Mathilde Mj van Rooijen1, An P Jairam2, Tim Tollens3, Lars N Jørgensen4, Tammo S de Vries Reilingh5, Guillaume Piessen6, Ferdinand Köckerling7, Marc Miserez8, Alastair Cj Windsor9, Frederik Berrevoet10, René H Fortelny11, Bertrand Dousset12, Guido Woeste13, Henderik L van Westreenen14, Francesco Gossetti15, Johan F Lange16, Geert Wm Tetteroo17, Andreas Koch18, Leonard F Kroese2, Johannes Jeekel2. 1. Erasmus University Medical Centre Rotterdam, Department of Surgery, Rotterdam, The Netherlands. Electronic address: m.vanrooijen@erasmusmc.nl. 2. Erasmus University Medical Centre Rotterdam, Department of Surgery, Rotterdam, The Netherlands. 3. Imelda Hospital, Department of General Surgery, Bonheiden, Belgium. 4. University of Copenhagen, Bispebjerg Hospital, Department of Surgery, Copenhagen, Denmark. 5. Elkerliek Hospital, Department of Surgery, Helmond, The Netherlands. 6. University Hospital Lille, Department of Surgery, Lille, France. 7. Vivantes Klinikum Spandau, Department of Surgery, Berlin, Germany. 8. University Hospital Leuven, Department of Abdominal Surgery, Leuven, Belgium. 9. University College London Hospital, Department of Colorectal Surgery, London, United Kingdom. 10. University Hospital Ghent, Department of General and Hepatobiliary Surgery, Ghent, Belgium. 11. Wilhelminenhospital, Department of General, Visceral and Oncologic Surgery, Vienna, Austria. 12. Hôpital Cochin, Department of Digestive, Hepatobiliary and Endocrine Surgery, Paris, France. 13. Klinikum der Johann Wolfgang Goethe-Universität, Frankfurt Am Main, Germany. 14. Isala Zwolle, Department of Surgery, Zwolle, The Netherlands. 15. Università di Roma Sapienza, Rome, Italy. 16. Erasmus University Medical Centre Rotterdam, Department of Surgery, Rotterdam, The Netherlands; IJsselland Ziekenhuis, Department of Surgery, Capelle Aan Den Ijssel, The Netherlands. 17. IJsselland Ziekenhuis, Department of Surgery, Capelle Aan Den Ijssel, The Netherlands. 18. Chirurgische Praxis Cottbus, Cottbus Area, Germany.
Abstract
BACKGROUND: Resorbable biomaterials have been developed to reduce the amount of foreign material remaining in the body after hernia repair over the long-term. However, on the short-term, these resorbable materials should render acceptable results with regard to complications, infections, and reoperations to be considered for repair. Additionally, the rate of resorption should not be any faster than collagen deposition and maturation; leading to early hernia recurrence. Therefore, the objective of this study was to collect data on the short-term performance of a new resorbable biosynthetic mesh (Phasix™) in patients requiring Ventral Hernia Working Group (VHWG) Grade 3 midline incisional hernia repair. MATERIALS AND METHODS: A prospective, multi-center, single-arm trial was conducted at surgical departments in 15 hospitals across Europe. Patients aged ≥18, scheduled to undergo elective Ventral Hernia Working Group Grade 3 hernia repair of a hernia larger than 10 cm2 were included. Hernia repair was performed with Phasix™ Mesh in sublay position when achievable. The primary outcome was the rate of surgical site occurrence (SSO), including infections, that required intervention until 3 months after repair. RESULTS: In total, 84 patients were treated with Phasix™ Mesh. Twenty-two patients (26.2%) developed 32 surgical site occurrences. These included 11 surgical site infections, 9 wound dehiscences, 7 seromas, 2 hematomas, 2 skin necroses, and 1 fistula. No significant differences in surgical site occurrence development were found between groups repaired with or without component separation technique, and between clean-contaminated or contaminated wound sites. At three months, there were no hernia recurrences. CONCLUSION: Phasix™ Mesh demonstrated acceptable postoperative surgical site occurrence rates in patients with a Ventral Hernia Working Group Grade 3 hernia. Longer follow-up is needed to evaluate the recurrence rate and the effects on quality of life. This study is ongoing through 24 months of follow-up.
BACKGROUND: Resorbable biomaterials have been developed to reduce the amount of foreign material remaining in the body after hernia repair over the long-term. However, on the short-term, these resorbable materials should render acceptable results with regard to complications, infections, and reoperations to be considered for repair. Additionally, the rate of resorption should not be any faster than collagen deposition and maturation; leading to early hernia recurrence. Therefore, the objective of this study was to collect data on the short-term performance of a new resorbable biosynthetic mesh (Phasix™) in patients requiring Ventral Hernia Working Group (VHWG) Grade 3 midline incisional hernia repair. MATERIALS AND METHODS: A prospective, multi-center, single-arm trial was conducted at surgical departments in 15 hospitals across Europe. Patients aged ≥18, scheduled to undergo elective Ventral Hernia Working Group Grade 3 hernia repair of a hernia larger than 10 cm2 were included. Hernia repair was performed with Phasix™ Mesh in sublay position when achievable. The primary outcome was the rate of surgical site occurrence (SSO), including infections, that required intervention until 3 months after repair. RESULTS: In total, 84 patients were treated with Phasix™ Mesh. Twenty-two patients (26.2%) developed 32 surgical site occurrences. These included 11 surgical site infections, 9 wound dehiscences, 7 seromas, 2 hematomas, 2 skin necroses, and 1 fistula. No significant differences in surgical site occurrence development were found between groups repaired with or without component separation technique, and between clean-contaminated or contaminated wound sites. At three months, there were no hernia recurrences. CONCLUSION: Phasix™ Mesh demonstrated acceptable postoperative surgical site occurrence rates in patients with a Ventral Hernia Working Group Grade 3 hernia. Longer follow-up is needed to evaluate the recurrence rate and the effects on quality of life. This study is ongoing through 24 months of follow-up.
Authors: Michael Katzen; Sullivan A Ayuso; Jana Sacco; Dau Ku; Gregory T Scarola; Kent W Kercher; Paul D Colavita; Vedra A Augenstein; B Todd Heniford Journal: Surg Endosc Date: 2022-08-04 Impact factor: 3.453
Authors: S Morales-Conde; P Hernández-Granados; L Tallón-Aguilar; M Verdaguer-Tremolosa; M López-Cano Journal: Hernia Date: 2022-09-13 Impact factor: 2.920
Authors: M M J Van Rooijen; T Tollens; L N Jørgensen; T S de Vries Reilingh; G Piessen; F Köckerling; M Miserez; A C J Windsor; F Berrevoet; R H Fortelny; B Dousset; G Woeste; H L van Westreenen; F Gossetti; J F Lange; G W M Tetteroo; A Koch; J Jeekel Journal: Hernia Date: 2021-07-19 Impact factor: 2.920