Minimally invasive lung surgery with an intraoperative completely or partially tubeless protocol: randomized clinical trial.

Background: Thoracic surgery is an invasive procedure and there has been a move towards minimally invasive approaches. This includes video-assisted thoracoscopic surgery. Non-intubated video-assisted thoracoscopic surgery without endotracheal intubation has been developed with a view to avoiding complications associated with intubation including tracheal injury, vocal cord injury and lung impairment due to mechanical ventilation. This study aims to compare outcomes from non-intubated 'completely tubeless' versus intubated 'partially tubeless' minimally invasive thoracic surgery.

Methods: A single-institution, prospective randomized clinical trial was conducted comparing patients who underwent minimally invasive lung completely tubeless versus partially tubeless surgery, both with enhanced recovery. The primary outcome was the short-term postoperative complication rate. Binary logistic regression analysis was performed to determine the significant predictors of severe mediastinal shift and receiver operating characteristic (ROC) curve plots were drawn.

Results: Among the 348 patients, 174 patients were assigned to the completely tubeless group and 174 patients were assigned to the partially tubeless group. There was no difference in postoperative complications including pulmonary complications, supraventricular arrhythmia, acute myocardial infarction, acute cerebral stroke, venous thromboembolism and urinary retention. The completely tubeless protocol was associated with a higher proportion of early mobilization (66.7% versus 55.7%, P = 0.047), a shorter median duration of drainage (1.0 versus 2.0 days, P = 0.002), and a shorter median duration of postoperative hospital stay (2.0 versus 3.0 days, P = 0.001). The completely tubeless group had less of a difference in white blood cell count before and after the operation (P = 0.042). Binary logistic regression analysis revealed that weight was a significant predictor of mediastinal shift in the completely tubeless group.

Conclusion: Under enhanced recovery after surgery protocols, there is no difference in postoperative complications in patients undergoing completely or partially tubeless surgery. However, patients having completely tubeless surgery have shorter durations of postoperative drainage, shorter durations of hospital stay, milder systemic inflammatory reactions, and better immune protection than patients who undergo lung resection with a partially tubeless protocol. The severity of mediastinal shift may be mainly related to body-weight.

Registration number: NCT05269784 (http://www.clinicaltrials.gov).