Clinical trial · Observational
Quantification of Breast Sensation Following Postmastectomy Breast Reconstruction
NCT00588419CI-TRIAL-00051187completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the return of sensation in the breast(s) following breast mastectomy with and without reconstruction. Four different sensations: touch, vibration, superficial pain, and temperature will be evaluated. In addition, we will look at factors that may contribute to the return of breast sensations.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| breast exam and questionaire | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 1
- description
- Patients who have undergone mastectomy Patients who have undergone immediate, twostage expander/implant breast reconstruction; Patients who have undergone immediate, autogenous tissue flap reconstruction including: pedicled and/or free TRAM flap or DIEP flap reconstruction
- interventionNames
- Behavioral: breast exam and questionaire
Primary outcomes (1)
- measure
- Evaluate the degree of touch, vibration, superficial pain, and temperature sensation recovered in the postmastectomy as well as in the reconstructed breast and to compare the sensations recovered in the different groups.
- timeFrame
- 1 year
Secondary outcomes (1)
- measure
- The secondary objective is to compare the sensations recovered following tissue expander/implant breast reconstruction with sensations recovered following autogenous tissue reconstruction.
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who have undergone mastectomy * Patients who have undergone immediate, twostage expander/implant breast reconstruction * Patients who have undergone immediate, autogenous tissue flap reconstruction including: pedicled and/or free TRAM flap or DIEP flap reconstruction * Patients at least 21 years of age * Patients at least 1 year from the time of mastectomy or completion of immediate, postmastectomy reconstruction Exclusion Criteria: Patients who have had any of the following: * delayed reconstruction (no reconstruction immediately after mastectomy) * combined autogenous tissue/implant breast reconstruction * tissue expander * Patients who have a history of complex regional pain syndrome * implant explantation (device is removed prematurely due to complications)
References
Publications (0)
Data not yet available
No reference posted for this study.