Persistent Pain After Reconstruction Following Mastectomy

Completed

• Conditions: Breast Cancer; Chronic Pain
• Interventions: Procedure: Reconstruction

• Registration Number: NCT01738048
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2008-01
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Status Verified: 2012-11
• Study First Submitted: 2012-11-22
• Study First Submitted QC: 2012-11-29
• Last Update Submitted: 2012-11-29
• Study First Posted: 2012-11-30
• Last Update Posted: 2012-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1352

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Reconstruction	Reconstruction	Patients treated with mastectomy followed by reconstruction

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark