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Clinical Trials/NCT03926715
NCT03926715
Unknown
Not Applicable

Prevalence of Malnutrition in Surgery

Società Italiana di Nutrizione Clinica e Metabolismo8 sites in 1 country700 target enrollmentJanuary 6, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Malnutrition
Sponsor
Società Italiana di Nutrizione Clinica e Metabolismo
Enrollment
700
Locations
8
Primary Endpoint
Malnutrition
Last Updated
7 years ago

Overview

Brief Summary

Nutritional disorders are highly prevalent in gastrointestinal cancer patients undergoing surgery and have shown to contribute significantly in short, mid and long-term clinical outcome. Although increasing evidence and expert suggestions there is still inadequate awareness about the clinical relevance of nutritional and metabolic alterations in surgical oncologic patients.

Detailed Description

Nutritional disorders are highly prevalent in cancer patients and have shown to contribute significantly in short-, mid- and long-term clinical outcome. The prevalence of malnutrition is reported between 25% and over 70% based on nutritional assessments. Nutritional disorders represent an important risk factor for the occurence of postoperative complications. Main obstacles to improving nutritional care include lack of awareness for the problem among the general public and lack of awareness among decision makers and even care providers. Considering the high prevalence of malnutrition and its repercussions in patient morbidity-mortality and healthcare cost, nutritional screening measures must be included in an integrated nutritional care plan for patients before surgery and while in the hospital. The PRoMiS study was conceived to quantify nutritional disorders among gastrointestinal cancer patients undergoing surgery in Italy. The data obtained will contribute to increase the awareness of nutritional disorders among oncology surgical patients and their impact on clinical outcome, favoring the inclusion of the initial assessment of nutritional status before surgery and of the nutritional intervention.

Registry
clinicaltrials.gov
Start Date
January 6, 2017
End Date
December 31, 2019
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Società Italiana di Nutrizione Clinica e Metabolismo
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients who are candidates for surgery for gastrointestinal cancer (esophagus, stomach, small intestine, pancreas, biliary tract, colon, rectum, liver)
  • Diagnosis of malignant solid tumor
  • Age\> 18 years
  • Informed consent

Exclusion Criteria

  • Uncontrolled metabolic disorders
  • Uncompensated heart failure
  • Severe psychiatric disorders
  • Appropriate logistical support for participation in the study.

Outcomes

Primary Outcomes

Malnutrition

Time Frame: Pre-operative

Malnutrition will be assessed by Malnutrition Universal Screening Tool (MUST)

Secondary Outcomes

  • Post-operative complications(Hospital discharge (10-15 days))

Study Sites (8)

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