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NCT07602868
A Comparative Study of Delayed Endoscopic DTI and Autologous Flap Reconstruction Post-Mastectomy
Conditions: Breast Reconstruction After Mastectomy
Sex: Female
Ages: 18 Years – 70 Years
Healthy volunteers: No
Enrollment: 588
Sponsor: West China Hospital
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.
Eligibility Criteria
Inclusion Criteria:
* Female patients aged 18-70 years
* One year after Modified Radical Mastectomy (MRM), Nipple-Sparing Mastectomy (NSM), or Skin-Sparing Mastectomy (SSM), or six months after the completion of radiotherapy, provided the local skin remains viable and sufficiently lax;
* voluntary participation and ability to provide written informed consent.
Exclusion Criteria:
* History of breast surgery in which the pectoralis major muscle was removed;
* Patients with serious preoperative co-morbidities and poor general condition who cannot tolerate the surgery;
* Diabetes mellitus with a long history of smoking or combined poor glycemic control;
* current enrollment in other clinical trials that may interfere with study outcomes;
* Review (clinical, imaging, pathological basis) reveals the presence of local/regional recurrence or uncontrollable distant metastasis.
Source: ClinicalTrials.gov (NCT07602868). StuddyBuddy aggregates publicly available trial information.