Does the Mesh Have to be Fixed in Laparoscopic eTEP Repair of Inguinal Hernia?

Study Overview
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Brief Summary
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Inguinal hernia surgery is one of the most frequently performed procedures among general surgery cases. As with many open surgical methods, this repair is also performed laparoscopically. Among these closed methods, the one method is laparoscopic extended total extraperitoneal repair (eTEP). The benefits of laparoscope include less postoperative pain and complications, faster recovery, reduced chronic pain, and recurrence rate. One of the recent debates regarding the laparoscopic technique is mesh fixation. Fixation of the mesh to the cooper ligament can prevent mesh migration and consequently reduce the recurrence rate. However, it has been reported that this fixation may increase postoperative pain. Several studies have reported that recurrence may be due to inadequate mesh fixation technique. In contrast, other prospective randomized studies have found relapse unrelated to mesh fixation. In the eTEP technique, dissection is performed in a larger area than in TEP. For this reason, it can be thought that the possibility of mesh displacement is higher in the eTEP procedure. The purpose of this study is to confirm this idea with a prospective study. There are studies in the literature on mesh fixation related to the total extraperitoneal repair (TEP) technique. However, there is no study on mesh detection in the eTEP technique. The aim of the study is to compare patients who underwent without mesh fixation laparoscopic TEP and eTEP repair in terms of clinical data such as mesh displacement and hernia recurrence, chronic pain, length of hospital stay, and postoperative complications.

Official Title
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Prospective Randomized Study of Comparison Mesh Displacement in Laparoscopic İnguinal Hernia Repair With No Fixation: eTEP Versus TEP

Conditions
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Migration of Implant, Pain, Postoperative Complications, Relapse

Intervention / Treatment
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* Procedure: TEP Group
* Procedure: eTEP Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with unilateral inguinal hernias, Patients aged 18-65. Exclusion Criteria: Younger than 18 years, and older than 65 years, Incarcerated or strangulated inguinal hernias, Recurrent hernias, Patients with bilateral inguinal hernias, Patients who are contraindicated to receive general anesthesia, Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TEP group<br>In 30 patients; Inguinal hernia surgery will be performed with the TEP method and the 15x12x10 cm polyprolene patch used in this surgery will be marked with small metallic clips from the lateral, superomedial and inferomedial sides. During the surgery, the mesh will not be fixed to the Cooper ligament. Patients whose pain scores (VAS score) are measured on the first postoperative day and who are suitable for discharge will be discharged after a pelvis x-ray is taken. One month after the surgery and 6 months later, patients will be called to the outpatient clinic and examined, their pain scores will be measured (VAS score) and pelvic radiographs will be taken. The movement of the clips marked on the patch will be compared with previous radiographs in cm. | Procedure: TEP Group<br>* Inguinal hernia surgery will be performed with the TEP method and the 15x12x10 cm polyprolene patch used in this surgery will be marked with small metallic clips from the lateral, superomedial and inferomedial sides.<br>|
| Experimental: eTEP Group<br>In 30 patients; Inguinal hernia surgery will be performed with the eTEP method and the 15x12x10 cm polyprolene patch used in this surgery will be marked with small metallic clips from the lateral, superomedial and inferomedial sides. During the surgery, the mesh will not be fixed to the Cooper ligament. Patients whose pain scores (VAS score) are measured on the first postoperative day and who are suitable for discharge will be discharged after a pelvis x-ray is taken. One month after the surgery and 6 months later, patients will be called to the outpatient clinic and examined, their pain scores will be measured (VAS score) and pelvic radiographs will be taken. The movement of the clips marked on the patch will be compared with previous radiographs in cm. | Procedure: eTEP Group<br>* Inguinal hernia surgery will be performed with the eTEP method and the 15x12x10 cm polyprolene patch used in this surgery will be marked with small metallic clips from the lateral, superomedial and inferomedial sides.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Status of Mesh Displacement | Patients who are suitable for discharge will be discharged after a pelvis x-ray is taken. One month after the surgery and 6 months later, patients will be called to the outpatient clinic and examined and pelvic radiographs will be taken. The movement of the clips marked on the patch will be compared with previous radiographs in cm. | postoperative 24 hours, 1 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Postoperative pain | It will be measured using the Visual Analog Score (VAS). The patient will be asked to choose between the number 1 with the least pain and the number 10 with the most pain. The lowest score on this scale is 1, and the highest score is 10. | postoperative 24 hours | 
| Rate of Hernia recurrence | hernia recurrence after six months of follow-up. It will be checked by physical examination. Imaging methods will be used in suspicious cases. | postoperative 6th month | 
| Rate of Postoperative complications | such as wound infection, bleeding | postoperative 24 hours and 1st month | 
| Rate of Chronic pain | It will be measured using the Visual Analog Score (VAS). The patient will be asked to choose between the number 1 with the least pain and the number 10 with the most pain. The lowest score on this scale is 1, and the highest score is 10. | postoperative 1st and 6th month |