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NCT Number: NCT06873594

Comparison of Three Ports and Four Ports Laparoscopic Cholecystectomy

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

three-ports laparoscopic cholecystectomy

Procedure

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

four-port laparoscopic cholecystectomy

Procedure

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

Primary outcomes

  1. Pain score

    Time frame: 48 hours

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

  2. Operative Time

    Time frame: same day of surgery

    Number of minutes of operative time

Secondary outcomes

  1. Return to normal activity

    Time frame: 2 weeks

    Measured in number of days

  2. hospital stay

    Time frame: 2 weeks

    post operative hospital stay measured in days

Study contacts

Contact information is provided by the study sponsor or research team.

Nisar Ahmed, MBBS, FCPS

CONTACT

[email protected]

+92 321 511 3569

Sponsors and collaborators

Lead sponsor

Khyber Medical College, Peshawar

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Mar 12, 2025
Registry last updated
Mar 12, 2025

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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