Prospective single-arm study of gastric surgery in experimental animals assisted by Kangduo surgical robot.

OBJECTIVE

To investigate the feasibility, efficacy, and safety of gastric surgery in experimental animals assisted by the domestic Kangduo Surgical Robot 2000 (SR2000).

METHODS

Eight porcine models were prospectively enrolled between August and December 2023 at Harbin SAGEBOT Intelligent Medical Animal Experiment Center. Preoperative baseline characteristics, intraoperative physiological parameters, surgical procedure, and postoperative assessments and investigations were recorded to compare the feasibility, efficacy, and safety evaluation indexes of experimental animals in the perioperative period. The primary endpoint was surgical success rate. The secondary endpoints were operative workflow parameters, intraoperative blood loss, postoperative laboratory changes, perioperative adverse events, and surgeon workload assessed using the NASA-TLX instrument.

RESULTS

In eight experimental pig models, the SR2000 successfully assisted in the completion of partial gastrectomy. All surgeries were completed according to plan, with no intermediate open or intraoperative complications, and the perioperative survival rate of animals was 100%. The mean operation time of partial gastrectomy was 76.75 min (range: 50-105 min), and the positioning time was 6-17 min. Intraoperative bleeding was ≤5 ml in all the animals, and some animals showed elevated white blood cell counts and neutrophil counts (Neu) on the first day of the postoperative period. The liver and kidney function indexes (alanine aminotransferase, blood urea nitrogen, creatinine) were not significantly abnormal before and after surgery. The anastomosis healed well without complications such as infection and anastomotic fistula.

CONCLUSION

The feasibility, efficacy, and safety of the SR2000 were verified in animal experiments, and ergonomically optimized design have the potential for clinical dissemination.