Surgical IncisionNCT06202053
Modified Uniportal Periareolar Incision Versus Conventional Uniportal Video-assisted Thoracic Surgery for Pulmonary Nodules: Protocol for a Prospective, Randomized, Controlled Study
A study testing Type of surgical incision in people with Surgical Incision and Minimally Invasive Surgery, run by Fujian Medical University Union Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Surgical Incision, Minimally Invasive Surgery
- What is being tested?
- Type of surgical incision
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Chun Chen, MD contact
China1 site, 1 recruiting
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Bin Zheng, MD, +8615959002753, Lacustrian@163.com
About this study
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,
- Conditions
- Surgical Incision, Minimally Invasive Surgery
- Being tested
- Type of surgical incision
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Type of surgical incisionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group (patients who received modified periareolar incision) | Experimental | Not described Receives: Procedure: Type of surgical incision |
| Control group (patients who received conventional uniportal thoracoscopic incision) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
Patients were followed up after surgery for complications
Measured: 1 month after the operation
Rate of conversion to thoracotomy during the operation.
Measured: During surgery
Secondary outcomes (3)
Postoperative pain score
Postoperative pain was assessed using the Visual Analogue Scale (VAS) on postoperative days 1, 2, 3, and 7
Measured: 1 week after the operation
Cosmetic satisfaction with the incision
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
Measured: 1 month after the operation
Incision recovery
Incision recovery was evaluated at 1 and 3 months post-surgery using the Patient and Observer Scar Assessment Scale (POSAS)
Measured: 3 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start1 Jan 2024
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical IncisionStudies of the same condition, open and under way.
- More trials run by Fujian Medical University Union HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06202053
- Sponsor's protocol ID
- Union-99
- Status last verified
- Jan 2024
- First submitted
- 2 Jan 2024
- Last updated
- 22 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Uniportal Periareolar Incision Versus Conventional Uniportal Video-assisted Thoracic Surgery for Pulmonary Nodules: Protocol for a Prospective, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT06202053
- Acronym / sponsor ID
- Union-99
- Conditions
- Surgical Incision, Minimally Invasive Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 11 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group (patients who received modified periareolar incision) | Experimental | Procedure: Type of surgical incision |
| Control group (patients who received conventional uniportal thoracoscopic incision) | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Type of surgical incisionThe 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. | Procedure or surgery | Experimental group (patients who received modified periareolar incision) |
Primary outcome
Postoperative complications
Time frame: 1 month after the operation
Patients were followed up after surgery for complications
Rate of conversion to thoracotomy during the operation.
Time frame: During surgery
3 secondary outcomes
Postoperative pain score
Time frame: 1 week after the operation
Cosmetic satisfaction with the incision
Time frame: 1 month after the operation
Incision recovery
Time frame: 3 months post-surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chun Chen, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Type of surgical incision in people with Surgical Incision and Minimally Invasive Surgery, run by Fujian Medical University Union Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bin Zheng, MD (15959002753, Lacustrian@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complications (time frame: 1 month after the operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.