1. Slowly resorbable biosynthetic mesh
- Author
-
G. W. M. Tetteroo, Alastair Windsor, René H. Fortelny, Johannes Jeekel, Tim Tollens, Francesco Gossetti, Janusz Lange, Andreas Koch, T. S. de Vries Reilingh, H. L. van Westreenen, Lars N. Jorgensen, Marc Miserez, M. M. J. van Rooijen, Bertrand Dousset, Guido Woeste, Ferdinand Köckerling, Frederik Berrevoet, Guillaume Piessen, Surgery, and Neurosciences
- Subjects
medicine.medical_specialty ,Incisional hernia ,medicine.medical_treatment ,030230 surgery ,Hernia surgery ,Biosynthetic mesh ,03 medical and health sciences ,SUTURE ,0302 clinical medicine ,Quality of life ,QUALITY-OF-LIFE ,POLY-4-HYDROXYBUTYRATE MESH ,Surgical site ,medicine ,Clinical endpoint ,Medicine and Health Sciences ,INCISIONAL HERNIA ,COMPLICATIONS ,OUTCOMES ,Science & Technology ,business.industry ,Significant difference ,medicine.disease ,Hernia repair ,Surgery ,Hernia recurrence ,030220 oncology & carcinogenesis ,business ,Life Sciences & Biomedicine ,Abdominal surgery - Abstract
Introduction Information on the long-term performance of biosynthetic meshes is scarce. This study analyses the performance of biosynthetic mesh (Phasix™) over 24 months. Methods A prospective, international European multi-center trial is described. Adult patients with a Ventral Hernia Working Group (VHWG) grade 3 incisional hernia larger than 10 cm2, scheduled for elective repair, were included. Biosynthetic mesh was placed in sublay position. Short-term outcomes included 3-month surgical site occurrences (SSO), and long-term outcomes comprised hernia recurrence, reoperation, and quality of life assessments until 24 months. Results Eighty-four patients were treated with biosynthetic mesh. Twenty-two patients (26.2%) developed 34 SSOs, of which 32 occurred within 3 months (primary endpoint). Eight patients (11.0%) developed a hernia recurrence. In 13 patients (15.5%), 14 reoperations took place, of which 6 were performed for hernia recurrence (42.9%), 3 for mesh infection (21.4%), and in 7 of which the mesh was explanted (50%). Compared to baseline, quality of life outcomes showed no significant difference after 24 months. Despite theoretical resorption, 10.7% of patients reported presence of mesh sensation in daily life 24 months after surgery. Conclusion After 2 years of follow-up, hernia repair with biosynthetic mesh shows manageable SSO rates and favorable recurrence rates in VHWG grade 3 patients. No statistically significant improvement in quality of life or reduction of pain was observed. Few patients report lasting presence of mesh sensation. Results of biosynthetic mesh after longer periods of follow-up on recurrences and remodeling will provide further valuable information to make clear recommendations. Trial registration Registered on clinicaltrials.gov (NCT02720042), March 25, 2016.
- Published
- 2022
- Full Text
- View/download PDF