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
About this trial
This is an interventional screening trial for Incidence of Mesh Infection In Hernioplasty
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.
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
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
Learn more about this trial
Incidence Of Mesh Infection After Hernioplasty In Obstructed and Strangulated Hernia Using Proline Mesh and Sutures
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