REDUCTION IN FIXATION TIME AND RELATED SURGICAL STRESS WITH THE USE OF ETHICON SECURESTRAP™ OPEN ABSORBABLE STRAP FIXATION DEVICE IN THE DEPLOYMENT OF INTRA-PERITONEAL ONLAY MESH (IPOM) FOR OPEN VENTRAL HERNIA REPAIR
Author(s)
Roy S*1;Shnoda P2;Savidge S2;Hammond J2;Panish J1, Wilson M3 1Johnson & Johnson Global Surgery Group, Somerville, NJ, USA, 2Ethicon, Somerville, NJ, USA, 3University of Exeter, Exeter, United Kingdom
OBJECTIVES: This study compared fixation time using ETHICON SECURESTRAP™ Open device to suture fixation of IPOM mesh in ventral/ incisional hernia repair. It also assesses surgeon-reported levels of task load experienced during the two fixation approaches. METHODS: Nine surgeons inserted skirted mesh using IPOM technique on created incisional defects in live swine models. Each surgeon performed two suture (using their standard technique) and two ETHICON SECURESTRAP™ Open fixation procedures. The duration of fixation procedure starting from mesh preparation through the last firing or suture knot was recorded. Surgical workload was measured using the validated Surgery Task Load Index (SURG-TLX) questionnaire. Time savings and task load reduction were determined by the lower limit of the two-sided 95% confidence interval for the difference between suture fixation and ETHICON SECURESTRAP™ Open groups. RESULTS: 38 IPOM fixation procedures were performed with equal numbers using suture and ETHICON SECURESTRAP™ Open. 89% reduction in mean fixation time was observed from suture to mechanical fixation with ETHICON SECURESTRAP™ Open [mean reduction: 34.9 minutes (SD: 17.9 minutes); p<0.0001]. Similarly, 55% reduction in perceived overall workload was observed with SECURESTRAP™ Open compared to suture fixation [mean reduction: 22.17 (SD: 15.12); p=0.0003]. ETHICON SECURESTRAP™ Open demonstrated significantly lower ratings in five of the six elements of surgical task load, namely – Mental Demand, Physical Demand, Situational Stress, Task Complexity, and Temporal Demand [p<0.05 for all] compared to suture fixation. CONCLUSIONS: Time for fixation and related surgical task load can be significantly reduced by using the ETHICON SECURESTRAP™ Open fixation device compared with suture fixation of IPOM mesh. This shows promise of reducing open IPOM procedure time which may realize related patient benefits of reduced anesthesia time, infection risks, costs etc. Also, reduction in surgical stress could potentially offer improvement in surgical performance – benefiting the surgeon, the patient and the healthcare system.
Conference/Value in Health Info
2013-11, ISPOR Europe 2013, The Convention Centre Dublin
Value in Health, Vol. 16, No. 7 (November 2013)
Code
PHP197
Topic
Health Service Delivery & Process of Care, Study Approaches
Topic Subcategory
Quality of Care Measurement, Registries
Disease
Multiple Diseases