscopic cholecystectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain score

    Mean pain score measured with a 0 to 10 scale visual analogue scale

    Measured: 48 hours

  2. Operative Time

    Number of minutes of operative time

    Measured: same day of surgery

Secondary outcomes (2)
  1. Return to normal activity

    Measured in number of days

    Measured: 2 weeks

  2. hospital stay

    post operative hospital stay measured in days

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2025
  2. Study start1 Jul 2025 (estimated)
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Mar 2026 (estimated)

Resources

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
Not applicable
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06873594
Sponsor's protocol ID
163/DME/KMC
Status last verified
Mar 2025
First submitted
7 Mar 2025
Last updated
12 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Patients demographics, operative data and outcome data

Questions about this trial

What is this clinical trial studying?

A study testing three-ports laparoscopic cholecystectomy and four-port laparoscopic cholecystectomy in people with Cholelithiasis and Laparoscopic Cholecystectomy, run by Khyber Medical College, Peshawar.

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 2 inclusion and 3 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: opening soon, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nisar Ahmed, MBBS, FCPS (+92 321 511 3569, nisar.ahmed@kmc.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain score (time frame: 48 hours). 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 12 Mar 2025.

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