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SP Robotic Versus VATS Anatomical Pulmonary Resection for Patients With NSCLC

ConditionsRoboticsLung Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKorea University Guro Hospital

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Single-port robotic-assisted thoracic surgery

    Procedure/Surgery

    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.

  • Single-port video-assisted thoracoscopic surgery

    Procedure/Surgery

    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.

Treatment groups

290 Participants
are divided into 2 treatment groups
Group A: SP-RATSActive comparator 1 intervention
Group B: SP-VATSPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative complications

complications will be classified according to Clavien-Dindo classfication

Time frame
Postoperative complications : within 30 days after surgery
2

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
3

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
4

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

Secondary outcomes

1

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.
2

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.
3

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.
4

Perioperative outcomes (Conversion rate)

Conversion rate = conversion to open thoracotomy / total number of surgery

Time frame
during hospitalization

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Korea University Guro Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: