Related Experiment Video
Updated: Jan 1, 2026
Single-Port Robotic-assisted Transaxillary Breast-conserving Surgery: A Prospective, Single-arm, Non-randomized Phase IIa Clinical Trial
Published on: August 19, 2025
A prospective, randomized controlled study of the safety and efficacy of gasless bilateral axillo-breast approach
Ik Beom Shin1, Do Hoon Koo1,2, Myoung Jin Ko3
1Department of Surgery, Haeundae Paik Hospital, Inje University College of Medicine, 875 Haeundae-ro, Haeundae-gu, Busan, 612-030, South Korea.
Background:
During bilateral axillo-breast approach (BABA) robotic thyroidectomy (RoT), carbon dioxide (CO2) gas is insufflated into the operative cavity, not only triggering hemodynamic and metabolic changes, but also inducing postoperative pain and gas embolism. Here, we explored whether the new gasless BABA RoT approach was as safe and efficacious as conventional robotic surgery using CO2 insufflation.
Patients And Methods:
We performed a prospective, randomized controlled trial comparing conventional BABA RoT to gasless BABA RoT (CO2 group, n = 14; gasless group, n = 14). All clinicopathological and oncological outcomes were evaluated. The hemodynamic parameters [heart rate (HR), mean arterial pressure (MAP), cardiac output (CO), and cardiac index (CI)] and metabolic parameters [partial pressure of carbon dioxide (PaCO2) and pH] were measured at baseline; 30, 60, 90, and 120 min after CO2 insufflation; and 30 min after desufflation. Pain parameters [numeric rating scale (NRS) score, number of analgesics (NA), and bottom hit count (BHC)] were measured at 2, 24, 48, and 72 h after surgery.
Results:
We found no statistically significant differences between the two groups in terms of any demographic or baseline characteristic. The clinicopathological and oncological outcomes did not differ significantly between the two groups, but the operation time was longer for the gasless group (187.50 ± 42.64 vs. 212.50 ± 35.88 min; P = 0.028). In terms of the hemodynamic, metabolic, and pain parameters, the pH fell significantly less in the gasless group (P = 0.047), but there were no significant between-group differences in the HR, MAP, CO, CI, PaCO2, NRS, NA, or BHC. No safety concerns arose.
Conclusion:
The new, gasless BABA RoT technique employing the da Vinci robotic surgical system is safe. Although metabolic changes during operation are thereby minimized, gasless BABA RoT should be used carefully when engaging in thyroid surgery; more experience is required.
