|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 December 2017 |
|
Main ID: |
NCT02742428 |
|
Date of registration:
|
11/04/2016 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Preoperative Ascites Drainage Versus Standard Care for Patients With Advanced Ovarian Cancer
|
|
Scientific 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. |
|
Date of first enrolment:
|
January 2018 |
|
Target sample size:
|
40 |
|
Recruitment status: |
Suspended |
|
URL:
|
https://clinicaltrials.gov/show/NCT02742428 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Poland
| | | | | | | |
|
Contacts
|
|
Name:
|
Maciej Stukan, MD, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Gdynia Oncology Center |
| | |
|
Key inclusion & exclusion criteria
|
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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Malnutrition
|
|
Ascites
|
|
Ovarian Epithelial Cancer
|
|
Intervention(s)
|
|
Behavioral: Interview.
|
|
Procedure: Acute paracentesis.
|
|
Behavioral: Nutritional status.
|
|
Behavioral: Quality of life.
|
|
Device: Systematic ascites evacuation
|
|
Primary Outcome(s)
|
|
Volume of intravenous fluids transfused.
[Time Frame: 1 hour]
|
|
Changes in median arterial pressure (MAP) during anesthesia.
[Time Frame: 1 hour]
|
|
Number of participants who required vasoconstrictors.
[Time Frame: 1 hour]
|
|
Changes in Heart Rate (HR).
[Time Frame: 1 hour]
|
|
Secondary Outcome(s)
|
|
Changes in feeding ability.
[Time Frame: 7 days]
|
|
Changes in patients' quality of life.
[Time Frame: 7 days]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|