Breast NeoplasmsNCT06319157
Minimal Access Versus Conventional Latissimus Dorsi Flap Harvest for Breast Reconstruction
A study testing minimal access breast reconstruction with a latissimus dorsi muscle flap and conventional breast reconstruction with a latissimus dorsi muscle flap in people with Breast Neoplasms, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
For patients refusing implants for breast reconstruction after cancer surgery, autologous tissue flap reconstruction using the latissimus dorsi muscle is an alternative. Conventional surgery leaves a long incision on the back, affecting aesthetics and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- minimal access breast reconstruction with a latissimus dorsi muscle flap and conventional breast reconstruction with a latissimus dorsi muscle flap
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteChina
- Study dates
- Mar 2024to Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients with early-stage breast cancer between the ages of 18 and 70.
- Breast cancer was confirmed by histology or biopsy.
- Breast-conserving surgery or multifocal breast cancer or large unifocal breast cancer (<5cm) can be accepted.
- After neoadjuvant therapy, large monofocal carcinoma (>5 cm) confined to the breast shrunk to <5 cm.
- No chest wall, cutaneous or NAC invasion (including Paget's disease).
- Mild to moderate breast sagging, and the patient has the willingness to undergo autologous reconstruction of the latissimus dorsi.
- There is no need to obtain additional back skins.
- Willing to participate and able to complete follow-up and evaluation during the study.
Who cannot join
- Patients with advanced breast cancer (stage III and above) or metastatic breast cancer or inflammatory breast cancer.
- The risk of recurrence is expected to be high.
- History of thoracic and dorsal vascular injury.
- Patients with severe heart, lung, or liver disease who cannot withstand surgery and anesthesia.
- Patients with active infection or severe immune system disease.
- Patients with severe allergic reactions to materials related to latissimus dorsi muscle flap transplantation.
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- Patients with other major surgeries or reconstructive surgeries planned for the near future.
- Patients with cognitive dysfunction or psychiatric disorders who cannot understand and cooperate with the requirements of the study.
- Patients who refuse to participate in the study or are unable to complete follow-up and evaluation during the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120
Shicheng Su, M.D., Ph.D., +86 13632394954, lnl_trial@126.com
Erwei Song, M.D., Ph.D., +86 13719237746, lnl_trial@126.com
About this study
Official title: A Randomized Controlled Study of Minimal Access Latissimus Dorsi Flap Harvest for Breast Reconstruction Versus Conventional Approaches in the Treatment of Early Breast Cancer
For patients refusing implants for breast reconstruction after cancer surgery, autologous tissue flap reconstruction using the latissimus dorsi muscle is an alternative. Conventional surgery leaves a long incision on the back, affecting aesthetics and quality of life. Minimal access techniques result in a smaller, more concealable scar. While previous studies suggest its safety and effectiveness, most are retrospective. To further validate patient satisfaction and short-term outcomes, a prospective, randomized controlled trial comparing minimal access with conventional surgery is planned. The primary endpoint is Breast Q-satisfaction with back score at 6 months. Secondary outcomes include other Breast Q subscales, surgical metrics, and complications. The study aims to enroll 94 patients in total, providing evidence for surgical decision-making in breast cancer reconstruction.
- Conditions
- Breast Neoplasms
- Being tested
- minimal access breast reconstruction with a latissimus dorsi muscle flap, conventional breast reconstruction with a latissimus dorsi muscle flap
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
minimal access breast reconstruction with a latissimus dorsi muscle flapDevice
minimal access breast reconstruction with a latissimus dorsi muscle flap
conventional breast reconstruction with a latissimus dorsi muscle flapDevice
conventional breast reconstruction with a latissimus dorsi muscle flap
| Study group | Role | What they receive |
|---|---|---|
| minimal access group | Experimental | Not described Receives: Device: minimal access breast reconstruction with a latissimus dorsi muscle flap |
| conventional group | Other | Not described Receives: Device: conventional breast reconstruction with a latissimus dorsi muscle flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast Q-satisfaction with back
Patient satisfaction with the back, assessed using the Breast Q-satisfaction with back subscale.
6 months after surgery, the doctor provided each patient with a Breast Q-satisfaction with back questionnaire, and asked the patient to fill in the questionnaire truthfully, and each questionnaire took 1-4 minutes to complete. Before each questionnaire is completed, the doctor will give the patient a simple guide to make it clear what each option means.
Measured: 6 months
Secondary outcomes (5)
Patient satisfaction
Other aspects of patient satisfaction, assessed using the Breast Q scale. 6 months after surgery, the doctor provided each patient with a questionnaire and asked the patient to fill it out truthfully, each questionnaire takes 1-4 minutes to complete, and a complete BREAST-Q survey can be completed in 10-15 minutes. Before each questionnaire is completed, the doctor will give the patient a simple guide to make it clear what each option means.
Measured: 6 months
Latissimus dorsi acquisition time
Calculated from the start of latissimus dorsi acquisition to the completion of latissimus dorsi acquisition.
Measured: Perioperative
Intraoperative blood loss
The amount of blood lost by the patient due to routine operations during surgery.
Measured: Perioperative
Postoperative pain
recorded using the Visual Analogue Scale (VAS) pain assessment tool.
Measured: Perioperative
Postoperative complications
including but not limited to surgical site infection, bleeding, wound dehiscence, breast/donor site flap/NAC necrosis, subcutaneous effusion in the chest and donor site, surgical side lymphedema, etc., are classified using the Clavien-Dindo grading system.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study startMar 2024 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06319157
- Sponsor's protocol ID
- SYSKY-2023-1263-02
- Status last verified
- Mar 2024
- First submitted
- 13 Mar 2024
- Last updated
- 19 Mar 2024
- 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 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Minimal Access Latissimus Dorsi Flap Harvest for Breast Reconstruction Versus Conventional Approaches in the Treatment of Early Breast Cancer
- ClinicalTrials.gov ID
- NCT06319157
- Acronym / sponsor ID
- SYSKY-2023-1263-02
- Conditions
- Breast Neoplasms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 19 Mar 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.
For patients refusing implants for breast reconstruction after cancer surgery, autologous tissue flap reconstruction using the latissimus dorsi muscle is an alternative. Conventional surgery leaves a long incision on the back, affecting aesthetics and quality of life. Minimal access techniques result in a smaller, more concealable scar. While previous studies suggest its safety and effectiveness, most are retrospective. To further validate patient satisfaction and short-term outcomes, a prospective, randomized controlled trial comparing minimal access with conventional surgery is planned. The primary endpoint is Breast Q-satisfaction with back score at 6 months. Secondary outcomes include other Breast Q subscales, surgical metrics, and complications. The study aims to enroll 94 patients in total, providing evidence for surgical decision-making in breast cancer reconstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| minimal access group | Experimental | Device: minimal access breast reconstruction with a latissimus dorsi muscle flap |
| conventional group | Other | Device: conventional breast reconstruction with a latissimus dorsi muscle flap |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female patients with early-stage breast cancer between the ages of 18 and 70.
- Breast cancer was confirmed by histology or biopsy.
- Breast-conserving surgery or multifocal breast cancer or large unifocal breast cancer (<5cm) can be accepted.
- After neoadjuvant therapy, large monofocal carcinoma (>5 cm) confined to the breast shrunk to <5 cm.
- No chest wall, cutaneous or NAC invasion (including Paget's disease).
Key exclusion criteria (9 listed)
- Patients with advanced breast cancer (stage III and above) or metastatic breast cancer or inflammatory breast cancer.
- The risk of recurrence is expected to be high.
- History of thoracic and dorsal vascular injury.
- Patients with severe heart, lung, or liver disease who cannot withstand surgery and anesthesia.
- Patients with active infection or severe immune system disease.
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 |
|---|---|---|
| minimal access breast reconstruction with a latissimus dorsi muscle flapminimal access breast reconstruction with a latissimus dorsi muscle flap | Device | minimal access group |
| conventional breast reconstruction with a latissimus dorsi muscle flapconventional breast reconstruction with a latissimus dorsi muscle flap | Device | conventional group |
Primary outcome
Breast Q-satisfaction with back
Time frame: 6 months
Patient satisfaction with the back, assessed using the Breast Q-satisfaction with back subscale. 6 months after surgery, the doctor provided each patient with a Breast Q-satisfaction with back questionnaire, and asked the patient to fill in the questionnaire truthfully, and each questionnaire took 1-4 minutes to complete. Before each questionnaire is completed, the doctor will give the patient a simple guide to make it clear what each option means.
5 secondary outcomes
Patient satisfaction
Time frame: 6 months
Latissimus dorsi acquisition time
Time frame: Perioperative
Intraoperative blood loss
Time frame: Perioperative
Postoperative pain
Time frame: Perioperative
Postoperative complications
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing minimal access breast reconstruction with a latissimus dorsi muscle flap and conventional breast reconstruction with a latissimus dorsi muscle flap in people with Breast Neoplasms, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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 8 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 19 Mar 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shicheng Su (+8613631304227, sushch@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breast Q-satisfaction with back (time frame: 6 months). 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 19 Mar 2024.