Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000975796
Ethics application status
Approved
Date submitted
5/07/2022
Date registered
11/07/2022
Date last updated
11/07/2022
Date data sharing statement initially provided
11/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A dietitian and physiotherapy approach to the management of bowel disorders.
Scientific title
The effect of conservative management of bowel disorders in a colorectal pelvic floor clinic: A randomised trial of dietary management and/or physiotherapy management
Secondary ID [1] 307494 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
faecal incontinence 326900 0
obstructed defecation 326901 0
constipation 326902 0
Condition category
Condition code
Oral and Gastrointestinal 324104 324104 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants are drawn from standard outpatient waitlist list and randomly assigned into group A, group B or group C. Interventions are personalised according to the condition and lifestyle/ preference of participant.

We would expect that participants would have a minimum of 1-2 appointments in the group assigned. We would encourage up to 6 months of appointments. However, the participant can stop when they are happy with the advice given, their symptoms improve or no longer want to attend. We are able to track how many appointments the participants attend through our electronic booking system.

Group A – Physiotherapy and Dietitian (intervention group)
• Group A will see both a physiotherapist and a dietitian for 6 months. Appointments will be every 3-4 weeks for physio and 4-6 weeks for dietetics, 30 to 60 minutes duration each appointment.
• Participants will be given the option to continue after this time if they wish.

Group B – Physiotherapy only (standard care)
• Group B will see a physiotherapist for 6 months with appointments every 3-4 weeks.
• Participants will be given the option to continue after this time if they wish. They will also be able to see a dietitian if requested or needed.

Group C – Dietitian only (intervention group)
• Group C will see a dietitian for 4-6 weeks for 6 months.
• Participants will be given the option to continue after this time if they wish. They will also be able to see a physiotherapist if requested or needed.

For all groups, physiotherapy will involve
• Assessment of bowel function, bladder function and general health and perform a rectal and/or vaginal examination. Appropriate treatment is recommended, for example toileting techniques &/or pelvic floor muscle training and is expected that participants will complete these at home.
• The level of intensity of training is individual. It is based on the assessment by the physiotherapist and the referring condition reason
• Adherence to strategies are participant determined. There may be bowel and urinary diaries for participants to do however these are for patients to monitor their own symptoms

For all groups, dietetics will involve
• The dietitian will develop an individualised food plan that may include changes to the amount and type of fibre (for example for soluble fibre, less FODMAP sources, increase overall fibre intake), fat (aiming for less than 20% of energy consumption), and fluid consumed and how and when food is consumed (for example, eating regularly/ not skipping meals, strategies to avoid swallowing air).
• Adherence to strategies are participant determined. There may be bowel and food diaries for participants to do however these are for patients to gain awareness about potential link between bowel symptoms and food intake.
Intervention will be given face to face, telehealth or via telephone

The Dietitians and Physiotherapists have over 15 years of experience and the physiotherapists have specialised training in pelvic floor/ colorectal issues.
Intervention code [1] 323950 0
Treatment: Other
Intervention code [2] 323951 0
Lifestyle
Intervention code [3] 323952 0
Behaviour
Comparator / control treatment
As described above Group B – Physiotherapy only is the standard care currently happening within the hospital outpatient setting

o Group B will see a physiotherapist for 6 months with appointments every 3-4 weeks.
o Physiotherapy: assesses bowel function, bladder function and general health and perform a rectal and/or vaginal examination. Appropriate treatment is recommended, for example toileting techniques &/or pelvic floor muscle training.
o Intervention is for 6 months, participants will be given the option to continue after this time if they wish. They will also be able to see a dietitian if requested or needed.
Control group
Active

Outcomes
Primary outcome [1] 331904 0
Faecal incontinence severity as measured by with FISI/ VAIZEY/ WEXNER Scores
This is a composite primary outcome. Given as one questionnaire to participants
Timepoint [1] 331904 0
Baseline & 3, 6 (primary end point), 9 and 12 months from start of outpatient group assigned
Primary outcome [2] 331905 0
Quality of life as measured by
o Patient Assessment of Constipation – Quality of Life Score (with scoring sheet)

Timepoint [2] 331905 0
Baseline & 3, 6 (primary endpoint), 9 and 12 months from start of outpatient group assigned
Primary outcome [3] 331906 0
Constipation & Obstructed defecation severity as measured by
- the constipation + obstructed defecation scoring system
- composite primary outcome, given as 1 questionnaire to participants
- Approved Metro South Health document and in use already within the colorectal unit. Adapted from Agachan F, Chen T, Pfeifer J, Reissmon P, Wexner SD (1996)
Timepoint [3] 331906 0
Baseline & 3, 6 (primary end point), 9 and 12 months from start of outpatient group assigned
Secondary outcome [1] 411554 0
Patient satisfaction, using the validated short assessment of patient satisfaction (SAPS)
Timepoint [1] 411554 0
6 months after receiving physio &/or dietetic intervention in the group assigned
Secondary outcome [2] 411597 0
Faecal Incontinence – Quality of Life Score (with scoring sheet). This is a primary outcome
Timepoint [2] 411597 0
Baseline, 3 months, 6 months (primary end point), 9 and 12 months

Eligibility
Key inclusion criteria
On the hospital colorectal pelvic floor new waitlist and primary diagnosis of
- Ano-rectal incontinence
- Faecal urgency
-Obstructed defecation
- Constipation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Primary Diagnosis of:
• Rectal bleeding
• Ano-rectal fistula
• Acute anal fissure
• External rectal prolapse
• Complicated hernia with recent history of bowel obstruction
• Diagnosed GI abnormality/ Any recent change in bowel habits (that has not been investigated)
• Pelvic pain syndromes including proctalgia
- any dietetic or physiotherapy intervention in the last 18 months

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)
allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
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
The sample size calculation is based on the constipation score. Based on previous data, the group means pre/post intervention were 13.4 +/- 4.9 (SD) units vs 8.8 +/- 3.9 (SD) units.

For 90% power and 5% significance (two-tailed) to detect this difference between constipation scores, 24 participants are required per group in this trial. However due to failed to attend rates within hospital outpatients, we aim to recruit 50 participants per group

Mean differences in outcome measures (faecal incontinence quality of life score, FISI/ VAIZEY/ WEXNER scores, patient assessment of constipation – quality of life score, constipation score, obstructed defecation score) at baseline and 3, 6, 9 and12 months, will be assessed using paired samples t tests. If normality assumptions are violated, Mann–Whitney tests of medians will be used to assess differences. Fisher’s exact test or Pearson’s chi- square test will be used to assess independence between two categorical variables. Statistical significance will be reported at the 95% level (2-tailed). Intention to treat, linear mixed models will be used to determine changes in outcome measures between physiotherapy + dietetics (Group A), physiotherapy first (Group B) and dietetic first (Group C) at baseline, 3, 6, 9 and 12 months

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/08/2022
Actual
Date of last participant enrolment
Anticipated
29/05/2023
Actual
Date of last data collection
Anticipated
27/05/2024
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 22705 0
Queen Elizabeth II Jubilee Hospital - Coopers Plains
Recruitment postcode(s) [1] 37983 0
4108 - Coopers Plains

Funding & Sponsors
Funding source category [1] 311773 0
Government body
Name [1] 311773 0
Metro South Health Research Support Scheme
Country [1] 311773 0
Australia
Primary sponsor type
Hospital
Name
Queen Elizabeth II Jubilee Hospital
Address
QE II Jubilee Hospital
Cnr Kessels Road and Troughton Road
Coopers Plains, Qld 4108
Country
Australia
Secondary sponsor category [1] 313234 0
None
Name [1] 313234 0
Address [1] 313234 0
Country [1] 313234 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311215 0
Metro South Research Ethics
Ethics committee address [1] 311215 0
Metro South Research, Translational Research Institute
L7 37 Kent Street, Woolloongabba Qld 4102
Ethics committee country [1] 311215 0
Australia
Date submitted for ethics approval [1] 311215 0
05/04/2022
Approval date [1] 311215 0
29/04/2022
Ethics approval number [1] 311215 0
HREC/2022/QMS/84767

Summary
Brief summary
We want to assess the value of having physiotherapists and dietitians involved early and routinely when treating patients with constipation, obstructed defecation and/or faecal incontinence. It will help us to know the best way to care for people and may reduce the need for surgery.

All participants will be gathered over a period of 2 years from a specialist colorectal pelvic floor waiting list. Participants will be a randomised into one of three groups; A, B and C, The study design was chosen to enable participants to be randomised to the groups whilst minimising the impact to outpatient services for other patients.

• Group A: will receive physiotherapy and dietetics treatment concurrently for 6 months (research component).

• Group B: will receive 6 months of physiotherapy treatment. After six months, participants have the option of continuing physiotherapy and adding dietetic treatment when they have progressed on the dietetic waiting list (standard care).

• Group C: will receive 6 months of dietetic treatment. After six months, participants have the option of continuing dietetics and adding physiotherapy treatment when they have progressed on the physiotherapy waiting list (research component).

The outcome measures are participant answered questionnaires on their experience of severity of symptoms and quality of life before and after intervention with dietetics &/or physiotherapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120358 0
Mrs Melody Chaussende
Address 120358 0
QE II Jubilee Hospital
Cnr Troughton & Kessels Rd QLD 4108
Country 120358 0
Australia
Phone 120358 0
+61 0731826241
Fax 120358 0
Email 120358 0
melody.chaussende2@health.qld.gov.au
Contact person for public queries
Name 120359 0
Mrs Melody Chaussende
Address 120359 0
QE II Jubilee Hospital
Cnr Troughton & Kessels Rd QLD 4108
Country 120359 0
Australia
Phone 120359 0
+61 0731826241
Fax 120359 0
Email 120359 0
melody.chaussende2@health.qld.gov.au
Contact person for scientific queries
Name 120360 0
Mrs Melody Chaussende
Address 120360 0
QE II Jubilee Hospital
Cnr Troughton & Kessels Rd QLD 4108
Country 120360 0
Australia
Phone 120360 0
+61 0731826241
Fax 120360 0
Email 120360 0
melody.chaussende2@health.qld.gov.au

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


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.