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Surgical innovation · Oct 2015
Randomized Controlled Trial Comparative StudyLaparoscopic Inguinal Hernia Repair With a Novel Hernia Mesh Incorporating a Nitinol Alloy Frame Compared With a Standard Lightweight Polypropylene Mesh.
- Curtis Bower, Jeffrey W Hazey, Edward L Jones, Kyle A Perry, Daniel L Davenport, and J Scott Roth.
- University of Kentucky, Lexington, KY, USA.
- Surg Innov. 2015 Oct 1; 22 (5): 508-13.
BackgroundNumerous mesh materials are available for laparoscopic inguinal hernia repair. The role of fixation of mesh in laparoscopic inguinal hernia repair remains controversial. Mesh materials have been engineered to anatomically conform to the pelvis to potentially reduce or eliminate the need for fixation. This study evaluates the outcomes of laparoscopic inguinal hernia utilizing a device consisting of a lightweight polypropylene mesh with a nitinol frame (Rebound HRD) compared with repair with lightweight polypropylene mesh with permanent tack fixation.MethodsA prospective randomized trial evaluating the outcomes of laparoscopic inguinal hernia repair with a lightweight polypropylene mesh with a nitinol frame (N-LWM) compared with standard lightweight polypropylene mesh (LWM) was conducted. Randomization was performed at an N-LWM to LWM ratio of 2:1. Repairs were standardized to a laparoscopic extraperitoneal approach without fixation for N-LWM and titanium tack fixation for LWM repairs. Follow-up assessments were performed at 7 days, 6 months, and 1 year. Outcome measures include visual analog pain scale (VAS), Short Form 36 (SF-36), Carolinas Comfort Scale (CCS), operative details, complications, and recurrences.ResultsThere were 47 patients that underwent laparoscopic inguinal hernia repair and adhered to study protocol (31 N-LWM, 16 LWM). The groups did not differ significantly in age, body mass index, ethnicity, or employment. The N-LWM group had bilateral mesh placed in 51.6% and LWM 43.8% (P = .76). Operative duration was similar, 59.6 ± 23.1 minutes for LWM and 62.4 ± 26.7 minutes for N-LWM (P = .705) as was mesh handling time was 5.4 ± 3.1 minutes LWM versus 7.3 ± 3.9 minutes N-LWM (P = .053). VAS, CCS, and SF-36 survey results were similar between groups. There was one recurrence (0.03%) in the N-LWM group.ConclusionsNitinol-framed lightweight polypropylene mesh may be safely used during laparoscopic inguinal hernia repair with outcomes comparable to LWM at 1 year. N-LWM does not impact operating room time, mesh handling time, pain, recurrences, or complications.© The Author(s) 2014.
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