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

ConditionBreast Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorDu Zhenggui

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

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

    Procedure/Surgery

    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.

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: DEDTI-BR groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
postoperative 6-month

Secondary outcomes

1

The surgical safety

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

Time frame
postoperative 6-month
2

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.

Time frame
postoperative 6-month
3

The implant-assisted complications

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

Time frame
postoperative 6-month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

This trial is not recruiting at the moment. You can still explore other options: