Malnutrition Assessment Tools in Surgery

NCT ID: NCT05393752

Last Updated: 2024-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1650 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-01

Study Completion Date

2024-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the main malnutrition risk assessment tools in patients undergoing operations of general surgery.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Malnutrition Surgery--Complications

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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)
* 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)

Exclusion Criteria

* Age \<18 years
* Magnitude of operation graded by POSSUM:

* Minor
* Intermediate
* Inability to perform nutritional assessment
* Inability to provide informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

108 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital of Crete

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Konstantinos Lasithiotakis

Assisstant Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Konstantinos Lasithiotakis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Heraklion, Crete, Greece

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Surgery, General Hospital of Nicosia, School of Medicine, University of Cyprus

Nicosia, , Cyprus

Site Status

Department of Surgery, University Hospital of Heraklion

Heraklion, , Greece

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Cyprus Greece

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

18981/4-11-2021

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Postoperative Muscle Loss After Gastrectomy
NCT07331038 NOT_YET_RECRUITING