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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06045546
Other study ID # PR00C1947
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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