Persistent Pain After Reconstruction Following Mastectomy

NCT ID: NCT01738048

Last Updated: 2012-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1352 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer Chronic Pain

Keywords

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Pain Neuropathic pain Chronic pain

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Mastectomy

Patients treated with mastectomy without reconstruction

No interventions assigned to this group

Reconstruction

Patients treated with mastectomy followed by reconstruction

Reconstruction

Intervention Type PROCEDURE

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

Interventions

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Reconstruction

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* recurrent cancer
* other malignancy
* emigration
* non-standardized treatment
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Danish Breast Cancer Cooperative Group

OTHER

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Kenneth Geving Andersen

Physician, research fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kenneth G Andersen, MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, University of Copenhagen

Locations

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Rigshospitalet

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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Andersen KG, Kehlet H. Persistent pain after breast cancer treatment: a critical review of risk factors and strategies for prevention. J Pain. 2011 Jul;12(7):725-46. doi: 10.1016/j.jpain.2010.12.005. Epub 2011 Mar 24.

Reference Type BACKGROUND
PMID: 21435953 (View on PubMed)

Other Identifiers

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H-D-2007-0099B

Identifier Type: -

Identifier Source: org_study_id