Comparing two methods of breast reconstruction using the latissimus dorsi muscle
A Randomized Controlled Study of Minimal Access Latissimus Dorsi Flap Harvest for Breast Reconstruction Versus Conventional Approaches in the Treatment of Early Breast Cancer
This study is testing two different ways to use a muscle from the back for breast reconstruction in women who don't want implants after cancer surgery to see which method leads to better satisfaction and results.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 94 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06319157 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare minimal access and conventional techniques for harvesting the latissimus dorsi muscle for breast reconstruction in patients who refuse implants after cancer surgery. The study will enroll 94 female patients with early-stage breast cancer and assess their satisfaction and outcomes at 6 months post-surgery. The primary endpoint is the Breast Q-satisfaction score related to back aesthetics, while secondary outcomes will include various satisfaction subscales, surgical metrics, and complication rates. By conducting a prospective, randomized controlled trial, the research seeks to provide robust evidence for surgical decision-making in breast cancer reconstruction.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 18 to 70 with early-stage breast cancer who are willing to undergo autologous reconstruction using the latissimus dorsi muscle.
Not a fit: Patients with advanced or metastatic breast cancer, or those with a high risk of recurrence, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved patient satisfaction and quality of life through less invasive surgical techniques.
How similar studies have performed: Previous studies have suggested the safety and effectiveness of minimal access techniques, but this is a prospective, randomized approach that aims to validate those findings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Female patients with early-stage breast cancer between the ages of 18 and 70. 2. Breast cancer was confirmed by histology or biopsy. 3. Breast-conserving surgery or multifocal breast cancer or large unifocal breast cancer (\<5cm) can be accepted. 4. After neoadjuvant therapy, large monofocal carcinoma (\>5 cm) confined to the breast shrunk to \<5 cm. 5. No chest wall, cutaneous or NAC invasion (including Paget's disease). 6. Mild to moderate breast sagging, and the patient has the willingness to undergo autologous reconstruction of the latissimus dorsi. 7. There is no need to obtain additional back skins. 8. Willing to participate and able to complete follow-up and evaluation during the study. Exclusion Criteria: 1. Patients with advanced breast cancer (stage III and above) or metastatic breast cancer or inflammatory breast cancer. 2. The risk of recurrence is expected to be high. 3. History of thoracic and dorsal vascular injury. 4. Patients with severe heart, lung, or liver disease who cannot withstand surgery and anesthesia. 5. Patients with active infection or severe immune system disease. 6. Patients with severe allergic reactions to materials related to latissimus dorsi muscle flap transplantation. 7. Patients with other major surgeries or reconstructive surgeries planned for the near future. 8. Patients with cognitive dysfunction or psychiatric disorders who cannot understand and cooperate with the requirements of the study. 9. Patients who refuse to participate in the study or are unable to complete follow-up and evaluation during the study.
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Shicheng Su
- Email: sushch@mail.sysu.edu.cn
- Phone: +8613631304227
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.