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Slowly resorbable biosynthetic mesh: 2-year results in VHWG grade 3 hernia repair |
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| Authors: | Van Rooijen M. M. J. Tollens T. Jørgensen L. N. de Vries Reilingh T. S. Piessen G. Köckerling F. Miserez M. Windsor A. C. J. Berrevoet F. Fortelny R. H. Dousset B. Woeste G. van Westreenen H. L. Gossetti F. Lange J. F. Tetteroo G. W. M. Koch A. Jeekel J. |
| Affiliation: | 1.Department of Surgery, Erasmus University Medical Centre Rotterdam, Room Ee-1453, PO BOX 2040, 3000 CA, Rotterdam, The Netherlands ;2.Department of General Surgery, Imelda Hospital, Bonheiden, Belgium ;3.Department of Surgery, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark ;4.Department of Surgery, Elkerliek Hospital, Helmond, The Netherlands ;5.Department of Surgery, University Hospital Lille, Lille, France ;6.Department of Surgery, Vivantes Klinikum Spandau, Berlin, Germany ;7.Department of Abdominal Surgery, University Hospital Leuven, Leuven, Belgium ;8.Department of Colorectal Surgery, University College London Hospital, London, UK ;9.Department of General and Hepatobiliary Surgery, University Hospital Ghent, Ghent, Belgium ;10.Department of General, Visceral and Oncologic Surgery, Wilhelminen Hospital, Vienna, Austria ;11.Department of Digestive, Hepatobiliary and Endocrine Surgery, H?pital Cochin, Paris, France ;12.Klinikum der Johann Wolfgang Goethe-Universit?t, Frankfurt am Main, Germany ;13.Department of Surgery, Isala Zwolle, Zwolle, The Netherlands ;14.Università di Roma Sapienza, Rome, Italy ;15.Department of Surgery, IJsselland Ziekenhuis, Capelle aan den Ijssel, The Netherlands ;16.Chirurgische Praxis Cottbus, Cottbus, Germany ;17.Department of Neuroscience, Erasmus University Medical Centre Rotterdam, Rotterdam, The Netherlands ; |
| 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. MethodsA 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. ResultsEighty-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. ConclusionAfter 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 registrationRegistered on clinicaltrials.gov (NCT02720042), March 25, 2016. |
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