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A Comparative Study of Delayed Endoscopic DTI and Latissimus Dorsi ±Impalnt Reconstruction Post-Mastectomy

Not Yet RecruitingN/A

Sponsor: Du Zhenggui

Conditions: Breast Cancer

Interventions: Surgery options

Countries: China

Breast cancer is the most common malignancy in women. In 2022, China saw about 357,200 new cases and 75,000 deaths, accounting for 15.59% and 7.94% of all new cancer cases and cancer-related deaths, respectively. Factors like physician skills, patient attitudes, economics, and tumor-related issues have led to a breast-conserving rate of about 19.5% nationwide, and less than 10% in non-first-tier cities. The immediate breast reconstruction rate after mastectomy is around 10.7%, with over 70% of patients losing their breasts during initial surgery. These patients often face long-term suboptimal psychological health post-surgery. As treatment outcomes improve, more patients are seeking delayed breast reconstruction. Breast reconstruction after simple mastectomy faces challenges due to insufficient skin and tissue volume. Traditional methods include: (1) A two - stage procedure with a tissue expander in the first stage and prosthesis replacement in the second stage. This approach increases costs, requires two surgeries and anesthetics, and carries higher risks of incision dehiscence, prosthesis exposure, infection, and surgical failure. (2) Autologous reconstruction using the latissimus dorsi muscle flap, which involves simultaneous surgery on donor and recipient sites. This method results in significant trauma, longer operating times, higher complication risks, compromised sensation and function, large scars, and potential shoulder - related issues. Due to limited tissue volume, a prosthesis is often needed. While autologous reconstruction offers better breast satisfaction and social psychological health, its complexity and costs limit patient acceptance. To tackle these challenges, our team has developed a minimally invasive, two - stage endoscopic breast reconstruction technique via an axillary approach with an inflation method. This approach reduces surgical time, trauma, and costs, minimizes complications, and enables faster recovery. The tension - free axillary incision eliminates the risk of dehiscence. Skin expansion through the prosthesis cavity results in a more natural - looking and softer breast. No studies have compared this technique with latissimus dorsi ± prosthesis reconstruction after simple mastectomy. We propose a prospective cohort study to evaluate its safety and feasibility, aiming to offer a more cost - effective, simple, and efficient reconstruction option to improve patients' quality of life.

Eligibility overview

Sex: FEMALE

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* Female patients aged 18 - 70 years (inclusive) who have undergone simple mastectomy for breast cancer;
* Patients with good local flap viability and laxity one year after total mastectomy or six months after completion of radiotherapy;
* Patients who are able and willing to sign the informed consent form.

Exclusion Criteria:

* Recurrence detected on follow-up (based on clinical, imaging, or pathological findings), including local/regional recurrence or uncontrollable distant metastasis;
* Patients who had the pectoralis major muscle resected during the initial mastectomy;
* History of thoracic or back surgery with suspected damage to the thoracodorsal vessels;
* Poor general condition and inability to tolerate surgery;
* Presence of severe comorbidities, such as uncontrolled diabetes, severe bone marrow suppression after breast cancer treatment, compromised immune function, or a history of long-term smoking;
* Participation in other clinical studies that may interfere with this trial.

Locations (1)

Chengdu, Sichuan, China