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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
290
All patients : 145 patients Single-port anatomical pulmonary resection(segmentectomy, lobectomy) with a complete mediastinal lymph node dissection will be performed using the SP robotic system. A 4-cm single incision will be made below the subcostal margin. A chest tube will be inserted in same incision.
All patients : 145 patients Single-port anatomical pulmonary resection(segmentectomy, lobectomy) with a complete mediastinal lymph node dissection will be performed using the VATS. A 4-cm single incision will be made at 5th intercostal space. A chest tube will be inserted in same incision.
Postoperative complications
complications will be classified according to Clavien-Dindo classfication
Time frame: Postoperative complications : within 30 days after surgery
Questionnaires for HRQOL of life (EQ-5D-5L) at month 3
Questionnaires for HRQOL of life (EQ-5D-5L) will be administered at months 3.
Time frame: at month 3 after surgery
Questionnaires for HRQOL of life (EQ-VAS) at month 3
Questionnaires for HRQOL of life (EQ-5D-5L, EQ-VAS) will be administered at months 3.
Time frame: at month 3 after surgery
Postoperative pain
Pain levels were assessed and recorded using the VAS score more than three times daily during the hospitalization period.
Time frame: during hospitalization
Questionnaires for HRQOL of life (EQ-5D-5L)
Questionnaires for HRQOL of life (EQ-5D-5L, EQ-VAS) will be administered at 2 weeks before surgery, and at 1 month, 6 months, and 12 months, as well as at years 2, 3, 4, and 5 after surgery.
Time frame: At 2 weeks before surgery, and at 1 month, 6 months, and 12 months, as well as at years 2, 3, 4, and 5 after surgery.
Questionnaires for HRQOL of life (EQ-VAS)
Questionnaires for HRQOL of life (EQ-5D-5L, EQ-VAS) will be administered at 2 weeks before surgery, and at 1 month, 6 months, and 12 months, as well as at years 2, 3, 4, and 5 after surgery.
Time frame: At 2 weeks before surgery, and at 1 month, 6 months, and 12 months, as well as at years 2, 3, 4, and 5 after surgery.
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Questionnaires for HRQOL of life (LCQ)
Questionnaires for HRQOL of life (LCQ) will be administered at 1 month, 3 months, and 6 months after surgery.
Time frame: at 1 month, 3 months, and 6 months after surgery.
Perioperative outcomes (Conversion rate)
Conversion rate = conversion to open thoracotomy / total number of surgery
Time frame: during hospitalization
Perioperative outcomes (number of lymph nodes harvested)
Total number of lymph nodes harvested during the surgical procedure.
Time frame: during hospitalization
Perioperative outcomes (total operative time)
the time taken from skin incision to completion of skin closure
Time frame: during hospitalization
Perioperative outcomes (duration of chest tube drainage, postoperative hospital stays)
duration of chest tube drainage: the time from the date of the operation to the date of chest tube removal postoperative hospital stays: the time from the date of the operation to the date of discharge
Time frame: during hospitalization
Perioperative outcomes (transfusion rate)
The transfusion rate was defined as the percentage of patients who received an allogeneic blood transfusion within 30 days after surgery.
Time frame: within 30 days after surgery.
Perioperative outcomes (estimated blood loss )
estimated measurement of intraoperative blood loss (ml)
Time frame: during surgery
5-year overall survival and disease-free survival
Overall survival (OS) is defined as the time from randomization to death. Disease-free survival (DFS) is defined as the time from randomization to recurrence of tumor or death.
Time frame: 5 years