Cholecystolithiasis
Conditions
Keywords
Laparoscopic removal
Brief summary
The study will investigate the efficacy and safety of a new fascial closure device Nasr Fascial Closure Device compared to the Karl Storz Berci Fascial Closure Device 26173AM.
Interventions
DEVICENasr fascial closure device
Nasr fascial closure device is a novel device for fascial closure
DEVICEBerci Fascial Closure Device
Berci Fascial Closure Device is a known device for fascial closure
Sponsors
Aswan University Hospital
ClinAmygate
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age \> 18 * eligible for Laparoscopic cholecystectomy
Exclusion criteria
* refused to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| duration of port site closure | 1 day | Duration in seconds |
| Rate of failure of port site | 1 day | Rate of failure to close the port site |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of port site infection | 1 month | Incidence of infection of the port site |
| Incidence of port site hernia | 6 weeks | Incidence of hernia at the port site |
Countries
Egypt
Contacts
Primary ContactMohie El-Din M Madany, MD
Backup ContactEmad R Issak, MSc
Outcome results
None listed