Malnutrition Assessment Tools in Surgery (MATS)

May 7, 2024 updated by: Konstantinos Lasithiotakis, University Hospital of Crete

Evaluation of Malnutrition Risk Assessment Tools in General Surgery.

The purpose of this study is to evaluate the main malnutrition risk assessment tools in patients undergoing operations of general surgery.

Study Overview

Status

Completed

Conditions

Detailed Description

This is a multi centre prospective observational study including patients undergoing major/major+ operation of general surgery. Patients will be interviewed by surgical trainees and their malnutrition risk will be assessed with the use of SGA, MUST, NRS, MNA-SF etc. Clinical variables and demographics will also be recorded in order to enable meaningful comparisons of malnutrition risk assessment tools in terms of serious postoperative complications.

Study Type

Observational

Enrollment (Actual)

1650

Contacts and Locations

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

Study Locations

  • Cyprus
      • Nicosia, Cyprus
        • Department of Surgery, General Hospital of Nicosia, School of Medicine, University of Cyprus
  • Greece
      • Heraklion, Greece, 71110
        • Department of Surgery, University Hospital of Heraklion

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 to 108 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This is a prospective observational study including patients admitted in a surgical department during a 1-year study period, from January 2022 until January 2023 (TBReviewed)

Description

Inclusion Criteria:

  • Age >18 years

  • Patients undergoing elective or emergency surgery. Urgency of emergent operations is classified as follows, according to the clinical judgment of the surgeon, regarding the maximum time a patient could wait for surgery:

    • 3.Expedited (>18 hours)
    • 2B. Urgent (6-18 hours)
    • 2A. Urgent (2-6 hours)
    • 1. Immediate (<2 hours)
  • Operations involving the gastrointestinal tract

  • Magnitude of operation graded by POSSUM [17,18]:

    • Major+ (examples include colonic resection abdominoperineal resection of the rectum, radical total gastrectomy, intestinal bypass, whipple resection)
    • Major (examples include adhesiolysis, stoma formation, small bowel resection, anterior resection, cholecystectomy and exploration of the bile duct)

Exclusion Criteria:

  • Age <18 years

  • Magnitude of operation graded by POSSUM:

    • Minor
    • Intermediate
  • Inability to perform nutritional assessment
  • Inability to provide informed consent

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serious postoperative complications
Time Frame: 30 days after the operation
Complications >II according to Clavien-Dindo classification
30 days after the operation

Collaborators and Investigators

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

Sponsor

University Hospital of Crete

Investigators

  • Principal Investigator: Konstantinos Lasithiotakis, MD, PhD, University Hospital of Heraklion, Crete, Greece

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)

May 1, 2022

Primary Completion (Actual)

May 1, 2024

Study Completion (Actual)

May 1, 2024

Study Registration Dates

First Submitted

May 16, 2022

First Submitted That Met QC Criteria

May 25, 2022

First Posted (Actual)

May 26, 2022

Study Record Updates

Last Update Posted (Actual)

May 8, 2024

Last Update Submitted That Met QC Criteria

May 7, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18981/4-11-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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