Colorectal CancerNCT03787537
Nutritional Status and Nutrient Supply in Hospitalised Surgical Patients
An observational study of Colorectal Cancer and Esophageal Cancer, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Prospective single arm, single center observational study to assess the nutritional status and the nutrient supply during hospitalization for elective gastrointestinal surgery. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Colorectal Cancer, Esophageal Cancer, Gastric Cancer
- How many people
- 128 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2017to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Adult, Older adult
Study population: Elective surgical patients
Who may be able to join
- 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
Who cannot join
- age <18 years
- inadequate ability to be compliant with the study protocol or to complete documentation for the Food frequency questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing Nutritional Status and Nutrient Supply in Hospitalised Patients Undergoing Major Abdominal Surgery of the Gastrointestinal Tract
Prospective single arm, single center observational study to assess the nutritional status and the nutrient supply during hospitalization for elective gastrointestinal surgery.
- Conditions
- Colorectal Cancer, Esophageal Cancer, Gastric Cancer
- Keywords
- Nutrition, Surgery
- Medical subject headings
- Colorectal Neoplasms, Esophageal Neoplasms, Stomach Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in nutritional status
Controlling Nutritional Status (CONUT) score will be assessed at baseline and on postoperative day 7
Measured: 24 hours pre-surgery and 7 days after surgery
Secondary outcomes (7)
Energy intake
Dietary intakes are collected by Food Frequency questionnaires and the data are expressed as the kilocalories (kcal) consumed per day
Measured: 1 day before surgery, the day of surgery and up to 7 days after surgery
Change in plasma amino acid levels
Blood sample analysis
Measured: 24 hours pre-surgery up to 7 days after surgery
Change in beta-hydroxybutyrate levels
Blood sample analysis
Measured: 24 hours pre-surgery up to 7 days after surgery
Change in free fatty acid levels
Blood sample analysis
Measured: 24 hours pre-surgery up to 7 days after surgery
Change in triacylglycerides levels
Blood sample analysis
Measured: 24 hours pre-surgery up to 7 days after surgery
Change in low density lipoprotein levels
Blood sample analysis
Measured: 24 hours pre-surgery up to 7 days after surgery
length of hospital stay
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start1 Aug 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Felix Aigner, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03787537
- Sponsor's protocol ID
- EA2/094/17
- Status last verified
- Jan 2019
- First submitted
- 7 Dec 2018
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Nutritional Status and Nutrient Supply in Hospitalised Patients Undergoing Major Abdominal Surgery of the Gastrointestinal Tract
- ClinicalTrials.gov ID
- NCT03787537
- Acronym / sponsor ID
- EA2/094/17
- Conditions
- Colorectal Cancer, Esophageal Cancer, Gastric Cancer
- Keywords
- Nutrition, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 26 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective single arm, single center observational study to assess the nutritional status and the nutrient supply during hospitalization for elective gastrointestinal surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Elective surgical patients
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- age <18 years
- inadequate ability to be compliant with the study protocol or to complete documentation for the Food frequency questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
7 secondary outcomes
Energy intake
Time frame: 1 day before surgery, the day of surgery and up to 7 days after surgery
Change in plasma amino acid levels
Time frame: 24 hours pre-surgery up to 7 days after surgery
Change in beta-hydroxybutyrate levels
Time frame: 24 hours pre-surgery up to 7 days after surgery
Change in free fatty acid levels
Time frame: 24 hours pre-surgery up to 7 days after surgery
Change in triacylglycerides levels
Time frame: 24 hours pre-surgery up to 7 days after surgery
Change in low density lipoprotein levels
Time frame: 24 hours pre-surgery up to 7 days after surgery
length of hospital stay
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Esophageal Cancer, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in nutritional status (time frame: 24 hours pre-surgery and 7 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2019.