Robotic-assisted cholecystectomy with DEXTER®: the first prospective multicenter study.

Introduction: Despite advancements in minimally invasive surgery, access to robotic-assisted cholecystectomy remains limited, largely due to robot availability and high costs for this procedure. The DEXTER^® Robotic Surgery System offers a small, mobile, and cost-effective alternative designed for ease of use and seamless integration into routine surgical workflows. The present study aimed to confirm the safety and performance of robotic-assisted cholecystectomy using DEXTER^®.

Methods: A prospective study of robotic-assisted cholecystectomy was conducted by six surgeons across four centers in three countries. The primary objectives were to document the successful completion of the surgeries without conversion to laparoscopic or open surgery and the occurrence of serious adverse events (Clavien-Dindo grade ≥ III) up to 30 days post-surgery. Secondary endpoints included surgical performance metrics such as operative time.

Results: A total of 51 patients underwent surgical intervention for the management of symptomatic Cholecystolithiasis, Cholecystitis, choledocholithiasis, and biliary pancreatitis. The median patient age was 59 years (IQR 42-65), and BMI was 28.0 kg/m² (IQR 24.9-29.6). All procedures were completed successfully without device deficiencies or conversions to open surgery. The median operative time was 58 min (IQR 49-78), including a median docking time of 3 min (IQR 2-5) and a median console time of 25 min (IQR 21-36). The median estimated blood loss was 5 mL (IQR 0-10) and no blood transfusions were required. One Clavien-Dindo grade IIIa event occurred in one patient requiring an ERCP for postoperative Choledocholithiasis, which was resolved without the need for reoperation. 26 patients (51%) were discharged within 24 h of the surgery.

Conclusion: This study confirmed that DEXTER^® enables safe and effective cholecystectomy in a non-emergent setting, including in outpatient sites of care.