Prospective Study of Sensation and Satisfaction in Cancer and Transgender Mastectomy Patients
RecruitingNCT06094257
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- 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.
- Conditions
- Sensation Disorders
- Sensation, Phantom
- Pain, Postoperative
- Pain, Chronic
- Numbness
- Sensory Disorder
- Sensory Defect
- Phantom Pain
- Phantom Sensation
- Interventions
- Diagnostic test: Sensory testing
- Sponsor
- Weill Medical College of Cornell University
- Collaborators
- Massachusetts General Hospital
- Start date
- 2022-02-09
- Primary completion
- 2033-03
- Sex
- All
- Age range
- from 18 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06094257