NCT06873594

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 12, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

March 12, 2025

Status Verified

March 1, 2025

Enrollment Period

6 months

First QC Date

March 7, 2025

Last Update Submit

March 11, 2025

Conditions

CholelithiasisLaparoscopic Cholecystectomy

Keywords

Three-portFour-portLaparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (2)

  • Pain score

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

    48 hours

  • Operative Time

    Number of minutes of operative time

    same day of surgery

Secondary Outcomes (2)

  • Return to normal activity

    2 weeks

  • hospital stay

    2 weeks

Study Arms (2)

four-ports laparoscopic cholecystectomy

ACTIVE COMPARATOR

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

Procedure: four-port laparoscopic cholecystectomy

Three-port Laparoscopic cholecystectomy

EXPERIMENTAL

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

Procedure: three-ports laparoscopic cholecystectomy

Interventions

three-ports laparoscopic cholecystectomyPROCEDURE

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

Three-port Laparoscopic cholecystectomy
four-port laparoscopic cholecystectomyPROCEDURE

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

four-ports laparoscopic cholecystectomy

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cholelithiasis

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Central Study Contacts

Nisar Ahmed, MBBS, FCPS

CONTACT

+92 321 511 3569nisar.ahmed@kmc.edu.pk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Surgery

Study Record Dates

First Submitted

March 7, 2025

First Posted

March 12, 2025

Study Start

July 1, 2025

Primary Completion

December 31, 2025

Study Completion

March 31, 2026

Last Updated

March 12, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

Patients demographics, operative data and outcome data

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
1 april 2025