Malnutrition Clinical Trial
Official title:
Preoperative Slow Ascites Drainage Versus Standard Care for Patients With Proven or Suspected Advanced Ovarian Cancer - a Hemodynamic Impact on Systemic Circulation, Patient's Nutritional Status and Quality of Life: a Randomized Trial.
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.
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