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

January 19, 2025 updated by: Fujian Medical University Union Hospital
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,

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
174

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Chun Chen, MD

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Recruiting
        • Fujian Medical University Union Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Study Population

After patients provided informed consent, they underwent nonstratified randomization with the use of computer-generated assignments, and enrolled patients were randomly assigned in a 1:1 ratio to the perareolar incision group or the axillary incision group. The randomization protocol was managed by an external study administrator to prevent selection bias.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental group (patients who received modified periareolar incision)
Procedure: Type of surgical incision

The experimental group (patients received periareolar incision):

An arc-shaped incision was made on the lateral side of the patient's affected areola. The subcutaneous tissue was then dissociated between the lateral mammary gland and the skin to the level of the fourth intercostal space in front of the midaxillary line. The fatty tissue behind the breast was separated horizontally to expose the serratus anterior muscle, and an intercostal incision was made. The skin was pulled back throughout the procedure to expose a better surgical field and avoid damage to the mammary gland.

The control group (patients underwent an axillary incision):

For patients in the control group, an incision was made into the fourth intercostal space in the midline of the axilla, where subcutaneous tissue was separated and entered the chest.
No Intervention: Control group (patients who received conventional uniportal thoracoscopic incision)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Postoperative complications
Time Frame: 1 month after the operation
Patients were followed up after surgery for complications
1 month after the operation
Rate of conversion to thoracotomy during the operation.
Time Frame: During surgery
During surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postoperative pain score
Time Frame: 1 week after the operation
Postoperative pain was assessed using the Visual Analogue Scale (VAS) on postoperative days 1, 2, 3, and 7
1 week after the operation
Cosmetic satisfaction with the incision
Time Frame: 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
1 month after the operation
Incision recovery
Time Frame: 3 months post-surgery
Incision recovery was evaluated at 1 and 3 months post-surgery using the Patient and Observer Scar Assessment Scale (POSAS)
3 months post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fujian Medical University Union Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 2, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Union-99

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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