NCT02742428

Preoperative Ascites Drainage Versus Standard Care for Patients With Advanced Ovarian Cancer

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.

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Gdynia Oncology Center · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ascites
• Ovarian Epithelial Cancer
• Malnutrition

Interventions

Type	Name	Description
DEVICE	Systematic 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.
PROCEDURE	Acute 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.
BEHAVIORAL	Interview.	Interview according to provided chart in order to collect data concerning symptoms, co-morbidities.
BEHAVIORAL	Quality of life.	Patients will be asked to fill in a quality of life questionnaire (EORTC-C15-PAL) before randomization and 7 days later.
BEHAVIORAL	Nutritional 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.

Timeline

• Start date: 2018-01-01
• Primary completion: 2020-01-01
• Completion: 2020-03-01
• First posted: 2016-04-19
• Last updated: 2017-05-02

Locations

1 site across 1 country: Poland