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

NCT07257003 | Not Yet Recruiting DMC

• 1 other identifier: 2025(1896)
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Endoscopic surgery; Breast reconstruction; Minimal invasive surgery

Outcome Measures

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.

  postoperative 6-month

Secondary Outcomes (3)

• The surgical safety

  postoperative 6-month

• The aesthetic outcomes

  postoperative 6-month

• The implant-assisted complications

  postoperative 6-month

Study Arms (1)

DEDTI-BR group

EXPERIMENTAL

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

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

Interventions

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.

DEDTI-BR 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:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Du Zhenggui: lead
• Fujian Cancer Hospital: collaborator
• Suzhou Municipal Hospital: collaborator
• The Second People's Hospital of Yibin: collaborator
• Mianyang Central Hospital: collaborator
• West China Fourth Hospital, Sichuan University: collaborator
• The Fourth People's Hospital of Sichuan Province: collaborator

Study Sites (1)

West China hospital of Sichuan University

Chengdu, Sichuan, 610000, China

Location

Related Publications (6)

• Xiu B, Zhang Q, Meng X, Hao S, Yang B, Li J, Shao ZM, Wu J; Chinese Anti-Cancer Association; Committee of Breast Cancer Society. Current practices and challenges of endoscopic-assisted breast surgery in China: A nationwide cross-sectional survey. Eur J Surg Oncol. 2025 May;51(5):109620. doi: 10.1016/j.ejso.2025.109620. Epub 2025 Jan 19.

  PMID: 39842261 BACKGROUND

• Bennett KG, Qi J, Kim HM, Hamill JB, Pusic AL, Wilkins EG. Comparison of 2-Year Complication Rates Among Common Techniques for Postmastectomy Breast Reconstruction. JAMA Surg. 2018 Oct 1;153(10):901-908. doi: 10.1001/jamasurg.2018.1687.

  PMID: 29926077 BACKGROUND

• Ren Y, Yu Y, Xu K, Li Z, Wang X. Meta-Analysis of Immediate Implant-Based Breast Reconstruction Versus Autologous Breast Reconstruction in the Setting of PMRT. Aesthetic Plast Surg. 2024 May;48(10):1940-1948. doi: 10.1007/s00266-023-03430-y. Epub 2023 Jun 28.

  PMID: 37380747 BACKGROUND

• Movassaghi K, Gilson A, Stewart CN, Cusic J, Movassaghi A. Prepectoral Two-Stage Implant-Based Breast Reconstruction with Poly-4-Hydroxybutyrate for Pocket Control without the Use of Acellular Dermal Matrix: A 4-Year Review. Plast Reconstr Surg. 2024 Jul 1;154(1):15-24. doi: 10.1097/PRS.0000000000010914. Epub 2023 Jul 6.

  PMID: 37410610 BACKGROUND

• Deliere A, Attai D, Victorson D, Kuchta K, Pesce C, Kopkash K, Sisco M, Seth A, Yao K. Patients Undergoing Bilateral Mastectomy and Breast-Conserving Surgery Have the Lowest Levels of Regret: The WhySurg Study. Ann Surg Oncol. 2021 Oct;28(10):5686-5697. doi: 10.1245/s10434-021-10452-w. Epub 2021 Aug 25.

  PMID: 34432189 BACKGROUND

• Erden Y, Celik HC, Karakurt N. Women's body image after mastectomy: a photovoice study. Support Care Cancer. 2025 May 27;33(6):501. doi: 10.1007/s00520-025-09541-3.

  PMID: 40423833 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Zhenggui Du

CONTACT

+86 13880768222; docduzg@163.com

Xiaoman Cao

CONTACT

+86 17208274564; cxm102938@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy director. Zhenggui Du

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 2, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After publication of relevant research outputs, such as academic papers and books.
• Access Criteria: When a request has been approved, the investigator will provide access to the de-identified individual patient-level data in the data management platform (Electronic Data Capture, EDC). A signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing the requested information. Additionally, all users will need to accept the terms and conditions of the data management platform to gain access.

Locations

CN (1)