Gynaecological tumour resection Surgery Tumour resection
Conditions
Interventions
During gynaecological tumour resection:
1. Intra-operative oesophageal Doppler guided fluid management with a balanced colloid solution
2. Intra-operative oesophageal Doppler guided fluid management w
Sponsors
Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Female patients aged 18 and over 2. Patients with metastatic ovarian carcinoma undergoing a tumour reduction operation at the University Hospital, Campus Virchow-Klinikum of the Charité - University Medicine Berlin 3. Offered patient information and written informed consent 4. No participation in another clinical trial during the trial until the 10th post-operative day
Exclusion criteria
Exclusion criteria: 1. Aged less than 18 years 2. Pregnancy or lactation 3. Lacking willingness to save and hand out pseudonymised data within the clinical study 4. Accommodation in an institution due to an official or judicial order 5. Advanced disease of the oesophagus of nasopharyngeal cavity 6. Operations in the area of the oesophagus or nasopharynx within the last two months 7. Liver disease (Child B or C cirrhosis, end-stage liver disease [MELD] score greater than 10) 8. Conditions after acute or chronic pancreatitis 9. History of bleeding tendency, e.g. Von Willebrands disease 10. Neurological or psychiatric disease 11. Unclear history of alcohol related disorder 12. Chronic heart failure class IV according to the New York Heart Association (NYHA) 13. American Society of Anaesthesiologists (ASA) classification greater than III 14. Renal insufficiency (serum creatinine greater than 2.0 mg/dl or greater than 150 µmol/l or dependency of haemodialysis) 15. Existence of a pulmonary oedema in the pre-operative chest x-ray 16. Allergy to hydroxyethyl starch or other ingredients of the intravenous solutions 17. History of intracranial haemorrhage within one year before participation in the study 18. Hyperkalaemia greater than 5.8 mmol/l and hypernatriaemia greater than 155 mmol/l 19. Pre-operative ileus symptomatology 20. Known history of hypermagnesaemia 21. Known history of metabolic alkalosis 22. Derailed diabetes mellitus (glucose greater than 300 mg/dl) before inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Differences of intra-operatively administered amount of intravenous fluids (balanced colloid versus balanced crystalloid solutions) within a goal-directed haemodynamic management | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Doses and duration of therapy with catecholamines measured intra-operatively and post-operatively during intensive care unit (ICU) stay 2. Time and number of hypotensive episodes measured intra-operatively and post-operatively during ICU stay 3. The quantity of intravenous fluid admininstered to the patient during the first 18 hours after surgery 4. The quantity of fluids per day lost by drainage during the first three days after surgery 5. Time that discharge criteria were met (measured by Post-Anaesthetic Discharge Scoring System [PADSS]) 6. Length of intensive care stay and length of hospital stay (LOS) 7. The rate of post-operative organ dysfuntions and complications (cardiac, pulmonal, renal, gastrointestinal) 8. The rate of post-operative delirium and the post-operative incidence of post-operative, cognitive dysfunction 9. Weight change until the fifth post-operative day 10. Peri-operative incidence of infections (according to the Centers for Disease Control and Prevention [CDC] and American Thoracic Society [ATS] criteria) 11. Patient, surgeon and anaesthetic satisfaction 12. Pain of the patient 13. Quality of life measured before the operation, at the day of hospital discharge and three months after surgery 14. Laboratory tests: peri-operative endothelial and immunological alterations The secondary outcome measures were determined if above not specified within the study up to the 10th post-operative day. | — |
Countries
Germany
Outcome results
None listed