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NCT Number: NCT07257003

A Nationwide Multicenter, Single-arm, Retrospective Study of Delayed Endoscopic DTI-BR After Simple Mastectomy

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.

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

West China hospital of Sichuan University

Chengdu, Sichuan, 610000, China

About this study

Breast cancer is the most common malignancy in women, with mastectomy remaining the predominant surgical approach in many regions-often leaving patients with psychological distress from breast loss. With the progress of treatment, patients' survival is prolonged and their quality of life is improved, so the demand for breast reconstruction is increasing. The two-stage implant-based breast reconstruction (TS-IBR) often needs two procedures, two anesthetics, and multiple hospital visits for the injection of water into the expander-costs that increase both financially and in time, ultimately affecting their work and daily routines. Ultimately, whether the procedure reopens the original scar or makes a new incision on the chest-and despite the skin being gradually expanded using an expander-there remains a high risk of dehiscence, implant exposure, infection, and even implant removal. Another method for breast reconstruction after total mastectomy is autologous breast reconstruction (ABR), which doesn't need a second operation. Still, it has serious scar problems and increases the risk of donor-site trauma and complications. Additionally, sensation and function at the donor site may be somewhat reduced, and both sites will likely have large scars, which can significantly impact the aesthetic results.

Therefore, the investigators need to find a simple, efficient, and safe method. The investigators developed the reverse-sequence endoscopic nipple-sparing mastectomy (R-E-NSM) with direct-to-implant breast reconstruction (DIBR), which changes the surgical sequence, makes the operation simple, and realizes immediate breast reconstruction. Inspired by endoscopic breast augmentation methods through the axillary incision, our team also developed a novel technique called delayed endoscopic direct-to-implant breast reconstruction (DEDTI-BR). Clinical practice shows that this technique is also suitable for patients after total mastectomy. This technique utilizes seroma for natural skin expansion, eliminates secondary operations, and preserves aesthetics without additional scars-significantly improving patients' quality of life. Despite its theoretical benefits, clinical evidence validating its efficacy and safety is currently lacking.

Therefore, the investigators plan to conduct a nationwide, multicenter, single-arm, retrospective study, analyzing operation-related parameters, aesthetic outcomes (e.g., BREAST-Q scores and Harris scores), and safety (e.g., surgical complication rates) in DEDTI-BR via the axillary approach. Our goal is to inform and guide clinical practice.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

delayed endoscopic direct-to-implant breast reconstruction via axillary approach after simple mastectomy

Procedure

This 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.

Primary outcomes

  1. The patient's satisfaction with the breasts

    Time frame: postoperative 6-month

    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

  1. The surgical safety

    Time frame: postoperative 6-month

    Surgical complication rates, including flap scald, NAC ischemia/necrosis, seroma, surgical area infection, bleeding, incision splitting, flap ischemia/necrosis

  2. The aesthetic outcomes

    Time frame: postoperative 6-month

    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.

  3. The implant-assisted complications

    Time frame: postoperative 6-month

    Implant-assisted complication rates, including rippling, prosthesis outline appearance, capsular contraction, animation deformity, pectoralis major pain, pectoralis major muscle spasm

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaoman Cao

CONTACT

[email protected]

+86 17208274564

Zhenggui Du

CONTACT

[email protected]

+86 13880768222

Sponsors and collaborators

Lead sponsor

Du Zhenggui

Other

Collaborators

  • Fourth People's Hospital of Sichuan Province
  • Fujian Cancer Hospital
  • Mianyang Central Hospital
  • Suzhou Municipal Hospital
  • The Second People's Hospital of Yibin
  • West China Hospital

Registry information

Official study title

A Nationwide Multicenter, Single-arm, Retrospective Study on Delayed Endoscopic Direct-to-implant Breast Reconstruction Via Axillary Approach After Simple Mastectomy in Breast Cancer Patients

Acronym: DEDTI-BR

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 2, 2025
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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