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NCT05393752 Clinical Trial

Malnutrition Assessment Tools in Surgery

Malnutrition Clinical Trial

— MATS  

Official title:
Evaluation of Malnutrition Risk Assessment Tools in General Surgery.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05393752
Other study ID # 18981/4-11-2021
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 1, 2022
Est. completion date May 1, 2024

Study information
Verified date May 2022
Source University Hospital of Crete
Contact Konstantinos Lasithiotakis, MD, PhD
Phone 00302810392677
Email k.lasithiotakis@uoc.gr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 2000
Est. completion date May 1, 2024
Est. primary completion date May 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 108 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Cyprus Department of Surgery, General Hospital of Nicosia, School of Medicine, University of Cyprus Nicosia
Greece Department of Surgery, University Hospital of Heraklion Heraklion

Sponsors (1)
Lead Sponsor Collaborator
University Hospital of Crete

Countries where clinical trial is conducted

Cyprus,  Greece, 

Outcome
Type Measure Description Time frame Safety issue
Primary serious postoperative complications Complications >II according to Clavien-Dindo classification 30 days after the operation
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