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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | 120 patients affected by Incisional Hernia with size between 3 to 10 cm, undergoing Intraperitoneal Onlay Mesh with the closure of defect |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraperitoneal Onlay Mesh positioning Plus | Device | 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. |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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From January 2023 a series of 120 patients affected by Incisional Hernia with size between 3 to 10 cm, undergoing Intraperitoneal Onlay Mesh positioning in patients with BMI >30 kg/m2 in the clean wounds. The maximum enrollment time is 12 months.
Clinical data will be collected in a prospective maintained electronic database, including patients' age, sex, body mass index (BMI), chronic corticosteroid use, albumin serum level, previous abdominal surgery or hernia, smoking habits, presence of diabetes mellitus (DM), presence of Chronic obstructive pulmonary disease (COPD). All the surgeries will be performed by experienced surgeons with at least 10 years of activity in the general surgery and emergency department with over 120 procedures of laparoscopically incisional hernia repair with insertion of non-absorbable and absorbable meshes. All patients enrolled in the study will be followed up by outpatient clinic controls performed by surgeons/surgical residents.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesco Pizza, MD, PhD | Contact | 3338275449 | francesco_pizza@libero.it | |
| Dario D'antonio, Md | Contact | 0815079245 | francesco.pizza@aslnapoli2nord.it |
| Name | Affiliation | Role |
|---|---|---|
| Francesco Pizza, MD, PhD | Azienda Sanitaria Locale Napoli 2 Nord | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Francdesco Pizza | Recruiting | Naples | Naples | 80035 | Italy |
All Individual Participant Data that underlie results in a publication
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D000069290 | Incisional Hernia |
| D006555 | Hernia, Ventral |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
| 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. |
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. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D046449 | Hernia, Abdominal |