the First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120, China
Location status: Recruiting
NCT Number: NCT07065604
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Guangzhou, Guangdong, 510120, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Non-intubated VATS for mediastinal neoplasm
Intubated VATS for mediastinal neoplasm
Time frame: postoperative in-hospital stay up to 30 days
Proportion of patients requiring conversion from VATS to open surgery.
Time frame: postoperative in-hospital stay up to 30 days
Proportion of patients requiring conversion from non-intubated approach to intubated anesthesia
Time frame: postoperative in-hospital stay up to 30 days
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 resection rate
Time frame: postoperative in-hospital stay up to 30 days
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
The volume of bleeding during the surgery.
Time frame: postoperative in-hospital stay up to 30 days
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, 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, measured from the end of surgery until drain removal.
Time frame: 1 year after surgery
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), 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: Quality of life (QOL) at 3 months post-discharge, as measured by [specify QOL scale], reflecting patient-reported physical, emotional, and social well-being.
3 months after discharge
Contact information is provided by the study sponsor or research team.
Shuben Li
Other
A Randomized Controlled Trial of Non-intubated Versus Intubated VATS for Mediastinal Neoplasm
Acronym: NOVA-02
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.
Published trials that share one or more normalized conditions with this study.
NCT05672108
Bronchial Neoplasms, Carcinoma, Bronchogenic
Duarte, California, United States
View Trial DetailsNCT07646288
Bronchial Neoplasms, Carcinoma, Bronchogenic
Ankara, Altındağ, Turkey (Türkiye)
View Trial DetailsNCT07577908
Intercostal Nerve Block, Post-operative Pain Management
İzmit, Turkey (Türkiye)
View Trial DetailsNCT06838039
Neurologic Manifestations, Pain
Hebron, Palestinian Territories
View Trial Details