Clinical trial · Observational
Prospective Study of 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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Numbness | — | UNRESOLVED | — |
| Pain, Chronic | — | UNRESOLVED | — |
| Pain, Postoperative | — | UNRESOLVED | — |
| Phantom Pain | — | UNRESOLVED | — |
| Phantom Sensation | — | UNRESOLVED | — |
| Sensation Disorders | — | UNRESOLVED | — |
| Sensation, Phantom | — | UNRESOLVED | — |
| Sensory Defect | — | UNRESOLVED | — |
| Sensory Disorder | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sensory testing | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- Nipple sparing mastectomy (NSM) and implant reconstruction
- description
- Nipple sparing mastectomy (NSM) and implant reconstruction
- interventionNames
- Diagnostic Test: Sensory testing
- label
- Nipple sparing mastectomy (NSM) and autologous reconstruction
- description
- Nipple sparing mastectomy (NSM) and autologous reconstruction
- interventionNames
- Diagnostic Test: Sensory testing
- label
- Gender mastectomy with free nipple grafting
- description
- Gender mastectomy with free nipple grafting
- interventionNames
- Diagnostic Test: Sensory testing
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available