Prospective Study of Sensation and Satisfaction in Cancer and Transgender Mastectomy Patients
Recruiting · NCT06094257 · Observational (researchers observe without assigning treatment) · Lead sponsor: Weill Medical College of Cornell University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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)
Where it is running
2 locations listed across 2 US states.
- Massachusetts General Hospital - Boston, Massachusetts, United States
- Weill Cornell Medicine - New York, New York, United States