Persistent Pain After Reconstruction Following Mastectomy

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01738048

Enrollment

1352

Registered

2012-11-30

Start date

2008-01-31

Completion date

2008-04-30

Last updated

2012-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Chronic Pain

Keywords

Pain, Neuropathic pain, Chronic pain

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.

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.

Interventions

PROCEDUREReconstruction

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

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
The risk of developing persistent if reconstructed	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

Measure	Time frame	Description
Prevalence of persistent pain after reconstruction after mastectomy	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	Cross-sectional, 2-3 years after surgery for breast cancer	—

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026