The primary aim of this study is to prospectively assess the incidence of pulmonary embolism in patients undergoing abdominal flap breast reconstruction.
ID
Source
Brief title
Condition
- Breast disorders
- Breast therapeutic procedures
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The occurrence of a pulmonary embolism.
Secondary outcome
To asses potential risk factors on pulmonary embolism: age, body mass index,
BRCA1 and BRCA2 gene mutations, smoking, a history of cancer, presence of
malignancy at the time of reconstruction, chemotherapy or hormonal therapy at
the time of reconstruction, previous radiotherapy, timing of reconstruction
(primary or secondary), laterality of reconstruction (unilateral or bilateral),
operation duration, complication other than pulmonary embolism and number of
re-operations will be recorded.
To investigate the potential etiology of pulmonary embolism in patients
undergoing an abdominal based breast reconstruction.
Background summary
Autologous abdominal free flap breast reconstruction is regarded as superior
compared to other breast reconstruction techniques available today. A
complication that has been reported less often is pulmonary embolism. A
possible explanation for this is that thromboembolic complications such as deep
venous thrombosis and pulmonary embolism often have a subclinical course. A
recent retrospective multicentre study performed at the Erasmus MC and the
Maastricht University Medical Centre, showed an incidence of pulmonary embolism
of four percent, which is high compared to other studies, especially when
taking into consideration that the thrombosis prophylaxis regimens did not
differ between these studies.
Study objective
The primary aim of this study is to prospectively assess the incidence of
pulmonary embolism in patients undergoing abdominal flap breast reconstruction.
Study design
A multicenter cohort study will be performed.
Study burden and risks
The first five days after surgery and at the outpatient clinic consultation two
weeks after surgery the patients will be scored on clinical sign suggestion
pulmonary embolism. Three months after surgery, patients will be asked, via a
telephonic interview, if a thrombo-vascular event occurred after surgery.
Taking part in the study is a minimal burden to patients in the form of a
questionnaire that will be completed six times and a telephone follow-up.
To investigate the potential etiology of pulmonary embolism in patients
undergoing an abdominal based breast reconstruction patient suspected of having
a pulmonary embolism will, apart from the normal CTA of the lungs, undergo a
CTA of the iliac vessels and a Duplex ultrasound of the lower extremities. The
CTA of the iliac vessels will be performed at the same time as the CTA of the
lungs to minimize the burden to patients. The scanning of the iliac vessels
adds a minimal radiation dose, which in our view is acceptable. The ultrasound
of the lower extremities is a non-invasive investigation with minimal risk for
the patient. It will however consume some time, approximately half an hour.
The aim of the research is to gain more insight in the incidence of pulmonary
embolism, possible risk factors and the aetiology.
Given the potential deadly effects of this less common complication we find it
justified with the burden and risks associated with participation.
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
All patients undergoing an abdominal flap breast reconstruction.
Aged 18 years or older
Exclusion criteria
Inability to confirm to the thrombosis prophylaxis protocol.
Patients who are on anticoagulant medication or have coagulopathy.
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 | NL50693.078.15 |