Comparison of Whole Mesh and Split Mesh Use in Laparoscopic Inguinal Hernia Repair

Study Overview
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Brief Summary
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At least 80 patients who will undergo laparoscopic inguinal hernia repair surgery will be randomized into 2 groups. For the patients in the first group, the whole mesh will be laid on the area without being fixed. The patients in the second group will be given a mesh of the same size, but partially divided horizontally and wrapped around the spermatic cord. Demographic data of patients in both groups, quality of life data(Carolinas Comfort Scale) at postoperative 1st, 7th, 30th, 3rd and 6th months, postoperative pain (VAS values), clinical seroma rate, recurrence and other complications will be monitored. When the desired number of patients and follow-up period are reached, the data in the 2 groups will be compared.

Official Title
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Prospective Comparison of Whole Mesh and Split Mesh Use in Patient Groups Undergoing Laparoscopic Inguinal Hernia Repair

Conditions
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Hernia, Inguinal

Intervention / Treatment
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* Procedure: Split Mesh


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical or/and radiological diagnosed primary inguinal hernia TEP or TAPP surgical methods Exclusion Criteria: Recurrent hernias Patients with previous groin operations on same side Pregnant women Patients who did not accept to participate in the study ASA score of 3 or higher,

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Whole Mesh<br>For the patients in the first group, the whole patch will be laid on the area without being fixed. | Procedure: Split Mesh<br>* TEP repair of inguinal hernias using either split or whole mesh<br>* Other names: Whole mesh;|
| Active Comparator: Split Mesh<br>The patients in the second group will be given a patch of the same size, but partially divided horizontally and wrapped around the spermatic cord. | Procedure: Split Mesh<br>* TEP repair of inguinal hernias using either split or whole mesh<br>* Other names: Whole mesh;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carolinas Comfort Scale values | Differences in postoperative pain and quality of life(Carolinas Comfort Scale at first month) in patients who use whole meshes and those who use split meshes. | 6 month | 
| Recurrence rates | Differences in recurrence rates in patients who use whole meshes and those who use split meshes. | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rates | Difference in recurrence rates at 6 months in patients who use whole meshes and those who use split meshes. | 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopic Inguinal Hernia, Laparoscopic Hernia, Whole Mesh, Split Mesh, TAP, TEPP, Inguinal hernia