Mesh Versus Patch Repair for Epigastric and Umbilical Hernia (MORPHEUS Trial); One-Year Results of a Randomized Controlled Trial
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This trial is a randomized controlled, patient-blinded, multicentre, superiority trial.
All patients ≥18 years with a single, symptomatic and primary umbilical or epigastric hernia (<2 fingers) qualified for participation in the study. Flat polypropylene mesh repair was compared to patch repair (PROCEED® Ventral Patch) (PVP). The objective of this trial was to identify a superior method for umbilical and epigastric hernia repair in terms of complication rates.
A total of 352 patients were randomized in this trial; 348 patients received the intervention (n = 177 PVP vs. n = 171 mesh). No peri-operative complications occurred. PVP placement was significantly faster compared to mesh placement (30 min, SD 11 vs. 35 min, SD 11) and was scored as an easier procedure. At 1-month follow-up, 76 patients suffered any kind of complication. There was no significant difference in the proportion of complications (24.9% for PVP and 18.7% for mesh, p = 0.195). A significant difference was seen in re-operation rate within 1 month, significantly less early re-operations in the mesh group (0.0 vs. 2.8%, p = 0.027). After 1-year follow-up, no significant differences are seen in recurrence rates (n = 13, 7.8% PVP vs. n = 5, 3.3% mesh, p = 0.08).
Both mesh and PVP had a comparable amount of reported complications. There was a significantly higher incidence of early re-operations due to early complications in the PVP group. No differences were seen in infection rates and the need for antibiotic treatment. No significant difference was seen in the recurrence rates.
This trial was registered in the Dutch Trail Registry (NTR) NTR2514NL33995.060.10. .
The authors would like to thank T.A. Mulders, MD and Ph.D., for his help and statistical knowledge, but above all, his friendship. Special thanks to Jax Café, New York City, USA, where the first lines of this manuscript were written, and Hotel Armentarola, Alto Adige, Italy, where this manuscript was finished. Both places are ideal writing environments.
The MORPHEUS trial started as a non-funded trial, because of slow inclusion rate in participating centres due to high device costs; an investigator initiated grant proposal was deposited. An Investigator Sponsored-Studies (ISS) proposal, which is investigator, initiated applied for and granted by the Johnson & Johnson Company. This funding was used to create levelling in costs for participating hospitals between the two mesh devices used. The Johnson & Johnson Company was not involved in the analysis of the data and the drafting of the manuscript.
The protocol was approved and published in an open access, peer reviewed journal .
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