Nutritional Status in Retroperitoneal Sarcoma.

NCT ID: NCT03877588

Last Updated: 2019-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-06

Study Completion Date

2018-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Retroperitoneal Sarcoma Malnutrition

Study Design

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Intervention Model

SEQUENTIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Oral Nutritional Support

Intervention Type DIETARY_SUPPLEMENT

Preoperative oral nutritional support is provided according to malnutrition grade

Interventions

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Oral Nutritional Support

Preoperative oral nutritional support is provided according to malnutrition grade

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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Previtali P, Fiore M, Colombo J, Arendar I, Fumagalli L, Pizzocri M, Colombo C, Rampello NN, Mariani L, Gronchi A, Codazzi D. Malnutrition and Perioperative Nutritional Support in Retroperitoneal Sarcoma Patients: Results from a Prospective Study. Ann Surg Oncol. 2020 Jun;27(6):2025-2032. doi: 10.1245/s10434-019-08121-0. Epub 2019 Dec 17.

Reference Type DERIVED
PMID: 31848820 (View on PubMed)

Other Identifiers

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INT-91/16

Identifier Type: -

Identifier Source: org_study_id

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