Clinical trial NCT03261323: 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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Cancer
Malignant Neoplasm of Breast
Keywords: Breast Reconstruction
Mastectomy
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2017-08-25
Enrollment: 0
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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

Primary outcomes:
measure: optimal timing of reconstruction in patients at a higher risk for developing breast reconstruction surgical complications
timeFrame: Until 1 year post breast reconstruction
Secondary outcomes:
measure: Major complications
timeFrame: Until 1 year post breast reconstruction
measure: Minor complications
timeFrame: Until 1 year post breast reconstruction
measure: Number of revision surgeries
timeFrame: Until 1 year post breast reconstruction
measure: Hospital cost of the complete reconstruction treatment
timeFrame: Until 1 year post breast reconstruction
measure: Change in patient satisfaction
timeFrame: Until 1 year post breast reconstruction
Other outcomes:
measure: Aesthetic evaluation
timeFrame: Until 1 year post breast reconstruction
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Cleveland Clinic, Case Comprehensive Cancer Center
name: Risal Djohan, MD
role: PRINCIPAL_INVESTIGATOR
References: