Primarily, we will evaluate and compare postoperative sensation between different sensate autologous breast reconstructions. Secondarily, we will evaluate and compare quality of life measured by the validated BREAST-Q questionnaire between theā¦
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To compare breast sensation in different types of autologous breast
reconstruction with sensory nerve coaptation.
Secondary outcome
To compare the patient reported quality of life in different types of
autologous breast reconstruction with sensory nerve coaptation..
Background summary
Breast cancer is the most common cancer worldwide. Over the last decades, the
focus of reconstruction after breast cancer has primarily been on aesthetics,
but is shifting more and more towards other aspects of the reconstruction as
well, such as breast sensation. Increase in postoperative breast sensation,
which is known to increase quality of life, can be established by adding nerve
coaptation to autologous reconstruction. Various studies regarding innervated
reconstructions and breast sensation have been published, but often focus on
one or two types of flaps. In this study, we will therefore compare sensation
between different types of autologous breast sensation.
Study objective
Primarily, we will evaluate and compare postoperative sensation between
different sensate autologous breast reconstructions. Secondarily, we will
evaluate and compare quality of life measured by the validated BREAST-Q
questionnaire between the different reconstructions.
Study design
A cross-sectional, explorative study performed in the Maastricht University
Medical Centre (MUMC+). Breast sensation will be measured with three
modalities: the Semmes-Weinstein monofilaments (SWM), the pressure specified
sensory device (PSSD), and the quantitative sensory testing (QST). We will
correct for several covariates with the statistical analysis, among which is
postoperative time.
Study burden and risks
Participation is voluntarily. Participants can withdraw at any time during the
study without further consequences. The measurement will take place at the
outpatient clinic and duration will be approximately 60-90 minutes. The methods
do not harm the participant and are not painful. There are no risks or
complications associated or reported with these measurement techniques.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
- Female sex
- 18 years or older
- A history of breast cancer or carrier of BRCA1/2 gene mutations
- Underwent autologous breast reconstruction with a free flap
(unilateral/bilateral, immediate/delayed)
- >7 months after reconstruction
- Sensory nerve coaptation
- Being mentally competent to be able to give informed consent.
Exclusion criteria
- Postoperative radiotherapy
- Known (neurological) conditions that affect the sensation such as diabetes
mellitus and neuropathy, regardless of cause
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 | NL83649.068.23 |