TY  - JOUR
A1  - Rooijen, Mathilde van
A1  - Tollens, Tim
A1  - Jørgensen, Lars Nannestad
A1  - Vries Reilingh, Tammo S. de
A1  - Piessen, Guillaume
A1  - Köckerling, Ferdinand
A1  - Miserez, Marc
A1  - Windsor, Alastair C. J.
A1  - Berrevoet, Frederik
A1  - Fortelny, René H.
A1  - Dousset, Bertrand
A1  - Woeste, Guido
A1  - Westreenen, Henderik Leendert van
A1  - Gossetti, Francesco
A1  - Lange, Johan F.
A1  - Tetteroo, Geert W. M.
A1  - Koch, Andreas
A1  - Jeekel, Johannes
T1  - Slowly resorbable biosynthetic mesh: 2-year results in VHWG grade 3 hernia repair
T2  - Hernia
N2  - 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.
KW  - Biosynthetic mesh
KW  - Incisional hernia
KW  - Hernia recurrence
KW  - Hernia surgery
Y1  - 2021
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/69517
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-695177
SN  - 1248-9204
N1  - Davol Inc. (subsidiary of C.R. Bard, Inc.; part of Becton Dickinson since 01-Jan-2018; the sponsor) has taken part in designing and has financially supported this trial for training in the protocol, additional study patient follow-up and data collection activities.
VL  - 26
IS  - 1
SP  - 131
EP  - 138
PB  - Springer
CY  - Paris
ER  -