Actively Recruiting
Minimal Access Versus Conventional Latissimus Dorsi Flap Harvest for Breast Reconstruction
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2024-03-19
94
Participants Needed
1
Research Sites
243 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Minimal Access Versus Conventional Latissimus Dorsi Flap Harvest for Breast Reconstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients with early-stage breast cancer aged 18 to 70
- Breast cancer confirmed by histology or biopsy
- Breast-conserving surgery or multifocal breast cancer or large unifocal breast cancer less than 5 cm accepted
- Large monofocal carcinoma larger than 5 cm shrunk to less than 5 cm after neoadjuvant therapy accepted
- No invasion of chest wall, skin, or nipple-areola complex including Paget's disease
- Mild to moderate breast sagging with willingness to undergo latissimus dorsi flap reconstruction
- No need for additional back skin
- Willing and able to participate and complete follow-up and evaluations during the study
You will not qualify if you...
- Advanced breast cancer (stage III or higher), metastatic or inflammatory breast cancer
- Expected high risk of cancer recurrence
- History of thoracic or back vascular injury
- Severe heart, lung, or liver disease preventing surgery or anesthesia
- Active infection or severe immune system disease
- Severe allergic reactions to materials used in latissimus dorsi muscle flap transplantation
- Planned major or reconstructive surgeries in the near future
- Cognitive dysfunction or psychiatric disorders preventing understanding or cooperation
- Refusal to participate or inability to complete follow-up and evaluations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510120
Actively Recruiting
Research Team
S
Shicheng Su
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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