Nutritional Status and Nutrient Supply in Hospitalised Surgical Patients

Completed

• Conditions: Gastric Cancer; Colorectal Cancer; Esophageal Cancer

• Registration Number: NCT03787537
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

Prospective single arm, single center observational study to assess the nutritional status and the nutrient supply during hospitalization for elective gastrointestinal surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-01
• Study First Submitted: 2018-12-07
• Study First Submitted QC: 2018-12-23
• Study First Posted: 2018-12-26
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-30
• Last Update Posted: 2019-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

• patients undergoing elective surgery of the upper or lower gastrointestinal tract
• mental and verbal ability to understand, read and write in German language
• written informed consent for study participation

Exclusion Criteria

• age <18 years
• inadequate ability to be compliant with the study protocol or to complete documentation for the Food frequency questionnaires

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in nutritional status	24 hours pre-surgery and 7 days after surgery	Controlling Nutritional Status (CONUT) score will be assessed at baseline and on postoperative day 7

Secondary Outcome Measures

Name	Time	Method
length of hospital stay	14 days
Energy intake	1 day before surgery, the day of surgery and up to 7 days after surgery	Dietary intakes are collected by Food Frequency questionnaires and the data are expressed as the kilocalories (kcal) consumed per day
Change in plasma amino acid levels	24 hours pre-surgery up to 7 days after surgery	Blood sample analysis
Change in beta-hydroxybutyrate levels	24 hours pre-surgery up to 7 days after surgery	Blood sample analysis
Change in free fatty acid levels	24 hours pre-surgery up to 7 days after surgery	Blood sample analysis
Change in triacylglycerides levels	24 hours pre-surgery up to 7 days after surgery	Blood sample analysis
Change in low density lipoprotein levels	24 hours pre-surgery up to 7 days after surgery	Blood sample analysis

Trial Locations

Locations (1)

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany