MATS: Malnutrition Assessment Tools in Surgery

• Sponsor: University Hospital of Crete (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05393752
• Collaborator: (none)
• Enrollment: 2,000
• Locations: 2
• Anticipated Duration (Months): 24
• Patients Per Site: 1000
• Patients Per Site Per Month: 41.6

Study Details

Study Description

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	Intervention/Treatment	Phase
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

• Study Type: Observational
• Anticipated 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
• Anticipated Primary Completion Date: May 1, 2024
• Anticipated Study Completion Date: May 1, 2024

Outcome Measures

Primary Outcome Measures

1. serious postoperative complications [30 days after the operation]

   Complications >II according to Clavien-Dindo classification

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 108 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Department of Surgery, General Hospital of Nicosia, School of Medicine, University of Cyprus	Nicosia		Cyprus
2	Department of Surgery, University Hospital of Heraklion	Heraklion		Greece	71110

Sponsors and Collaborators

• University Hospital of Crete

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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
• Last Update Posted: May 26, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Konstantinos Lasithiotakis, Assisstant Professor of Surgery, University Hospital of Crete: nutrition; malnutrition; malnutrition risk tools; nutritional assessment; surgery
• Additional relevant MeSH terms: Malnutrition

Study Results

No Results Posted as of May 26, 2022