Efficacy and Safety Analysis of Single‐Port Robotic Assisted Cholecystectomy Using a Novel Surgical Platform: A Bicentre, Single‐Arm, Prospective Phase II Clinical Study
Prospective phase II trial demonstrates high feasibility and low morbidity with single-port robotic cholecystectomy, highlighting effective minimally invasive gallbladder removal.
Key Points
To evaluate the feasibility, surgical efficacy, and safety profile of the novel MicroPort SA-1000 single-port robotic platform during cholecystectomy.
Conducted a prospective, dual-centre, single-arm phase II clinical trial (ChiCTR2500107401) enrolling 44 eligible patients between June 2023 and December 2023.
Evaluated the primary endpoint of surgical completion rate alongside secondary outcomes including estimated blood loss, operative time, hospital length of stay, and postoperative complications.
All 44 patients successfully completed single-port robot-assisted cholecystectomy without conversion to open or multi-port surgery (100% completion rate).
Patients achieved a median estimated blood loss of 10 mL (range 5–200 mL), a mean operative time of 88.43 ± 25.87 minutes, and a median hospital stay of 2.5 days (range 1–7 days).
No serious surgery-related adverse events were documented throughout the trial.