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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06035302
Other study ID # PR00C1940
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 15, 2023
Est. completion date December 15, 2023

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

this study aims to evaluate the effectiveness of the use of a basic laparoscopic instrument (Only needle holder) with a new technique for port site closure


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date December 15, 2023
Est. primary completion date November 15, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - age . 18 years - eligible for Laparoscopic cholecystectomy Exclusion Criteria: - refused to participate

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Madany Closure
Madany Closure is a new technique for the porte site closure
Standard closure
Standard closure technique of the port site from ecternal

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 closure time closure time in seconds 1 day
Primary rate of closure failure rate failure to close the port site 1 day
Secondary incidence of port site infection incidence of infection of the port site 1 month
Secondary incidence of port site hernia incidence of hernia at the port site 6 weeks
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