Malnutrition Using GLIM Criteria and Comparing CT and BIA for Muscle Mass Measurement

December 30, 2021 updated by: Maria Wobith, Klinikum St. Georg gGmbH

Evaluation of Malnutrition in Patients Undergoing Major Abdominal Surgery Using GLIM Criteria and Comparing CT and BIA for Muscle Mass Measurement

Evaluation of malnutrition with the help of the GLIM criteria. Muscle mass measurement, as recommended in the GLIM criteria was done with the help of abdominal CT scan and BIA. Both methods were compared and their association to the clinical outcome was assessed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We retrospectively analysed 260 patients undergoing major abdominal surgery between January 2017 and December 2019. Patients were prospectively screened and assessed for malnutrition with Nutritional Risk Score (NRS) and Subjective Global assessment (SGA). Body composition was analysed with CT scan and BIA within 30 days before surgery. GLIM criteria were retrospectively determined referring to the Fat free Mass from BIA (FFMBIA) and Muscle Mass from axial CT scan at lumbar level 3 (MMCT). The prevalence of GLIM - malnutrition according to BIA and CT was evaluated. Multivariate logistic regression analysis was used to determine association between malnutrition and outcome parameters. ROC-curves specified sensitivity and specificity of the different tools and areas under the curve were calculated.

Study Type

Observational

Enrollment (Actual)

260

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing major abdominal surgery for gastrointestinal cancer

Description

Inclusion Criteria:

  • age above 18 years
  • BIA and CT scan was available within 31 days before surgery
  • patients undergoing major abdominal surgery for gastrointestinal cancer

Exclusion Criteria:

  • patients who were not able to agree to the participation
  • missing assessment of the nutritional status
  • leck of quality of the CT scan

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall complications
Time Frame: 31 days POD
all complications perioperatively including surgical side infections, anastomic leakage, sepsis
31 days POD

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Klinikum St. Georg gGmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2017

Primary Completion (ACTUAL)

December 31, 2019

Study Completion (ACTUAL)

July 15, 2020

Study Registration Dates

First Submitted

December 14, 2021

First Submitted That Met QC Criteria

December 14, 2021

First Posted (ACTUAL)

January 3, 2022

Study Record Updates

Last Update Posted (ACTUAL)

January 14, 2022

Last Update Submitted That Met QC Criteria

December 30, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GLIMCTBIA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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