Robot-assisted single-site compared with laparoscopic single-incision cholecystectomy for benign gallbladder disease: results of a single-blinded randomized controlled trial

Abstract

Background: Recent advances in robotic technology suggest that da Vinci Single-Site cholecystectomy (dVSSC) is safe, feasible and reduces the stress load of the surgeon compared to single-incision laparoscopic cholecystectomy (SILC). However, evidence needed to objectively assess differences based on high-quality comparative data is lacking to date. Methods: This single centre, single-blinded controlled trial included 60 patients with benign gallbladder disease randomly assigned to dVSSC (n=30) or SILC (n=30). The primary endpoint surgeon's physical and mental stress load was assessed using the validated Local Experienced Discomfort (LED) and Subjective Mental Effort Questionnaires (SMEQ). Secondary endpoints included operating time, conversion rates, additional trocar placement, intra-operative blood loss, length of hospital stay, procedure costs, health-related quality of life, cosmesis and complications. Patients and ward staff were blinded until 12 months postoperatively. Results: The dVSSC-group showed a significant reduction of mental stress load of the surgeon compared to SILC (SMEQ: median 25.0 vs. 42.5 points; p=0.002) and a trend toward reduced physical stress load (LED: median 8 vs. 12 points; p=0.088). The rate of postoperative complications that required a re-intervention (Dindo-Clavien grade≥IIIa) was similar in both groups (SILC n=2 vs dVSSC n=0, p=0.492). The length of stay was longer in the SILC group (3.06 vs 1.9 days, p=0.034) but overall hospital costs were higher for dVSSC (9831 vs. 6900 CHF; p=0.001). Conclusions: dVSSC provides significant benefits over SILC in terms of surgeon's stress load, matches the standards of the laparoscopic single-incision approach with regard to patients' outcomes but increases overall expenses. Clinicaltrials.gov trial-no: NCT02485392.