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| Name | Class |
|---|---|
| The First Affiliated Hospital of Guangzhou Medical University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-intubated group | Experimental | Patients received tubeless VATS for mediastinal neoplasm |
|
| Intubated group | Active Comparator | Patients received VATS mediastinal neoplasm resection under intubated general anesthesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-intubated VATS for mediastinal neoplasm | Procedure | Non-intubated VATS for mediastinal neoplasm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Conversion rate to open surgery | Proportion of patients requiring conversion from VATS to open surgery. | 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 | 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. | postoperative in-hospital stay up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| R0 rate | R0 resection rate | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuben Li, Deputy Director | Contact | 86(020) 8306 2114 | 13500030280@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | 510120 | China |
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| ID | Term |
|---|---|
| D008479 | Mediastinal Neoplasms |
| ID | Term |
|---|---|
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008477 | Mediastinal Diseases |
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| Intubated VATS for mediastinal neoplasm | Procedure | Intubated VATS for mediastinal neoplasm |
|
| postoperative in-hospital stay up to 30 days |
| Intraoperative bleeding loss | The volume of bleeding during the surgery. | 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. | postoperative in-hospital stay up to 30 days |
| Hospital stay | Hospital stay, defined as the duration from the day of surgery to the day of discharge. | 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. | 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. | 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. | 1 year after surgery |
| Quality of life (QOL) at 3 month | 3 months after discharge | Quality of life (QOL) at 3 months post-discharge, as measured by [specify QOL scale], reflecting patient-reported physical, emotional, and social well-being. |
| D013896 |
| Thoracic Diseases |
| D012140 | Respiratory Tract Diseases |