Madany Closure: A Novel Technique for Fascial Closure in Laparoscopic Surgery

Not Applicable

Recruiting

• Conditions: Cholecystolithiasis
• Interventions: Procedure: Madany Closure; Procedure: Standard closure

• Registration Number: NCT06035302
• Lead Sponsor: ClinAmygate

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-06
• Study First Submitted QC: 2023-09-06
• 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: 90

Inclusion Criteria

• age . 18 years
• eligible for Laparoscopic cholecystectomy

Exclusion Criteria

• refused to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Madany closure	Madany Closure	the novel port site closure technique is to be done for this group
Control	Standard closure	external closure of the port site

Primary Outcome Measures

Name	Time	Method
rate of closure failure	1 day	rate failure to close the port site
closure time	1 day	closure time in seconds

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Aswan University Hospital; 🇪🇬 Aswan, Egypt