TY - JOUR

T1 - Slowly resorbable biosynthetic mesh

T2 - 2-year results in VHWG grade 3 hernia repair

AU - Van Rooijen, M. M.J.

AU - Tollens, T.

AU - Jørgensen, L. N.

AU - de Vries Reilingh, T. S.

AU - Piessen, G.

AU - Köckerling, F.

AU - Miserez, M.

AU - Windsor, A. C.J.

AU - Berrevoet, F.

AU - Fortelny, R. H.

AU - Dousset, B.

AU - Woeste, G.

AU - van Westreenen, H. L.

AU - Gossetti, F.

AU - Lange, J. F.

AU - Tetteroo, G. W.M.

AU - Koch, A.

AU - Jeekel, J.

N1 - Publisher Copyright: © 2021, The Author(s).

PY - 2022

Y1 - 2022

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.

AB - 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 - Hernia recurrence

KW - Hernia surgery

KW - Incisional hernia

U2 - 10.1007/s10029-021-02453-1

DO - 10.1007/s10029-021-02453-1

M3 - Journal article

C2 - 34282506

AN - SCOPUS:85110902783

VL - 26

SP - 131

EP - 138

JO - Hernia : the journal of hernias and abdominal wall surgery

JF - Hernia : the journal of hernias and abdominal wall surgery

SN - 1265-4906

ER -