Malnutrition Assessment Tools in Surgery (MATS)

• ClinicalTrials.gov Identifier: NCT05393752
• Recruitment Status: Completed
• First Posted: May 26, 2022
• Last Update Posted: May 8, 2024
• Sponsor: University Hospital of Crete
• Information provided by (Responsible Party): Konstantinos Lasithiotakis, University Hospital of Crete

Tracking Information

• First Submitted Date: May 16, 2022
• First Posted Date: May 26, 2022
• Last Update Posted Date: May 8, 2024
• Actual Study Start Date: May 1, 2022
• Actual Primary Completion Date: May 1, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 25, 2022)

serious postoperative complications [ Time Frame: 30 days after the operation ]

Complications >II according to Clavien-Dindo classification

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Malnutrition Assessment Tools in Surgery
• Official Title: Evaluation of Malnutrition Risk Assessment Tools in General Surgery.
• 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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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)

Condition

• Malnutrition
• Surgery--Complications

• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 7, 2024): 1650
• Original Estimated Enrollment (submitted: May 25, 2022): 2000
• Actual Study Completion Date: May 1, 2024
• Actual Primary Completion Date: May 1, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 108 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Cyprus, Greece

Administrative Information

• NCT Number: NCT05393752
• Other Study ID Numbers: 18981/4-11-2021
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Konstantinos Lasithiotakis, University Hospital of Crete
• Original Responsible Party: Same as current
• Current Study Sponsor: University Hospital of Crete
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: University Hospital of Crete
• Verification Date: May 2024