Safety and feasibility of a low-cost laparoscope in a porcine model

The KeyScope (KS) is a low-cost laparoscope that is designed specifically for use in low- and middle-income countries (LMICs). This study evaluates its safety and feasibility in a porcine model.

Surgeons performed three laparoscopic tasks fundamental to the performance of laparoscopy, including stapled bowel resection, intracorporeal knot tying, and cholecystectomy in three pigs: a practice pig, KS, and standard-of-care (SOC). Vital signs, complications, and task completion times were compared using paired nonparametric tests. After completing laparoscopic tasks, surgeons completed a survey to assess feasibility and identify opportunities for technology improvement.

Five surgeons completed 45 laparoscopic tasks in 15 animals. There were no significant differences in vital signs between KS and SOC. There were no significant differences in median times to perform stapled bowel resection or cholecystectomy (KS 3 min, SOC 3 min, p = 0.185; KS 6 min, SOC 8 min, p = 0.887, respectively). Surgeons performed intracorporeal knot tying on SOC significantly faster than KS (KS 5 min, SOC 3 min, p = 0.012). All surgeons entered the gallbladder during dissection, with more liver bed injuries using the SOC compared to KS (n = 3, 60% vs. n = 2, 40%). Surgeons reported they would be willing to use the KS for laparoscopic procedures they do not routinely perform. When asked to rate the performance of KS versus SOC, there was a preference for KS in ergonomics and degree of fogging but a preference for SOC for light intensity, distance vision, and amount of focus. They felt KS and SOC performed similarly in glare, tissue color, and close vision. Surgeons reported a preference for the KS to an open approach.

In standardized porcine studies, KS performed similarly to the SOC with fewer complications, demonstrating both its feasibility and safety. Overall, surgeons reported comfort using the KS for laparoscopic cases. This data supports that KeyScope is a feasible tool to enable laparoscopy in LMICs.