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NCT05174715 Clinical Trial

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

Malnutrition Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05174715
Other study ID # GLIMCTBIA
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2017
Est. completion date July 15, 2020

Study information
Verified date December 2021
Source Klinikum St. Georg gGmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 260
Est. completion date July 15, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• BIA
nutritional status was evaluated using BIA

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Klinikum St. Georg gGmbH

Outcome
Type Measure Description Time frame Safety issue
Primary overall complications all complications perioperatively including surgical side infections, anastomic leakage, sepsis 31 days POD
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