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

• Sponsor: ClinAmygate (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06035302
• Collaborator: Aswan University Hospital (Other)
• Enrollment: 90
• Arms: 2
• Anticipated Duration (Months): 3

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Cholecystolithiasis	Procedure: Madany Closure; Procedure: Standard closure	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Madany Closure: A Novel Technique for Fascial Closure in Laparoscopic Surgery
• Anticipated Study Start Date: Sep 15, 2023
• Anticipated Primary Completion Date: Nov 15, 2023
• Anticipated Study Completion Date: Dec 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Madany closure the novel port site closure technique is to be done for this group	Procedure: Madany Closure; Madany Closure is a new technique for the porte site closure
Active Comparator: Control external closure of the port site	Procedure: Standard closure; Standard closure technique of the port site from ecternal

Outcome Measures

Primary Outcome Measures

1. closure time [1 day]

   closure time in seconds

2. rate of closure failure [1 day]

   rate failure to close the port site

Secondary Outcome Measures

1. incidence of port site infection [1 month]

   incidence of infection of the port site

2. incidence of port site hernia [6 weeks]

   incidence of hernia at the port site

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• age . 18 years

• eligible for Laparoscopic cholecystectomy

Exclusion Criteria:

• refused to participate

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• ClinAmygate
• Aswan University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ClinAmygate
• ClinicalTrials.gov Identifier: NCT06035302
• Other Study ID Numbers: PR00C1940
• First Posted: Sep 13, 2023
• Last Update Posted: Sep 15, 2023
• Last Verified: Sep 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cholecystolithiasis; Cholelithiasis; Gallstones

Study Results

No Results Posted as of Sep 15, 2023