Incidence Of Mesh Infection After Hernioplasty In Obstructed and Strangulated Hernia Using Proline Mesh and Sutures

March 7, 2023 updated by: Mohamed Ashraf Abdelnaeem, Assiut University
The primary aim of this study is to detect incidence of mesh infection in cases presented with obstructed or strandulated hernia.A prospective controlled study will be carried out after obtaining written informed consent from all patients and approval of the ethics committee of the faculty of medicine, Assuit University.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

There is controversy regarding the use of prolene mesh in cases of obstructed and strangulated hernia. The main aim and objective of this prospective study is to evaluate the outcomes and incidence of mesh infection in hernioplasty in emergency situations like obstructed and strangulated hernia .Hernioplasty is the most common surgery for hernia repair with Propylene mesh,but the use of synthetic prosthesis is associated with increase risk of developing a prosthetic infection that may manifest after time as subtle symptoms in the form of fever, myalgia, erythema of overlying skin and in some cases as chronic discharging sinus(1). clinicians have been challenged in the past few years by an increasing variety of novel non-infectious and infectious complications following the widespread use of meshes after open repair of hernias this incidence is influenced by underlying co-morbidities, the type of mesh, the surgical technique and the strategy used to prevent infections. An approach that combines medical and surgical management is necessary for cases of mesh infection.(2)

Study Type

Interventional

Enrollment (Anticipated)

60

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

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

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All adult patients aging above 21 years old, who presented with obstructed or strangulated hernia with viable bowel loops by clinical examination or detected by preoperative ultrasound or computed tomography CT imaging.

Exclusion Criteria:

  • Uncomplicated hernia.
  • patients who will underwent rescection and anastmosis
  • patient cannot withstand anethesia.
  • Decompensated liver patients.
  • Pregnancy.
  • Immunosuppressed patients e.g.: under chemotherapy or steroids.

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: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Incidence Of Mesh Infection After proline mesh Hernioplasty
Cases presented with strangulated or obstructed hernia
Procedure: Proline mesh in hernioplasty
Hernioplasty using proline mesh then follow up for incidence of infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence Of Mesh Infection After Hernioplasty In Complicated Hernia Using Proline Mesh and Sutures
Time Frame: Baseline
To evaluate the incidence of mesh infection in Complicated hernia using prolene mesh and sutures,along postoperative hospital stay, routine follow up and time to return to activities of daily living.
Baseline

Collaborators and Investigators

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

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

March 1, 2023

Primary Completion (Anticipated)

January 1, 2025

Study Completion (Anticipated)

February 1, 2025

Study Registration Dates

First Submitted

February 16, 2023

First Submitted That Met QC Criteria

March 7, 2023

First Posted (Actual)

March 20, 2023

Study Record Updates

Last Update Posted (Actual)

March 20, 2023

Last Update Submitted That Met QC Criteria

March 7, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Incidence Of Mesh Infection

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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