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Not yet recruitingNCT06873594Updated Mar 12, 2025

Comparison of Three Ports and Four Ports Laparoscopic Cholecystectomy

An interventional study of three-ports laparoscopic cholecystectomy and four-port laparoscopic cholecystectomy in Cholelithiasis and Laparoscopic Cholecystectomy, sponsored by Khyber Medical College, Peshawar. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-03-12.

Sponsored by Khyber Medical College, Peshawar · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
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Study 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 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.

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Conditions studied

  • Cholelithiasis
  • Laparoscopic Cholecystectomy

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Keywords

  • Three-port
  • Four-port
  • Laparoscopic Cholecystectomy
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In context

Cholelithiasis

189 studies on the registry are indexed under Cholelithiasis; 42 are open to participants now.

This study's planned enrollment of 110 is above the median of 90 across 135 interventional studies indexed under Cholelithiasis.

Browse Cholelithiasis studies →

Lead sponsor

Khyber Medical College, Peshawar is the lead sponsor of 5 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
110 participants (estimated)

Study arms

  • Active comparator
    four-ports laparoscopic cholecystectomy

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

    Procedure: four-port laparoscopic cholecystectomy

  • Experimental
    Three-port Laparoscopic cholecystectomy

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

    Procedure: three-ports laparoscopic cholecystectomy

Interventions

  • Procedurethree-ports laparoscopic cholecystectomy

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

  • Procedurefour-port laparoscopic cholecystectomy

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

06

What researchers measure

Primary outcomes

  1. Pain score

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

    Time frame: 48 hours

  2. Operative Time

    Number of minutes of operative time

    Time frame: same day of surgery

Secondary outcomes

  1. Return to normal activity

    Measured in number of days

    Time frame: 2 weeks

  2. hospital stay

    post operative hospital stay measured in days

    Time frame: 2 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — Patients demographics, operative data and outcome data

Supporting information: Study protocol, Statistical analysis plan

Time frame: 1 april 2025

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jul 2025; primary completion for Dec 2025, 5 months later.

Of 54 non-industry interventional studies with no phase under Cholelithiasis, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 27. This study's planned 5 months is below that.

Counting every sponsor, half of 58 studies reached it within 15 months; a quarter within 6 and three quarters within 24.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 7, 2025
First posted
Mar 12, 2025
StartEst.
Jul 1, 2025
Primary completionEst.
Dec 31, 2025
CompletionEst.
Mar 31, 2026
Last update
Mar 12, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06873594
Lead sponsor
Khyber Medical College, Peshawar
Responsible party
Nisar Ahmed (Associate Professor Surgery, Khyber Medical College, Peshawar) — Principal investigator
First posted
Mar 12, 2025
Start date
Jul 1, 2025 (estimated)
Primary completion
Dec 31, 2025 (estimated)
Completion
Mar 31, 2026 (estimated)
Last update
Mar 12, 2025

Study contacts

Nisar Ahmed, MBBS, FCPS
Contact
nisar.ahmed@kmc.edu.pk
+92 321 511 3569

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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