NCT03261323

Breast Reconstruction Following Breast Cancer in Very High Risk Patients

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Not accepted

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

Conditions

• Breast Cancer
• Malignant Neoplasm of Breast

Interventions

Type	Name	Description
PROCEDURE	Immediate Breast Reconstruction	Only implant based surgeries will be considered in this study. The patient will be followed for at least 1 year after the last reconstruction surgery. Reconstruction will be attempted immediately after mastectomy.
PROCEDURE	Delayed Breast Reconstruction	Risk reduction strategies on smoking, weight, and chronic disease control will be offered. The individual risk will be recalculated every three months. Delayed breast reconstruction will be offered when core cancer therapies (mastectomy, chemotherapy and radiation) are complete. Only implant based surgeries will be considered in this study. The patient will be followed for at least 1 year after the last reconstruction surgery.
OTHER	Breast-Q questionnaire	Developed out of Memorial Sloan-Kettering Institute for Cancer Research, this questionnaire is designed to create a patient-reported outcome measure to provide quantifiable information about the impact and effectiveness of breast surgery. In this study it will be used for quality of life assessment

Timeline

• Start date: 2019-05-31
• Primary completion: 2022-07-01
• Completion: 2022-07-01
• First posted: 2017-08-25
• Last updated: 2022-05-20

Locations

1 site across 1 country: United States