Nasr Fascial Closure: A Novel Device for Fascial Closure in Laparoscopic Surgery

Not Applicable

Recruiting

• Conditions: Cholecystolithiasis

• Registration Number: NCT06036303
• Lead Sponsor: ClinAmygate

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-05
• Study First Submitted QC: 2023-09-12
• Study First Posted: 2023-09-13
• Study Start: 2023-09-15
• Last Update Submitted: 2023-09-17
• Last Update Posted: 2023-09-21
• Primary Completion: 2023-11-15
• Study Completion: 2023-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• age > 18
• eligible for Laparoscopic cholecystectomy

Exclusion Criteria

• refused to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Incidence of port site hernia	6 weeks	Incidence of hernia at the port site
Incidence of port site infection	1 month	Incidence of infection of the port site

Trial Locations

Locations (1)

Aswan University Hospital; 🇪🇬 Aswan, Egypt