About this trial
This study is a nationwide multicenter, single-arm, retrospective study. The study aims to conduct a detailed analysis of operation-related parameters, aesthetic outcomes (e.g., BREAST-Q scores and Harris scores), and safety (e.g., surgical complication rates) in delayed endoscopic direct-to-implant breast reconstruction via the axillary approach.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Breast cancer patients who underwent delayed endoscopic direct-to-implant breast reconstruction after simple mastectomy at various centers from July 2024 to August 2025, all delayed endoscopic direct-to-implant breast reconstructions were performed ≥ 6 months after the initial mastectomy.
Disqualifiers
Poor skin elasticity;
Re-evaluation (based on clinical, imaging, and pathological findings) indicates local or regional recurrence or uncontrolled distant metastasis;
Patients who have previously undergone radical mastectomy;
Patients who refused to provide postoperative follow-up information.
Trial design
Single group
Treatments tested in this trial
delayed endoscopic direct-to-implant breast reconstruction via axillary approach after simple mastectomy
Procedure/SurgeryThis technique allows for breast reconstruction in a single operation. Taking dual-plane breast reconstruction as an example, preoperative marking lines are drawn to indicate the contour and inframammary fold of the reconstructed breast. A 4-5 cm axillary incision is placed one finger-breadth below the axillary apex. After making the skin incision, the plane between the pectoralis major and minor muscles is identified and dissected, extending approximately 2 cm below the previous mastectomy horizontal scar. The inner and lower parts of the pectoralis major muscle were then separated. Proceed to the subcutaneous layer and continue to dissociate the flap until it reaches the pre-designed folds and the breast boundary. The use of the TiLOOP® Bra depends on the thickness of the patient's flap. Finally, the prosthesis is placed behind the pectoralis major muscle for breast reconstruction.
Treatment groups
Trial outcomes
Primary outcomes
The patient's satisfaction with the breasts
Satisfaction with the breast of the BREAST-Q scale. The BREAST-Q is commonly used to assess health-related satisfaction and quality of life in patients who have undergone breast reconstruction after mastectomy. Responses for each subscale are scored from 0 to 100, with higher scores indicating better outcomes.
Secondary outcomes
The surgical safety
Surgical complication rates, including flap scald, NAC ischemia/necrosis, seroma, surgical area infection, bleeding, incision splitting, flap ischemia/necrosis
The aesthetic outcomes
BREAST-Q scale (physical well-being: chest, psychosocial well-being, sexual well-being) and Harris scale. The BREAST-Q is commonly used to assess health-related satisfaction and quality of life in patients who have undergone breast reconstruction after mastectomy. Responses for each subscale are scored from 0 to 100, with higher scores indicating better outcomes. The Harris score is used to evaluate the postoperative cosmetic outcome, which is classified as excellent, good, general, and poor.
The implant-assisted complications
Implant-assisted complication rates, including rippling, prosthesis outline appearance, capsular contraction, animation deformity, pectoralis major pain, pectoralis major muscle spasm
Sponsors and contacts
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Du Zhenggui
Lead sponsor
West China Hospital
Sponsor institution
Fujian Cancer Hospital
Collaborator
Suzhou Municipal Hospital
Collaborator
The Second People's Hospital of Yibin
Collaborator
Mianyang Central Hospital
Collaborator
West China Hospital
Collaborator
Fourth People's Hospital of Sichuan Province
Collaborator
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