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

Not Applicable

Active, not recruiting

• Conditions: Cholecystitis; Gallstone; Cholecystolithiasis; Cholecystitis, Chronic

• Registration Number: NCT06045546
• Lead Sponsor: ClinAmygate

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

Study Timeline

• Study First Submitted: 2023-09-11
• Study Start: 2023-09-20
• Study First Submitted QC: 2023-09-20
• Study First Posted: 2023-09-21
• Primary Completion: 2024-09-20
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-12
• Last Update Posted: 2025-04-16
• Study Completion: 2026-09-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 524

Inclusion Criteria

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

Exclusion Criteria

• refused to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Duration of the operation	1 hour	Duration of the operation in minutes
Number of participants with Conversion to open surgery	1 hour	Number of participants with Failure of the technique and conversion to open surgery
Incidence of intra operative visceral injury	2 hours	Incidence of intra operative visceral injury
intra operative amount of blood loss	2 hours	intra operative amount of blood loss in ml
incidence of intra operative complications	2 hours	incidence of intra operative complications

Secondary Outcome Measures

Name	Time	Method
post operative stay	1 week	post operative stay in days
incidence of port site infection	1 month	incidence of infection of the port site
Incidence of port site hernia	24 months	Incidence of hernia of the port site

Trial Locations

Locations (1)

Aswan University Hospital; 🇪🇬 Aswan, Egypt