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

John H Marks; Deborah S Keller; Jorge A Lagares-Garcia; Henry P Schoonyoung; Shane M Farritor; Dmitry Oleynikov; Michael A Jobst

doi:10.1097/DCR.0000000000003249

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

Dis Colon Rectum. 2024 Apr 23. doi: 10.1097/DCR.0000000000003249. Online ahead of print.

Authors

John H Marks¹, Deborah S Keller¹, Jorge A Lagares-Garcia², Henry P Schoonyoung³, Shane M Farritor⁴, Dmitry Oleynikov⁵, Michael A Jobst⁶

Affiliations

¹ Lankenau Medical Center and Lankenau Institute for Medical Research, Wynnewood, Pennsylvania.
² Roper St. Francis Health Alliance, Charleston, South Carolina.
³ Lankenau Medical Center, Wynnewood, Pennsylvania.
⁴ Department of Mechanical Engineering, University of Nebraska, Lincoln, Nebraska.
⁵ Monmouth Medical Center Robert Wood Johnson and Barnabas Health, Long Branch, New Jersey.
⁶ Bryan Medical Center, Lincoln, Nebraska.

PMID: 38653496
DOI: 10.1097/DCR.0000000000003249

Abstract

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.