Breast Reconstruction Following Breast Cancer in Very High Risk Patients

Not Applicable

Withdrawn

• Conditions: Malignant Neoplasm of Breast; Breast Cancer
• Interventions: Procedure: Immediate Breast Reconstruction; Procedure: Delayed Breast Reconstruction; Other: Breast-Q questionnaire

• Registration Number: NCT03261323
• Lead Sponsor: Case Comprehensive Cancer Center

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

Study Timeline

• Study First Submitted: 2017-07-19
• Study First Submitted QC: 2017-08-23
• Study First Posted: 2017-08-25
• Study Start: 2019-05-31
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-16
• Last Update Posted: 2022-05-20
• Primary Completion: 2022-07
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Subjects must have histologically or cytologically confirmed breast cancer or indication for prophylactic mastectomy.
• Subjects must be breast reconstruction candidates using implant based breast reconstruction.
• Subjects must have a pre-operative risk >20% complication prediction from the Breast Reconstruction Risk Assessment (BRA) Score for implant-based breast reconstruction candidates
• Subjects must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

• Prior breast cancer surgical treatment
• Prior breast reconstruction
• Inability to provide written consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate breast reconstruction	Immediate Breast Reconstruction	The surgical schedule will follow unaltered standard protocol for immediate reconstruction right after the patient's mastectomy. Patients will complete a quality of life questionnaire (Breast-Q) both pre-operatively and at different time points during the follow up. The patient's chart will be followed from the mastectomy surgery onwards until 1 year post-final reconstructive surgery for determining complications and hospital costs.
Delayed breast reconstruction	Delayed Breast Reconstruction	Patients will start the reconstruction process after cancer therapy has been completed. Patients will be directed to smoking cessation and weight loss resources such as the Bariatric Institute to most directly facilitate risk reduction goals. Risk scores will be assessed at a plastic surgery appointment every 3 months. Reconstruction will proceed after the cancer treatment has been completed, according to individual patient evaluation. Patients will complete a quality of life questionnaire (Breast-Q) both pre-operatively and after the final reconstruction surgery. The patient's chart will be followed from the mastectomy surgery onwards until 1 year post-final reconstructive surgery for determining complications and hospital costs.
Delayed breast reconstruction	Breast-Q questionnaire	Patients will start the reconstruction process after cancer therapy has been completed. Patients will be directed to smoking cessation and weight loss resources such as the Bariatric Institute to most directly facilitate risk reduction goals. Risk scores will be assessed at a plastic surgery appointment every 3 months. Reconstruction will proceed after the cancer treatment has been completed, according to individual patient evaluation. Patients will complete a quality of life questionnaire (Breast-Q) both pre-operatively and after the final reconstruction surgery. The patient's chart will be followed from the mastectomy surgery onwards until 1 year post-final reconstructive surgery for determining complications and hospital costs.
Immediate breast reconstruction	Breast-Q questionnaire	The surgical schedule will follow unaltered standard protocol for immediate reconstruction right after the patient's mastectomy. Patients will complete a quality of life questionnaire (Breast-Q) both pre-operatively and at different time points during the follow up. The patient's chart will be followed from the mastectomy surgery onwards until 1 year post-final reconstructive surgery for determining complications and hospital costs.

Primary Outcome Measures

Name	Time	Method
optimal timing of reconstruction in patients at a higher risk for developing breast reconstruction surgical complications	Until 1 year post breast reconstruction	Proportion of patients preferring delayed reconstruction.

Secondary Outcome Measures

Name	Time	Method
Minor complications	Until 1 year post breast reconstruction	defined as the ones that were office treated, not requiring a reoperation
Major complications	Until 1 year post breast reconstruction	defined as the ones that required reoperation (infection, capsular contracture, hematoma, seroma, skin flap and flap necrosis, etc).
Number of revision surgeries	Until 1 year post breast reconstruction	defined as surgeries not related to complications, indicated for symmetrization, aesthetic improvement, nipple reconstruction, or skin paddle removal
Hospital cost of the complete reconstruction treatment	Until 1 year post breast reconstruction	Cost of reconstruction including the cost of complications
Change in patient satisfaction	Until 1 year post breast reconstruction	Patient satisfaction using the pre-operative Breast-Q questionnaire to define the baseline compared to score on Breast-Q questionnaire during follow-up

Trial Locations

Locations (1)

Cleveland Clinic, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States