Malnutrition Assessment Tools in Surgery

Completed

• Conditions: Malnutrition; Surgery--Complications

• Registration Number: NCT05393752
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2022-05-01
• Study First Submitted: 2022-05-16
• Study First Submitted QC: 2022-05-25
• Study First Posted: 2022-05-26
• Status Verified: 2024-05
• Primary Completion: 2024-05-01
• Study Completion: 2024-05-01
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1650

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
serious postoperative complications	30 days after the operation	Complications \>II according to Clavien-Dindo classification

Trial Locations

Locations (2)

Department of Surgery, General Hospital of Nicosia, School of Medicine, University of Cyprus; 🇨🇾 Nicosia, Cyprus

Department of Surgery, University Hospital of Heraklion; 🇬🇷 Heraklion, Greece