Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000782932
Ethics application status
Approved
Date submitted
17/07/2011
Date registered
27/07/2011
Date last updated
27/07/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Bowel cleansing for colonoscopy a new approach: a randomised study of bisacodyl tablets and diet versus standard bowel preparation.
Scientific title
Blinded randomised study comparing the quality of bowel preparation achieved using bisacodyl tablets and diet versus standard Sodium phosphate or Polyethylene glycol bowel preparation regimens.
Secondary ID [1] 262640 0
Nil Known
Universal Trial Number (UTN)
U1111-1122-9733
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Quality of bowel preparation for colonoscopy. 268352 0
Condition category
Condition code
Oral and Gastrointestinal 268481 268481 0 0
Normal oral and gastrointestinal development and function
Diet and Nutrition 268482 268482 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Bisacodyl tablets and diet restrictions for three days prior to colonoscopy. 10mg twice daily and low residue diet to prepare the bowel for investigation.
Arm 2: Prepkit C which is the standard bowel preparation at The Western Hospital taken the day prior to the procedure. Contains 1 x GlycoPrep-C 70g sachet and 2 x Picoprep 15.5g sachets
taken with water.

Low residue diet as designed by study dietician includes:
Fruit - Apple juice allowed. Not allowed fresh and dried fruit, jam or other juices.
Vegetables - Mashed pumpkin and potato allowed. Not allowed other vegetables or salad of any kind, no peas, beans or lentils.
Protein - Well cooked chicken, fish or poached eggs allowed. Not allowed other meats, sausages, gravy, backed beans or spagetti.
Dairy - Limited to 2 serves per day with no cheese.
Carbohydrates - Boiled white rice or pasta, white bread, rice bubbles allowed. Not allowed brown rice/pasta, no wholegrain bread, no nuts or seeds, no other cereals.
Fluids - Water, tea, coffee, milk sport drinks allowed. Not allowed alcohol, orange juice, prune juice or tomato juice.
Intervention code [1] 266991 0
Treatment: Drugs
Intervention code [2] 267037 0
Treatment: Other
Comparator / control treatment
The comparator treatment in this study is standard bowel preparation with Prepkit C. It is considered standard bowel preparation.
Control group
Active

Outcomes
Primary outcome [1] 269228 0
Quality of bowel preparation assessed using the Boston Bowel Preparation scale with a score greater than 5 considered good quality bowel preparation.
Timepoint [1] 269228 0
Assessed using DVD recording of colonoscopy following procedure by a blinded endoscopist applying the Boston Bowel Preparation Scale.
Secondary outcome [1] 279165 0
Compliance and tolerability of bowel preparation using a questionnaire with questions used in similar studies previously.

Questions include:
Type of bowel preparation taken?
Did the patient complete the entire bowel preparation?
Symptoms: Difficulty completing preparation?
Sleep loss?
Abdominal fullness/bloating?
Nausea?
Vomiting?
Anal irritation?
Weak or tired?
Hungry?
Would you be willing to take the same bowel preparation again?
Timepoint [1] 279165 0
Questionnaire filled in just prior to colonoscopy with the assistance of the endoscopy nursing staff or unit resident.

Eligibility
Key inclusion criteria
All patients presenting for colonoscopy at The Western hospital.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Women who are pregnant and the human foetus.
Children and/or young people (ie. <18 years)
People with an intellectual or mental impairment
People highly dependent on medical care

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Random allocation to a specific bowel preparation will occur at the time of booking for colonoscopy and will be via computer generated random numbers. This process is conducted by the endoscopy booking office (central administration) and not by the study investigators.

All patients presenting for colonoscopy at The Western Hospital colorectal unit will be eligible to take part. Exclusions included patient who cannot consent, unable to speak English or understand the bowel preparation regimen adequately, pregnant women and children under the age of 18yo. Each suitable patient will be consented for both the colonoscopy and then entry into the trial by the consultant surgeon booking their procedure.
When contacted by the Western Hospital endoscopy booking office the patient will verbally confirm they have agreed to the trial and then be randomised into either the standard bowel preparation group or the new bisacodyl and diet group and appropriate information given to them. There is a contact number on the patient information sheet for the study investigators, dietician and pharmacy to answer any questions.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random numbers.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267464 0
Hospital
Name [1] 267464 0
The Western Hospital Colorectal Unit
Country [1] 267464 0
Australia
Primary sponsor type
Individual
Name
Dr Paul Simpson
Address
The Western Hospital Gordon Street Footscray VIC 3011
Country
Australia
Secondary sponsor category [1] 266552 0
Hospital
Name [1] 266552 0
The Western Hospital Colorectal Unit
Address [1] 266552 0
The Western Hospital Gordon Street Footscray VIC 3011
Country [1] 266552 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269435 0
Melbourne Health HREC
Ethics committee address [1] 269435 0
Office For Research
Melbourne Health
Royal Melbourne Hospital Parkville Victoria 3050
Ethics committee country [1] 269435 0
Australia
Date submitted for ethics approval [1] 269435 0
27/06/2011
Approval date [1] 269435 0
19/07/2011
Ethics approval number [1] 269435 0
2011.093

Summary
Brief summary
The aim of this project is to study a new way of cleaning the bowel prior to colonoscopy. Current methods of cleaning the bowel are very effective but have some limitations. Bowel preparation currently involves drinking a large volume of salty tasting fluid which many patients do not like. An alternative method involves drinking a smaller volume of solution that can cause complications associated with dehydration and decreased salt levels within the body.
In this study we will evaluate a new way of cleaning the bowel involving the use of a more gentle tablet laxative and diet restrictions in the three days before your colonoscopy.
We are also interested in how you as the patient feel about this method of cleaning the bowel and we will ask you to fill in a questionnaire prior to your colonoscopy.
The laxative we are using in this trial (Dulcolax) is freely available and works by stimulating the colon to pass bowel motions. It is a safe drug that is proven to be effective in helping empty the bowel.
Dulcolax (bisacodyl) is approved by the Therapeutic Goods Administration of Australia to treat constipation and evacuation of the bowel.

This study will be conducted at The Western Hospital Footscray.
200 people will be asked to participate in this trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32886 0
Address 32886 0
Country 32886 0
Phone 32886 0
Fax 32886 0
Email 32886 0
Contact person for public queries
Name 16133 0
Dr Paul Simpson
Address 16133 0
The Western Hospital, Gordon Street, Footscray VIC 3011
Country 16133 0
Australia
Phone 16133 0
+61 3 8345 6666
Fax 16133 0
+61 3 9576 0318
Email 16133 0
[email protected]
Contact person for scientific queries
Name 7061 0
Dr Paul Simpson
Address 7061 0
The Western Hospital, Gordon Street, Footscray VIC 3011
Country 7061 0
Australia
Phone 7061 0
+61 3 8345 6666
Fax 7061 0
+61 3 9576 0318
Email 7061 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



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.