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A Comparative Study of Delayed Endoscopic DTI and Autologous Flap Reconstruction Post-Mastectomy

NCT07602868 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 588

Last updated 2026-05-22

No results posted yet for this study

Summary

In China, low breast-conserving surgery rates and historically minimal immediate reconstruction following mastectomy have resulted in a significant population of women living without a breast, often leading to long-term psychosocial distress. Current delayed reconstruction options are limited: traditional two-stage implant reconstruction necessitates two surgeries with associated costs and risks like infection and implant exposure, while autologous tissue transfer (e.g., TRAM/DIEP flaps), though offering superior natural aesthetics and patient satisfaction, involves extensive donor-site morbidity, prolonged recovery, and significant scarring, restricting its suitability. To address the drawbacks of both established methods-significant trauma, cost, and complexity-this study evaluates a novel technique for breast cancer patients post-mastectomy: endoscopic delayed direct-to-implant breast reconstruction. This study proposes to conduct a prospective cohort study to analyze complication rates, breast aesthetic scores, quality of life metrics, and other dimensions between delayed direct-to-implant breast reconstruction and abdominal flap breast reconstruction（DIEP and TRAM). The aim is to comprehensively evaluate the safety and clinical feasibility of endoscopic delayed direct-to-implant breast reconstruction.

Conditions

  • Breast Reconstruction After Mastectomy

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2028-12-31
Completion
2030-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07602868 on ClinicalTrials.gov