Comparison of Laparoscopic Totally Extraperitoneal (TEP) and Lichtenstein Technique

Study Overview
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Brief Summary
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Open tension-free mesh repair (Lichtenstein) and laparoscopic totally extraperitoneal (TEP) repair are the most commonly preferred techniques for inguinal hernia surgery. There's still a debate going on about which of these two techniques (open versus laparoscopic) is effective. This prospective randomized study aimed at comparing the early and long-term results of these two techniques (TEP vs. Lichtenstein).

Detailed Description
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Various studies comparing the laparoscopic totally extraperitoneal (TEP) and Lichtenstein techniques have been reported. These studies have shown that TEP repair is associated with less postoperative pain and faster recovery. However, there are different views on the long-term (recurrence, chronic pain, etc.) results of the two techniques. This study was designed to compare the short- and long-term outcomes of open tension-free mesh repair technique(Lichtenstein) and laparoscopic repair technique(TEP).

Official Title
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Comparison of Laparoscopic Totally Extraperitoneal (TEP) and Lichtenstein Technique in Long-term Follow-up

Conditions
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Hernia, Inguinal

Intervention / Treatment
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* Procedure: inguinal hernia repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who were diagnosed with inguinal hernia (primary, recurrent, unilateral, bilateral) American Society of Anesthesiologists (ASA) score of I and II Gave informed consent to participate in the study Exclusion Criteria: Patients with scrotal, strangulated, or obstructed hernia Periumbilical or subumbilical incision scar (median, right or left paramedian) Undergoing prostatectomy or abdominal bladder surgery Pfannenstiel incision scar ASA score >3

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laparoscopic Totally Extraperitoneal (TEP)<br>Patients who underwent Laparoscopic Totally Extraperitoneal (TEP) will be included in this group. | Procedure: inguinal hernia repair<br>* Patients who will undergo inguinal hernia repair will be divided into two groups(TEP versus Lichtenstein) according to the technique to be applied<br>|
| Placebo Comparator: Open tension-free mesh repair technique (Lichtenstein)<br>Patients with open tension-free inguinal hernia(Lichtenstein) repair will be included in this group. | Procedure: inguinal hernia repair<br>* Patients who will undergo inguinal hernia repair will be divided into two groups(TEP versus Lichtenstein) according to the technique to be applied<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative complication status | number of patients with complications | up to the first 10 days postoperatively | 
| early period complication status | number of patients with complications | up to the first 3 months postoperatively | 
| late period complication status | number of patients with complications | Postoperative 3rd to 84th month | 
| early recurrence rate | number of patients with recurrence | up to the first 3 months postoperatively | 
| late recurrence rate | number of patients with recurrence | Postoperative 3rd to 84th month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Score for pain | Units on a Scale; 0: no pain, 1-3: mild pain, 4-6: moderate pain, 7-9: severe pain, 10: worst pain possible. | postoperative 24th hour | 
| total analgesic requirement | the number of analgesics used. | postoperative 1 to 10 days | 
| time to return to work after surgery | day | Postoperative 3rd month | 
| early complication status | Number of patients with complications | postoperative 1st month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hernia, laparoscopic, Lichtenstein