Preoperative nutritional status and body composition in patients undergoing major abdominal surgery, particularly preoperative malnutrition, reduced muscle mass/sarcopenia, and unfavorable body composition as perioperative risk factors.
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Age = 18 years Scheduled major abdominal surgery, e.g., colorectal, hepatobiliary, pancreatic, gastric, or retroperitoneal surgery Availability of a preoperative CT scan performed for clinical reasons, usually within = 6 weeks prior to surgery Feasibility of a standardized bioelectrical impedance analysis, BIA, in standing or supine position depending on the device Capacity to provide informed consent Written voluntary informed consent after comprehensive information about the study
Exclusion criteria
Exclusion criteria: Presence of implantable electronic devices, e.g., pacemaker or implantable cardioverter-defibrillator, ICD, for which BIA is contraindicated Poor CT image quality or missing slice data preventing CT-based body and organ analysis, BOA Emergency or acute surgery preventing preoperative study enrollment and BIA measurement Pregnancy, if listed as a contraindication for BIA by the device manufacturer Lack of capacity to provide informed consent or refusal to participate in the study Insufficient language skills preventing complete study information and informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the correlation coefficient between the preoperatively assessed bioelectrical impedance analysis-derived fat-free mass index, FFMI in kg/m², and the CT-/BOA-derived skeletal muscle index, SMI in cm²/m², at the L3 level in patients prior to major abdominal surgery. The analysis will be performed exploratively using Spearman’s rank correlation coefficient with 95% confidence interval. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include the agreement between BIA-derived and CT-/BOA-derived body composition parameters assessed using Bland–Altman analysis, the association of BIA and CT-/BOA parameters with preoperative nutritional risk assessed by the Nutritional Risk Score 2002, NRS-2002, the association with postoperative complications, particularly severe postoperative complications defined as Clavien–Dindo grade = IIIa within 30 days after surgery, the association with length of hospital stay in days, and the feasibility of preoperative BIA measurement in routine clinical practice. | — |
Countries
Germany
Contacts
Universitätsklinikum Schleswig-Holstein