Clinical trial · Interventional
A Nationwide Multicenter, Single-arm, Retrospective Study of Delayed Endoscopic DTI-BR After Simple Mastectomy
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
NCT07257003CI-TRIAL-00098174DEDTI-BRnot yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| delayed endoscopic direct-to-implant breast reconstruction via axillary approach after simple mastectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DEDTI-BR group
- description
- delayed endoscopic direct-to-implant breast reconstruction via axillary approach after simple mastectomy
- interventionNames
- Procedure: delayed endoscopic direct-to-implant breast reconstruction via axillary approach after simple mastectomy
Primary outcomes (1)
- measure
- The patient's satisfaction with the breasts
- timeFrame
- postoperative 6-month
- description
- 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 (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (6)
- BACKGROUNDXiu 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
- BACKGROUNDBennett 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
- BACKGROUNDRen 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
- BACKGROUNDMovassaghi 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
- BACKGROUNDDeliere 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
- BACKGROUNDErden 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