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Trial registered on ANZCTR
Registration number
ACTRN12618001253291
Ethics application status
Approved
Date submitted
23/07/2018
Date registered
25/07/2018
Date last updated
25/07/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
Minimally Invasive Umbilical Ileostomy Versus Traditional Ileostomy - A Randomised control study targeting patient quality of life
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Scientific title
Minimally Invasive Umbilical Ileostomy Versus Traditional Ileostomy - A Randomised control study targeting patient quality of life
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Secondary ID [1]
295483
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None
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Universal Trial Number (UTN)
U1111-1216-9753
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Trial acronym
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Linked study record
N/A
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Health condition
Health condition(s) or problem(s) studied:
Ileostomy
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Condition category
Condition code
Surgery
307681
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0
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Surgical techniques
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Intervention - Ileostomy through umbilicus instead of through a standard right lower quadrant position. This will be performed by an experienced colorectal surgeon. This will be performed one at the time of their surgery, usually as a defunctioning stoma for a bowel resection. This will be performed in a standard operating theatre, the only difference being the site of stoma placement, each patient would be receiving an ileostomy regardless of which group they are randomised to. They will be followed up during their hospital admission and in outpatient department following their discharge. A one of quality of life questionaire will be performed after one month to compare impacts of stoma placement on quality of life.
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Intervention code [1]
301797
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Treatment: Surgery
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Comparator / control treatment
The control arm is an ileostomy in the standard right lower quadrant position.
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Control group
Active
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Outcomes
Primary outcome [1]
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Stoma-QOL - A quality of life questionnaire for people with ostomy
- Validated Quality of life questionnaire
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1274339/
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Assessment method [1]
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Timepoint [1]
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1 month after formation of their ileostomy
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Secondary outcome [1]
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Stoma related adverse events, examples include
- Parastomal hernia - clinical examination within routine clinic follow up
- Stoma prolapse - clinical examination within routine clinic follow up
- Skin excoriation - clinical examination within routine clinic follow up
- Stoma leakage - clinical examination within routine clinic follow up
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Assessment method [1]
349940
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Timepoint [1]
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1 month after ileostomy formation
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Eligibility
Key inclusion criteria
Patients deemed fit for surgical intervention, no difference between patients, just position of stoma formation.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patient's undergoing open surgery precluding the use of a minimally invasive umbilical ileostomy
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not concealed
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation to either umbilical vs traditional ileostomy using sealed envelopes
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
26/07/2018
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Actual
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Date of last participant enrolment
Anticipated
19/07/2019
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Actual
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Date of last data collection
Anticipated
31/08/2019
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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The Townsville Hospital - Douglas
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Recruitment hospital [2]
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Box Hill Hospital - Box Hill
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Recruitment postcode(s) [1]
23297
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4814 - Douglas
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Recruitment postcode(s) [2]
23298
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3128 - Box Hill
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Funding & Sponsors
Funding source category [1]
300070
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Hospital
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Name [1]
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Townsville Hospital and Health Service
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Address [1]
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Townsville Hospital
100 Angus Smith Drive
Douglas, QLD, 4814
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Country [1]
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Australia
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Primary sponsor type
Hospital
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Name
Townsville Hospital and Health Service
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Address
Townsville Hospital
100 Angus Smith Drive
Douglas, QLD, 4814
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Country
Australia
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Secondary sponsor category [1]
299624
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None
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Name [1]
299624
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Address [1]
299624
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Country [1]
299624
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Townsville Hospital and Health Service Human Research Ethics Committee
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Ethics committee address [1]
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Townsville Hospital
100 Angus Smith Drive
Douglas, QLD, 4814
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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13/12/2017
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Approval date [1]
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19/12/2017
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Ethics approval number [1]
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HREC/17/QTHS/161
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Summary
Brief summary
The purpose of the study is to investigate the impact that ileostomy site placement has on patient quality of life. This study compares the traditional ileostomy in the right lower quadrant to a minimally invasive ileostomy formed through the umbilicus. The hypothesis is that a minimally invasive ileostomy through the umbilicus is better for the patient as:
- There is no damage to the muscle when forming this umbilicus
- It's midline position makes it easier for patient's to manage
- There is not an extra incision made for this (umbilicus is a common site for port placement during laparoscopic (keyhole) surgery
- Patient's are able to sleep on either side due to the midline position
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Benjamin Swinson
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Address
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Townsville Hospital
100 Angus Smith Drive
Douglas, QLD, 4814
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Country
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Australia
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Phone
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+61744331111
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Benjamin Swinson
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Address
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Townsville Hospital
100 Angus Smith Drive
Douglas, QLD, 4814
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Country
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Australia
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Phone
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+61744331111
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Benjamin Swinson
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Address
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Townsville Hospital
100 Angus Smith Drive
Douglas, QLD, 4814
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Country
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Australia
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Phone
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+61744331111
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Fax
85272
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Email
85272
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[email protected]
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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.
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