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Compares treatment options for Breast Neoplasms
Official title Minimal Access Versus Conventional Latissimus Dorsi Flap Harvest for Breast Reconstruction
ClinicalTrials.gov ID: NCT06319157
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70, women only
You may be able to join if
- 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).
You likely can't join if
- 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.
See the full eligibility criteria
- 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.
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.