Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID06094257

Prospective Cohort Study Comparing Sensory Outcome, Chronic Pain, Phantom Pain, and Patient Satisfaction in Cancer and Transgender Patients Undergoing Mastectomy and Reconstruction With and Without Reinnervation

Led by Weill Medical College of Cornell University · Updated on 2025-08-27

400

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

W

Weill Medical College of Cornell University

Lead Sponsor

M

Massachusetts General Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying the effects of sensory nerve preservation and reconnection during mastectomy surgeries, including gender-affirming mastectomy, implant-based breast reconstruction, and autologous breast reconstruction. The study aims to compare postoperative sensation and patient satisfaction between patients who receive surgical nerve reinnervation and those who do not. This research addresses the common issues of reduced sensation, chronic pain, and phantom pain occurring after mastectomy by using advanced nerve surgery techniques and comprehensive sensory testing. The study groups include patients undergoing nipple sparing mastectomy with implant reconstruction, nipple sparing mastectomy with autologous reconstruction, gender mastectomy with free nipple grafting, and a control group matched by surgical procedure, age, BMI, and mastectomy weight. Sensory outcomes will be measured with quantitative sensory testing (QST) that assesses multiple sensory functions such as cold, warm, pain, pressure, vibration, and two-point discrimination. Patient-reported outcomes will also be collected to evaluate satisfaction and pain levels over time. Participants will undergo assessments before surgery and at 1 month, 3 months, 6 months, and 1 year postoperatively, with some measures continuing annually up to 10 years. The study involves physical examinations, QST, and questionnaires to track changes in sensation, pain thresholds, and patient satisfaction. The research team will analyze sensory recovery, the incidence of chronic and phantom pain, and overall patient experience to inform future guidelines and potential broader clinical trials.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years
  • Scheduled for gender mastectomy surgery (including nipple sparing mastectomy and mastectomy with free nipple graft)
  • Scheduled for nipple sparing mastectomy with breast implant or autologous reconstruction
  • Capable and willing to provide informed consent
Not Eligible

You will not qualify if you...

  • Presence of a nerve condition preventing assessment of sensation
  • Considered unsuitable for study inclusion or unlikely to comply with follow-up by the investigator
  • Currently prescribed medication known to impact nerve regeneration or cause peripheral neuropathy
  • Undergoing bilateral reconstruction with non-uniform treatment (one breast neurotized, the other non-neurotized)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery

Duration - Day of surgery

Participants undergo gender mastectomy, nipple sparing mastectomy with implant reconstruction, or nipple sparing mastectomy with autologous reconstruction, with or without nerve reinnervation.

1 visit (in-person)

Diagnostic Evaluation

Duration - Preoperative and postoperative assessments at 1 month, 3 months, 6 months, and 1 year

Participants undergo quantitative sensory testing (QST) and patient-reported outcome measures (PROMs) before surgery and at multiple time points after surgery to assess sensation, pain, and satisfaction.

5 visits (in-person) including 1 preoperative and 4 postoperative visits

Long-term Monitoring

Duration - Annually for 2 to 10 years post-operation

Participants are monitored annually for up to 10 years after surgery to assess long-term sensory outcomes, chronic pain, phantom pain, and satisfaction.

Annual visits for up to 9 visits (in-person)

Trial Site Locations

Total: 2 locations

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

2

Weill Cornell Medicine

New York, New York, United States, 10065

Actively Recruiting

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Research Team

L

Lisa Gfrerer, MD, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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