Minimal Access Versus Conventional Latissimus Dorsi Flap Harvest for Breast Reconstruction

NCT06319157 | Recruiting

• 1 other identifier: SYSKY-2023-1263-02
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

• Breast Q-satisfaction with back

  Patient satisfaction with the back, assessed using the Breast Q-satisfaction with back subscale. 6 months after surgery, the doctor provided each patient with a Breast Q-satisfaction with back questionnaire, and asked the patient to fill in the questionnaire truthfully, and each questionnaire took 1-4 minutes to complete. Before each questionnaire is completed, the doctor will give the patient a simple guide to make it clear what each option means.

  6 months

Secondary Outcomes (5)

• Patient satisfaction

  6 months

• Latissimus dorsi acquisition time

  Perioperative

• Intraoperative blood loss

  Perioperative

• Postoperative pain

  Perioperative

• Postoperative complications

  6 months

Study Arms (2)

minimal access group

EXPERIMENTAL

Device: minimal access breast reconstruction with a latissimus dorsi muscle flap

conventional group

OTHER

Device: conventional breast reconstruction with a latissimus dorsi muscle flap

Interventions

minimal access breast reconstruction with a latissimus dorsi muscle flap DEVICE

minimal access breast reconstruction with a latissimus dorsi muscle flap

minimal access group

conventional breast reconstruction with a latissimus dorsi muscle flap DEVICE

conventional breast reconstruction with a latissimus dorsi muscle flap

conventional group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Shicheng Su

CONTACT

+8613631304227; sushch@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 19, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: March 19, 2024

Record last verified: 2024-03

Locations

CN (1)