Malnutrition Assessment Tools in Surgery

NCT05393752 | Completed

• 1 other identifier: 18981/4-11-2021
• Study Type: observational
• Target: 1,650
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Malnutrition; Surgery--Complications

Keywords

nutrition; malnutrition; malnutrition risk tools; nutritional assessment; surgery

Outcome Measures

Primary Outcomes (1)

• serious postoperative complications

  Complications \>II according to Clavien-Dindo classification

  30 days after the operation

Eligibility Criteria

• Age: 18 Years - 108 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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:
• Expedited (\>18 hours)
• B. Urgent (6-18 hours)
• A. Urgent (2-6 hours)
• \. 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)

You may not qualify if:

• Age \<18 years
• Magnitude of operation graded by POSSUM:
• Minor
• Intermediate
• Inability to perform nutritional assessment
• Inability to provide informed consent

Sponsors & Collaborators

• University Hospital of Crete: lead

Study Sites (2)

Department of Surgery, General Hospital of Nicosia, School of Medicine, University of Cyprus

Nicosia, Cyprus

Location

Department of Surgery, University Hospital of Heraklion

Heraklion, 71110, Greece

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Konstantinos Lasithiotakis, MD, PhD

  University Hospital of Heraklion, Crete, Greece

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant Professor of Surgery

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: May 26, 2022
• Study Start: May 1, 2022
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CY (1); GR (1)