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

Recruitingn/aAges 18 Years - anyAllWeill Medical College of Cornell University
NCT06094257 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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)
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What it tests

  • Sensory testing
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Where

2 sites
Massachusetts General Hospital
Boston, United States
Weill Cornell Medicine
New York, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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