TY - JOUR
T1 - Evaluating the Impact of Technique and Mesh Type in Complicated Ventral Hernia Repair
T2 - A Prospective Randomized Multicenter Controlled Trial
AU - Bochicchio, Grant V.
AU - Garcia, Alvaro
AU - Kaufman, Jarrod
AU - Zhang, Qiao
AU - Horn, Christopher
AU - Bochicchio, Kelly
AU - Sato, Bryan
AU - Reese, Stacey
AU - Ilahi, Obeid
N1 - Funding Information:
Disclosure Information: This study was supported by a grant from MTF Biologics. Drs G Bochicchio, K Bochicchio, and Garcia received consulting fees and reimbursement for travel from MTF. Dr Ilahi's institution received grant money from Bard.
Publisher Copyright:
© 2019 American College of Surgeons
PY - 2019/4
Y1 - 2019/4
N2 - Background: To our knowledge, there is an absence of prospective randomized multicenter controlled trials evaluating both the impact of technique and mesh type on outcomes in complicated ventral hernia repair. Study Design: A prospective randomized multicenter controlled trial of 120 patients at 3 sites was conducted in which patients were randomized to either overlay (anterior component separation) or underlay mesh placement (posterior component separation) and mesh type (human acellular dermis [HADM] vs porcine acellular dermis [PADM]). Key inclusion criteria included hernia size (>200 cm 2 ), BMI < 40 kg/m 2 , hemoglobin A1C < 7%, tobacco free > 6 weeks and primary fascial closure. Primary outcome was hernia recurrence at 1 year, determined by independent examiner/imaging. Secondary outcomes included complications and patient satisfaction (short form [SF]-36v2). Standardized investigator training included a porcine model followed by a 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 kg/m 2 , 51% female). The overall 1-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), 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 < 0.03). Conclusions: Recurrence rates were not affected by either anatomic location or type of mesh used. To our knowledge, this represents the first prospective randomized multicenter controlled trial that demonstrates similar clinical outcomes using HADM vs PADM (not inferiority, contrary to previously published literature), with several advantages identified using the overlay technique.
AB - Background: To our knowledge, there is an absence of prospective randomized multicenter controlled trials evaluating both the impact of technique and mesh type on outcomes in complicated ventral hernia repair. Study Design: A prospective randomized multicenter controlled trial of 120 patients at 3 sites was conducted in which patients were randomized to either overlay (anterior component separation) or underlay mesh placement (posterior component separation) and mesh type (human acellular dermis [HADM] vs porcine acellular dermis [PADM]). Key inclusion criteria included hernia size (>200 cm 2 ), BMI < 40 kg/m 2 , hemoglobin A1C < 7%, tobacco free > 6 weeks and primary fascial closure. Primary outcome was hernia recurrence at 1 year, determined by independent examiner/imaging. Secondary outcomes included complications and patient satisfaction (short form [SF]-36v2). Standardized investigator training included a porcine model followed by a 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 kg/m 2 , 51% female). The overall 1-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), 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 < 0.03). Conclusions: Recurrence rates were not affected by either anatomic location or type of mesh used. To our knowledge, this represents the first prospective randomized multicenter controlled trial that demonstrates similar clinical outcomes using HADM vs PADM (not inferiority, contrary to previously published literature), with several advantages identified using the overlay technique.
UR - http://www.scopus.com/inward/record.url?scp=85062883405&partnerID=8YFLogxK
U2 - 10.1016/j.jamcollsurg.2019.01.012
DO - 10.1016/j.jamcollsurg.2019.01.012
M3 - Article
C2 - 30707935
AN - SCOPUS:85062883405
SN - 1072-7515
VL - 228
SP - 377
EP - 390
JO - Journal of the American College of Surgeons
JF - Journal of the American College of Surgeons
IS - 4
ER -