Preperitoneal Versus Pre-trasversalis Hernia Repair

Study Overview
=================
Brief Summary
-----------------
Chronic pain rate is from 0 to 50% after prosthetic groin hernia repair. We compared two anterior technique positioning the mesh in the pre-trasversalis space vs preperitoneal space to assess any differences in term of chronic pain and early and late complications

Detailed Description
-----------------
Chronic pain is evaluated in all presenting types (achy, dull, etc.) moreover foreing body sensation, wall stiffness, paresthesia and numbness are controlled in each patients. Limiting of daily, working, sport and sexual activities (disejaculation) are reported as well.

Official Title
-----------------
Early and Late Results of Transinguinal Preperitoneal Patch Repair Versus Anterior Pre-Trasversalis Mesh Repair. A Randomised Study

Conditions
-----------------
Direct Inguinal Hernia, Indirect Inguinal Hernia

Intervention / Treatment
-----------------
* Procedure: anterior hernia repair
* Procedure: transinguinal preperitoneal patch repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years older Exclusion Criteria: recurrent inguinal hernia previous low abdominal operation

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

Sexes Eligible for Study
-----------------
All

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

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

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: pre-trasversalis mesh repair group<br> | Procedure: anterior hernia repair<br>* Inguinal incision is made, external oblique divided and the cord is encircled after identifying ilioinguinal and iliohypogastric nerves. The sac is dissected and reduced, in case of direct hernia the posterior wall of inguinal canal is plicated with polypropylene suture; in presence of indirect hernia the sac is reduced and a stitch is passed in manner that the deep ring is snug about the cord. A pre-shaped mesh is positioned on the floor of the canal around the cord with the two tails overlapping laterally; the mesh is then anchored to the pubic tubercle. External oblique is reapproximated with the cord transposed in the subcutaneous space and skin is sutured.<br>* Other names: tension free hernia repair;|
| Active Comparator: trans-inguinal preperitoneal patch group<br> | Procedure: transinguinal preperitoneal patch repair<br>* Through a 5-cm inguinal incision external oblique fascia is divided, cremasteric fibers are separated and the elements of the cord are skeletonized. Indirect or direct hernia is approached and through the hernia orifice, the sac is reduced, preperitoneal space is accessed and dissected to allow easily placement of the patch facilitated by the memory recoil ring. In case of indirect hernia the lateral part of patch is split and the two tails sutured around vas and gonadic vessels. Hernia orifice is closed with a polypropylene stitch through transversalis fascia and the mesh; external oblique is closed followed by skin approximation.<br>* Other names: Polysoft™ Hernia Patch Bard®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| chronic pain rate | phone interview and clinic visit | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence rate | clinic visit | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
inguinal hernia, groin hernia, chronic pain, mesh repair