ProSpectic Italian Laparoscopic Hybrid mEsh hErnia Repair in Obese patientS Trials

Obesity Clinical Trial

— PSICHE-EROS  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05632952
• Other study ID #: 419N.Reg 26-2022oss
• Status: Recruiting
• Start date: November 1, 2022
• Est. completion date: January 31, 2024

Study information

• Verified date: March 2023
• Source: Azienda Sanitaria Locale Napoli 2 Nord
• Contact: Francesco Pizza, MD, PhD
• Phone: 3338275449
• Email: francesco_pizza[@]libero.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Incisional Hernia
• Obesity

Intervention

Device:
• Intraperitoneal Onlay Mesh positioning Plus
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.

Locations

Country	Name	City	State
Italy	Francdesco Pizza	Napoli	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Sanitaria Locale Napoli 2 Nord

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	Number of patients affected by Superficial surgical site infections	Superficial infections according to Clavien-Dindo criteria	Within 30 days postoperatively
Secondary	Number of patients affected by Deep surgical site infections	Deep surgical site infections according to Clavien-Dindo criteria	Within 30 days postoperatively
Secondary	Number of patients affected by organ space infections	Organ space infections according to Clavien-Dindo criteria	Within 30 days postoperatively
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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.