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

Cholecystolithiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06045546
• Other study ID #: PR00C1947
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2023
• Est. completion date: February 15, 2024

Study information

• Verified date: September 2023
• Source: ClinAmygate
• Contact: Mohie El-Din M Madani, MD
• Phone: 01141341342
• Email: Mohie.madany[@]med.aswu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: February 15, 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged > 18 years

• Patients eligible for LC during the study period

Exclusion Criteria:

• refused to participate

Related Conditions & MeSH terms

• Cholecystitis
• Cholecystitis, Chronic
• Cholecystitis; Gallstone
• Cholecystolithiasis
• Cholelithiasis
• Gallstones

Intervention

Procedure:
• 5-5-5-8 technique
the new technique of 5-5-5-8 for laparoscopic cholecystectomy
• 10-10-10-5 technique
the standard technique of 10-10-10-5 for laparoscopic cholecystectomy

Locations

Country	Name	City	State
Egypt	Aswan University Hospital	Aswan

Sponsors (2)

Lead Sponsor	Collaborator
ClinAmygate	Aswan University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of the operation	Duration of the operation in minutes	1 hour
Primary	Number of participants with Conversion to open surgery	Number of participants with Failure of the technique and conversion to open surgery	1 hour
Secondary	incidence of port site infection	incidence of infection of the port site	1 month
Secondary	Incidence of port site hernia	Incidence of hernia of the port site	6 weeks