ProSpectic Italian Laparoscopic Hybrid mEsh hErnia Repair in Obese patientS Trials

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate safety and effectiveness of a hybrid mesh (GORE® SYNECOR Intraperitoneal Biomaterial) in patients with a BMI of 30 kg/m2 or more undergoing laparoscopic ventral hernia repair (LVHR) with intraperitoneal position of the mesh.

Detailed Description
-----------------
A prospective Italian multicenter observational trial will be conducted in 8 different Italian centers to compare the effectiveness and feasibility of treatment of Incisional Hernia with GORE® SYNECOR Intraperitoneal Biomaterial mesh in patients with BMI >30 kg/m2. This study was reviewed and approved by the local regional Ethics Committee. The study adhered to the CONSORT guidelines in reporting this trial's results

Official Title
-----------------
Laparoscopic Ventral Hernia Repair in Obese Patients: Safe and Effective Use of a Hybrid (PTFE / Biosynthetic) Mesh. Results of a Multicentric Prospective Trial.

Conditions
-----------------
Uncomplicated Ventral Incisional Hernia, Obesity

Intervention / Treatment
-----------------
* Device: Intraperitoneal Onlay Mesh positioning Plus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 years Clean wounds Informed consent Patients affected by Incisional and Ventral Hernia Elective surgery Hernia size between 3 e 7 cm BMI > 30 kg/m2 Exclusion Criteria: age < 18 years; Life expectancy < 24 months (as estimated by the operating surgeon), - Pregnancy Immunosuppressant therapy within 2 weeks before surgery Clean-contaminated and contaminated, dirty wounds Cirrhosis

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br>120 patients affected by Incisional Hernia with size between 3 to 10 cm, undergoing Intraperitoneal Onlay Mesh with the closure of defect | Device: Intraperitoneal Onlay Mesh positioning Plus<br>* Intraperitoneal Onlay Mesh (IPOM) Plus with closure of the hernia defect will be performed according to the common recommendations. The closure of the wall defect will be decided according to the surgeon evaluations: hernia size and choice of technique will be recorded in the database. The mesh will have an overlap of at least 5 cm on all sides of the defect. Dimension of the mesh will be sized to overlap the hernia orifice by at least five centimetres and placed in the intraperitoneal position. Using non-articulating laparoscopic fixation devices, 5.1-mm non-absorbable or absorbable tacks will be then positioned around the circumference of the prosthesis in a 3-row manner or 2-row manner based on the intraoperative findings, the patient's specific situation and the operating surgeon's decision.<br>* Other names: IPOM plus;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Incisional Hernia at Clinical examination | Clinical examination: Incisional Hernia is clinically defined as any visible or palpable ''blowout'' in site of incisional hernia treated | Patients are postoperatively examined at 1 months. | 
| Rate of Incisional Hernia at Clinical examination | Clinical examination: Incisional Hernia is clinically defined as any visible or palpable ''blowout'' in site of incisional hernia treated | Patients are postoperatively examined at 3 months. | 
| Rate of Incisional Hernia at Clinical examination | Clinical examination: Incisional Hernia is clinically defined as any visible or palpable ''blowout'' in site of incisional hernia treated | Patients are postoperatively examined at 6 months. | 
| Rate of Incisional Hernia at Clinical examination | Clinical examination: Incisional Hernia is clinically defined as any visible or palpable ''blowout'' in site of incisional hernia treated | Patients are postoperatively examined at 12 months. | 
| Rate of Incisional Hernia at Clinical examination | Clinical examination: Incisional Hernia is clinically defined as any visible or palpable ''blowout'' in site of incisional hernia treated | Patients are postoperatively examined at 24 months. | 
| Rate of Incisional Hernia at Clinical examination | Clinical examination: Incisional Hernia is clinically defined as any visible or palpable ''blowout'' in site of incisional hernia treated | Patients are postoperatively examined at 36 months. | 
| Rate of Incisional Hernia at ultrasonographic examination | An abdominal ultrasonography with the patient lying prone, will be performed in in all patients (symptomatic or asymptomatic) providing any valuable information about Hernia Recurrence onset. Valsalva maneuver will be performed during the ultrasonography scan. Size and location of all imaging detected Hernia Recurrence will be recorded, as well as any other patient's complaint. | Patients are postoperatively examined at 1 months. | 
| Rate of Incisional Hernia at ultrasonographic examination | An abdominal ultrasonography with the patient lying prone, will be performed in in all patients (symptomatic or asymptomatic) providing any valuable information about Hernia Recurrence onset. Valsalva maneuver will be performed during the ultrasonography scan. Size and location of all imaging detected Hernia Recurrence will be recorded, as well as any other patient's complaint. | Patients are postoperatively examined at 3 months. | 
| Rate of Incisional Hernia at ultrasonographic examination | An abdominal ultrasonography with the patient lying prone, will be performed in in all patients (symptomatic or asymptomatic) providing any valuable information about Hernia Recurrence onset. Valsalva maneuver will be performed during the ultrasonography scan. Size and location of all imaging detected Hernia Recurrence will be recorded, as well as any other patient's complaint. | Patients are postoperatively examined at 6 months. | 
| Rate of Incisional Hernia at ultrasonographic examination | An abdominal ultrasonography with the patient lying prone, will be performed in in all patients (symptomatic or asymptomatic) providing any valuable information about Hernia Recurrence onset. Valsalva maneuver will be performed during the ultrasonography scan. Size and location of all imaging detected Hernia Recurrence will be recorded, as well as any other patient's complaint. | Patients are postoperatively examined at 12 months. | 
| Rate of Incisional Hernia at ultrasonographic examination | An abdominal ultrasonography with the patient lying prone, will be performed in in all patients (symptomatic or asymptomatic) providing any valuable information about Hernia Recurrence onset. Valsalva maneuver will be performed during the ultrasonography scan. Size and location of all imaging detected Hernia Recurrence will be recorded, as well as any other patient's complaint. | Patients are postoperatively examined at 24 months. | 
| Rate of Incisional Hernia at ultrasonographic examination | An abdominal ultrasonography with the patient lying prone, will be performed in in all patients (symptomatic or asymptomatic) providing any valuable information about Hernia Recurrence onset. Valsalva maneuver will be performed during the ultrasonography scan. Size and location of all imaging detected Hernia Recurrence will be recorded, as well as any other patient's complaint. | Patients are postoperatively examined at 36 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients affected by Superficial surgical site infections | Superficial infections according to Clavien-Dindo criteria | Within 30 days postoperatively | 
| Number of patients affected by Deep surgical site infections | Deep surgical site infections according to Clavien-Dindo criteria | Within 30 days postoperatively | 
| Number of patients affected by organ space infections | Organ space infections according to Clavien-Dindo criteria | Within 30 days postoperatively | 
| Number of patients affected by Surgical Site Occurence | Surgical Site Occurence Reported according to the Ventral Hernia Working Group (VHWG) definitions | Within 30 days postoperatively | 
| Postoperative pain | Postoperative pain will be recorded according to the Visual Analogue Scale (VAS). The Visual Analogue Scale (VAS) measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). | Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 1 month. | 
| Postoperative pain | Postoperative pain will be recorded according to the Visual Analogue Scale (VAS). The Visual Analogue Scale (VAS) measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). | Postoperative pain will be recorded according to visual analogue scale at 12 months. | 
| Postoperative pain | Postoperative pain will be recorded according to the Visual Analogue Scale (VAS). The Visual Analogue Scale (VAS) measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). | Postoperative pain will be recorded according to visual analogue scale at 24 months. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IPOM Plus,, incisional Hernia, Ventral Hernia, Obesity