Last reviewed · How we verify
NCT06166069: SHIELD
Early Surgical Outcomes in the Use of Hybrid Mesh for Incisional Hernia Repair: Results From a Multicenter Italian Study
trial in Hernia in 272 participants. Completed in 18 November 2023.
30 October 2022
Quick facts
| Lead sponsor | Azienda Sanitaria Locale Napoli 2 Nord |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 272 |
| Start date | 1 January 2021 |
| Primary completion | 30 October 2022 |
| Estimated completion | 18 November 2023 |
| Sites | 1 location across Italy |
Conditions studied
- Hernia — all drugs for Hernia →
- Incisional Hernia — all drugs for Incisional Hernia →
- Laparoscopic — all drugs for Laparoscopic →
Sponsor
Azienda Sanitaria Locale Napoli 2 Nord
Who can join
18 and older, any sex, with Hernia or Incisional Hernia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Postoperative outcomes and wound events in incisional hernia repair using hybrid mesh: results from a prospective multicenter italian study.
Pizza F, Iuppa A, Maida P, Pilone V, et al · · 2025 · PMID 39966208 · DOI 10.1007/s10029-025-03285-z
Verify or expand the search:
- PubMed search for NCT06166069
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hernia
Currently open trials in the same condition.
- NCT07220382 — Preoperative BOTOX® Injection for Large Ventral Hernia Repair · Phase 4 · recruiting
- NCT07316426 — Preoptimisation in Ventral Hernia Surgery · NA · recruiting
- NCT07166172 — Prospective Registry for Long-term Outcomes Following FETO in Severe Left and Right CDH · NA · recruiting
- NCT06449378 — Transorb™ Self-Gripping Resorbable Mesh in High-risk Subjects Undergoing Open Repair of Ventral Hernia · NA · active not recruiting
- NCT06042205 — TISSIUM™ Atraumatic Hernia Repair System (TAHRS) Pilot Study · NA · active not recruiting
Other Azienda Sanitaria Locale Napoli 2 Nord trials
Trials by the same sponsor.
- NCT07382180 — Real-World Tirzepatide Therapy in Post-Bariatric Weight Regain and Preoperative Obesity Patients · completed
- NCT04749329 — Use of Resorbable Prosthetic Mesh "Ante Rectus" as Prevention of Parastomal Hernia. · NA · unknown
- NCT04471311 — Safety and Efficacy of Prophylactic Re-sorbable Biosynthetic Mesh Following Midline Laparotomy in Clean/Contaminated Fie · NA · unknown
- NCT05632952 — ProSpectic Italian Laparoscopic Hybrid mEsh hErnia Repair in Obese patientS Trials · unknown
- NCT07349628 — Botulinum Toxin A Facilitates Fascial Closure in Complex Incisional Hernias · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06166069 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Azienda Sanitaria Locale Napoli 2 Nord
- Last refreshed: 18 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06166069.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing