HTA of NIVATS Based on RWE
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Lung Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Health Technology Assessment of Pulmonary Nodules Using Non-intubated Video-assisted Thoracic Surgery Based on the Real-world Evidence
Overview
This research focuses on a Health Technology Assessment (HTA) of non-intubated video-assisted thoracic surgery (VATS) for lung nodules. Lung cancer, one of the most prevalent malignancies globally, has a high incidence and mortality rate, particularly in China. Traditional treatments like thoracotomy are highly invasive, while conventional thoracoscopic surgery can induce anesthesia-related complications. Non-intubated VATS offers a promising alternative by avoiding intubation and mechanical ventilation, thus reducing complications, anesthesia burden, and recovery time. The study aims to comprehensively assess the clinical effectiveness, safety, and economic viability of non-intubated VATS for lung cancer treatment through systematic literature reviews, real-world evidence (RWE), and cost-effectiveness analysis. The research will also explore patient preferences using discrete choice experiments (DCE). By evaluating this technology from a Chinese perspective, the study seeks to provide evidence-based recommendations for the broader adoption of non-intubated VATS in clinical settings.
Primary outcome measures
- Patient-reported Outcomes [Time frame: Measured within 3 days post-surgery]
- Postoperative hospitalization time [Time frame: Measured in days from surgery completion to hospital discharge.]
Eligibility criteria
Inclusion criteria
\- Experimental Group (Non-intubated Video-assisted Thoracic Surgery)：
- Patients diagnosed with pulmonary nodules or lung cancer who are scheduled for minimally invasive surgery (including wedge resection, segmentectomy, or lobectomy).
- Aged between 18 and 75 years, regardless of gender.
- Preoperative assessment indicates that the patient can tolerate non-intubated video-assisted thoracic surgery.
- The patient has signed an informed consent form and voluntarily agrees to participate in the study.
Control Group (Intubated Video-assisted Thoracic Surgery)：
- Patients diagnosed with pulmonary nodules or lung cancer who are scheduled for minimally invasive surgery (including wedge resection, segmentectomy, or lobectomy).
- Aged between 18 and 75 years, regardless of gender.
- Preoperative assessment indicates that the patient can tolerate minimally invasive surgery.
- The patient has signed an informed consent form and voluntarily agrees to participate in the study.
Exclusion criteria
- Patients unable to provide sufficient preoperative and postoperative follow-up data.
- Pregnant or breastfeeding women.
- Patients with severe cardiopulmonary dysfunction preoperatively, making them unfit for surgery.
- Patients who have previously undergone surgery or radiotherapy in the same chest region.
- Patients with active infections or other severe comorbidities that may affect surgical outcomes.
- Patients with mental illness or cognitive impairment who cannot understand the study content or comply with follow-up requirements.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- School of Public Health, Fudan University — Shanghai
Identifiers
NCT: NCT06574295 · FudanU-2024-07-1145