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Completed

NCT Number: NCT01738048

Persistent Pain After Reconstruction Following Mastectomy

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Chronic Pain Neoplasms Neoplasms by Site Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

Rigshospitalet

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Reconstruction

Procedure

Reconstructive surgery after mastectomy, either by expander or autologous tissue. Includes both primary and secondary reconstruction

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Danish Breast Cancer Cooperative Group

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Nov 30, 2012
Registry last updated
Nov 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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