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

NASuspendedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

January 31, 2018

Primary Completion Date

January 31, 2020

Study Completion Date

March 31, 2020

Conditions
AscitesOvarian Epithelial CancerMalnutrition
Interventions
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.

Trial Locations (1)

81-519

Gdynia Oncology Center, Gdynia

Sponsors
All Listed Sponsors
lead

Gdynia Oncology Center

OTHER_GOV