Clinical trial NCT06319157: Minimal Access Versus Conventional Latissimus Dorsi Flap Harvest for Breast Reconstruction
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Neoplasms
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2024-03-19
Enrollment: 94
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: Breast Q-satisfaction with back
timeFrame: 6 months
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 6 months
measure: Latissimus dorsi acquisition time
timeFrame: Perioperative
measure: Intraoperative blood loss
timeFrame: Perioperative
measure: Postoperative pain
timeFrame: Perioperative
measure: Postoperative complications
timeFrame: 6 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
References: