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Sensory Morbidity Following Breast Surgery


N/A
21 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Sensory Morbidity Following Breast Surgery


Inclusion Criteria:



- The Samples used will be derived from three cohorts below and will only include
patients who have completed mastectomy or reconstruction within 1-5 years of
enrollment.

- Patients who have undergone immediate, two-stage expander/implant postmastectomy
reconstruction

- Patients who have undergone immediate, autogenous tissue flap reconstruction
following mastectomy

- Patients who have undergone mastectomy alone

- Patients at least 21 years of age

- Patients who completed mastectomy ± immediate post-mastectomy reconstruction at least
one year but no longer than five years prior to study entry

Exclusion Criteria:

- Patients who have had any of the following:

- delayed reconstruction (no reconstruction at time of surgery) combined autogenous
tissue/implant breast reconstruction, and/or

- Patients who have a pre-surgical history of complex regional pain syndrome

- Patients who have had radiation therapy

- Patients who have had a local recurrence

- Patients who do not speak the English language (validated translations of key
questionnaires are not available).

Type of Study:

Observational

Study Design:

Observational Model: Case-Crossover, Time Perspective: Retrospective

Outcome Measure:

To evaluate the prevalence, severity and level of distress of subjective breast sensations following mastectomy and postmastectomy reconstruction.

Outcome Time Frame:

conclusion of the study

Safety Issue:

No

Principal Investigator

Andrea Pusic, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

08-009

NCT ID:

NCT00625924

Start Date:

February 2008

Completion Date:

February 2014

Related Keywords:

  • Breast Cancer
  • Plastic surgery
  • reconstruction
  • Breast Neoplasms

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021