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

Recruiting at 1 trial location

Overseen By Lisa Gfrerer, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

400 Participants Needed

Trial Summary

What is the purpose of 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.

Research Team

Lisa Gfrerer, MD, PhD

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

Inclusion Criteria

You must be over 18 years of age.

You are scheduled for gender mastectomy surgery (including nipple-sparing mastectomy and mastectomy with free nipple graft) or NSM combined with breast implantation or autologous reconstruction.

The patient has the capacity and readiness to provide informed consent.

Treatment Details

Participant Groups

Group I: Nipple sparing mastectomy (NSM) and implant reconstruction Experimental Treatment 1 Intervention

Nipple sparing mastectomy (NSM) and implant reconstruction

Group II: Nipple sparing mastectomy (NSM) and autologous reconstruction Experimental Treatment 1 Intervention

Nipple sparing mastectomy (NSM) and autologous reconstruction

Group III: Gender mastectomy with free nipple grafting Experimental Treatment 1 Intervention

Gender mastectomy with free nipple grafting

Group IV: Control patients matched by surgical procedure, age, BMI and mastectomy weight. Experimental Treatment 1 Intervention

Control patients matched by surgical procedure, age, BMI and mastectomy weight.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+