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

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05775276

Collaborator

(none)

Enrollment

Arm

23.1

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Incidence of Mesh Infection In Hernioplasty	Procedure: Proline mesh in hernioplasty	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Feb 1, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Incidence Of Mesh Infection After Hernioplasty In Complicated Hernia Using Proline Mesh and Sutures [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohamed Ashraf Abdelnaeem, Principal Investigator, Assiut University

ClinicalTrials.gov Identifier:

NCT05775276

Other Study ID Numbers:

Incidence Of Mesh Infection

First Posted:

Mar 20, 2023

Last Update Posted:

Mar 20, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infections

Communicable Diseases

Study Results

No Results Posted as of Mar 20, 2023