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Completed

NCT Number: NCT03787537

Nutritional Status and Nutrient Supply in Hospitalised Surgical Patients

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

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Stomach Diseases Stomach Neoplasms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Charité - Universitätsmedizin Berlin

Berlin, 13353, Germany

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 26, 2018
Registry last updated
Jan 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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