Robot-assisted versus laparoscopic single-incision cholecystectomy: results of a randomized controlled trial.

Grochola, Lukasz Filip; Soll, Christopher; Zehnder, Adrian; Wyss, Roland; Herzog, Pascal; Breitenstein, Stefan

BACKGROUND Although single-port laparoscopic cholecystectomy (SILC) is safe and effective, inherent surgeons' discomfort has prevented a large-scale adaptation of this technique. Recent advances in robotic technology suggest that da Vinci Single-Site™ cholecystectomy (dVSSC) may overcome this issue by reducing the stress load of the surgeon compared to SILC. However, evidence to objectively assess differences between the two approaches is lacking. METHODS 60 patients [36 women, 24 men (mean age 52 years)] with benign gallbladder disease were randomly assigned to dVSSC (n = 30) or SILC (n = 30) in this single-centre, single-blinded controlled trial. The primary endpoint was surgeon's stress load. Secondary endpoints included operating time, conversion rates, additional trocar placement, blood loss, length of hospital stay, procedure costs, health-related quality of life, cosmesis and complications. Data were collected preoperatively, during the hospital stay, and at 1 and 12 months' follow-up. RESULTS The dVSSC group showed a significant reduction of mental stress load of the surgeon compared to SILC [Subjective Mental Effort Questionnaire (SMEQ) score: median 25.0 (range 8-89) vs. 42.5 (range 13-110) points; p = 0.002] and a trend towards reduced physical stress load [Local Experienced Discomfort (LED) score: median 8 (range 2-27) vs. 12 (range 0-64) points; p = 0.088]. The length of hospital stay was longer in the SILC group [mean 3.06 (median 2; range 1-26) vs. 1.9 (median 2; range 1-4) days, p = 0.034] but overall hospital costs were higher for dVSSC [median 9734 (range 5775-16729) vs. 6900 (range 4156-99977) CHF; p = 0.001]. There were no differences in the rate of postoperative complications that required re-intervention (Dindo-Clavien grade ≥ IIIa; SILC n = 2 vs. dVSSC n = 0, p = 0.492) or other secondary endpoints. CONCLUSIONS Da Vinci Single-Site™ cholecystectomy provides significant benefits over Single-Port Laparoscopic Cholecystectomy in terms of surgeon's stress load, matches the standards of the laparoscopic single-incision approach with regard to patients' outcomes but increases expenses. Clinicaltrials.gov registration-No.: NCT02485392.