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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-70
SponsorWest China Hospital

About this trial

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

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

263 Participants
are grouped into 2 trial groups

Locations

This trial has no locations

Sponsors and collaborators

West China Hospital

Lead sponsor

Hunan Cancer Hospital

Collaborator

West China Fourth Hospital

Collaborator

West China Second University Hospital

Collaborator