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Persistent Pain After Reconstruction Following Mastectomy

This study has been completed.
Danish Breast Cancer Cooperative Group
Information provided by (Responsible Party):
Kenneth Geving Andersen, Rigshospitalet, Denmark Identifier:
First received: November 22, 2012
Last updated: November 29, 2012
Last verified: November 2012
A cross sectional study to determine the prevalence of persistent pain after reconstructive surgery after mastectomy for breast cancer, with a comparative analysis of a cohort treated with mastectomy without reconstruction.

Condition Intervention
Breast Cancer
Chronic Pain
Procedure: Reconstruction

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Persistent Pain After Reconstruction Following Mastectomy

Resource links provided by NLM:

Further study details as provided by Kenneth Geving Andersen, Rigshospitalet, Denmark:

Primary Outcome Measures:
  • The risk of developing persistent if reconstructed [ Time Frame: Cross-sectional, 2-3 years after surgery for breast cancer ]
    The risk of developing persistent if reconstructed compared to patients mastectomized without reconstruction expressed as an odds ratio.

Secondary Outcome Measures:
  • Prevalence of persistent pain after reconstruction after mastectomy [ Time Frame: Cross-sectional, 2-3 years after surgery for breast cancer ]
    Self reported pain expressed as a percentage of the population of patients reconstructed with expander and autologous tissue. Pain intensity measured with a numerical rating scale 0-10, divided in mild (NRS 1-3), moderate (4-6) and severe pain (7-10). Patients regarded as having clinically relevant pain: NRS 4 or above, at least at a weekly basis.

  • Prevalence of sensory disturbances after reconstruction after mastectomy [ Time Frame: Cross-sectional, 2-3 years after surgery for breast cancer ]

Enrollment: 1352
Study Start Date: January 2008
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients treated with mastectomy without reconstruction
Patients treated with mastectomy followed by reconstruction
Procedure: Reconstruction
Reconstructive surgery after mastectomy, either by expander or autologous tissue. Includes both primary and secondary reconstruction

Detailed Description:
The aim of the study is to determine if reconstruction of the breast after mastectomy increases the risk of reporting persistent pain 2-3 years after surgery.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Nationwide cross-sectional cohort

Inclusion Criteria:

  • Patients with unilateral primary breast cancer aged 18-70 years

Exclusion Criteria:

  • recurrent cancer
  • other malignancy
  • emigration
  • non-standardized treatment
  Contacts and Locations
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Please refer to this study by its identifier: NCT01738048

Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Danish Breast Cancer Cooperative Group
Principal Investigator: Kenneth G Andersen, MD Rigshospitalet, University of Copenhagen
  More Information

Responsible Party: Kenneth Geving Andersen, Physician, research fellow, Rigshospitalet, Denmark Identifier: NCT01738048     History of Changes
Other Study ID Numbers: H-D-2007-0099B
Study First Received: November 22, 2012
Last Updated: November 29, 2012

Keywords provided by Kenneth Geving Andersen, Rigshospitalet, Denmark:
Neuropathic pain
Chronic pain

Additional relevant MeSH terms:
Chronic Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms processed this record on May 25, 2017