Ascites, Malnutrition, Ovarian Epithelial Cancer
Conditions
Brief summary
Patients with significant ascites and advanced ovarian cancer (AOC), undergoing complex, cytoreductive surgery are at risk of malnutrition, poor quality of life and the risk of hypo- or hypervolemia in a perioperative period. All these factors may cause hemodynamic consequences during anesthesia and surgery, and elevate the risk of morbidity and mortality. The objective of the study is to evaluate, whether slow ascites evacuation for a few days before the surgery for AOC, could 1) influence the hemodynamic consequences of ascites on systemic circulation in patients undergoing surgery, 2) improve patient's quality of life and 3) ability to feed correctly before treatment starts, and thus lower the risk of perioperative morbidity. Eligible patients are those with significant ascites, diagnosed or suspected for AOC, who are scheduled for primary surgery (both upfront cytoreduction or laparoscopic evaluation before neoadjuvant chemotherapy), that cannot be performed within next 7 or more days, for any reason. Patients will be asked to fill in quality of life questionnaire (QLQ). Clinical data, a Subjective Global Assessment (SGA) will be recorded. Patients will be randomized to either intervention arm A - insertion of vascular catheter into abdominal cavity and slow, systematic, daily ascites evacuation, or to observation arm B - standard of care with just observation (acute large volume (\>5000ml) paracentesis allowed if needed). Patients in both groups will be encouraged to use oral nutritional support. Randomization will be open, 1:1, for every eligible, consecutive patient. After 7 days patients will be interviewed, asked to fill in QLQ, patient's experience on the treatment survey, a SGA will be recorded. During the first hour of the surgery hemodynamic data from anethetic charts will be recorded along with other clinical data concerning patient's characteristics, surgery details and 30-day postoperative follow-up. A template is provided. The hypothesis of the study is that slow, systematic ascites evacuation few days before surgery for advanced ovarian cancer can facilitate hemodynamic control of systemic circulation of patients undergoing surgery, and improve patients' quality of life, feeding ability before treatment starts. Secondary we would expect lower risk of perioperative morbidity and mortality.
Interventions
DEVICESystematic ascites evacuation
Systematic ascites evacuation via indwelling catheter inserted into abdominal cavity, sutured to the skin. Drainage performed by the patient, on demand with day limit of 2000ml, in ambulatory settings.
PROCEDUREAcute paracentesis.
Evacuation of a large (\>5000ml) volume of ascites via single abdominocentesis. Allowed in observational arm only, in case of acute symptoms concerned with ascites.
BEHAVIORALInterview.
Interview according to provided chart in order to collect data concerning symptoms, co-morbidities.
BEHAVIORALQuality of life.
Patients will be asked to fill in a quality of life questionnaire (EORTC-C15-PAL) before randomization and 7 days later.
BEHAVIORALNutritional status.
Patients will be asked to fill in (together with a physician) a questionnaire to assess risk of malnutrition (SGA) before randomization and 7 days later.
Sponsors
Gdynia Oncology Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients with significant ascites and suspected ovarian cancer scheduled for upfront cytoreductive surgery, or diagnostic laparoscopy and neoadjuvant chemotherapy, and the surgery is planned to be performed in at least 7 days, * signed informed consent of the patient.
Exclusion criteria
* ascites not of malignant origin, * low volume ascites, * other then primary ovarian malignancy suspected, * suspected or clinically apparent infection especially at the site of planned drainage placement, * no patient's consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in median arterial pressure (MAP) during anesthesia. | 1 hour | Changes (minimal and maximal) in median arterial pressure during 1st hour of anesthesia during cytoreductive surgery for advanced ovarian cancer - comparison of two groups: with and without preoperative ascites drainage. MAP calculation - MAP = \[(2 x diastolic)+systolic\] / 3. |
| Changes in Heart Rate (HR). | 1 hour | Changes in HR (minimal and maximal) during 1st hour of anesthesia during cytoreductive surgery for advanced ovarian cancer - comparison of two groups: with and without preoperative ascites drainage. |
| Number of participants who required vasoconstrictors. | 1 hour | Need for using vasoconstrictors during 1st hour of cytoreductive surgery for advanced ovarian cancer - comparison of two groups: with and without preoperative ascites drainage. |
| Volume of intravenous fluids transfused. | 1 hour | Volume of intravenous fluids transfused during the 1st hour of cytoreductive surgery for advanced ovarian cancer - comparison of two groups: with and without preoperative ascites drainage. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in feeding ability. | 7 days | Evaluation of changes in feeding ability before the treatment starts, according to Subjective Global Assesment survey - comparison of two groups: with and without preoperative ascites drainage. |
| Changes in patients' quality of life. | 7 days | To note any changes in quality of life evaluated with standardized quality of life questionnaire. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of participants correctly diagnosed with ovarian cancer based on ascitic fluid cytology. | 1 day | Ascitis fluid collected for cytology examination. The accuracy of ascitic fluid cytology in diagnosing ovarian cancer. |
| Changes in prealbumin concentration. | 7 days | Changes in nutritional status measured with prealbumin plasma concentration. |
| Changes in Phase Angle (PA). | 7 days | Changes in nutritional status measured with bioimpedance analysis tools and defined with PA. Parameters will be recorded at randomisation and before the surgery. |
| Changes in Extracellular Fluid (ECF) and Intracellular Fluid (ICF). | 7 days | Changes in body fluid balance measured with bioimpedance analysis tools and defined with ECF and ICF. Parameters will be recorded at randomization, before surgery, and during the 1st hour of the anesthesia. |
| Number of adverse events concerned with indwelling catheter insertion. | 7 days | Number of adverse events concerned with catheter insertion for ascites drainage. |
Countries
Poland
Outcome results
None listed