Trial Review

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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
Scientific title
Minimally Invasive Umbilical Ileostomy Versus Traditional Ileostomy - A Randomised control study targeting patient quality of life
Secondary ID [1] 295483 0
None
Universal Trial Number (UTN)
U1111-1216-9753
Trial acronym
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Ileostomy 308745 0
Condition category
Condition code
Surgery 307681 307681 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 301797 0
Treatment: Surgery
Comparator / control treatment
The control arm is an ileostomy in the standard right lower quadrant position.
Control group
Active

Outcomes
Primary outcome [1] 306664 0
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/
Timepoint [1] 306664 0
1 month after formation of their ileostomy
Secondary outcome [1] 349940 0
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
Timepoint [1] 349940 0
1 month after ileostomy formation

Eligibility
Key inclusion criteria
Patients deemed fit for surgical intervention, no difference between patients, just position of stoma formation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient's undergoing open surgery precluding the use of a minimally invasive umbilical ileostomy

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)
Not concealed
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
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/07/2018
Actual
Date of last participant enrolment
Anticipated
19/07/2019
Actual
Date of last data collection
Anticipated
31/08/2019
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 11396 0
The Townsville Hospital - Douglas
Recruitment hospital [2] 11397 0
Box Hill Hospital - Box Hill
Recruitment postcode(s) [1] 23298 0
3128 - Box Hill
Recruitment postcode(s) [2] 23297 0
4814 - Douglas

Funding & Sponsors
Funding source category [1] 300070 0
Hospital
Name [1] 300070 0
Townsville Hospital and Health Service
Country [1] 300070 0
Australia
Primary sponsor type
Hospital
Name
Townsville Hospital and Health Service
Address
Townsville Hospital
100 Angus Smith Drive
Douglas, QLD, 4814
Country
Australia
Secondary sponsor category [1] 299624 0
None
Name [1] 299624 0
Address [1] 299624 0
Country [1] 299624 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300917 0
Townsville Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 300917 0
Townsville Hospital
100 Angus Smith Drive
Douglas, QLD, 4814
Ethics committee country [1] 300917 0
Australia
Date submitted for ethics approval [1] 300917 0
13/12/2017
Approval date [1] 300917 0
19/12/2017
Ethics approval number [1] 300917 0
HREC/17/QTHS/161

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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85270 0
Dr Benjamin Swinson
Address 85270 0
Townsville Hospital
100 Angus Smith Drive
Douglas, QLD, 4814
Country 85270 0
Australia
Phone 85270 0
+61744331111
Fax 85270 0
Email 85270 0
benjamin.swinson@health.qld.gov.au
Contact person for public queries
Name 85271 0
Dr Benjamin Swinson
Address 85271 0
Townsville Hospital
100 Angus Smith Drive
Douglas, QLD, 4814
Country 85271 0
Australia
Phone 85271 0
+61744331111
Fax 85271 0
Email 85271 0
benjamin.swinson@health.qld.gov.au
Contact person for scientific queries
Name 85272 0
Dr Benjamin Swinson
Address 85272 0
Townsville Hospital
100 Angus Smith Drive
Douglas, QLD, 4814
Country 85272 0
Australia
Phone 85272 0
+61744331111
Fax 85272 0
Email 85272 0
benjamin.swinson@health.qld.gov.au

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.