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

Area of Science:

• Minimally Invasive Surgery
• Robotic Surgery
• Gastrointestinal Surgery

Background:

• Robotic-assisted cholecystectomy access is limited by robot availability and cost.
• The DEXTER® system offers a compact, mobile, and cost-effective robotic alternative.
• The system is designed for user-friendliness and integration into surgical workflows.

Purpose of the Study:

• To confirm the safety and performance of robotic-assisted cholecystectomy using the DEXTER® system.
• To evaluate the system's efficacy in a multi-center, multi-national prospective study.

Main Methods:

• Prospective study involving six surgeons across four centers in three countries.
• Primary objectives: successful completion without conversion and absence of serious adverse events (Clavien-Dindo grade ≥ III) within 30 days.
• Secondary endpoints: surgical performance metrics including operative time.

Main Results:

• 51 patients underwent robotic-assisted cholecystectomy for various gallbladder conditions.
• All procedures were completed successfully with no device deficiencies or conversions.
• Median operative time was 58 minutes; median estimated blood loss was 5 mL.
• One Clavien-Dindo grade IIIa event occurred, resolved without reoperation.
• 51% of patients were discharged within 24 hours.

Conclusions:

• The DEXTER® system enables safe and effective cholecystectomy.
• The system is suitable for non-emergent procedures, including outpatient settings.