Short- and long-term complications after slowly resorbable biosynthetic P4HB mesh (Phasix) implantation in European centres: a protocol paper for a multiregistry study

Background:

Phasix mesh is a fully resorbable synthetic mesh for use in clean and contaminated ventral incisional hernia repairs. Long-term absorbable Phasix mesh appears to be a safe and promising device in incisional hernia repair, with low recurrence rates; however, data on long-term complications after surgery, particularly after the resorption period of the mesh, are scarce. 

Methods and analysis: 

This protocol describes a study of several European registries on the use of a Phasix mesh in incisional hernia repair. The primary endpoint of the study is long-term complications at 2–5year follow-up after mesh implantation, with secondary endpoints including hernia recurrence and complications during short-term follow-up. 

Ethics and dissemination: 

Ethical approval was not required for this protocol as the study is based on anonymised registry data collected with prior patient consent in each registry. Each participating registry has its own ethical approval process, and this study will adhere to those regulations. The results will be disseminated through peer-reviewed publications and conference presentations.