In recent year, non-intubated anesthesia had emerged as an available and promising alternative for thoracic procedure. However, its safety and feasibility in video-assisted thoracoscopic surgery (VATS) for mediastinal neoplasm remain controversial. This randomized controlled trial is designed to evaluate the impact of the non-intubated approach on surgical and perioperative outcomes in patients undergoing mediastinal neoplasm resection.
Non-intubated anesthesia has gained widespread adoption in recent years, representing a significant advancement in both thoracic surgery and anesthetic practice. The surgical safety and feasibility of tubeless VATS for mediastinal neoplasm has been confirmed. However, the oncological long-term outcomes of RATS lobectomy has not been studied by randomized controlled trial. Accordingly, this randomized controlled trial aims to evaluate whether the non-intubated approach provides comparable short-term and long-term outcomes to the conventional intubated technique in VATS for mediastinal neoplasm resection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
132
Non-intubated VATS for mediastinal neoplasm
Intubated VATS for mediastinal neoplasm
the First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGConversion rate to open surgery
Proportion of patients requiring conversion from VATS to open surgery.
Time frame: postoperative in-hospital stay up to 30 days
Conversion rate to intubated anesthesia
Proportion of patients requiring conversion from non-intubated approach to intubated anesthesia
Time frame: postoperative in-hospital stay up to 30 days
Postoperative complication rate
Incidence and severity of treatment-related adverse events, classified by Clavien-Dindo for surgical complications and CTCAE v5.0 for systemic adverse events.
Time frame: postoperative in-hospital stay up to 30 days
R0 rate
R0 resection rate
Time frame: postoperative in-hospital stay up to 30 days
Operation time
Operative time was defined as the time between the start of the surgery (incision) and the finish of surgery (closure of the skin).
Time frame: postoperative in-hospital stay up to 30 days
Intraoperative bleeding loss
The volume of bleeding during the surgery.
Time frame: postoperative in-hospital stay up to 30 days
ICU stay
ICU stay (in days), defined as the duration from ICU admission post-surgery to ICU discharge.
Time frame: postoperative in-hospital stay up to 30 days
Hospital stay
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Hospital stay, defined as the duration from the day of surgery to the day of discharge.
Time frame: postoperative in-hospital stay up to 30 days
Volume of postoperative drainage
Volume of postoperative drainage, measured from the end of surgery until drain removal.
Time frame: postoperative in-hospital stay up to 30 days
1-year disease-free survival (DFS)
1-year disease-free survival (DFS), defined as the percentage of patients alive without evidence of tumor recurrence or progression at 12 months.
Time frame: 1 year after surgery
1-year overall survival(OS)
1-year overall survival(OS), defined as the percentage of patients alive at 12 months from the date of surgery or treatment initiation, irrespective of disease recurrence or progression.
Time frame: 1 year after surgery
Quality of life (QOL) at 3 month
3 months after discharge
Time frame: Quality of life (QOL) at 3 months post-discharge, as measured by [specify QOL scale], reflecting patient-reported physical, emotional, and social well-being.