Uncomplicated Ventral Incisional HerniaPSICHE-EROSNCT05632952
ProSpectic Italian Laparoscopic Hybrid mEsh hErnia Repair in Obese patientS Trials
An observational study of Uncomplicated Ventral Incisional Hernia and Obesity, run by Azienda Sanitaria Locale Napoli 2 Nord at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uncomplicated Ventral Incisional Hernia, Obesity
- What is being tested?
- Intraperitoneal Onlay Mesh positioning Plus
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2022to 31 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Francdesco Pizza
Naples, Naples, 80035
francesco Pizza, Md PhD, 3338275449, francesco_pizza@libero.it
About this study
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.
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.
Read the 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
- Conditions
- Uncomplicated Ventral Incisional Hernia, Obesity
- Being tested
- Intraperitoneal Onlay Mesh positioning Plus
- Keywords
- IPOM Plus,, incisional Hernia, Ventral Hernia, Obesity
- Medical subject headings
- Obesity, Incisional Hernia, Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraperitoneal Onlay Mesh positioning PlusDevice
Also called IPOM 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.
| Study group | Role | What they receive |
|---|---|---|
| A | 120 patients affected by Incisional Hernia with size between 3 to 10 cm, undergoing Intraperitoneal Onlay Mesh with the closure of defect Receives: Device: Intraperitoneal Onlay Mesh positioning Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Patients are postoperatively examined at 36 months.
Secondary outcomes (7)
Number of patients affected by Superficial surgical site infections
Superficial infections according to Clavien-Dindo criteria
Measured: Within 30 days postoperatively
Number of patients affected by Deep surgical site infections
Deep surgical site infections according to Clavien-Dindo criteria
Measured: Within 30 days postoperatively
Number of patients affected by organ space infections
Organ space infections according to Clavien-Dindo criteria
Measured: 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
Measured: 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').
Measured: 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').
Measured: 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').
Measured: Postoperative pain will be recorded according to visual analogue scale at 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start1 Nov 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uncomplicated Ventral Incisional HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria Locale Napoli 2 Nord
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Pizza, Azienda Sanitaria Locale Napoli 2 Nord
- Investigators
- Francesco Pizza, MD, PhD, Principal investigator, Azienda Sanitaria Locale Napoli 2 Nord
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05632952
- Sponsor's protocol ID
- 419N.Reg 26-2022oss
- Acronym
- PSICHE-EROS
- Status last verified
- Mar 2023
- First submitted
- 21 Nov 2022
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: All Individual Participant Data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05632952
- Acronym / sponsor ID
- PSICHE-EROS / 419N.Reg 26-2022oss
- Conditions
- Uncomplicated Ventral Incisional Hernia, Obesity
- Keywords
- IPOM Plus,, incisional Hernia, Ventral Hernia, Obesity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Azienda Sanitaria Locale Napoli 2 NordUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 1 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Device: Intraperitoneal Onlay Mesh positioning Plus120 patients affected by Incisional Hernia with size between 3 to 10 cm, undergoing Intraperitoneal Onlay Mesh with the closure of defect |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (7 listed)
- age > 18 years
- Clean wounds
- Informed consent
- Patients affected by Incisional and Ventral Hernia
- Elective surgery
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraperitoneal Onlay Mesh positioning PlusAlso: IPOM plusIntraperitoneal 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. | Device | A |
Primary outcome
Rate of Incisional Hernia at Clinical examination
Time frame: Patients are postoperatively examined at 1 months.
Clinical examination: Incisional Hernia is clinically defined as any visible or palpable ''blowout'' in site of incisional hernia treated
Rate of Incisional Hernia at Clinical examination
Time frame: Patients are postoperatively examined at 3 months.
Clinical examination: Incisional Hernia is clinically defined as any visible or palpable ''blowout'' in site of incisional hernia treated
Rate of Incisional Hernia at Clinical examination
Time frame: Patients are postoperatively examined at 6 months.
Clinical examination: Incisional Hernia is clinically defined as any visible or palpable ''blowout'' in site of incisional hernia treated
Rate of Incisional Hernia at Clinical examination
Time frame: Patients are postoperatively examined at 12 months.
Clinical examination: Incisional Hernia is clinically defined as any visible or palpable ''blowout'' in site of incisional hernia treated
Rate of Incisional Hernia at Clinical examination
Time frame: Patients are postoperatively examined at 24 months.
Clinical examination: Incisional Hernia is clinically defined as any visible or palpable ''blowout'' in site of incisional hernia treated
Rate of Incisional Hernia at Clinical examination
Time frame: Patients are postoperatively examined at 36 months.
Clinical examination: Incisional Hernia is clinically defined as any visible or palpable ''blowout'' in site of incisional hernia treated
Rate of Incisional Hernia at ultrasonographic examination
Time frame: Patients are postoperatively examined at 1 months.
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.
Rate of Incisional Hernia at ultrasonographic examination
Time frame: Patients are postoperatively examined at 3 months.
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.
Rate of Incisional Hernia at ultrasonographic examination
Time frame: Patients are postoperatively examined at 6 months.
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.
Rate of Incisional Hernia at ultrasonographic examination
Time frame: Patients are postoperatively examined at 12 months.
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.
Rate of Incisional Hernia at ultrasonographic examination
Time frame: Patients are postoperatively examined at 24 months.
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.
Rate of Incisional Hernia at ultrasonographic examination
Time frame: Patients are postoperatively examined at 36 months.
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.
7 secondary outcomes
Number of patients affected by Superficial surgical site infections
Time frame: Within 30 days postoperatively
Number of patients affected by Deep surgical site infections
Time frame: Within 30 days postoperatively
Number of patients affected by organ space infections
Time frame: Within 30 days postoperatively
Number of patients affected by Surgical Site Occurence
Time frame: Within 30 days postoperatively
Postoperative pain
Time frame: Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 1 month.
Postoperative pain
Time frame: Postoperative pain will be recorded according to visual analogue scale at 12 months.
Postoperative pain
Time frame: Postoperative pain will be recorded according to visual analogue scale at 24 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Individual participant dataSharing planned: Undecided. All Individual Participant Data that underlie results in a publication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Pizza, MD, PhD principal investigator
Azienda Sanitaria Locale Napoli 2 Nord
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uncomplicated Ventral Incisional Hernia and Obesity, run by Azienda Sanitaria Locale Napoli 2 Nord at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesco Pizza, MD, PhD (3338275449, francesco_pizza@libero.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Incisional Hernia at Clinical examination (time frame: Patients are postoperatively examined at 1 months.). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2023.