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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorWeill Medical College of Cornell University

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Sensory testing

Treatment groups

400 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Weill Medical College of Cornell University

Lead sponsor

Massachusetts General Hospital

Collaborator