Malnutrition Assessment Tools in Surgery

Malnutrition Clinical Trial

— MATS  

Official title:

Evaluation of Malnutrition Risk Assessment Tools in General Surgery.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05393752
• Other study ID #: 18981/4-11-2021
• Status: Completed
• Start date: May 1, 2022
• Est. completion date: May 1, 2024

Study information

• Verified date: May 2024
• Source: University Hospital of Crete
• Contact: n/a
• Is FDA regulated: No
• 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: Completed
• Enrollment: 1650
• 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

Related Conditions & MeSH terms

• Malnutrition
• Surgery--Complications

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