NCT03787537

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 26, 2018

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

January 31, 2019

Status Verified

January 1, 2019

Enrollment Period

1.4 years

First QC Date

December 7, 2018

Last Update Submit

January 30, 2019

Conditions

Colorectal CancerEsophageal CancerGastric Cancer

Keywords

NutritionSurgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Energy intake

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

  • Change in plasma amino acid levels

    24 hours pre-surgery up to 7 days after surgery

  • Change in beta-hydroxybutyrate levels

    24 hours pre-surgery up to 7 days after surgery

  • Change in free fatty acid levels

    24 hours pre-surgery up to 7 days after surgery

  • Change in triacylglycerides levels

    24 hours pre-surgery up to 7 days after surgery

  • +2 more secondary outcomes

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Elective surgical patients

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité - Universitätsmedizin Berlin

Berlin, 13353, Germany

Location

MeSH Terms

Conditions

Colorectal NeoplasmsEsophageal NeoplasmsStomach Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesHead and Neck NeoplasmsEsophageal DiseasesStomach Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 7, 2018

First Posted

December 26, 2018

Study Start

August 1, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

January 31, 2019

Record last verified: 2019-01

Locations

DE(1)