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

The impact of reconstructive breast surgery on the risk of developing lymphedema - PAL 2

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON38329

Enrollment

300

Registered

2011-10-19

Start date

2011-11-15

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

arm swelling lymphatic dysfunction

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The main endpoints are objective lymphedema (water displacement volume difference > 200 ml) and subjective lymphedema (swelling and heaviness of the treated limb perceived by patient).	—

Secondary

Measure	Time frame
In the descriptive part of this study we will look at the 1) presence and severity of lymphedema and the correlation with risk factors, 2) functional consequences due to lymphedema and 3) lymphedema staging	—

Countries

Netherlands

Outcome results