Sensation After Nipple Sparing Mastectomy and Breast Reconstruction With or Without Neurotized Free Tissue Transfer
NCT ID: NCT03135392
Last Updated: 2018-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2018-10-31
2020-10-31
Brief Summary
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Autologous Tissue Reconstruction: The purpose of this study is to determine whether the tissue being used to reconstruct your breast can provide sensation by using your own nerves. Typically all sensation is lost immediately after this type of surgery and returns to varying degrees. We are hoping to demonstrate that by connecting the two nerves (one from abdomen and one from the chest wall) together, we can attain meaningful sensation in the transferred tissues thereby improving your quality of life following surgery.
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Detailed Description
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Specific Aims
1. Determine the timing and degree of return of breast in women who underwent mastectomy with autologous tissue or with implant based reconstruction.
2. Determine sensation following neurotized free flap reconstruction
3. Determine whether neurotization has an impact on quality of life measures post operatively
Study Design Patients will be enrolled prospectively in this data collection study in which they will receive the standard of care for breast cancer resection and oncologically safe and accepted means of breast reconstruction with tissue expander and/or prosthetic implants. Patients will receive additional, non-invasive sensory testing, performed at standard follow up intervals in clinic by their reconstructive team. All patients participating in the study will be consented for enrollment at the pre-operative visit by either the surgeon or physician assistant. As this is a prospective study, all women fitting inclusion criteria over a 6-month minimal, but projected goal 12-month period will be included.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
If the participant is having both of her breasts reconstructed, one side will receive the nerve reconstruction and one will not. The participant will not know which group you have been assigned to until the completion of the study or if voluntarily withdraw from the study
Study Groups
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Breast Reconstruction with Artificial Implant
Participants undergoing unilateral reconstruction: patient will serve as internal control with contralateral breast and reconstructed breast will be compared to all other reconstructed breasts. Participants undergoing bilateral reconstruction: reconstructed breasts will be compared to all other reconstructed breasts
Breast Reconstruction with Artificial Implant
Patients undergo unilateral or bilateral reconstruction of breasts after nipple sparing mastectomy. Breasts are reconstructed with artificial implants
Autologous Breast Reconstruction without Neurotization
Participants undergoing autologous tissue (her own tissue from other areas of the body) reconstruction which do not have their nerves reconstructed during surgery
Autologous Breast Reconstruction
Patients undergo unilateral or bilateral reconstruction of breasts after nipple sparing mastectomy. Breasts are reconstructed with the patient's own tissue
Autologous Breast Reconstruction with Neurotization
Participants undergoing autologous tissue (her own tissue from other areas of the body) reconstruction which have a nerve connected (neurotized) during surgery.
Autologous Breast Reconstruction
Patients undergo unilateral or bilateral reconstruction of breasts after nipple sparing mastectomy. Breasts are reconstructed with the patient's own tissue
Neurotization
Nerve will be reconstructed during autologous breast tissue reconstruction
Interventions
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Breast Reconstruction with Artificial Implant
Patients undergo unilateral or bilateral reconstruction of breasts after nipple sparing mastectomy. Breasts are reconstructed with artificial implants
Autologous Breast Reconstruction
Patients undergo unilateral or bilateral reconstruction of breasts after nipple sparing mastectomy. Breasts are reconstructed with the patient's own tissue
Neurotization
Nerve will be reconstructed during autologous breast tissue reconstruction
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient must have one of the following reconstructions in planned:
* Immediate tissue expander placement
* Immediate implant placement
* Immediate autologous breast reconstruction
* All patients participating in the study must be willing to be consented for enrollment at the pre-operative visit.
Exclusion Criteria
* Any pre-excising
* Patients with absent or prior damaged nipple areola-complex (NAC) on the "non-surgical breast"
18 Years
FEMALE
No
Sponsors
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Case Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Andrea Moreira, MD
Role: PRINCIPAL_INVESTIGATOR
Cleveland Clinic, Case Comprehensive Cancer Center
Locations
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Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Countries
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Other Identifiers
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CASE2117
Identifier Type: -
Identifier Source: org_study_id
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