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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Date results information initially provided
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study to establish whether administering intravenous fluids or not during a colonoscopy make a difference to the outcomes of adult patients.
Scientific title
A randomised controlled study to evaluate whether the administration of IV fluids during routine colonoscopy makes a difference to patient outcome.
Secondary ID [1] 300729 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colonoscopy 316550 0
Bowel Cancer Screening 316551 0
Procedural Anesthesia 316553 0
Condition category
Condition code
Surgery 314789 314789 0 0
Other surgery
Cancer 314790 314790 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Anaesthesiology 314791 314791 0 0
Other anaesthesiology

Study type
Description of intervention(s) / exposure
The patients will be randomised to either receive or not receive IV crystalloid fluids during their routine colonoscopy. The intervention treatment in this study is the administration of IV fluids; therefore the intervention arm is recieving fluids. The fluids will be administered by anaesthetic staff through an IV cannula (the IV cannula will be placed in the patient regardless of whether they participate in the trial or not).

All participants who agree to be a part of the study will be asked a series of questions before and after the procedure to gauge their tolerance and outcomes. All participants will also have a blood sample analysed before and after their procedure, and will be appropriately consented as to the risks involved. All participants in this study will be recieving a form of procedural anaesthesia, a black bag will be placed over the intra-venous fluid set up as well to ensure blinding.

The treatment is not personalized nor is it tailored to the individuals, and will be administered according to their randomization. There will be no specific monitoring of adherence, withdrawal after randomization has been recorded.
Intervention code [1] 317050 0
Diagnosis / Prognosis
Intervention code [2] 317051 0
Early detection / Screening
Comparator / control treatment
The control group will NOT be receiving IV fluids during their routine colonoscopy, which is the current standard of practice at the study site.
Control group

Primary outcome [1] 323149 0
Hypotensive episodes – this will be defined by a drop in the systolic BP of >20% during the procedure. This outcome will be assessed by comparing their recorded blood pressure at the begingn of the procedure with the recordings made during the procedure at 5 minute intervals. It will be performed by automated cuff linked to the anaesthetic machine.
Timepoint [1] 323149 0
At the time of the intervention
Primary outcome [2] 323150 0
Electrolyte change - Sodium, Urea, Creatinine)
This will be assessed as a composite primary outcome
Timepoint [2] 323150 0
These will be collected pre and post procedure by venipuncture. The will be analyzed to assess for evidence statistically significant differences in the patient’s hydration with/without hydration during the procedure.
Secondary outcome [1] 380959 0
Quality of Recovery Score

This will be assessed using an anaesthesia recovery score that was publised by Myels et al. (Development and Psychometric Testing of a Quality of Recovery Score After General Anesthesia and Surgery in Adults) and is widely used by anaethetists at the institution where the study will be conducted.
Timepoint [1] 380959 0
Immediately pre and post procedure

Secondary outcome [2] 380960 0
Patient completed Visual Analogue scales (VAS) to assess nausea, headache, dizziness, drowsiness

Composite outcome - The VAS combines all of these symptoms to give an overall score
Timepoint [2] 380960 0
Immediately pre and post procedure
Secondary outcome [3] 380961 0
Modified Post anaesthetic recovery score for patients having anaesthesia on an ambulatory basis
Timepoint [3] 380961 0
Immediately pre and post procedure

Key inclusion criteria
Age>18 & <80
No documented evidence of significant renal impairment (creatinine clearance level)
Routine endoscopies and colonoscopies on outpatients
Minimum age
18 Years
Maximum age
80 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
age <18 & >80
renal failure, creatinine clearance <60
Patients unable to consent
Inpatients, patients actively bleeding or with acute illness to be excluded

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomization was performed by a computer and then provided to the recruiter
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
The sample has been powered for the proportion of subjects experiencing a 20% drop in blood pressure as there is no information to guide power calculations for the electrolyte data. It was assumed that all effects were to be assessed at a 5% alpha level with 80% statistical power. Based on clinical experience, we would anticipate that 5% of patients would experience a drop of blood pressure greater than 20%. Allowing for a difference of interest of 0.05, we would require a sample of 235 patients per group to assess equivalence at the requisite level of power.

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 16070 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment postcode(s) [1] 29582 0
5112 - Elizabeth Vale

Funding & Sponsors
Funding source category [1] 305179 0
Name [1] 305179 0
Lyell McEwin Hospital - Division of Surgery
Address [1] 305179 0
Haydown Rd, Elizabeth Vale SA 5112
Country [1] 305179 0
Primary sponsor type
Timothy Ganguly
Lyell McEwin Hospital
Haydown Road
Elizabeth Vale 5112 SA
Secondary sponsor category [1] 305536 0
Name [1] 305536 0
Elizabeth Murphy
Address [1] 305536 0
Lyell McEwin Hospital
Haydown Road
Elizabeth Vale 5112 SA
Country [1] 305536 0

Ethics approval
Ethics application status
Ethics committee name [1] 305537 0
Human Research Ethics Committee (TQEH/LMH/MH)
Ethics committee address [1] 305537 0
The Queen Elizabeth Hospital
Basil Hetzel Institute DX465101
28 Woodville Road
Woodville South SA 5011
Ethics committee country [1] 305537 0
Date submitted for ethics approval [1] 305537 0
Approval date [1] 305537 0
Ethics approval number [1] 305537 0

Brief summary
The purpose of this study was to see if there is a role for intravenous (IV) fluids in improving patient outcomes during routine colonoscopies.

Who is it for?
You may be eligible for this study if you are aged 18 to 80, and are scheduled for a colonoscopy.

Study details
Participants in this study were randomised by chance (like flipping a coin) into two groups. One group received intravenous fluids through a needle in the arm while they have their colonoscopy. The other group did not receive the needle in the arm and had no fluids during the procedure. As part of this study, participants had additional blood tests (to see if they were adequately hydrated) as well as completed some questionnaires.

It was believed this research will demonstrate there is no significant difference between the groups, which could reduce the unnecessary use of intravenous fluids during colonoscopy.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 100714 0
Dr Timothy Ganguly
Address 100714 0
Royal Adelaide Hospital
Port Road Adelaide
5000 SA
Country 100714 0
Phone 100714 0
+61 8 7074 0000
Fax 100714 0
Email 100714 0
Contact person for public queries
Name 100715 0
Dr Timothy Ganguly
Address 100715 0
Royal Adelaide Hospital
Port Road Adelaide
5000 SA
Country 100715 0
Phone 100715 0
+61 8 7074 0000
Fax 100715 0
Email 100715 0
Contact person for scientific queries
Name 100716 0
Dr Timothy Ganguly
Address 100716 0
Royal Adelaide Hospital
Port Road Adelaide
5000 SA
Country 100716 0
Phone 100716 0
+61 8 7074 0000
Fax 100716 0
Email 100716 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 7255 0
Study protocol
Citation [1] 7255 0
Link [1] 7255 0
Email [1] 7255 0
Other [1] 7255 0
Type [2] 7256 0
Ethical approval
Citation [2] 7256 0
Link [2] 7256 0
Email [2] 7256 0
Other [2] 7256 0
Type [3] 7257 0
Informed consent form
Citation [3] 7257 0
Link [3] 7257 0
Email [3] 7257 0
Other [3] 7257 0
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary