Comparison of Three Ports and Four Ports Laparoscopic Cholecystectomy
Comparison of the Outcomes of Three Port and Four Port Laparoscopic Cholecystectomy in Patients Presenting to Tertiary Care Hospital: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nisar Ahmed, MBBS, FCPS
- Phone Number: +92 321 511 3569
- Email: nisar.ahmed@kmc.edu.pk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: four-ports laparoscopic cholecystectomy
in this arm, laparoscopic cholecystectomy will be done with three ports
|
in this arm, laparoscopic cholecystectomy will be done with four ports
|
|
Experimental: Three-port Laparoscopic cholecystectomy
in this arm, laparoscopic cholecystectomy will be done with three ports
|
in this arm, laparoscopic cholecystectomy will be done with three ports
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain score
Time Frame: 48 hours
|
Mean pain score measured with a 0 to 10 scale visual analogue scale
|
48 hours
|
|
Operative Time
Time Frame: same day of surgery
|
Number of minutes of operative time
|
same day of surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Return to normal activity
Time Frame: 2 weeks
|
Measured in number of days
|
2 weeks
|
|
hospital stay
Time Frame: 2 weeks
|
post operative hospital stay measured in days
|
2 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 163/DME/KMC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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