RecruitingNCT06094257

Prospective Study of Sensation and Satisfaction in Cancer and Transgender Mastectomy Patients

Prospective Cohort Study Comparing Sensory Outcome, Development of Chronic Pain and Phantom Pain, as Well as Patient Satisfaction in Cancer and Transgender Patients Undergoing Mastectomy and Reconstruction With and Without Reinnervation.

Sponsor

Weill Medical College of Cornell University

Enrollment

400 participants

Start Date

Feb 9, 2022

Study Type

OBSERVATIONAL

Conditions

Pain, Chronic Pain, Postoperative Sensation Disorders Sensation, Phantom Numbness Sensory Disorder Sensory Defect Phantom Pain Phantom Sensation

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

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

Exclusion Criteria4

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)

Interventions

DIAGNOSTIC_TESTSensory testing

Quantitative 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)