This study compares two established robotic surgical approaches for removing lung tumors in adults with non-small cell lung cancer: biportal robotic-assisted thoracic surgery (biRATS) and multiportal robotic-assisted thoracic surgery (multiRATS). Participants are assigned at random to one of the two approaches. The study will compare surgical safety, recovery after surgery, pain, length of hospital stay, quality of life, and other clinical outcomes during 12 months of follow-up.
Robotic-assisted thoracic surgery is widely used for pulmonary resection in patients with resectable non-small cell lung cancer. Multiportal RATS uses several access ports. Biportal RATS uses two access incisions and aims to preserve minimally invasive benefits while improving ergonomic access and instrument maneuverability. This single-center, prospective, randomized, partially blinded clinical trial will compare biRATS with multiRATS in adults undergoing pulmonary resection with curative intent at Hospital Universitari de Bellvitge. Eligible participants who provide written informed consent will be randomly assigned using the study REDCap randomization system. A standardized dressing will be maintained for 48 hours after surgery to support partial blinding. The main analysis will compare intraoperative and immediate postoperative complications between groups. Additional assessments include intraoperative blood loss, conversion, chest-drain duration, hospital length of stay, postoperative pain, readmission, mortality, and health-related quality of life. Quality of life will be assessed using EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13; pain will be measured with a visual analogue scale and DN4 questionnaire. Follow-up occurs during hospitalization and at 1, 6, and 12 months after surgery. The planned sample is 70 to 80 participants (approximately 35 per group). The study is investigator initiated and has CEIm approval (PR208/24; protocol version 3.0 dated June 18, 2025).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Pulmonary resection performed with a biportal robotic-assisted thoracic surgery approach using two access incisions.
Pulmonary resection performed with a multiportal robotic-assisted thoracic surgery approach using multiple access ports.
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
RECRUITINGIncidence of Intraoperative and Immediate Postoperative Complications
Proportion of participants with intraoperative or immediate postoperative complications, classified by Clavien-Dindo grade. Events include, among others, prolonged air leak, pleuropulmonary infection, pneumothorax, postoperative hemorrhage, chylothorax, respiratory failure, wound infection, readmission, and perioperative death.
Time frame: From surgery through hospital discharge, up to 30 days
Intraoperative Blood Loss
Estimated intraoperative blood loss in milliliters.
Time frame: During surgery
Length of Hospital Stay
Number of days from surgery to medical discharge.
Time frame: From surgery through hospital discharge, up to 30 days
Postoperative Pain Intensity (Visual Analog Scale)
Pain intensity measured using the Visual Analog Scale (VAS), a 0 to 10 scale, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain.
Time frame: From baseline through 12 months after surgery
Neuropathic Pain (Douleur Neuropathique 4 Questionnaire)
Neuropathic pain assessed using the Douleur Neuropathique 4 (DN4) questionnaire, scored from 0 to 10. Scores of 4 or higher are consistent with neuropathic pain; higher scores indicate a greater likelihood of neuropathic pain.
Time frame: From baseline through 12 months after surgery
Health Status (EuroQol 5-Dimension 5-Level Questionnaire)
Health status assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) descriptive system. Five dimensions are each rated from 1 (no problems) to 5 (extreme problems); lower levels indicate better health status.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Enrollment
80
Time frame: From baseline through 12 months after surgery
Global Health Status/Quality of Life (EORTC QLQ-C30)
Global health status/quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) global health status/QoL scale, transformed to a 0 to 100 score; higher scores indicate better global health status/quality of life.
Time frame: From baseline through 12 months after surgery
Patient-Reported Lung Cancer Symptoms (EORTC QLQ-LC13)
Lung cancer-related symptoms assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13). Symptom scores are transformed to 0 to 100; higher scores indicate greater symptom burden.
Time frame: From baseline through 12 months after surgery
Postoperative Healthcare Procedures
Number of additional medical procedures required during the index hospitalization, including chest-drain management interventions.
Time frame: From surgery through hospital discharge, up to 30 days