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Clinical Trials/NCT06045546
NCT06045546
Active, not recruiting
Not Applicable

A (5-5-5-8) Technique for Laparoscopic Cholecystectomy

ClinAmygate1 site in 1 country524 target enrollmentSeptember 20, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cholecystitis; Gallstone
Sponsor
ClinAmygate
Enrollment
524
Locations
1
Primary Endpoint
Duration of the operation
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

The aim of this current study is to investigate the effectiveness and safety of a novel technique which is the 5-5-5-8 where the camera port is 5 mm.

Detailed Description

More than 50 different LC procedures are described in the literature, mostly as a result of changes made by surgeons to enhance cosmetic and postoperative results. Some adjustments include port size and/or number reductions relative to conventional LC usage. Each of these methods has benefits and drawbacks, and each one is appropriate for usage in particular circumstances. The aim of this current study is to investigate the effectiveness and safety of a novel technique which is the 5-5-5-8 where the camera port is 5 mm. The study has two analyses: 1. at 6 month follow up 2. at 24 months follow up

Registry
clinicaltrials.gov
Start Date
September 20, 2023
End Date
September 20, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
ClinAmygate
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Aged \> 18 years
  • Patients eligible for LC during the study period

Exclusion Criteria

  • refused to participate

Outcomes

Primary Outcomes

Duration of the operation

Time Frame: 1 hour

Duration of the operation in minutes

Number of participants with Conversion to open surgery

Time Frame: 1 hour

Number of participants with Failure of the technique and conversion to open surgery

Incidence of intra operative visceral injury

Time Frame: 2 hours

Incidence of intra operative visceral injury

intra operative amount of blood loss

Time Frame: 2 hours

intra operative amount of blood loss in ml

incidence of intra operative complications

Time Frame: 2 hours

incidence of intra operative complications

Secondary Outcomes

  • post operative stay(1 week)
  • incidence of port site infection(1 month)
  • Incidence of port site hernia(24 months)

Study Sites (1)

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