Clinical trial NCT06202053: Modified Uniportal Periareolar Incision Versus Conventional Uniportal Video-assisted Thoracic Surgery for Pulmonary Nodules: Protocol for a Prospective, Randomized, Controlled Study
Official title: Modified Uniportal Periareolar Incision Versus Conventional Uniportal Video-assisted Thoracic Surgery for Pulmonary Nodules: Protocol for a Prospective, Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Surgical Incision
Minimally Invasive Surgery
Lead sponsor: Fujian Medical University Union Hospital
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 invasive and cosmetically favorable as possible. However, achieving the ideal uniportal incision remains challenging, as some patients inevitably experience complications such as scar hyperplasia or incision depression. Increasing expectations for superior surgical outcomes and improved postoperative quality of life place additional demands on thoracic surgeons. The periareolar approach, although rarely reported, typically involves entering the chest cavity directly through the mammary gland. Its application has been limited in the literature. In this study, we modified the periareolar incision by establishing a subcutaneous tunnel to minimize damage to the mammary gland. We aim to assess the feasibility and safety of this modified periareolar incision as a novel option for uniportal thoracoscopic surgery.Participants were divided into two groups: the modified periareolar incision group and the conventional uniportal video-assisted thoracic surgery (VATS) group. In the modified periareolar incision group, a curved incision was made along the lateral areola of the affected side. A subcutaneous tunnel was created between the mammary gland and the skin, extending to the fourth or fifth intercostal space along the anterior midaxillary line, where an intercostal incision was performed to access the thoracic cavity. In the conventional uniportal VATS group, patients were directly accessed through an intercostal incision in the midaxillary line. The primary endpoints of the study were the incidence of postoperative complications and the rate of conversion to thoracotomy during the operation. Postoperative complications were monitored and recorded for up to 3 months after surgery. The secondary endpoints of the study were differences in postoperative pain scores and cosmetic satisfaction between the two groups. Additional analyses included baseline patient characteristics and operative data. Postoperative pain was assessed using the Visual Analogue Scale (VAS) on postoperative days 1, 2, 3, and 7. Incision recovery was evaluated at 1 and 3 months post-surgery using the Patient and Observer Scar Assessment Scale (POSAS). Cosmetic satisfaction with the incision was assessed 1 month postoperatively using a 5-point scale (1 = very dissatisfied; 5 = very satisfied). Patients were also presented with photos of two incision types and asked to choose their preferred style. Modified periareolar incision is a small improvement of previously reported incision, but it significantly increases the number of procedures available and the number of patients who can be included. The modified periareolar incision could be used as a new option for uniportal VATS segmentectomy, and it was more cosmetic and less invasive,


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

Primary outcomes:
measure: Postoperative complications
timeFrame: 1 month after the operation
measure: Rate of conversion to thoracotomy during the operation.
timeFrame: During surgery
Secondary outcomes:
measure: Postoperative pain score
timeFrame: 1 week after the operation
measure: Cosmetic satisfaction with the incision
timeFrame: 1 month after the operation
measure: Incision recovery
timeFrame: 3 months post-surgery
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
References: