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Periareolar incision versus conventional incision for VATS lung resection: A multicentre randomised controlled trial

Subcutaneous Tunnel-Type Periareolar Incision versus Conventional Lateral Chest Wall Incision for Single-Port Thoracoscopic Lung Resection: A Multicentre Randomised Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115514
Enrollment
Unknown
Registered
2025-12-26
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early-stage lung cancer

Interventions

Conventional lateral chest wall incision group:Surgery was performed via a conventional lateral thoracic wall incision.
Subcutaneous tunnel periareolar incision group:Performing surgery via a subcutaneous tunnel periareolar incision

Sponsors

Fujian Medical University Union Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 60 years old; 2. Patients planning to undergo minimally invasive (VATS) lung surgery (including wedge resection, segmentectomy, and lobectomy, etc.); 3. American Society of Anesthesiologists (ASA) physical status I-II; 4. Patients and their families agree to participate in this study and have signed written informed consent; 5. Major organ function tests meet surgical standards, with no obvious surgical contraindications; 6. Voluntarily accept treatment and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Previous thoracic surgery on the operative side; 2. History of breast or chest wall surgery (e.g., breast implantation, mass resection, etc.) on the operative side, or previous trauma/surgery (e.g., radiation injury, chest wall reconstruction) that causes regional tissue adhesions; 3. Breast diseases that are expected to require surgical intervention on the operative side (such as benign breasts, malignant tumors, or breast cysts, etc.); 4. The patient underwent contemporaneous bilateral lung wedge resection surgery; 5. Active infection in the surgical area; 6. Patients with known scar constitution; 7. There is a risk of transmission of thoracotomy or change of incision during surgery, the surgical procedure may be more complicated, and the surgical resection scope is large (whole lung, right upper middle lung, etc.); 8. Poor pulmonary function evaluated before surgery and unable to tolerate surgery; 9. Combined with other cancers or other advanced diseases; 10. Uncontrolled lung infection or acute lung disease before surgery or acute onset of chronic obstructive pulmonary disease; 11. Severe hypertension (resting systolic/diastolic blood pressure exceeding 180/100 mmHg), intracranial mass occupancy or intracranial hypertension; 12. Those who have recently had brain injury, cerebral infarction, or cerebral hemorrhage; Those with severe organ dysfunction; hyperthyroidism; 13. Previous history of angina, myocardial infarction or heart failure; 14. Thoracoscopic mediastinum, pleura and other non-pulmonary mass resection; 15. Combined with central nervous system lesions; Those with mental or neurological diseases, cognitive and language dysfunction, unable to cooperate with the completion of follow-up; 16. Those who have a history of chest and back surgery or abnormal surgical anesthesia recovery; 17. Pregnant or lactating women; 18. Presence of any serious or uncontrollable systemic disease, such as: (1) Resting ECG has significant abnormalities in rhythm, conduction or morphology with severe symptoms that are difficult to control, such as complete left bundle branch block, heart block of the second degree or above, ventricular arrhythmia or atrial fibrillation; (2) Unstable angina, congestive heart failure, chronic heart failure graded >= 2 by the New York Heart Association (NYHA); (3) Myocardial infarction within 6 months prior to randomization; (4) Poor blood pressure control (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg); (5) Active tuberculosis; (6) Presence of active or uncontrolled infection requiring systemic treatment; (7) Presence of clinically active diverticulitis, abdominal abscess, gastrointestinal obstruction; (8) Liver disease such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis; (9) Poorly controlled diabetes (fasting blood glucose (FBG)>10mmol/L); (10) Patients with mental disorders who cannot cooperate with treatment. 19. History or evidence of disease that may interfere with the results of the trial, prevent the subject from participating in the whole process of the study, abnormal treatment or laboratory test values, or other conditions that the investigator believes are not suitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Incison cosmetic satisfaction score;Scar recovery rating;

Secondary

MeasureTime frame
Changes in nipple sensitivity;Postoperative pain score;Incidence of incision-related complications;Incidence of conversion to open surgery or multi-port surgery during the procedure;

Countries

China

Contacts

Public ContactZheng Bing

Fujian Medical University Union Hospital

lacustrian@163.com+86 591 8621 8408

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026