Evaluating sensation and satisfaction in cancer and transgender mastectomy patients
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.
Weill Medical College of Cornell University · NCT06094257
This study is testing if advanced surgical techniques can improve sensation and satisfaction for people undergoing gender-affirming mastectomy and breast reconstruction.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Weill Medical College of Cornell University (other) |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT06094257 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess postoperative sensation and patient-reported outcomes in individuals undergoing gender-affirming mastectomy and breast reconstruction. It compares patients who receive advanced surgical reinnervation techniques to those who do not, focusing on the impact of these techniques on sensation and satisfaction. The study employs quantitative sensory testing to measure various aspects of sensation, addressing limitations in previous research. By utilizing a standardized approach, the study seeks to provide comprehensive insights into the effectiveness of nerve preservation and grafting during mastectomy procedures.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 scheduled for gender-affirming mastectomy or breast reconstruction.
Not a fit: Patients with pre-existing nerve conditions or those on medications affecting nerve regeneration may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved postoperative sensation and satisfaction for patients undergoing mastectomy.
How similar studies have performed: Previous studies have shown positive outcomes with similar reinnervation techniques, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Boston, Massachusetts and 1 other locations
- Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)
- Weill Cornell Medicine — New York, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Lisa Gfrerer, MD, PhD — Weill Medical College of Cornell University
- Study coordinator: Lisa Gfrerer, MD, PhD
- Email: lig4013@med.cornell.edu
- Phone: 646.962.4250
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sensation Disorders, Sensation, Phantom, Pain, Postoperative, Pain, Chronic, Numbness, Sensory Disorder, Sensory Defect, Phantom Pain