breast reconstruction with own tissue DIEP-flap reconstruction
Conditions
Interventions
1. Dobutamine 5microgram/kg/min peroperative, 18hours postoperative 0.9% NaCl
infusion
2. Dobtuamine 5microgram/kg/min until 18hours postoperative
3. 0.9% NaCl infusion both per- and 18hours postoper
Sponsors
Orbis Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - women - age between 30 and 65 years old - breast carcinoma in the history - mastectomy in the history - planned secondary reconstruction by means of a DIEP-flap
Exclusion criteria
Exclusion criteria: - cardiac history (i.e. atrial fibrillation) - clotting disorders (deep venous thrombosis or pulmonary embolus in the history) - smoking - allergic reaction to dobutamine or bisulfate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increase in microcirculatory blood flow after dobutamine infusion and measured by means of laser Doppler flowmetry. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Is the incidence of partial or total flap necrosis lower after peroperative intravenous dobutamine infusion as compared to placebo [clinical judgement: the amount of visible necrotic (black) tissue, measured and calculated as percentage of the total flap]? 2. Is the incidence of fat necrosis lower after peroperative intravenous dobutamine infusion as compared to placebo (postoperative ultrasound)? 3. Is the incidence of partial or total flap necrosis and fat necrosis lower when dobutamine is given 18 hours post-operative as compared to peroperative? 4. How often has the escape been used to keep the blood pressure at level? 5. Quality of life (measured by means of a questionnaire sent after 2 weeks, 6 weeks and 3 months) Other study parameters which might intervene with the main study endpoints are body weight, chemotherapy, radiation therapy, previously abdominal surgery, diabetes and smoking. | — |
Countries
Netherlands
Outcome results
None listed