Safety and Efficiency of an Articulating Needle Driver in Advanced Laparoscopic Abdominal Surgery

摘要

Objective: Robotic platforms offer articulating needle drivers but are associated with high costs and lack tactile feedback. The recently developed mechanical Laparoscopic Articulating Needle Driver (LAND) (Flexdex®) for conventional laparoscopy offers enhanced dexterity without these limitations. The goal of this study was to assess safety and efficiency during the implementation of the LAND, and describe its learning curve, in an expert center for laparoscopic surgery. Methods: All LAND-assisted procedures after clinical implementation for a period of 16 months were included into this study. Primary outcome domains were safety (intra- and postoperative complications within 30 days) and efficiency (operative time, suturing, and knot tying time of staple defects of enteroenterostomy). CUmulative SUM (CUSUM) analysis was utilized to describe the enteroenterostomy suturing time learning curve across consecutive cases by plotting the deviation from the series mean. Results: Forty-five procedures (34 Roux-en-Y gastric bypass [of which 7 including diaphragmatic hernia repair], 2 diaphragmatic hernia repair with Nissen fundoplication, and 2 right-sided hemicolectomy) were included into this study. Median (range) operative time and enteroenterostomy suturing time were 68 (46–177) minutes and 161 (112–241) seconds, respectively, comparable with conventional needle driver standards. One procedure was converted to the conventional needle driver due to device malfunctioning and one patients' postoperative course was complicated by a Clavien–Dindo grade 3a complication (intraluminal bleeding requiring gastroscopy). CUSUM chart displays a progression toward the mean from case 22 onward, indicating a limited learning curve. Conclusion: The LAND can be implemented safely and efficiently at a center of excellence for laparoscopic surgery and is associated with a limited learning curve.