Persistent Pain After Reconstruction Following Mastectomy

November 29, 2012 updated by: Kenneth Geving Andersen, Rigshospitalet, Denmark
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1352

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Nationwide cross-sectional cohort

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Cross-sectional, 2-3 years after surgery for breast cancer

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

Danish Breast Cancer Cooperative Group

Investigators

  • Principal Investigator: Kenneth G Andersen, MD, Rigshospitalet, University of Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

November 22, 2012

First Submitted That Met QC Criteria

November 29, 2012

First Posted (Estimate)

November 30, 2012

Study Record Updates

Last Update Posted (Estimate)

November 30, 2012

Last Update Submitted That Met QC Criteria

November 29, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-D-2007-0099B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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