Prevalence of Malnutrition in Surgery (PROMIS)

April 23, 2019 updated by: Società Italiana di Nutrizione Clinica e Metabolismo
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Simona Saracco
  • Phone Number: (+39) 06 845431

Study Locations

  • Italy
      • Brescia, Italy
        • Recruiting
        • Pof. Romario Fumagalli
      • Catania, Italy
        • Recruiting
        • Leonardo De Meo
      • Reggio Emilia, Italy
        • Recruiting
        • Claudio Pedrazzi
      • Rome, Italy, 00198
      • Rome, Italy
        • Recruiting
        • Antonio Gasbarrini
      • Rome, Italy
        • Recruiting
        • Roberto Caronna
      • Terni, Italy
        • Recruiting
        • Amilcare Parisi
      • Verona, Italy
        • Recruiting
        • Giovanni de Manzoni

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

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who are candidates for surgery for gastrointestinal cancer (esophagus, stomach, small intestine, pancreas, biliary tract, colon, rectum, liver)

Description

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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Malnutrition
Time Frame: Pre-operative
Malnutrition will be assessed by Malnutrition Universal Screening Tool (MUST)
Pre-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative complications
Time Frame: Hospital discharge (10-15 days)
Incidence of pneumonia, sepsis and dehiscence of the surgical wound.
Hospital discharge (10-15 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Società Italiana di Nutrizione Clinica e Metabolismo

Collaborators

University of Roma La Sapienza
Catholic University of the Sacred Heart
Campus Bio-Medico University

Investigators

  • Principal Investigator: Roberto Coppola, Campus Bio-Medico of Rome

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.

General Publications

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)

January 6, 2017

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

December 31, 2019

Study Registration Dates

First Submitted

March 17, 2018

First Submitted That Met QC Criteria

April 23, 2019

First Posted (Actual)

April 24, 2019

Study Record Updates

Last Update Posted (Actual)

April 24, 2019

Last Update Submitted That Met QC Criteria

April 23, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01 (Miami VAHS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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