Preoperative CareNCT03757208
Preoperative Carbohydrate Loading in Patients Undergoing Day-case Cholecystectomy
A study testing carbohydrate rich drink in people with Preoperative Care, run by University of Oulu.
Trial summary
Background: Preoperative carbohydrate loading has been shown to reduce preoperative discomfort and postoperative nausea and vomiting in general surgical patients. Few studies have been focused on patients undergoing day-case surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Preoperative Care
- What is being tested?
- carbohydrate rich drink
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- No sites listed yet
- Study dates
- 8 Apr 2013to 15 Nov 2017
- Phase
- Interventional
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients between 18-70 yr (ASA physical status I-II) eligible for day-case cholecystectomy
Who cannot join
- Patients with bleeding or coagulation disorders, BMI >40, dementia or suffering from insulin-treated diabetes, migraine, Meniere's disease or with history of alcohol or drug abuse
About this study
Official title: Effect of Preoperative Oral Carbohydrate Loading on Recovery in Patients Undergoing Day-case Cholecystectomy. A Randomised Controlled Trial.
Background: Preoperative carbohydrate loading has been shown to reduce preoperative discomfort and postoperative nausea and vomiting in general surgical patients. Few studies have been focused on patients undergoing day-case surgery.
Objective: The aim of this prospective randomized study was to determine whether preoperative carbohydrate loading enhanced the recovery of patients undergoing day-case cholecystectomy.
Read more
Design: A randomised controlled trial. Setting: Secondary care in a district general and a university hospital in Finland between 2013-2016.
Patients: A total of 113 patients ASA physical status I or II (18-70 yr) undergoing day-case cholecystectomy were included in the study. Exclusion criteria were bleeding or coagulation disorders, BMI >40, dementia, insulin-treated diabetes, migraine, Meniere's disease or a history of alcohol or drug abuse.
Intervention: The carbohydrate rich drink (CHD) group received oral carbohydrate (200 ml) 2-3 h before surgery, and the control (Fasting) group fasted from midnight according to standard protocol.
Main outcome measures: Visual analogue scales (VAS) were used to score six discomfort parameters. The needs for analgesia or antiemetics, the time to drinking, eating and first mobilization after surgery, and the time to discharge and hospital readmission were recorded.
- Conditions
- Preoperative Care
- Being tested
- carbohydrate rich drink
- Keywords
- Carbohydrate loading, oral carbohydrate beverage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carbohydrate rich drinkDietary supplement
The carbohydrate rich drink (CHD) group received oral carbohydrate (200 ml) 2-3 h before surgery,
| Study group | Role | What they receive |
|---|---|---|
| Fasting group | No intervention | Not described |
| Carbohydrate rich drink (CHD) group | Active comparator | Not described Receives: Dietary Supplement: carbohydrate rich drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of given pain and antiemetic medication (n)
Measured: One day (in recovery room after operation to discharge time)
Thirst, hunger, dryness of mouth, tiredness, nausea, and pain (Visual analogue scale, VAS 0-100)
Measured: One day (4 hours after operation and at discharge)
Time of drinking, eating and first mobilisation (minutes after operation)
Measured: One day (in recovery room after operation to discharge time)
Time of discharge (hours after operation)
Measured: One day (time of discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start8 Apr 2013
- Primary completion16 May 2016
- Study completion15 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preoperative CareStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Collaborators
- Seinajoki Central Hospital
- Responsible party
- Principal investigator, Heli Helminen, University of Oulu
- Investigators
- Kari Haukipuro, Ph.M.D, Study chair, University Hospital of Oulu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03757208
- Sponsor's protocol ID
- Uoulu 192/2012
- Status last verified
- Nov 2018
- First submitted
- 20 Nov 2018
- Last updated
- 28 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Helminen H, Branders H, Ohtonen P, Saarnio J. Effect of pre-operative oral carbohydrate loading on recovery after day-case cholecystectomy: A randomised controlled trial. Eur J Anaesthesiol. 2019 Aug;36(8):605-611. doi: 10.1097/EJA.0000000000001002.
PubMed 31021880
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Oral Carbohydrate Loading on Recovery in Patients Undergoing Day-case Cholecystectomy. A Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT03757208
- Acronym / sponsor ID
- Uoulu 192/2012
- Conditions
- Preoperative Care
- Keywords
- Carbohydrate loading, oral carbohydrate beverage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Collaborators
- Seinajoki Central Hospital
- Study start
- 8 Apr 2013 (actual)
- Primary completion
- 16 May 2016 (actual)
- Study completion
- 15 Nov 2017 (actual)
- First posted
- 28 Nov 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.
Background: Preoperative carbohydrate loading has been shown to reduce preoperative discomfort and postoperative nausea and vomiting in general surgical patients. Few studies have been focused on patients undergoing day-case surgery.
Objective: The aim of this prospective randomized study was to determine whether preoperative carbohydrate loading enhanced the recovery of patients undergoing day-case cholecystectomy.
Design: A randomised controlled trial. Setting: Secondary care in a district general and a university hospital in Finland between 2013-2016.
Patients: A total of 113 patients ASA physical status I or II (18-70 yr) undergoing day-case cholecystectomy were included in the study. Exclusion criteria were bleeding or coagulation disorders, BMI >40, dementia, insulin-treated diabetes, migraine, Meniere's disease or a history of alcohol or drug abuse.
Intervention: The carbohydrate rich drink (CHD) group received oral carbohydrate (200 ml) 2-3 h before surgery, and the control (Fasting) group fasted from midnight according to standard protocol.
Main outcome measures: Visual analogue scales (VAS) were used to score six discomfort parameters. The needs for analgesia or antiemetics, the time to drinking, eating and first mobilization after surgery, and the time to discharge and hospital readmission were recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fasting group | No intervention | – |
| Carbohydrate rich drink (CHD) group | Active comparator | Dietary Supplement: carbohydrate rich drink |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients between 18-70 yr (ASA physical status I-II) eligible for day-case cholecystectomy
Key exclusion criteria (1 listed)
- Patients with bleeding or coagulation disorders, BMI >40, dementia or suffering from insulin-treated diabetes, migraine, Meniere's disease or with history of alcohol or drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carbohydrate rich drinkThe carbohydrate rich drink (CHD) group received oral carbohydrate (200 ml) 2-3 h before surgery, | Dietary supplement | Carbohydrate rich drink (CHD) group |
Primary outcome
Number of given pain and antiemetic medication (n)
Time frame: One day (in recovery room after operation to discharge time)
Thirst, hunger, dryness of mouth, tiredness, nausea, and pain (Visual analogue scale, VAS 0-100)
Time frame: One day (4 hours after operation and at discharge)
Time of drinking, eating and first mobilisation (minutes after operation)
Time frame: One day (in recovery room after operation to discharge time)
Time of discharge (hours after operation)
Time frame: One day (time of discharge)
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 28 Nov 2018.
- Derived from this study: PubMed 31021880Helminen H, Branders H, Ohtonen P, Saarnio J. Effect of pre-operative oral carbohydrate loading on recovery after day-case cholecystectomy: A randomised controlled trial. Eur J Anaesthesiol. 2019 Aug;36(8):605-611. doi: 10.1097/EJA.0000000000001002.
- 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.
Kari Haukipuro, Ph.M.D study chair
University Hospital of Oulu
Questions about this trial
What is this clinical trial studying?
A study testing carbohydrate rich drink in people with Preoperative Care, run by University of Oulu.
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 1 inclusion and 1 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 28 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of given pain and antiemetic medication (n) (time frame: One day (in recovery room after operation to discharge time)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03757208, which also lists 1 linked publication.
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 28 Nov 2018.