Laparoscopic vs Open Bilateral Inguinal Hernia Repair

Study Overview
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Brief Summary
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The European Hernia Society Guidelines of 2018 suggest that laparoscopic surgery should be preferred over open surgery for bilateral inguinal hernia repair even though scientific evidence are scarce. We will conduct a prospective, non randomise control trial, to investigate the superiority of one technique over the other.

Official Title
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Laparoscopic vs Open Bilateral Inguinal Hernia Repair

Conditions
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Inguinal Hernia Bilateral

Intervention / Treatment
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* Procedure: Laparoscopic bilateral inguinal hernia repair
* Procedure: Open bilateral inguinal hernia repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: bilateral inguinal hernia Exclusion Criteria: American Society of Anaesthesiology score >3 complicated inguinal hernias

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

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: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective, non randomised
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Laparoscopic<br>laparoscopic inguinal hernia repair, TAPP | Procedure: Laparoscopic bilateral inguinal hernia repair<br>* Laparoscopic bilateral inguinal hernia repair<br>|
| Other: Open<br>open inguinal hernia repair | Procedure: Open bilateral inguinal hernia repair<br>* Open bilateral inguinal hernia repair<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative Pain | Evaluation of the post operative pain 24 hours after surgery. For the assessment of the pain will be used the Visual Analog Scale (VAS) score. (VAS Score Scale from 0-10, 0 no pain, 10 max pain) | 24 hours post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| days of hospitalization | days that need to be hospitalised after surgery | 30 days | 
| urinary retention | inability to voluntarily void urine up to 8 hours post surgery | 8 hours | 
| complications | presence of surgery related complications | 30 days | 
| recurrence | recurrence of one or two of the hernias treated at the clinical evaluation one year after surgery | 1 year | 
| chronic pain | For the evaluation of the chronic pain will be used the registry for abdominal wall hernias Quality of Life questionnaire (EuraHS QoL) scale from 0 to 10. (0 = no pain 10=worst pain imaginable) | 1 year | 
| foreign body sensation to the inguinal area | For the evaluation of the foreign body sensation to the inguinal area will be used the Carolinas Comfort Scale (scale from 0 to 5, 0= no symptoms, 5 = disabling symptoms) | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bilateral inguinal hernia repair