Lichtenstein Versus TAPP and TEP in Groin Hernioplasty

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the effectiveness of various methods of inguinal hernia repair and to evaluate techniques of synthetic mesh fixation during laparoscopic and open hernia repair.

Detailed Description
-----------------
In modern literature there is no conclusive evidence for the superiority of endoscopic over open inguinal hernia repair techniques, due to the lack of prospective, multicenter, randomized studies involving a sufficient number of patients. Both Lichtenstein and TAPP/TEP techniques are widely used and accepted methods of treatment. The clinical significance of this study is to show the differences in the incidence of perioperative complications, the evaluation of postoperative pain, full recovery time and improving the quality of life. The diagnosis of inguinal hernia will be based on a physical examination performed by an experienced surgeon based on the medical history of the patient and, if necessary, on ultrasound examination of the abdominal wall. Random assignment of patients to one of three treatment arms will take place the day before the surgery using computer-generated randomization list. The operating surgeon will be determined prior to randomization. Each patient before the study will receive complete information about the study which will be explained in detail regarding all planned procedures, the patient will obtain answers to any questions. After explaining any doubts the patient will sign the informed consent to participate in the study, in the presence of the investigator. Patients will be divided into three groups - TAPP, TEP and Lichtenstein method. Patients treated by TAPP and Lichtenstein will be further divided into subgroups - fixation glue or stitching - Lichtenstein method; fixation glue, tackers or implantation without fixation - TAPP method. Patients will receive preoperative antibiotic prophylaxis with a single dose of cephalosporin. Patients undergoing surgery will be hospitalized in the Department of Surgery until the first postop day. In justified cases, hospitalization will be extended.

Official Title
-----------------
Comparison of Lichtenstein Versus TAPP and TEP Techniques for Inguinal Hernia Repair

Conditions
-----------------
Inguinal Hernia

Intervention / Treatment
-----------------
* Procedure: Hernia Repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male age: 18 - 65 planned inguinal hernia repair using synthetic implant BMI range: 20-35 kg / m2 written informed consent Exclusion Criteria: prior midline laparotomy contraindications for general anaesthesia ASA > IV cirrhosis (Child B or C) or ascites active treatment with use of chemiotherapy incarcerated hernia

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

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lichtenstein technique<br>Lichtenstein inguinal hernia repair | Procedure: Hernia Repair<br> <br> |
| Active Comparator: TAPP<br>Transabdominal preperitoneal (TAPP) approach for inguinal hernia repair | Procedure: Hernia Repair<br> <br> |
| Active Comparator: TEP<br>Totally extraperitoneal (TEP) approach for inguinal hernia repair | Procedure: Hernia Repair<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative complications associated with wound | Wound infection with or without the need to remove the mesh, Wound necrosis, Hematoma or seroma in the wound. | 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The frequency of conversions (from laparoscopic to open approach) |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TAPP, TEP, Lichtenstein, syntethic mesh, hernioplasty