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Persistent Pain After Reconstruction Following Mastectomy

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ClinicalTrials.gov Identifier: NCT01738048
Recruitment Status : Completed
First Posted : November 30, 2012
Last Update Posted : November 30, 2012
Sponsor:
Collaborator:
Danish Breast Cancer Cooperative Group
Information provided by (Responsible Party):
Kenneth Geving Andersen, Rigshospitalet, Denmark

Brief Summary:
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 or disease Intervention/treatment
Breast Cancer Chronic Pain Procedure: 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.

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Study Type : Observational
Actual Enrollment : 1352 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Persistent Pain After Reconstruction Following Mastectomy
Study Start Date : January 2008
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Mastectomy
Patients treated with mastectomy without reconstruction
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




Primary Outcome Measures :
  1. 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 :
  1. 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.

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


Information from the National Library of Medicine

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

Inclusion Criteria:

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

Exclusion Criteria:

  • recurrent cancer
  • other malignancy
  • emigration
  • non-standardized treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01738048


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

Publications:
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Responsible Party: Kenneth Geving Andersen, Physician, research fellow, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01738048    
Other Study ID Numbers: H-D-2007-0099B
First Posted: November 30, 2012    Key Record Dates
Last Update Posted: November 30, 2012
Last Verified: November 2012
Keywords provided by Kenneth Geving Andersen, Rigshospitalet, Denmark:
Pain
Neuropathic pain
Chronic pain
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms