Status:
RECRUITING
Modified Uniportal Periareolar Incision Versus Conventional Uniportal Video-assisted Thoracic Surgery for Pulmonary Nodules: Protocol for a Prospective, Randomized, Controlled Study
Lead Sponsor:
Fujian Medical University Union Hospital
Conditions:
Surgical Incision
Minimally Invasive Surgery
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Minimally invasive surgical techniques, including the uniportal approach, have become widely adopted in thoracic surgery. Both surgeons and patients aim to achieve incisions that are as minimally inva...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Male or female patients aged 18-75 years
- Good degree of movement of the areola (being able to move to the anterior axillary line)
- Meeting the criteria for thoracoscopic surgery, including lobectomy (expected absence of adhesions, well-developed interlobar fissure) and sublobectomy (including segmentectomy and wedge resection)
- No evidence of advanced lung cancer on preoperative evaluation
- No history of chemotherapy, immunotherapy, or radiotherapy
- ECOG performance status 0-1;
- Patients and their families agreed to participate in this study and signed a written informed consent form.
- Exclusion criteria:
- Patients had previously undergone pneumonectomy or preoperative chemotherapy and/or radiotherapy
- Previous breast surgery
- Risk of conversion to thoracotomy or changing the incision during the operation
- Poor preoperative lung function
- Presence of other cancers or other advanced diseases
- Preoperative pulmonary infection or uncontrolled acute pulmonary disease or acute exacerbation of chronic obstructive pulmonary disease
- Severe hypertension (resting systolic/diastolic blood pressure of \>180/100 mmHg), intracranial mass, or intracranial hypertension
- Recent brain injury, cerebral infarction, or cerebral hemorrhage
- Hyperthyroidism
- Previous history of angina pectoris, myocardial infarction, or heart failure
- History of thoracoscopic resection of mediastinal and pleura tumors
- 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
- Pregnant or lactating women
Exclusion
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT06202053
Start Date
January 1 2024
End Date
December 1 2025
Last Update
January 22 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001