Modified Uniportal Periareolar Incision Versus Conventional Uniportal Video-assisted Thoracic Surgery for Pulmonary Nodules: Protocol for a Prospective, Randomized, Controlled Study

Launched by FUJIAN MEDICAL UNIVERSITY UNION HOSPITAL · Jan 2, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how patients feel after having a specific type of lung surgery called uniportal video-assisted thoracoscopic surgery (VATS). This surgery is done through a small incision near the nipple and is less invasive than traditional methods, which can lead to less pain and a shorter hospital stay. The study aims to see how this approach affects the quality of life for patients with early-stage lung cancer who meet certain health criteria.

To participate in the trial, individuals need to be at least 18 years old, have a confirmed diagnosis of non-small cell lung cancer (NSCLC), and be suitable for thoracoscopic surgery. They should not have had any prior cancer treatments like chemotherapy or radiation. Participants will have the chance to share their experiences and health changes after the surgery, helping researchers understand the benefits of this innovative surgical technique. If you're considering this surgery and meet the eligibility requirements, this study could be an important opportunity to contribute to medical research and also gain insights into your recovery journey.

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • 1. Male or female patients aged 18-75 years
• • 2. Good degree of movement of the areola (being able to move to the anterior axillary line)
• • 3. Meeting the criteria for thoracoscopic surgery, including lobectomy (expected absence of adhesions, well-developed interlobar fissure) and sublobectomy (including segmentectomy and wedge resection)
• • 4. No evidence of advanced lung cancer on preoperative evaluation
• • 5. No history of chemotherapy, immunotherapy, or radiotherapy
• • 6. ECOG performance status 0-1;
• • 7. Patients and their families agreed to participate in this study and signed a written informed consent form.
• Exclusion criteria:
• • 1. Patients had previously undergone pneumonectomy or preoperative chemotherapy and/or radiotherapy
• • 2. Previous breast surgery
• • 3. Risk of conversion to thoracotomy or changing the incision during the operation
• • 4. Poor preoperative lung function
• • 5. Presence of other cancers or other advanced diseases
• • 6. Preoperative pulmonary infection or uncontrolled acute pulmonary disease or acute exacerbation of chronic obstructive pulmonary disease
• • 7. Severe hypertension (resting systolic/diastolic blood pressure of \>180/100 mmHg), intracranial mass, or intracranial hypertension
• • 8. Recent brain injury, cerebral infarction, or cerebral hemorrhage
• • 9. Hyperthyroidism
• • 10. Previous history of angina pectoris, myocardial infarction, or heart failure
• • 11. History of thoracoscopic resection of mediastinal and pleura tumors
• • 12. Central nervous system disease; mental or neurological diseases, cognitive or language dysfunction due to which the patient was unable to cooperate with the follow-up
• • 13. Pregnant or lactating women