Robot-assisted lobectomy
ProcedurePatients will receive robot-assisted lobectomy using Da Vinci surgical system
NCT Number: NCT06524427
Video-assisted thoracic surgery (VATS) has been recommended by clinical guidelines as one of the preferred surgeries for early-stage non-small cell lung cancer (NSCLC) for many years. However, VATS has inherent drawbacks, so at the beginning of this century, robotic-assisted thoracoscopic surgery (RATS) was first applied for lung resection. In recent years, RATS has developed rapidly, but there are still many unsolved scientific problems in the field of RATS. Thus, a multicenter prospective randomized controlled trial was conducted with stage I-II NSCLC patients as the study subject and 5-year DFS as the primary endpoint to compare the short-term and long-term outcomes of RATS and VATS in the treatment of early-stage NSCLC.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing Municipality, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will receive robot-assisted lobectomy using Da Vinci surgical system
Patients will receive video-assisted lobectomy
Time frame: 5 years after surgery
Difference of 5-year disease free survival rate between the two groups
Time frame: 5 years after surgery
Difference of 5-year overall survival rate between the two groups
Time frame: 3 years after surgery
Difference of 3-year disease free survival rate between the two groups
Time frame: 3 years after surgery
Difference of 3-year overall survival rate between the two groups
Time frame: During the surgery
Blood loss during the surgery
Time frame: During the surgery
The number of patients converted to thoracotomy divided by the total number of included patients in a group
Time frame: The day of surgery, 2/4/8/12/26/52 weeks after surgery
Intraoperative and postoperative complications
Time frame: 30/90 days after surgery
The number of patients died within 30/90 days after surgery divided by the total number of included patients in a group
Time frame: Between the date of surgery and the date of discharge, assessed up to 30 days
The length of stay in hospital after surgery
Time frame: Scores were given daily after surgery and at weeks 2/4/8/12/26/52 after discharge
The degree of pain after surgery was measured using Numerical Rating Scale (NRS). The patient is asked to make three pain ratings, corresponding to current, best and worst pain experienced over the past 24 hours on a scale of 0 (no pain) to 10 (worst pain imaginable). The average of the 3 ratings was used to represent the patient's level of pain over the previous 24 hours.
Time frame: Postoperative in-hospital stay up to 30 days
The number of patients received R0 surgery divided by the total number of included patients in a group
Time frame: During the surgery
The total time from skin to skin and the time of each step were recorded
Time frame: Postoperative in-hospital stay up to 30 days
The number of resected lymph nodes were calculated according to the official pathological report after surgery
Time frame: Postoperative in-hospital stay up to 30 days
The number of days between the date of surgery and the date of chest tube removal
Time frame: Postoperative in-hospital stay up to 30 days
The total amount of morphine used by the patient during the postoperative hospital stay, including morphine, pethidine, and fentanyl etc.
Time frame: From the date of admission to the date of discharge, assessed up to 30 days
The total cost of the patient from admission to discharge
Contact information is provided by the study sponsor or research team.
Hao-Xian Yang, M.D.
CONTACT
Mu-Zi Yang, M.D.
CONTACT
Sun Yat-sen University
Other
Robot-Assisted Versus Video-Assisted Lobectomy for Non-Small Cell Lung Cancer (RAVAR): A Multicenter, Open-Label, Randomized, Non-Inferiority Trial
Acronym: RAVAR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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