The Efficacy of a Self-fixating Mesh in Unilateral Open Inguinal Hernia Repair

Study Overview
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Brief Summary
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This study's objective is to assess the efficacy of a Self-fixating mesh in the surgical repair of unilateral inguinal hernia, which is becoming the new standard of care in open surgical repair of inguinal hernia. The study design is interventional, enrolling 300 patients above 18 years of age, admitted for elective repair in the surgical department of Rambam Medical Health Care Campus, an academic medical center. The study will assess several outcomes including post-surgical pain, recurrence, quality of life and post surgical complications (e.g. wound infection, the formation of hematoma or seroma, etc).

Detailed Description
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This study's objective is to assess the efficacy of a Self-fixating mesh in the surgical repair of unilateral inguinal hernia, which is becoming the new standard of care in open surgical repair of inguinal hernia. The study design is interventional, enrolling 300 patients above 18 years of age, admitted for elective repair in the surgical department of Rambam Medical Health Care Campus, an academic medical center. The study will assess several outcomes including post-surgical pain, recurrence, quality of life and post surgical complications (e.g. wound infection, the formation of hematoma or seroma, etc). The data will be compared to the literature and will be statistically analysed. The follow-up for each patient will be two years.

Official Title
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The Efficacy of a Self-fixating Mesh in Unilateral Open Inguinal Hernia Repair, in Comparison to the Standard Treatment in the Literature

Conditions
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Primary Inguinal Hernia, Unilateral Hernia, Open Surgery

Intervention / Treatment
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* Device: Self-fixating Mesh


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients undergoing primary unilateral open Inguinal Hernia Repair . patients undergoing elective surgery. above the age of 18 years old Exclusion Criteria: patients having repeated Inguinal Hernia. patients having bilateral Hernia. patients undergoing laparoscopic surgery. patients undergoing non-elective surgery.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Self-fixating Mesh<br>patients attributed to that arm, undergoing surgery of open inguinal unilateral hernia repair, using Self-fixating Mesh which is acceptable in the literature. | Device: Self-fixating Mesh<br>* Using Self-fixating Mesh for Inguinal Hernia Repair<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of post operative inguinal Hernia recurrence. |  | 2 weeks, 3,6,12,24 months post-operative | 
| Post-operative patient quality of life will be assessed using a validated questionnaire. |  | 2 weeks, 3,6,12,24 months post-operative | 
| Pain will be assessed by NRS (Numerical Rating Scale) |  | 2 weeks, 3,6,12,24 months post-operative | 
| Post-operative complications will be assessed using a validated questionnaire. |  | 2 weeks, 3,6,12,24 months post-operative |