Comparing Delayed-immediate and Delayed Breast Reconstruction after Mastectomy and Radiation Therapy in Women with Early Breast Cancer

What this Trial Is About

This research aims to compare two methods of breast reconstruction in female breast cancer patients who undergo mastectomy followed by post-mastectomy radiation therapy PMRT. The study evaluates the safety and outcomes of delayed-immediate reconstruction, where a skin-sparing mastectomy and implant reconstruction are done at the time of primary surgery to preserve native skin for later reconstruction, versus the standard delayed reconstruction which occurs 6 to 12 months after chemotherapy and PMRT. The goal is to assess complications, aesthetic results, and psychological well-being associated with each approach. Participants are assigned to one of two groups the delayed-immediate reconstruction group receives a skin-sparing mastectomy with silicone implant or expander covered by muscle and mesh, followed by a final reconstruction 6 to 12 months after chemotherapy and radiation. The delayed reconstruction group undergoes total mastectomy initially and final reconstruction 6 to 12 months after PMRT using any reconstructive method. Contralateral procedures are allowed during delayed surgeries. This design allows comparison of complication rates and outcomes between the two approaches. Throughout the study, patients will be closely monitored for surgical complications requiring intervention within one year of final reconstruction. Secondary measures include complications not requiring surgery, patient depression, fear of cancer recurrence, satisfaction, quality of life, body image, pain, lymphoedema, shoulder mobility, capsular contracture, and aesthetic outcomes evaluated up to 10 years after reconstruction. Timely start of adjuvant therapy is also assessed. Participation involves surgery, follow-up visits, physical and psychological assessments over many years to evaluate safety and long-term effects.

Delayed-immediate Versus Delayed Breast Reconstruction in Breast Cancer Patients With Mastectomy and Radiation Therapy