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NCT03877588 Clinical Trial

Nutritional Status in Retroperitoneal Sarcoma.

Malnutrition Clinical Trial

— NOVA  

Official title:
Perioperative Nutritional and Hemodinamic Support in Retroperitoneal Sarcoma Patients. A Phase II Prospective Feasibility Study.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03877588
Other study ID # INT-91/16
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 6, 2016
Est. completion date November 30, 2018

Study information
Verified date March 2019
Source Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Prospective feasibility study of perioperative nutrition in patients affected by primary retroperitoneal sarcoma

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.

Recruitment information / eligibility
Status Completed
Enrollment 35
Est. completion date November 30, 2018
Est. primary completion date June 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Oral Nutritional Support
Preoperative oral nutritional support is provided according to malnutrition grade

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of Adherence to protocol Rate of adherence to prescribed oral nutritional support 15 days
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