Clinical trial NCT05632952: ProSpectic Italian Laparoscopic Hybrid mEsh hErnia Repair in Obese patientS Trials
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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Uncomplicated Ventral Incisional Hernia
Obesity
Keywords: IPOM Plus,
incisional Hernia
Ventral Hernia
Obesity
Lead sponsor: Azienda Sanitaria Locale Napoli 2 Nord
Sponsor class: OTHER
First posted: 2022-12-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Rate of Incisional Hernia at Clinical examination
timeFrame: Patients are postoperatively examined at 1 months.
measure: Rate of Incisional Hernia at Clinical examination
timeFrame: Patients are postoperatively examined at 3 months.
measure: Rate of Incisional Hernia at Clinical examination
timeFrame: Patients are postoperatively examined at 6 months.
measure: Rate of Incisional Hernia at Clinical examination
timeFrame: Patients are postoperatively examined at 12 months.
measure: Rate of Incisional Hernia at Clinical examination
timeFrame: Patients are postoperatively examined at 24 months.
measure: Rate of Incisional Hernia at Clinical examination
timeFrame: Patients are postoperatively examined at 36 months.
measure: Rate of Incisional Hernia at ultrasonographic examination
timeFrame: Patients are postoperatively examined at 1 months.
measure: Rate of Incisional Hernia at ultrasonographic examination
timeFrame: Patients are postoperatively examined at 3 months.
measure: Rate of Incisional Hernia at ultrasonographic examination
timeFrame: Patients are postoperatively examined at 6 months.
measure: Rate of Incisional Hernia at ultrasonographic examination
timeFrame: Patients are postoperatively examined at 12 months.
measure: Rate of Incisional Hernia at ultrasonographic examination
timeFrame: Patients are postoperatively examined at 24 months.
measure: Rate of Incisional Hernia at ultrasonographic examination
timeFrame: Patients are postoperatively examined at 36 months.
Secondary outcomes:
measure: Number of patients affected by Superficial surgical site infections
timeFrame: Within 30 days postoperatively
measure: Number of patients affected by Deep surgical site infections
timeFrame: Within 30 days postoperatively
measure: Number of patients affected by organ space infections
timeFrame: Within 30 days postoperatively
measure: Number of patients affected by Surgical Site Occurence
timeFrame: Within 30 days postoperatively
measure: Postoperative pain
timeFrame: Postoperative pain will be recorded according to visual analogue scale Visual Analogue Scale at 1 month.
measure: Postoperative pain
timeFrame: Postoperative pain will be recorded according to visual analogue scale at 12 months.
measure: Postoperative pain
timeFrame: Postoperative pain will be recorded according to visual analogue scale at 24 months.
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Francdesco Pizza
state: Naples
Study officials:
affiliation: Azienda Sanitaria Locale Napoli 2 Nord
name: Francesco Pizza, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: