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

Not Applicable

Recruiting

• Conditions: Minimally Invasive Surgery; Surgical Incision
• Interventions: Procedure: Type of surgical incision

• Registration Number: NCT06202053
• Lead Sponsor: Fujian Medical University Union Hospital

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,

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study Start: 2024-01-01
• Study First Submitted: 2024-01-02
• Study First Submitted QC: 2024-01-02
• Study First Posted: 2024-01-11
• Last Update Submitted: 2025-01-19
• Last Update Posted: 2025-01-22
• Primary Completion: 2025-10-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 174

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The experimental group (patients received the periareolar incision)	Type of surgical incision	-

Primary Outcome Measures

Name	Time	Method
Postoperative complications	1 month after the operation	Patients were followed up after surgery for complications
Rate of conversion to thoracotomy during the operation.	During surgery

Secondary Outcome Measures

Name	Time	Method
Postoperative pain score	1 week after the operation	Postoperative pain was assessed using the Visual Analogue Scale (VAS) on postoperative days 1, 2, 3, and 7
Cosmetic satisfaction with the incision	1 month after the operation	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
Incision recovery	3 months post-surgery	Incision recovery was evaluated at 1 and 3 months post-surgery using the Patient and Observer Scar Assessment Scale (POSAS)

Trial Locations

Locations (1)

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China