Tokyo, May 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061632) titled 'Safety and Effectiveness of Fat Grafting as an Adjunct to Breast Reconstruction: A Multicenter Retrospective Observational Study in Japan' on May 19.

Study Type: Observational

Primary Sponsor: Institute - Kanto Central Hospital of the Mutual Aid Association of Public School Teachers

Condition: Condition - Postmastectomy breast defect Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to retrospectively collect multicenter data on clinical characteristics, postoperative complications, reoperations, aesthetic outcomes, and oncological outcomes in patients who underwent breast reconstruction with adjunctive fat grafting after breast cancer surgery, and to evaluate the safety and effectiveness of this approach. Basic objectives2 - Safety

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Female Key inclusion criteria - Patients who meet all of the following criteria will be included:

Patients who underwent postmastectomy breast reconstruction at a participating institution between January 1, 2013 and December 31, 2025. Patients who underwent implant-based or autologous breast reconstruction. Patients for whom medical record information is available regarding the use or non-use of adjunctive fat grafting and the major postoperative clinical course. Female patients aged 18 years or older at the time of surgery. Key exclusion criteria - Patients who meet any of the following criteria will be excluded:

Patients with insufficient medical record information to determine the use or non-use of adjunctive fat grafting or to evaluate the primary outcome. Patients whose procedures do not correspond to postmastectomy breast reconstruction, even if performed during the study period. Patients who refuse the use of their clinical information for this study through the opt-out process. Patients deemed unsuitable for inclusion in this study by the principal investigator or co-investigators. Target Size - 1000

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2026 Year 02 Month 24 Day Date of IRB - 2026 Year 02 Month 24 Day Anticipated trial start date - 2026 Year 02 Month 24 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070517

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