Quantification of Breast Sensation Following Postmastectomy Breast Reconstruction
NCT ID: NCT00588419
Last Updated: 2021-04-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
153 participants
OBSERVATIONAL
2006-06-30
2021-04-07
Brief Summary
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Detailed Description
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A formal sensory examination will be performed. SemmesWeinstein monofilaments will evaluate touchpressure sensation in the breast. A Bioesthesiometer will determine the recovery of vibratory sensation. Temperature sensation will be evaluated by application of warm and cool stimuli. Superficial pain sensation will be evaluated by application of sharp and dull stimuli.
A patient reported assessment of sensory changes in the breast will be administered to patients. The Breast Sensation Assessment Scale © is designed to measure the prevalence, severity, and distress of 18 different sensory symptoms following breast surgery. A "Patient Demographic and Treatment Information Form" and patients' medical records will be used to obtain demographic and treatment data. The role of confounding variables (including: patient age, breast volume, axillary procedures performed and adjuvant therapies received) on the recovery of sensation will be evaluated.
The estimated accrual time for this study is 12 months.
Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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1
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
breast exam and questionaire
A physical examination of your breast(s), we will ask you to complete a short questionnaire that asks questions regarding sensations in your reconstructed breast(s) and another short questionnaire that asks questions regarding your medical and surgical history. The physical examination and the questionnaires will be completed in the outpatient clinic. This should take about 30 minutes to complete.
Interventions
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breast exam and questionaire
A physical examination of your breast(s), we will ask you to complete a short questionnaire that asks questions regarding sensations in your reconstructed breast(s) and another short questionnaire that asks questions regarding your medical and surgical history. The physical examination and the questionnaires will be completed in the outpatient clinic. This should take about 30 minutes to complete.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
21 Years
FEMALE
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Babak Mehrara, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, United States
Countries
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Related Links
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Memorial Sloan-Kettering web site
Other Identifiers
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06-047
Identifier Type: -
Identifier Source: org_study_id
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