During breast surgery, sensory nerves are cut which may lead to reduced sensation and pain. Surgical reinnervation techniques have been developed with the aim of improving postoperative sensation by preserving the nerves and connecting them to the nipple and areola. The investigators aim to compare postoperative sensation and patient reported outcomes in patients undergoing reinnervation versus those not undergoing reinnervation to determine if there is a difference. The investigators will investigate this in patients undergoing gender-affirming mastectomy, implant-based breast reconstruction and autologous breast reconstruction. The investigators will use various tools that measure sensation quantitatively.
Age over 18
Patient is scheduled for gender mastectomy surgery (including nipple sparing mastectomy and mastectomy with free nipple graft) or NSM with breast implant or autologous reconstruction
Patient is capable and willing to provide informed consent
Patient has a nerve condition that does not allow for assessment of sensation
Any subject who at the discretion of the Investigator is not suitable for inclusion in the study or is unlikely to comply with follow-up schedule
Currently prescribed medication known to impact nerve regeneration or to cause peripheral neuropathy
Bilateral reconstruction with non-uniform treatment (i.e. 1 reconstructed breast is non-neurotized, 1 reconstructed breast is neurotized)
Massachusetts General Hospital (MGH) and Weill Cornell Medicine (WCM) are ideally suited for enrollment of patients in this study. Both institutions are high-volume center of expertise for gender affirming mastectomy and breast reconstructions as well as peripheral nerve surgery. Patients will be matched by BMI, age and mastectomy weight. Patients scheduled to undergo gender affirming mastectomy or breast reduction surgery at MGH and WCM will be evaluated for the study and will be presented with the option to hear about the study by our research assistant. Those interested in the study will be presented with all the necessary details required by the IRB including a study fact sheet. Verbal consent will be obtained and documented.
Case-control
Prospective
Sensory testing
Diagnostic testQuantitative sensory testing (QST) will be performed. QST was developed to standardize the noninvasive assessment of the somatosensory nervous system and quantify functioning of all aspects of sensation (light touch, pressure, warm, cold, pain, vibration): 1. Thermal detection (Medoc TSA system): Cold detection threshold B) Warm detection threshold C) Heat pain threshold 2. Mechanical detection threshold (MRC Opti Hair von Frey Filaments) 3. Two-point discrimination (MRC Opti Hair von Frey Filaments) 4. Mechanical pain threshold (MRC Pinprick Stimulator) 5. Pressure pain threshold (Medoc Pressure algometer) 6. Tinel sign on physical exam 7. Vibration (tuning fork)
Change in Breast Q scores
All BREAST-Q scores range from 0-100. The scores are computed from the responses to the separate questions by adding them together and converting the score to a scale from 0 to 100 (similar to conversion into a percentage). A higher score means high satisfaction or better health-related quality of life.
Change in Gender-Q scores
All Gender-Q scores range from 0-100. The scores are computed from the responses to the separate questions by adding them together and converting the score to a scale from 0 to 100 (similar to conversion into a percentage). A higher score means high satisfaction or better health-related quality of life.
Change in cold detection threshold
Thermal detection measured by Medoc TSA system
Change in warm detection threshold
Thermal detection measured by Medoc TSA system
Change in Breast Q scores long term
All BREAST-Q scores range from 0-100. The scores are computed from the responses to the separate questions by adding them together and converting the score to a scale from 0 to 100 (similar to conversion into a percentage). A higher score means high satisfaction or better health-related quality of life.
Change in Gender Q scores long term
All Gender-Q scores range from 0-100. The scores are computed from the responses to the separate questions by adding them together and converting the score to a scale from 0 to 100 (similar to conversion into a percentage). A higher score means high satisfaction or better health-related quality of life.
Change in vibration sensation
Measured by tuning fork
Change in Tinel sensation
Measure on physical exam
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Weill Medical College of Cornell University
Lead sponsor
Massachusetts General Hospital
Collaborator
