Incisional Hernia Clinical Trial
— SHIELDOfficial title:
Early Surgical Outcomes in the Use of Hybrid Mesh for Incisional Hernia Repair: Results From a Multicenter Italian Study
NCT number | NCT06166069 |
Other study ID # | 202318 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2021 |
Est. completion date | November 18, 2023 |
Verified date | December 2023 |
Source | Azienda Sanitaria Locale Napoli 2 Nord |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Background: Ventral hernia repair poses challenges for surgeons due to controversies in approach, patient selection, and mesh selection. The GORE® SYNECOR Intraperitoneal (IP) Biomaterial, a hybrid mesh, aims to balance durability and infection risk. Objective: To analyze extended-term outcomes of using the Intaperitoneal device for ventral and incisional hernia repair. Methods: Retrospective analysis of patients undergoing surgery in eight Italian Surgery Centers, evaluating pIPOM and sIPOM techniques with GORE® SYNECOR IP Biomaterial. Preoperative evaluations included anthropometric measurements, comorbidities, CT scans, and GIQLI assessments. Surgical procedures and interventions were recorded. Postoperative complications, GIQLI changes, cosmesis, hernia recurrence, and mesh bulging were assessed.
Status | Completed |
Enrollment | 272 |
Est. completion date | November 18, 2023 |
Est. primary completion date | October 30, 2022 |
Accepts healthy volunteers | |
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 10 cm 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 |
Country | Name | City | State |
---|---|---|---|
Italy | francesco Pizza | Naples |
Lead Sponsor | Collaborator |
---|---|
Azienda Sanitaria Locale Napoli 2 Nord |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients affected by Superficial surgical site infections | Superficial infections according to Clavien-Dindo criteria | Within 30 days postoperatively | |
Primary | Number of patients affected by Deep surgical site infections | Deep surgical site infections according to Clavien-Dindo criteria | Within 30 days postoperatively | |
Primary | Number of patients affected by organ space infections | Organ space infections according to Clavien-Dindo criteria | Within 30 days postoperatively | |
Primary | 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 | |
Primary | 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. | |
Primary | 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 6 month. | |
Primary | 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 12 month. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. |
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