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Malnutrition Assessment Tools in Surgery (MATS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05393752
Recruitment Status : Recruiting
First Posted : May 26, 2022
Last Update Posted : May 26, 2022
Information provided by (Responsible Party):
Konstantinos Lasithiotakis, University Hospital of Crete

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

Condition or disease
Malnutrition Surgery--Complications

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.

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Malnutrition Risk Assessment Tools in General Surgery.
Actual Study Start Date : May 1, 2022
Estimated Primary Completion Date : May 1, 2024
Estimated Study Completion Date : May 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

Primary Outcome Measures :
  1. serious postoperative complications [ Time Frame: 30 days after the operation ]
    Complications >II according to Clavien-Dindo classification

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 108 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05393752

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Contact: Konstantinos Lasithiotakis, MD, PhD 00302810392677
Contact: Georgia Petra, MD, PhDc 00302810392751

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Department of Surgery, General Hospital of Nicosia, School of Medicine, University of Cyprus Not yet recruiting
Nicosia, Cyprus
Contact: Nikolaos Gouvas, PhD   
Department of Surgery, University Hospital of Heraklion Recruiting
Heraklion, Greece, 71110
Contact: Konstantinos Lasithiotakis    00302810392677   
Sponsors and Collaborators
University Hospital of Crete
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Principal Investigator: Konstantinos Lasithiotakis, MD, PhD University Hospital of Heraklion, Crete, Greece
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Responsible Party: Konstantinos Lasithiotakis, Assisstant Professor of Surgery, University Hospital of Crete Identifier: NCT05393752    
Other Study ID Numbers: 18981/4-11-2021
First Posted: May 26, 2022    Key Record Dates
Last Update Posted: May 26, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Konstantinos Lasithiotakis, University Hospital of Crete:
malnutrition risk tools
nutritional assessment
Additional relevant MeSH terms:
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Nutrition Disorders