ProSpectic Italian Laparoscopic Hybrid mEsh hErnia Repair in Obese patientS Trials

NCT05632952 | Unknown FDA Device

• 1 other identifier: 419N.Reg 26-2022oss
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Uncomplicated Ventral Incisional Hernia; Obesity

Keywords

IPOM Plus,; incisional Hernia; Ventral Hernia; Obesity

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (7)

• 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.

Study Arms (1)

A

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

Interventions

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.

Also known as: IPOM plus

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Sanitaria Locale Napoli 2 Nord: lead

Study Sites (1)

Francdesco Pizza

Napoli, Naples, 80035, Italy

RECRUITING

MeSH Terms

Conditions

Obesity; Incisional Hernia; Hernia, Ventral

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hernia; Pathological Conditions, Anatomical; Postoperative Complications; Pathologic Processes; Hernia, Abdominal

Study Officials

• Francesco Pizza, MD, PhD

  Azienda Sanitaria Locale Napoli 2 Nord

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Pizza, MD, PhD

CONTACT

3338275449; francesco_pizza@libero.it

Dario D'antonio, Md

CONTACT

0815079245; francesco.pizza@aslnapoli2nord.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Md

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 1, 2022
• Study Start: November 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: January 31, 2024
• Last Updated: March 8, 2023

Record last verified: 2023-03

Locations

IT (1)