Safety and Efficacy of a Novel Miniaturized Robotic Assisted Surgery System in Colectomy: A Prospective, Investigational Device Exemption Clinical Study Using the IDEAL Framework.

BACKGROUND:Robotics has increased rates of minimally invasive surgery, with distinct advantages over open surgery. However, current commercially available robotic platforms have device and system issues that limit robot-assisted surgery expansion. OBJECTIVE:To demonstrate the safety and efficacy of a novel miniaturized robotic assisted surgery device in colectomy. DESIGN:Prospective, Investigational Device Exemption clinical study following the idea, development, exploration, assessment, and long-term follow-up (IDEAL) framework (Stage 2b, exploration). SETTINGS:Three centers with high-volume robotic colorectal cases and surgeons. PATIENTS:Patients scheduled for a right or left colectomy for benign or malignant disease. INTERVENTION:Colectomy with the novel miniaturized robotic assisted surgery device. MAIN OUTCOME MEASURES:For safety, intraoperative and device-related adverse events and 30-day morbidity. For efficacy, successful completion of pre-defined procedural steps without conversion. RESULTS:Thirty patients (13 female, 17 male) were analyzed. The mean age was 59.4 (SD 13.4) years. Seventy percent (n = 21) were overweight/obese and 53.3% (n = 16) had prior abdominal surgery. Forty percent had malignant and 60% benign disease. Cases were 15 right and 15 left colectomies. Overall operative time was median 146 (range, 80-309) minutes; 70 (range, 34-174) minutes was console time. There were no conversions to open surgery, and no intraoperative or device-related adverse events. In 100% (n = 30), the primary dissection was completed, and hemostasis maintained with the novel miniaturized robotic assisted surgery device. The morbidity rate was 26.7% minor and 3.3% major. The median length of stay was 2 days. There were no mortalities. LIMITATIONS:Single arm study, short-term follow-up. CONCLUSIONS:This first clinical study of a novel miniaturized robotic-assisted surgery device along the IDEAL framework demonstrated it was safe and effective. Given this success, further assessment and long-term follow-up of the miniaturized robotic assisted surgery device are planned for comparative clinical and economic effectiveness in colorectal surgery. See Video.