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CompletedNCT03787537Updated Jan 31, 2019

Nutritional Status and Nutrient Supply in Hospitalised Surgical Patients

An observational study in Colorectal Cancer, Esophageal Cancer and Gastric Cancer, sponsored by Charite University, Berlin, Germany. Completed at 1 site in Germany. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-01-31.

Sponsored by Charite University, Berlin, Germany · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
128
Ages
18 Years to 85 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Colorectal Cancer
  • Esophageal Cancer
  • Gastric Cancer

Keywords

  • Nutrition
  • Surgery
03

In context

Lead sponsor

Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

Elective surgical patients

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

Exclusion Criteria:

  • age \<18 years
  • inadequate ability to be compliant with the study protocol or to complete documentation for the Food frequency questionnaires
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
128 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Change in nutritional status

    Controlling Nutritional Status (CONUT) score will be assessed at baseline and on postoperative day 7

    Time frame: 24 hours pre-surgery and 7 days after surgery

Secondary outcomes

  1. Energy intake

    Dietary intakes are collected by Food Frequency questionnaires and the data are expressed as the kilocalories (kcal) consumed per day

    Time frame: 1 day before surgery, the day of surgery and up to 7 days after surgery

  2. Change in plasma amino acid levels

    Blood sample analysis

    Time frame: 24 hours pre-surgery up to 7 days after surgery

  3. Change in beta-hydroxybutyrate levels

    Blood sample analysis

    Time frame: 24 hours pre-surgery up to 7 days after surgery

  4. Change in free fatty acid levels

    Blood sample analysis

    Time frame: 24 hours pre-surgery up to 7 days after surgery

  5. Change in triacylglycerides levels

    Blood sample analysis

    Time frame: 24 hours pre-surgery up to 7 days after surgery

  6. Change in low density lipoprotein levels

    Blood sample analysis

    Time frame: 24 hours pre-surgery up to 7 days after surgery

  7. length of hospital stay

    Time frame: 14 days

07

Study locations

1 site
  • Charité - Universitätsmedizin Berlin
    Berlin, 13353, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03787537
Lead sponsor
Charite University, Berlin, Germany
Responsible party
Dr. Felix Aigner (Principal Investigator, Charite University, Berlin, Germany) — Principal investigator
First posted
Dec 26, 2018
Start date
Aug 1, 2017
Primary completion
Dec 31, 2018
Completion
Dec 31, 2018
Last update
Jan 31, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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