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.

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
United States
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
New York
Weill Cornell Medicine
RECRUITING
New York
Contact Information
Primary
Lisa Gfrerer, MD, PhD
lig4013@med.cornell.edu
646.962.4250
Time Frame
Start Date: 2022-02-09
Estimated Completion Date: 2033-03
Participants
Target number of participants: 400
Treatments
Nipple sparing mastectomy (NSM) and implant reconstruction
Nipple sparing mastectomy (NSM) and implant reconstruction
Nipple sparing mastectomy (NSM) and autologous reconstruction
Nipple sparing mastectomy (NSM) and autologous reconstruction
Gender mastectomy with free nipple grafting
Gender mastectomy with free nipple grafting
Control patients matched by surgical procedure, age, BMI and mastectomy weight.
Control patients matched by surgical procedure, age, BMI and mastectomy weight.
Sponsors
Leads: Weill Medical College of Cornell University
Collaborators: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov