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Trial Title:
Minimal Access Versus Conventional Latissimus Dorsi Flap Harvest for Breast Reconstruction
NCT ID:
NCT06319157
Condition:
Breast Neoplasms
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
minimal access breast reconstruction with a latissimus dorsi muscle flap
Description:
minimal access breast reconstruction with a latissimus dorsi muscle flap
Arm group label:
minimal access group
Intervention type:
Device
Intervention name:
conventional breast reconstruction with a latissimus dorsi muscle flap
Description:
conventional breast reconstruction with a latissimus dorsi muscle flap
Arm group label:
conventional group
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. 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.
Criteria for eligibility:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Address:
City:
Guangzhou
Zip:
510120
Country:
China
Status:
Recruiting
Contact:
Last name:
Shicheng Su, M.D., Ph.D.
Phone:
+86 13632394954
Email:
lnl_trial@126.com
Contact backup:
Last name:
Erwei Song, M.D., Ph.D.
Phone:
+86 13719237746
Email:
lnl_trial@126.com
Start date:
March 2024
Completion date:
November 2028
Lead sponsor:
Agency:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Agency class:
Other
Source:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06319157
