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Trial registered on ANZCTR


Registration number
ACTRN12620000545965
Ethics application status
Approved
Date submitted
5/03/2020
Date registered
7/05/2020
Date last updated
7/05/2020
Date data sharing statement initially provided
7/05/2020
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
None
Universal Trial Number (UTN)
U1111-1249-2870
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

Intervention/exposure
Study type
Interventional
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
Active

Outcomes
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

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

Study design
Purpose of the study
Diagnosis
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
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
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
20/02/2017
Date of last participant enrolment
Anticipated
Actual
25/01/2018
Date of last data collection
Anticipated
Actual
25/01/2018
Sample size
Target
470
Accrual to date
Final
470
Recruitment in Australia
Recruitment state(s)
SA
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
Hospital
Name [1] 305179 0
Lyell McEwin Hospital - Division of Surgery
Country [1] 305179 0
Australia
Primary sponsor type
Individual
Name
Timothy Ganguly
Address
Lyell McEwin Hospital
Haydown Road
Elizabeth Vale 5112 SA
Country
Australia
Secondary sponsor category [1] 305536 0
Individual
Name [1] 305536 0
Elizabeth Murphy
Address [1] 305536 0
Lyell McEwin Hospital
Haydown Road
Elizabeth Vale 5112 SA
Country [1] 305536 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305537 0
Human Research Ethics Committee (TQEH/LMH/MH)
Ethics committee address [1] 305537 0
Ethics committee country [1] 305537 0
Australia
Date submitted for ethics approval [1] 305537 0
Approval date [1] 305537 0
21/09/2016
Ethics approval number [1] 305537 0
Q20151212

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100714 0
Dr Timothy Ganguly
Address 100714 0
Royal Adelaide Hospital
Port Road Adelaide
5000 SA
Country 100714 0
Australia
Phone 100714 0
+61 8 7074 0000
Fax 100714 0
Email 100714 0
timothy.ganguly@sa.gov.au
Contact person for public queries
Name 100715 0
Timothy Ganguly
Address 100715 0
Royal Adelaide Hospital
Port Road Adelaide
5000 SA
Country 100715 0
Australia
Phone 100715 0
+61 8 7074 0000
Fax 100715 0
Email 100715 0
timothy.ganguly@sa.gov.au
Contact person for scientific queries
Name 100716 0
Timothy Ganguly
Address 100716 0
Royal Adelaide Hospital
Port Road Adelaide
5000 SA
Country 100716 0
Australia
Phone 100716 0
+61 8 7074 0000
Fax 100716 0
Email 100716 0
timothy.ganguly@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7255Study protocol    379414-(Uploaded-05-03-2020-17-51-13)-Study-related document.docx
7256Ethical approval    379414-(Uploaded-05-03-2020-17-51-28)-Study-related document.pdf
7257Informed consent form    379414-(Uploaded-05-03-2020-17-53-20)-Study-related document.docx



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.