An observational study in Diabetes Mellitus, Hypertension and Ischaemic Heart Disease, sponsored by Mater Dei Hospital, Malta. Completed at 1 site in Malta. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-09.
Sponsored by Mater Dei Hospital, Malta · Observational
The investigators will be performing an international prospective, observational, multi-centre, cross-sectional study to determine the actual duration of preoperative liquid fasting time in European patients.
Research has shown that prolonged fasting, particularly for liquids, is likely harmful to patients before, during, and after an operation. Harm from prolonged fasting for liquids includes dehydration, dysregulated blood sugar levels, increased stress response, and postoperative complications. Recent studies show an average preoperative fasting time for liquids that are significantly longer than necessary.
Reducing fasting time is associated with improved patient well-being, a smoother perioperative course, shorter hospital stays, cost savings, and enhanced environmental sustainability.
The investigators hypothesize that excessive preoperative fasting is still common practice in most European countries and would like to investigate the actual length of liquid fasting practices amongst patients in Europe, to determine whether the current guidelines are being followed.
The investigators will be performing an international prospective, observational, multi-centre, cross-sectional study to determine the actual duration of preoperative liquid fasting time in European patients. The investigators have interest and commitment from 12 countries and hope to recruit more hospitals in the coming weeks.
Research has shown that prolonged fasting, particularly for liquids, is likely harmful to patients before, during, and after an operation. Harm from prolonged fasting for liquids includes dehydration, dysregulated blood sugar levels, increased stress response, and postoperative complications. Recent studies show an average preoperative fasting time for liquids that are significantly longer than necessary.
In the pilot study the investigators conducted a few weeks ago, the average preoperative liquid fasting time was 12 hours instead of the recommended 2 hours. Reducing fasting time is associated with improved patient well-being, a smoother perioperative course, shorter hospital stays, cost savings, and enhanced environmental sustainability. The investigators hypothesise that excessive preoperative fasting is still common practice in most European countries and would like to investigate the actual length of liquid fasting practices amongst patients in Europe, to determine whether the current guidelines are being followed. This will give further insight to colleagues and encourage healthcare professionals to follow the fasting guidelines from the European Society of Anaesthesia and Intensive Care.
The methodology and other details can be found in the study protocol and the other documents. Adult patients scheduled for elective procedures and either requiring general anaesthetic, regional anaesthesia or sedation will be eligible to participate. Data will be collected on the same day among the participating centres and the target date is the 23rd October 2024.
After obtaining consent and screening for eligibility, the patients will answer a short questionnaire regarding their last liquid intake. The following data will be collected:
Patient Number:
Informed Consent: ☐ yes ☐ no
Screening for eligibility Age >= 18 years: ☐ yes ☐ no
Gender: ☐ M ☐ F Patient undergoing elective procedure: ☐ yes ☐ no Time of arrival in the operating room _________________
Procedure:
General surgery ☐ Orthopaedic surgery ☐ Neurosurgery ☐ Cardiac surgery ☐ Vascular ☐ Urology ☐ ENT/ dental/ maxillo-facial ☐ Obstetrics and Gynaecology surgery ☐ Ophthalmic surgery ☐ Non-operating room anaesthesia ☐ Endoscopy ☐ Other ____________________
Type of Anaesthesia (choose 1):
GA ☐ Sedation ☐ Regional ☐
Date and Time at which clear fluids were last consumed:_______________________
The questionnaire will last less than 5 minutes.
This questionnaire is very simple and no patient identifiable data will be recorded on the data collection tool.
8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.
This study's enrollment of 5,100 is above the median of 246 across 1,936 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Mater Dei Hospital, Malta is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Adult patients scheduled for elective procedures and either requiring general anaesthetic, regional anaesthesia or sedation will be eligible to participate.
Data will be collected on the same day among the participating centres. After obtaining consent and screening for eligibility, the patients will answer a short questionnaire regarding their last liquid intake.
The type of procedure, type of anaesthesia and time of arrival in the holding bay / operating room as well as the date and time at which clear fluids were last consumed will be recorded
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult patients scheduled for elective procedures and either requiring general anaesthetic, regional anaesthesia or sedation will be eligible to participate. The necessary institutional approvals will be obtained. Data will be collected on the same day among the participating centres. After obtaining consent and screening for eligibility, the patients will answer a short questionnaire regarding their last liquid intake. The type of procedure, type of anaesthesia and time of arrival in the holding bay / operating room as well as the date and time at which clear fluids were last consumed will be recorded
Other: no intervention
Adult patients scheduled for elective procedures and either requiring general anaesthetic, regional anaesthesia or sedation will be eligible to participate. The necessary institutional approvals will be obtained. Data will be collected on the same day among the participating centres. After obtaining consent and screening for eligibility, the patients will answer a short questionnaire regarding their last liquid intake. The type of procedure, type of anaesthesia and time of arrival in the holding bay / operating room as well as the date and time at which clear fluids were last consumed will be recorded
Other: no intervention
Patients have to answer a questionnaire. The following data will be recorded: Patient Number: Informed Consent: ☐ yes ☐ no Screening for eligibility Age \>/= 18 years: ☐ yes ☐ no Gender: ☐ M ☐ F Patient undergoing elective procedure: ☐ yes ☐ no Time of arrival in the operating room \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Procedure: General surgery ☐ Orthopaedic surgery ☐ Neurosurgery ☐ Cardiac surgery ☐ Vascular ☐ Urology ☐ ENT/ dental/ maxillo-facial ☐ Obstetrics and Gynaecology surgery ☐ Ophthalmic surgery ☐ Non-operating room anaesthesia ☐ Endoscopy ☐ Other \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Type of Anaesthesia (choose 1): GA ☐ Sedation ☐ Regional ☐ Date and Time at which clear fluids were last consumed:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
The primary objective of this observational study is to determine the actual duration of preoperative liquid fasting time.
Adult patients scheduled for elective procedures and either requiring general anaesthetic, regional anaesthesia or sedation will be eligible to participate. After obtaining consent and screening for eligibility, the patients will answer a short questionnaire regarding their last liquid intake.
Time frame: Data will be collected on the same day among the participating centres. This is planned for the 23rd October 2024
Plan to share: No — There is no plan to share IPD The results from the study will be published
Ran from Nov 2024 to primary completion in Dec 2024, 1 month.
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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Mater Dei Hospital, Malta