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Nutritional Status and Nutrient Supply in Hospitalised Surgical Patients

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ClinicalTrials.gov Identifier: NCT03787537
Recruitment Status : Completed
First Posted : December 25, 2018
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Felix Aigner, 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.

Condition or disease
Colorectal Cancer Esophageal Cancer Gastric Cancer

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Study Type : Observational
Actual Enrollment : 128 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessing Nutritional Status and Nutrient Supply in Hospitalised Patients Undergoing Major Abdominal Surgery of the Gastrointestinal Tract
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Change in nutritional status [ Time Frame: 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 :
  1. Energy intake [ Time Frame: 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

  2. Change in plasma amino acid levels [ Time Frame: 24 hours pre-surgery up to 7 days after surgery ]
    Blood sample analysis

  3. Change in beta-hydroxybutyrate levels [ Time Frame: 24 hours pre-surgery up to 7 days after surgery ]
    Blood sample analysis

  4. Change in free fatty acid levels [ Time Frame: 24 hours pre-surgery up to 7 days after surgery ]
    Blood sample analysis

  5. Change in triacylglycerides levels [ Time Frame: 24 hours pre-surgery up to 7 days after surgery ]
    Blood sample analysis

  6. Change in low density lipoprotein levels [ Time Frame: 24 hours pre-surgery up to 7 days after surgery ]
    Blood sample analysis

  7. length of hospital stay [ Time Frame: 14 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Elective surgical patients
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03787537


Locations
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Germany
Charité - Universitätsmedizin Berlin
Berlin, Germany, 13353
Sponsors and Collaborators
Charite University, Berlin, Germany

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Responsible Party: Dr. Felix Aigner, Principal Investigator, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT03787537     History of Changes
Other Study ID Numbers: EA2/094/17
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Felix Aigner, Charite University, Berlin, Germany:
Nutrition
Surgery

Additional relevant MeSH terms:
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Colorectal Neoplasms
Esophageal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Head and Neck Neoplasms
Esophageal Diseases
Nutrients
Growth Substances
Physiological Effects of Drugs