Clinical and Patient-Reported Outcomes after Absorbable Strap Fixation for Ventral Hernia Repair.

INTRODUCTION: Various mesh fixation methods are employed by surgeons during ventral hernia repair. These may include tacks, straps, sutures, glue, or a combination of methods. One of these choices is an absorbable fixation device, Securestrap® (Ethicon Inc., Somerville, New Jersey), consisting of an absorbable copolymer barbed U-shaped strap with a spring-loaded deployment system.

MATERIALS AND METHODS: The International Hernia Mesh Registry is a prospective multi-center registry, designed to collect longitudinal data on hernia repair methods, products, and outcomes. Patients complete the Carolinas Comfort Scale™ (CCS) (The Charlotte-Mecklenburg Hospital Authority, Charlotte, North Carolina) pre-operatively, and at one month, six months, and 12 months post-operatively. Symptomatic patients defined as responding >1 to any CCS™ question. Statistical comparison of symptom frequency was made with the McNemar test and Kaplan Meier methods to determine the recurrence rate up to 365 days.

RESULTS: Patients were enrolled at 16 centers. Data was available on 100 of the 203 patients at six months and on 119 patients at 12 months. Demographics: mean age of 52.7 (13.2 standard deviation[ SD]); mean body mass index (BMI) of 33.2 (7.5 SD) kg/m2; 64.3% having a BMI over 30kg/m2; male patients 47.4%; 16.7% for recurrent hernias. Mesh fixation with straps alone in 48.3% of cases or straps and sutures in 51.7% of cases. Percentage of patients with symptomatic pain decreased slightly from baseline to one month (70.0 vs. 60.6, p=0.0782) and significantly from one month to six months (60.6% symptomatic vs. 23.2%; p=0.0004). From six months to twelve months, the change in percentage of symptomatic patients was not significant (23.2% vs. 28.7%; p=0.8084). Similar results were observed with symptomatic CCS™ movement limitations. Overall recurrence rate at 12 months was 4.72% (2.39%-9.22%).

CONCLUSION: Mesh fixation with straps with or without additional sutures is associated with significant improvements in patient-reported pain and movement limitation from baseline to six months post-operative.