Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000485932
Ethics application status
Not required
Date submitted
16/03/2020
Date registered
17/04/2020
Date last updated
17/04/2020
Date data sharing statement initially provided
17/04/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of ambient temperature on quality of bowel preparation for colonoscopy
Scientific title
Effect of ambient temperature on quality of bowel preparation for colonoscopy
Secondary ID [1] 300801 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
This project is a sub-study of ACTRN12619001424190

Health condition
Health condition(s) or problem(s) studied:
Inflammatory bowel disease 316673 0
Colorectal polyps 316674 0
Colorectal cancer 316675 0
Condition category
Condition code
Oral and Gastrointestinal 314916 314916 0 0
Inflammatory bowel disease
Oral and Gastrointestinal 314917 314917 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 314967 314967 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This trial is a secondary analysis of existing data collected as part of a previous prospective trial investigating the efficacy and tolerability of different bowel preparations in both inflammatory bowel disease patients and the general population.
In the original trial, patients were randomised to two different types of bowel preparation (Moviprep or Prep Kit C).
We added ambient temperature as the minimum and maximum temperature documented by the local Bureau of Meteorology weather observation station on the day prior to the scheduled colonoscopy.
No additional participant involvement was required.
Intervention code [1] 317124 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323238 0
Quality of bowel preparation as determined using the validated Ottawa Bowel Preparation Score. This grades the quality of bowel preparation from 0 to 4 (with 0 being no fluid and 4 pertaining to fluid/faecal material unable to be cleared) in three colonic segments (right, left and rectosigmoid) to reach a total score out of 14. All endoscopists attended calibrating sessions prior to study commencement. Two endoscopists assessed the efficacy of bowel cleansing regime independently at the time of the procedure. An average score was then calculated. Inadequate bowel preparation is defined as an Ottawa Bowel Preparation Score equal to or greater than 8.
Timepoint [1] 323238 0
At time of colonoscopy.
Secondary outcome [1] 381249 0
Tolerability as determined by patient questionnaire
A numerically higher score indicates a better tolerance. The questionnaire includes a five point Likert scale to assess tolerability (ranging from 0 to 5; very hard to very easy) and palatability (ranging from 0 to 5: very bad to very good) of the preparation. Common side effects (abdominal discomfort, abdominal pain, nausea, vomiting, abdominal distension, dizziness and shortness of breath) were also measure on a five point Likert scale (ranging from 0 to 5: severe degree of complaints to no complaints).
Timepoint [1] 381249 0
On day of completion of bowel preparation
Secondary outcome [2] 381254 0
Safety of bowel preparation
Blood tests were collected within one week before commencing bowel preparation, and on the day of the colonoscopy prior to the procedure for serum electrolyte determination in all participants. Changes in serum sodium, chloride, potassium, bicarbonate, urea, creatinine, magnesium, calcium and phosphate were measure.
Timepoint [2] 381254 0
Analysis of electrolytes and renal function one week prior to commencement of bowel preparation.
This analysis is repeated on day of completion of bowel preparation.

Eligibility
Key inclusion criteria
Participants from original study ACTRN12619001424190
Patients undergoing outpatient colonoscopy
For IBD cohort - endoscopic and histological evidence of Crohn's disease or ulcerative colitis on a previous colonoscopy
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-English speaking
Renal insufficiency (defined as estimated glomerular filtration rate of less than 50ml/min
Cardiac failure (New York Heart Association Class greater than 2)
Advanced liver disease (Child Pugh B or C)
Poorly controlled diabetes mellitus
Bowel obstruction or megacolon
Total or limited colonic resection
Dysphagia
Pregnancy or plans to become pregnant during trial period

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/03/2013
Date of last participant enrolment
Anticipated
Actual
30/12/2016
Date of last data collection
Anticipated
Actual
14/02/2020
Sample size
Target
250
Accrual to date
Final
280
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 16129 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 29657 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 305258 0
Hospital
Name [1] 305258 0
Liverpool Hospital
Country [1] 305258 0
Australia
Primary sponsor type
Individual
Name
Linda Zhang
Address
Liverpool Hospital
Corner of Elizabeth and Goulburn Sts
Liverpool NSW 2170
Country
Australia
Secondary sponsor category [1] 305619 0
None
Name [1] 305619 0
Address [1] 305619 0
Country [1] 305619 0

Ethics approval
Ethics application status
Not required

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

Contacts
Principal investigator
Name 100922 0
Dr Linda Zhang
Address 100922 0
Department of Gastroenterology & Hepatology
Liverpool Hospital
Corner of Elizabeth and Goulburn Sts
Liverpool NSW 2170
Country 100922 0
Australia
Phone 100922 0
+61 02 87383000
Fax 100922 0
Email 100922 0
[email protected]
Contact person for public queries
Name 100923 0
Linda Zhang
Address 100923 0
Department of Gastroenterology & Hepatology
Liverpool Hospital
Corner of Elizabeth and Goulburn Sts
Liverpool NSW 2170
Country 100923 0
Australia
Phone 100923 0
+61 02 87383000
Fax 100923 0
Email 100923 0
[email protected]
Contact person for scientific queries
Name 100924 0
Linda Zhang
Address 100924 0
Department of Gastroenterology & Hepatology
Liverpool Hospital
Corner of Elizabeth and Goulburn Sts
Liverpool NSW 2170
Country 100924 0
Australia
Phone 100924 0
+61 02 87383000
Fax 100924 0
Email 100924 0
[email protected]

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


What supporting documents are/will be available?




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.