PSICHE-EROS
Laparoscopic Ventral Hernia Repair in Obese Patients: Safe and Effective Use of a Hybrid (PTFE / Biosynthetic) Mesh. Results of a Multicentric Prospective Trial.
Sponsor study identifier
observational
120
1 country
1
Study Start
November 1, 2022
Actual (reported)Primary Completion
December 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 1, 2022
Actual (reported)November 21, 2022
Actual (reported)December 1, 2022
Actual (reported)December 31, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Number of patients affected by Superficial surgical site infections
Within 30 days postoperatively
Number of patients affected by Deep surgical site infections
Within 30 days postoperatively
Number of patients affected by organ space infections
Within 30 days postoperatively
Number of patients affected by Surgical Site Occurence
Within 30 days postoperatively
Postoperative pain
Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 1 month.
120 patients affected by Incisional Hernia with size between 3 to 10 cm, undergoing Intraperitoneal Onlay Mesh with the closure of defect
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Francdesco Pizza
Naples, Naples, 80035, Italy
Francesco Pizza, MD, PhD
Azienda Sanitaria Locale Napoli 2 Nord
First Submitted
November 21, 2022
First Posted
December 1, 2022
Study Start
November 1, 2022
Actual (reported)Primary Completion
December 31, 2023
Estimated (date passed)Dietary Treatment for Post Bariatric Weight Regain
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.
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 8, 2023
Record last verified: 2023-03
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