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

September 17, 2023 updated by: ClinAmygate
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Aswan, Egypt
        • Recruiting
        • Aswan university hospital
        • Contact:
        • Principal Investigator:
          • Mohie El-Din M Madany, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age . 18 years
  • eligible for Laparoscopic cholecystectomy

Exclusion Criteria:

  • refused to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
closure time
Time Frame: 1 day
closure time in seconds
1 day
rate of closure failure
Time Frame: 1 day
rate failure to close the port site
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of port site infection
Time Frame: 1 month
incidence of infection of the port site
1 month
incidence of port site hernia
Time Frame: 6 weeks
incidence of hernia at the port site
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ClinAmygate

Collaborators

Aswan University Hospital

Investigators

  • Principal Investigator: Mohie El-Din M Madani, MD, Aswan university hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2023

Primary Completion (Estimated)

November 15, 2023

Study Completion (Estimated)

December 15, 2023

Study Registration Dates

First Submitted

September 6, 2023

First Submitted That Met QC Criteria

September 6, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 17, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR00C1940

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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