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

NCT ID: NCT05775276

Last Updated: 2023-03-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-31
• Study Completion Date: 2025-02-28

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.

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)

Conditions

Incidence of Mesh Infection In Hernioplasty

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Incidence Of Mesh Infection After proline mesh Hernioplasty

Cases presented with strangulated or obstructed hernia

Group Type: EXPERIMENTAL

Proline mesh in hernioplasty

Intervention Type: PROCEDURE

Hernioplasty using proline mesh then follow up for incidence of infection

Interventions

Proline mesh in hernioplasty

Hernioplasty using proline mesh then follow up for incidence of infection

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Ashraf Abdelnaeem

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Mohamed Sayed

Role: CONTACT

Mohamedashraf016@gmail.com

01060164660

References

Chung L, Tse GH, O'Dwyer PJ. Outcome of patients with chronic mesh infection following abdominal wall hernia repair. Hernia. 2014 Oct;18(5):701-4. doi: 10.1007/s10029-014-1277-x. Epub 2014 Jul 20.

Reference Type: RESULT

PMID: 25038894 (View on PubMed)

Sanchez VM, Abi-Haidar YE, Itani KM. Mesh infection in ventral incisional hernia repair: incidence, contributing factors, and treatment. Surg Infect (Larchmt). 2011 Jun;12(3):205-10. doi: 10.1089/sur.2011.033. Epub 2011 Jul 18.

Reference Type: RESULT

PMID: 21767146 (View on PubMed)

Other Identifiers

Incidence Of Mesh Infection

Identifier Type: -

Identifier Source: org_study_id