Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000014853
Ethics application status
Approved
Date submitted
1/12/2011
Date registered
4/01/2012
Date last updated
30/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study to evaluate a new treatment protocol for post operative orthopaedic constipation
Scientific title
The effect of an evidence based bowel protocol on time taken to return to normal bowel function in post operative major joint replacement patients
Secondary ID [1] 273453 0
Nil
Universal Trial Number (UTN)
U1111-1126-0176
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post operative constipation in major joint replacement patients 279251 0
constipation 309467 0
Condition category
Condition code
Musculoskeletal 279452 279452 0 0
Osteoarthritis
Oral and Gastrointestinal 285622 285622 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients at intervention hospitals to receive a post operative bowel protocol based on the adminstration of polyethylene glycol with electrolytes (Movicol) according to bowel type as per the Bristol Stool Chart (BSC). Dosage of Movicol depends on BSC number but maximum dose is one sachet (13.125g Macrogol 3350) per day in two divided doses. This powder is dissolved in 125 ml of water. The intervention lasts for the duration of the inpatient stay usually maximum of 8 days.
Intervention code [1] 283779 0
Treatment: Drugs
Comparator / control treatment
Patients at the five control hospitals are to receive bowel management as per that hospital's current regime. This regime is very variable depending on doctor, nurse, hospital and patient preference therefore I am unable to describe it here.
Control group
Active

Outcomes
Primary outcome [1] 286014 0
Time taken (in days) to return to baseline bowel function
Timepoint [1] 286014 0
before discharge from hospital, at one week post discharge and at two weeks post discharge
Secondary outcome [1] 294976 0
Nil
Timepoint [1] 294976 0
Nil

Eligibility
Key inclusion criteria
Patients undergoing total hip or knee replacement
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
history or Crohns disease, toxic megacolon, pregnant or breastfeeding, known allergy to polyethylene glycol

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)
Patients whose orthopaedic surgeon has consented, who are seen in the hospital pre-admission clinic and who are having total hip or total knee surgeon are eligible to participate in the study. This study is a cluster randomised study so of the seven hospitals participating each was randomised (by a biostatastician) into either a control or intervention hospital with each hospital aware of its randomisation.
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not applicable as hospitals were randomised, not patients.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2011
Actual
1/05/2011
Date of last participant enrolment
Anticipated
Actual
18/05/2012
Date of last data collection
Anticipated
Actual
31/05/2012
Sample size
Target
382
Accrual to date
Final
382
Recruitment in Australia
Recruitment state(s)
WA,VIC
Recruitment postcode(s) [1] 4753 0
6230
Recruitment postcode(s) [2] 4754 0
3350
Recruitment postcode(s) [3] 4755 0
3550
Recruitment postcode(s) [4] 4756 0
6008
Recruitment postcode(s) [5] 4757 0
3806
Recruitment postcode(s) [6] 4758 0
3220
Recruitment postcode(s) [7] 4759 0
3280

Funding & Sponsors
Funding source category [1] 284307 0
Hospital
Name [1] 284307 0
St John of God Health Care
Country [1] 284307 0
Australia
Primary sponsor type
Hospital
Name
St John of God Health Care
Address
111 Coventry Street, South Melbourne, Victoria, 3205
Country
Australia
Secondary sponsor category [1] 283251 0
None
Name [1] 283251 0
Address [1] 283251 0
Country [1] 283251 0
Other collaborator category [1] 260368 0
University
Name [1] 260368 0
University of Notre Dame Australia
Address [1] 260368 0
PO Box 1225
FREMANTLE
Western Australia 6959
Country [1] 260368 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286268 0
University of Notre Dame Australia
Ethics committee address [1] 286268 0
Ethics committee country [1] 286268 0
Australia
Date submitted for ethics approval [1] 286268 0
Approval date [1] 286268 0
12/01/2011
Ethics approval number [1] 286268 0
010145F

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

Contacts
Principal investigator
Name 33434 0
Dr Dr Gail Ross-Adjie
Address 33434 0
Centre for Nursing and Midwifery Research
St John of God Murdoch Hospital
100 Murdoch Drive
Murdoch WA 6150
Country 33434 0
Australia
Phone 33434 0
+61 8 94389005
Fax 33434 0
Email 33434 0
Gail.Ross-Adjie@sjog.org.au
Contact person for public queries
Name 16681 0
Gail Ross-Adjie
Address 16681 0
St John of God Hospital
100 Murdoch Drive
Murdoch Western Australia 6150
Country 16681 0
Australia
Phone 16681 0
+61 8 94389005
Fax 16681 0
Email 16681 0
Gail.Ross-Adjie@sjog.org.au
Contact person for scientific queries
Name 7609 0
Gail Ross-Adjie
Address 7609 0
St John of God Hospital
100 Murdoch Drive
Murdoch Western Australia 6150
Country 7609 0
Australia
Phone 7609 0
+61 8 94389005
Fax 7609 0
Email 7609 0
Gail.Ross-Adjie@sjog.org.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.