The impact of reconstructive breast surgery on the risk of developing lymphedema

Recruiting

• Conditions: arm swelling; lymphatic dysfunction; 10006232; 10006295; 10025231

• Registration Number: NL-OMON38329
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 300

Inclusion Criteria

1) Female 2) Mastectomy with or without breast reconstruction ( primary or secondary and by means of prosthesis or autologous tissue) 3)Operated on between January 1st 2006 and December 31st 2010. 4) unilateral disease and oncological operation.

Exclusion Criteria

1) Bilateral breast disease or oncological operation 2) Refused informed consent 3) Death 4) Relapsed cancer at time of study inclusion 5)Metastatic disease

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main endpoints are objective lymphedema (water displacement volume<br /><br>difference > 200 ml) and subjective lymphedema (swelling and heaviness of the<br /><br>treated limb perceived by patient).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>In the descriptive part of this study we will look at the 1) presence and<br /><br>severity of lymphedema and the correlation with risk factors, 2) functional<br /><br>consequences due to lymphedema and 3) lymphedema staging</p><br>