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

Primary Purpose

Incidence of Mesh Infection In Hernioplasty

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Proline mesh in hernioplasty
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Incidence of Mesh Infection In Hernioplasty

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Incidence Of Mesh Infection After proline mesh Hernioplasty

    Arm Description

    Cases presented with strangulated or obstructed hernia

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    February 16, 2023
    Last Updated
    March 7, 2023
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05775276
    Brief Title
    Incidence Of Mesh Infection After Hernioplasty In Obstructed and Strangulated Hernia Using Proline Mesh and Sutures
    Official Title
    Incidence Of Mesh Infection After Hernioplasty In Obstructed and Strangulated Hernia Using Proline Mesh and Sutures
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 2023 (Anticipated)
    Primary Completion Date
    January 2025 (Anticipated)
    Study Completion Date
    February 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. 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.
    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)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Incidence of Mesh Infection In Hernioplasty

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    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.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Incidence Of Mesh Infection After proline mesh Hernioplasty
    Arm Type
    Experimental
    Arm Description
    Cases presented with strangulated or obstructed hernia
    Intervention Type
    Procedure
    Intervention Name(s)
    Proline mesh in hernioplasty
    Intervention Description
    Hernioplasty using proline mesh then follow up for incidence of infection
    Primary Outcome Measure Information:
    Title
    Incidence Of Mesh Infection After Hernioplasty In Complicated Hernia Using Proline Mesh and Sutures
    Description
    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.
    Time Frame
    Baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohamed Sayed
    Phone
    01060164660
    Email
    Mohamedashraf016@gmail.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25038894
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    21767146
    Citation
    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.
    Results Reference
    result

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

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