Comparison of valve-less and standard insufflation on pneumoperitoneum-related complications in robotic partial nephrectomy: a prospective randomized trial

To prospectively compare standard and valve-less insufflation systems on pneumoperitoneum-related complications in robotic-assisted laparoscopic partial nephrectomy. A prospective randomized controlled trial was conducted during a 1.5-year period to compare insufflation-related complications in partial nephrectomy surgery by a single surgeon. Thirty-one patients were recruited for each group: AirSeal insufflation system at 12 mmHg (AIS12), AirSeal at 15 mmHg (AIS15), and conventional insufflation system at 15 mmHg (CIS). Primary outcome assessed was rate of subcutaneous emphysema. Secondary outcomes included rates of pneumothorax, pneumomediastinum, shoulder pain scores, overall pain scores, pain medication usage, insufflation time, recovery room time, length of hospital stay and impact of surgical approach. Predictors for subcutaneous emphysema were assessed with univariate and multivariate logistic models. 93 patients with similar baseline characteristics were randomized into the three insufflation groups. Incidence of subcutaneous emphysema was lower in the AIS12 group compared to CIS (19% vs 48%, p = 0.03,). Mean pain score was less for AIS12 compared to CIS at 12 h (3.1 vs 4.4, p = 0.03). Shoulder pain was less in AIS12 and AIS15 groups compared to CIS at 8 h (AIS12 vs CIS: 0.6 vs 1.6, p = 0.01, AIS15 vs CIS: 0.6 vs 1.6, p = 0.02), and between AIS12 as compared to CIS at 12 h (0.4 vs 1.4, p = 0.003) postoperatively. There was no difference between morphine equivalent use, insufflation time, recovery room time, and length of hospital stay. Multivariable regression analysis showed AirSeal at 12 mmHg and the transperitoneal approach to be the only significant predictors for lower risk of developing subcutaneous emphysema (p < 0.001). Compared to standard insufflation, AirSeal insufflation at 12 mmHg was associated with reduced risk of developing subcutaneous emphysema in robotic partial nephrectomy. Furthermore, shoulder pain was reduced in both AirSeal groups compared to standard insufflation. The retroperitoneal approach increases the risk of developing subcutaneous emphysema.