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Mesh OR Patch for Hernia on Epigastric and Umbilical Sites (MORPHEUS-Trial)

The Complete Two-year Follow-up

Ponten, Jeroen E. H., MD*; Leclercq, Wouter K. G., MD, PhD; Lettinga, Tanja, MD; Heemskerk, Jeroen, MD, PhD§; Konsten, Joop L. M., MD, PhD; Bouvy, Nicole D., MD, PhD||; Nienhuijs, Simon W., MD, PhD*

doi: 10.1097/SLA.0000000000003086
RANDOMIZED CONTROLLED TRIALS
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Objective: The objective of this trial was to identify a superior method for umbilical and epigastric hernia repair in terms of complications. Complications such as an extended operation duration, additional use of painkillers, reoperation, infection, seroma, extended wound care, extended hospitalization, and early recurrence were reported according to the Clavien–Dindo grading system.

Summary Background Data: Over the years mesh repair is proven the gold standard for umbilical and epigastric hernias. The question remains, which mesh should be used?

Methods: In this randomized controlled, multicenter trial, all patients ≥ 18 years with a single, symptomatic, and primary small umbilical or epigastric hernia qualified for inclusion. Flat preperitoneal polypropylene mesh repair was compared with patch repair (PROCEED Ventral Patch) (PVP).

Results: A total of 352 patients were randomized; 348 patients received the intervention (n = 177 PVP vs n = 171 mesh). One out of 4 suffered from any kind of complication within 2 years postoperative (27.6%). A significant difference in complications was seen, in favor of polypropylene mesh repair (P = 0.044, 22.1% mesh vs 32.5% PVP). Reoperation was performed in 19 PVP operated patients (10.7%) versus 7 patients with polypropylene mesh repair (4.0%, P = 0.021).

No significant differences were seen in recurrences (n = 13, 8.4% PVP vs n = 6, 4.1% mesh, P = 0.127).

Conclusions: In small epigastric and small umbilical hernia repair a flat polypropylene mesh repair was associated with a lower complication rate than PVP repair. No differences in recurrence rates were seen. Combining all complications, the preperitoneal positioned flat polypropylene mesh performed better.

*Department of Surgery, Catharina Ziekenhuis Eindhoven, Eindhoven, The Netherlands

Department of Surgery, Maxima Medisch Centrum, Veldhoven, The Netherlands

Department of Surgery, St. Jans Gasthuis Weert, Weert, The Netherlands

§Department of Surgery, Laurentius Ziekenhuis Roermond, Roermond, The Netherlands

Department of Surgery, VieCuri Medisch Centrum, Venlo, The Netherlands

||Department of Surgery, Maastricht Universitair Medisch Centrum, Maastricht, The Netherlands.

Reprints: Jeroen E. H. Ponten, MD, Department of Surgery, Catharina Ziekenhuis Eindhoven, Michelangelolaan 2, 5623 EJ Eindhoven, The Netherlands. E-mail: jeroen.ponten@catharinaziekenhuis.nl.

This trial was registered in the Dutch Trial Registry (NTR) NTR2514NL33995.060.10. NTR. Nederlands Trial Register. 2010; Available at: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2514.

The MORPHEUS trial started as a non-funded trial, because of slow inclusion rate in participating centers 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 leveling in costs for participating hospitals between the 2 mesh devices used. The Johnson & Johnson Company was not involved in the analysis of the data and the drafting of the manuscript.

The authors report no conflicts of interest.

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