Nutritional Status and Nutrient Supply in Hospitalised Surgical Patients

Colorectal Cancer Clinical Trial

Official title:

Assessing Nutritional Status and Nutrient Supply in Hospitalised Patients Undergoing Major Abdominal Surgery of the Gastrointestinal Tract

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03787537
• Other study ID #: EA2/094/17
• Status: Completed
• Start date: August 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: January 2019
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Esophageal Cancer
• Esophageal Neoplasms
• Gastric Cancer
• Stomach Neoplasms

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in nutritional status	Controlling Nutritional Status (CONUT) score will be assessed at baseline and on postoperative day 7	24 hours pre-surgery and 7 days after surgery
Secondary	Energy intake	Dietary intakes are collected by Food Frequency questionnaires and the data are expressed as the kilocalories (kcal) consumed per day	1 day before surgery, the day of surgery and up to 7 days after surgery
Secondary	Change in plasma amino acid levels	Blood sample analysis	24 hours pre-surgery up to 7 days after surgery
Secondary	Change in beta-hydroxybutyrate levels	Blood sample analysis	24 hours pre-surgery up to 7 days after surgery
Secondary	Change in free fatty acid levels	Blood sample analysis	24 hours pre-surgery up to 7 days after surgery
Secondary	Change in triacylglycerides levels	Blood sample analysis	24 hours pre-surgery up to 7 days after surgery
Secondary	Change in low density lipoprotein levels	Blood sample analysis	24 hours pre-surgery up to 7 days after surgery
Secondary	length of hospital stay		14 days