MalnutritionMATSNCT05393752
Malnutrition Assessment Tools in Surgery
An observational study of Malnutrition and Surgery--Complications, run by University Hospital of Crete at 2 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the main malnutrition risk assessment tools in patients undergoing operations of general surgery. Read more about this study
- Who is it for?
- Ages 18 to 108 years
- Conditions the study is for
- Malnutrition, Surgery--Complications
- How many people
- 1,650 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 May 2022to 1 May 2024
- 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 108 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a prospective observational study including patients admitted in a surgical department during a 1-year study period, from January 2022 until January 2023 (TBReviewed)
Who may be able to join
- Age >18 years
- Patients undergoing elective or emergency surgery. Urgency of emergent operations is classified as follows, according to the clinical judgment of the surgeon, regarding the maximum time a patient could wait for surgery:
- 3.Expedited (>18 hours)
- 2B. Urgent (6-18 hours)
- 2A. Urgent (2-6 hours)
- 1. Immediate (<2 hours)
Show all 10Show fewer
- Operations involving the gastrointestinal tract
- Magnitude of operation graded by POSSUM [17,18]:
- Major+ (examples include colonic resection abdominoperineal resection of the rectum, radical total gastrectomy, intestinal bypass, whipple resection)
- Major (examples include adhesiolysis, stoma formation, small bowel resection, anterior resection, cholecystectomy and exploration of the bile duct)
Who cannot join
- Age <18 years
- Magnitude of operation graded by POSSUM:
- Minor
- Intermediate
- Inability to perform nutritional assessment
- Inability to provide informed consent
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Cyprus1 site
Department of Surgery, General Hospital of Nicosia, School of Medicine, University of Cyprus
Nicosia
Greece1 site
Department of Surgery, University Hospital of Heraklion
Heraklion, 71110
About this study
Official title: Evaluation of Malnutrition Risk Assessment Tools in General Surgery.
The purpose of this study is to evaluate the main malnutrition risk assessment tools in patients undergoing operations of general surgery.
Read the detailed description
This is a multi centre prospective observational study including patients undergoing major/major+ operation of general surgery. Patients will be interviewed by surgical trainees and their malnutrition risk will be assessed with the use of SGA, MUST, NRS, MNA-SF etc. Clinical variables and demographics will also be recorded in order to enable meaningful comparisons of malnutrition risk assessment tools in terms of serious postoperative complications.
- Conditions
- Malnutrition, Surgery--Complications
- Keywords
- nutrition, malnutrition, malnutrition risk tools, nutritional assessment, surgery
- Medical subject headings
- Malnutrition
What is being measured
The primary outcome is the main question the study is designed to answer.
serious postoperative complications
Complications >II according to Clavien-Dindo classification
Measured: 30 days after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start1 May 2022
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- 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
- 1,650 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Crete
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Konstantinos Lasithiotakis, University Hospital of Crete
- Investigators
- Konstantinos Lasithiotakis, MD, PhD, Principal investigator, University Hospital of Heraklion, Crete, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05393752
- Sponsor's protocol ID
- 18981/4-11-2021
- Acronym
- MATS
- Status last verified
- May 2024
- First submitted
- 16 May 2022
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Malnutrition Risk Assessment Tools in General Surgery.
- ClinicalTrials.gov ID
- NCT05393752
- Acronym / sponsor ID
- MATS / 18981/4-11-2021
- Conditions
- Malnutrition, Surgery--Complications
- Keywords
- nutrition, malnutrition, malnutrition risk tools, nutritional assessment, surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,650 participants (actual)
- Lead sponsor
- University Hospital of CreteUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 26 May 2022 (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.
The purpose of this study is to evaluate the main malnutrition risk assessment tools in patients undergoing operations of general surgery.
Detailed description
This is a multi centre prospective observational study including patients undergoing major/major+ operation of general surgery. Patients will be interviewed by surgical trainees and their malnutrition risk will be assessed with the use of SGA, MUST, NRS, MNA-SF etc. Clinical variables and demographics will also be recorded in order to enable meaningful comparisons of malnutrition risk assessment tools in terms of serious postoperative complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 108 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a prospective observational study including patients admitted in a surgical department during a 1-year study period, from January 2022 until January 2023 (TBReviewed)
Key inclusion criteria (10 listed)
- Age >18 years
- Patients undergoing elective or emergency surgery. Urgency of emergent operations is classified as follows, according to the clinical judgment of the surgeon, regarding the maximum time a patient could wait for surgery:
- Operations involving the gastrointestinal tract
- Magnitude of operation graded by POSSUM [17,18]:
Key exclusion criteria (6 listed)
- Age <18 years
- Magnitude of operation graded by POSSUM:
- Inability to perform nutritional assessment
- Inability to provide informed consent
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
serious postoperative complications
Time frame: 30 days after the operation
Complications >II according to Clavien-Dindo classification
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 8 May 2024.
- Individual participant dataSharing planned: No
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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.
Konstantinos Lasithiotakis, MD, PhD principal investigator
University Hospital of Heraklion, Crete, Greece
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition and Surgery--Complications, run by University Hospital of Crete at 2 sites in 2 countries.
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 10 inclusion and 6 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 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Cyprus, Greece. 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?
serious postoperative complications (time frame: 30 days after the operation). 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 8 May 2024; AzTrials last refreshed its copy on 5 Nov 2026.