Evaluating the Impact of Technique and Mesh Type in Complicated Ventral Hernia Repair: A Prospective Randomized Multicenter Controlled Trial

Abstract Background To our knowledge, there is an absence of PRMCTs evaluating both the impact of technique and mesh type on outcome in CVHR. Study Design A PRMCT of 120 patients at 3 sites was conducted in which patients were randomized to either overlay (anterior component separation) vs. underlay mesh placement (posterior component separation) and mesh type (human acellular HADM vs porcine acellular PADM dermis). Key inclusion criteria included hernia size (>200 cm 2 ) , BMI 2 , HBA1C 6 weeks and primary fascial closure. Primary outcome was hernia recurrence at one year determined by independent examiner/imaging. Secondary outcomes included complications and patient satisfaction (SF-36v2). Standardized investigator training included a porcine model followed by proctored first case by the lead investigator. Results There were no significant differences in demographics between the 4 groups (age 60 ±12 years, BMI 32 ± 5, 51% female). The overall one year recurrence rate was 10.8%. There was no significant difference in recurrence rate by location of mesh placement (overlay = 9.8%, underlay=11.9%) or mesh type (HADM = 10.3%, PADM=11.3%). Overlay patients had a significantly lower surgical site infection rate (1.6% vs. 11.9% p=0.03) and reported better physical functioning (p=0.001) and role limitation scores (p=0.04) in the early postoperative period and achieved the highest physical functioning score during the 12 month period (p Conclusions Recurrence rates were not impacted by either anatomical location or type of mesh used. To our knowledge this represents the first PRMCT that demonstrates similar clinical outcomes using HADM vs. PADM (not inferiority, contrary to previously published literature), with several advantages identified using the overlay technique.