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Malnutrition Assessment Tools in Surgery (MATS)

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ClinicalTrials.gov Identifier: NCT05393752
Recruitment Status : Recruiting
First Posted : May 26, 2022
Last Update Posted : May 26, 2022
Sponsor:
Information provided by (Responsible Party):
Konstantinos Lasithiotakis, University Hospital of Crete

Study Description
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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.
Study Design
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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

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


Eligibility Criteria
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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)
Criteria

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT05393752


Contacts
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Contact: Konstantinos Lasithiotakis, MD, PhD 00302810392677 k.lasithiotakis@uoc.gr
Contact: Georgia Petra, MD, PhDc 00302810392751 geopetra94@gmail.com

Locations
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Cyprus
Department of Surgery, General Hospital of Nicosia, School of Medicine, University of Cyprus Not yet recruiting
Nicosia, Cyprus
Contact: Nikolaos Gouvas, PhD       gouvas.nikolaos@ucy.ac.cy   
Greece
Department of Surgery, University Hospital of Heraklion Recruiting
Heraklion, Greece, 71110
Contact: Konstantinos Lasithiotakis    00302810392677    k.lasithiotakis@uoc.gr   
Sponsors and Collaborators
University Hospital of Crete
Investigators
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Principal Investigator: Konstantinos Lasithiotakis, MD, PhD University Hospital of Heraklion, Crete, Greece
More Information
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Responsible Party: Konstantinos Lasithiotakis, Assisstant Professor of Surgery, University Hospital of Crete
ClinicalTrials.gov 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:
nutrition
malnutrition
malnutrition risk tools
nutritional assessment
surgery
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders