Study of Laparoscopic Inguinal Hernia Repair

Study Overview
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Brief Summary
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Although mesh fixation has been associated to an increased incidence of nerve injury and involves increased operative costs, many surgeons feel that fixation is necessary to reduce the risk of hernia recurrence. The aim of this study is to evaluate the outcomes of laparoscopic herniorrhaphies performed with and without mesh fixation at our institution.

Detailed Description
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A randomized prospective study was conducted. Four groups of patients were constituted: (1) TEP with mesh fixation (2) TEP without fixation, (3) TAPP with mesh fixation, (4) TAPP without fixation. 120 patients were randomized to each group. The principal outcomes assessed were postoperative chronic groin pain assessed by visual analogue pain scale (VAS), hernia recurrence, other morbidity rates and hospital costs. Patients were reviewed in outpatient unit at 1 week and at 1, 6, 12 and 24 months.

Official Title
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Prospective, Randomized and Controlled Study Comparing Fixation Versus no Fixation of Mesh in Laparoscopic Inguinal Hernia Repair

Conditions
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Hernia, Inguinal, Inguinal Hernia, Direct, Inguinal Hernia, Indirect, Hernia, Femoral, Recurrence, Neuralgia, Atypical, Neuralgia, Ilioinguinal, Neuralgia, Iliohypogastric Nerve

Intervention / Treatment
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* Procedure: TEP without fixation
* Procedure: TEP with fixation
* Procedure: TAPP without fixation
* Procedure: TAPP with fixation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: unilateral hernia uncomplicated hernia medical fitness for general anesthesia Exclusion Criteria: unfit for general anesthesia complicated hernia uncorrectable coagulopathy BMI > 35 concomitant pathologies requiring simultaneous surgery bilateral hernia

Ages Eligible for Study
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Minimum Age: 16 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TEP without fixation<br>Standard totally extraperitoneoscopic preperitoneal (TEP) hernia repair without mesh fixation | Procedure: TEP without fixation<br>* Standard totally extraperitoneal preperitoneal (TEP) inguinal hernia repair<br>* Other names: TEP no fixation;|
| Active Comparator: TEP with fixation<br>Standard totally extraperitoneoscopic preperitoneal (TEP) hernia repair | Procedure: TEP with fixation<br>* Standard totally extraperitoneal preperitoneal (TEP) inguinal hernia repair<br>* Other names: Standard TEP;|
| Experimental: TAPP without fixation<br>Standard transabdominal preperitoneal (TAPP) hernia repair without mesh fixation | Procedure: TAPP without fixation<br>* Standard transabdominal preperitoneal (TAPP) inguinal hernia repair without mesh fixation<br>* Other names: TAPP no fixation;|
| Active Comparator: TAPP with fixation<br>Standard transabdominal preperitoneal (TAPP) hernia repair | Procedure: TAPP with fixation<br>* Standard transabdominal preperitoneal (TAPP) inguinal hernia repair<br>* Other names: Standard TAPP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from preoperative pain levels at 2 years assessed by the visual analogue pain scale (VAS) | neuralgia, inguinal | preoperative and postoperative 2nd year | 
| Change from preoperative pain levels at 1 year assessed by the VAS | neuralgia, inguinal | preoperative and postoperative 1st year | 
| Change from preoperative pain levels at 6 months assessed by the VAS | neuralgia, inguinal | preoperative and postoperative 6th month | 
| Change from preoperative pain levels at 3 months assessed by the VAS | neuralgia, inguinal | preoperative and postoperative 3th month | 
| Change from preoperative pain levels at 1 month assessed by the VAS | neuralgia, inguinal | preoperative and postoperative 1 month | 
| Change from preoperative pain levels at 1 week assessed by the VAS | neuralgia, inguinal | preoperative and postoperative 1th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total hospital costs | consisted all costs of hospital stays and outpatient treatments | up to 24 months | 
| conversion rate | conversion to open surgery | through the first day | 
| recurrence rate | clinical and radiological diagnosed | up to 24 months | 
| rate of minor and major complications | it was assessed as; no complication, minor complications, major complications and complications needed reoperation | 2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopic inguinal hernia repair, total extraperitoneoscopic hernia repair, transabdominal preperitoneal hernia repair, inguinal hernia, laparoscopy, hernia repair, herniorraphy, laparoscopic surgery