- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03877588
Nutritional Status in Retroperitoneal Sarcoma. (NOVA)
March 14, 2019 updated by: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Perioperative Nutritional and Hemodinamic Support in Retroperitoneal Sarcoma Patients. A Phase II Prospective Feasibility Study.
Prospective feasibility study of perioperative nutrition in patients affected by primary retroperitoneal sarcoma
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Aim of our study was to investigate the feasibility of a prehabilitation policy to optimize protein energetic reserves in a group of patients affected by primary localized RPS, candidate to a multiple organ resection surgery, as well as the feasibility of a standardized nutritional postoperative caloric target and its adequacy.
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- every patient with retroperitoneal sarcoma scheduled for surgery
Exclusion Criteria:
- chronic renal failure
- diabetes mellitus
- emergency surgery
- physical status classification system ASA>3
- any contraindication to arterial catheter in Femoral artery for PICCO hemodynamic monitoring
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Primary retroperitoneal sarcoma
All eligible patients are screened in preoperative phase, at least 30 days before surgery, for presence of protein energetic malnutrition (PEM).
PEM is defined according to biochemical and physiological parameters (Table).
3 class of PEM are identified: no PEM, mild PEM and serious PEM.
Different nutritional oral supplements are provided according to the degree of malnutrition.
|
Preoperative oral nutritional support is provided according to malnutrition grade
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Adherence to protocol
Time Frame: 15 days
|
Rate of adherence to prescribed oral nutritional support
|
15 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 6, 2016
Primary Completion (Actual)
June 30, 2018
Study Completion (Actual)
November 30, 2018
Study Registration Dates
First Submitted
March 14, 2019
First Submitted That Met QC Criteria
March 14, 2019
First Posted (Actual)
March 15, 2019
Study Record Updates
Last Update Posted (Actual)
March 15, 2019
Last Update Submitted That Met QC Criteria
March 14, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- INT-91/16
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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