Spots Global Cancer Trial Database for Breast Reconstruction Following Breast Cancer in Very High Risk Patients

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Trial Identification

Brief Title: Breast Reconstruction Following Breast Cancer in Very High Risk Patients

Official Title: Evaluating Breast Reconstruction Timing and Risk Reduction Strategies in Patients at a Higher Risk for Developing Breast Reconstruction Surgical Complications: A Prospective Randomized Study

Study ID: NCT03261323

Conditions

Breast Cancer

Malignant Neoplasm of Breast

Interventions

Immediate Breast Reconstruction

Delayed Breast Reconstruction

Breast-Q questionnaire

Study Description

Brief Summary: The purpose of this study is to: 1. Evaluate whether immediate or delayed reconstruction should be offered for breast reconstruction candidates with higher risk for surgical complications by comparing complications, quality of life, and hospital costs 2. Determine the efficacy of risk reduction strategies for breast reconstruction patients with higher risk for surgical complications

Detailed Description: Primary Endpoint(s) 1. Define the optimal timing of reconstruction in patients at a higher risk for developing breast reconstruction surgical complications through a randomized prospective cohort 2. Compare immediate and delayed reconstruction outcome metrics through retrospective review Secondary Endpoint(s) 1. Evaluate Quality of life of patients at a higher risk for developing breast reconstruction surgical complications undergoing immediate versus delayed reconstruction. 2. Compare complications and reoperations between immediate versus delayed reconstruction. 3. Compare the hospital costs between immediate versus delayed reconstruction 4. Evaluate the effectiveness of risk reduction strategies