Single-POrt Robotic-assisted thoracic surgery versus single-port video-assisted Thoracic Surgery major pulmonary resection for patients with non-small cell lung cancer (SPORTS trial): a single-center, a single blinded, randomized controlled trial

Investigators initially began single-port robotic thoracic surgery using the SP robotic system for simple procedures, such as thymectomy and mediastinal mass excision. As their expertise grew, they expanded to more complex procedures, including major pulmonary resection and esophagectomy. However, the long-term outcomes of SP robotic anatomical pulmonary resection using the SP robotic system have not yet been studied.

The aim of this study is to compare the short-term and long-term outcomes of SP robotic anatomical pulmonary resection using the SP robotic system with those of single-port video-assisted thoracoscopic surgery (SP-VATS) anatomical pulmonary resection.

This trial is a single-center, single-blinded, randomized controlled trial. Participants will be randomized at a 1:1 ratio to either single-port video-assisted thoracoscopic surgery (SP-VATS) or single-port robotic thoracic surgery.

Inclusion Criteria:

• Candidate for anatomical pulmonary resection (segmentectomy or lobectomy) via minimally invasive thoracic surgery (RATS or VATS) for patient with non-small cell lung cancer or suspected malignant lesion.
• Age ≥ 18 years
• Patients who can comply with the requirements of the clinical trial and who, or their legal representatives, provide written consent before the start of the clinical trial
• Patients with the nationality of South Korea
• American Society of Anesthesiologists score 1-3.
• Clinical stage I, II or IIIa non-small cell lung cancer (NSCLC)

Exclusion Criteria:

• Patients who require surgery for accompanying other organ diseases
• Tumor invasion into the chest wall, diaphragm, another lobe or diaphragm
• Patients who are considered unsuitable based on the researcher's judgment
• Patients with cognitive impairments who are unable to understand the instructions and informed consent of this study
• Patients who specifically desire a certain surgical method (robotic, thoracoscopic, open thoracotomy)
• Patients who previously undergone a thoracic surgical procedure in the hemithorax to be operated on
• Pathological results other than NSCLC (ex, benign nodules, metastatic lung cancer, SCLC)
• Patients who received neoadjuvant therapy.
• Candidate for pneumonectomy, bilobectomy, lobectomy plus segmentectomy, non-anatomic resection (ex, wedge resection).
• History of other cancers in the past 5 years.

The principal investigator will explain the study at the time of consent for the surgery. Written consent will be obtained by the principal investigator or a sub-investigator. Once eligibility for surgery is confirmed, randomization will take place within 4 weeks prior to the surgery. Participants will be randomized in a 1:1 ratio to either SP-RATS or SP-VATS using a website software randomization system. While the surgeon will be informed of the group allocations, participants will remain unaware (maintaining a single-blind approach) until the completion of the follow-up period