Our primary objective is to determine the effect of breast reconstruction on the risk of developing lymphedema. Secondarily, we will look at lymphedema and the correlation with 1) primary and secondary breast reconstruction, 2) the extent of…
ID
Source
Brief title
Condition
- Breast disorders
- Breast therapeutic procedures
- Lymphatic vessel disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
Breast reconstructive surgery has over the years become an important addition
to the management of breast cancer in women. Little is known about the effect
breast reconstruction has on the development of lymphedema: a possible additive
risk increase or even a risk decrease. Lymphedema is a highly debilitating
complication that among others causes pain, reduced range of motion and
emotional stress. Given the fact that women under the age of 65 represent the
majority of patients undergoing reconstruction and with focus on the quality of
survivorship, research is relevant.
Study objective
Our primary objective is to determine the effect of breast reconstruction on
the risk of developing lymphedema. Secondarily, we will look at lymphedema and
the correlation with 1) primary and secondary breast reconstruction, 2) the
extent of axillary dissection, 3) adjuvant therapy, 4) risk factors, and 5)
functional consequences.
Study design
This study is a cross-sectional study, a partnership of the general and plastic
surgery department. Together we will form a cohort of women with the aim of
determining the impact of breast reconstruction on the development of
lymphedema.
Study burden and risks
The patients are not subject to any risks or complications during the course of
this study, therefore insurance exemption is requested. The women will visit
one of the participating institutes for a one time medical examination and
interview of approximately 1 hour. During this examination, the upper limbs
will be assessed for sensory, motor, strength and mobility changes.
Furthermore, we will measure the volume and circumference difference between
the treated and untreated side using two measuring techniques. One
questionnaire about *risk factors for lymphedema* is to be filled in.
Tongersestraat 17
6211 LL Maastricht
NL
Tongersestraat 17
6211 LL Maastricht
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL37212.068.11 |