Menu
Recruiting NCT06319157

Minimal Access Versus Conventional Latissimus Dorsi Flap Harvest for Breast Reconstruction

No phase Interventional Breast Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: minimal access breast reconstruction with a latissimus dorsi muscle flap, conventional breast reconstruction with a latissimus dorsi muscle flap.
Who it may be relevant to
Registry conditions: Breast Neoplasms. Basic parameters: 18 years — 70 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Device minimal access breast reconstruction with a latissimus dorsi muscle flap
    minimal access breast reconstruction with a latissimus dorsi muscle flap
  • Device conventional breast reconstruction with a latissimus dorsi muscle flap
    conventional breast reconstruction with a latissimus dorsi muscle flap

Primary outcome measures

  • Breast Q-satisfaction with back [Time frame: 6 months]
Secondary outcome measures (5)
  • Patient satisfaction [Time frame: 6 months]
  • Latissimus dorsi acquisition time [Time frame: Perioperative]
  • Intraoperative blood loss [Time frame: Perioperative]
  • Postoperative pain [Time frame: Perioperative]
  • Postoperative complications [Time frame: 6 months]

Eligibility criteria

Inclusion 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou

Identifiers

NCT: NCT06319157 · SYSKY-2023-1263-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗