Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000951055
Ethics application status
Not yet submitted
Date submitted
27/10/2010
Date registered
5/11/2010
Date last updated
18/01/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of Rectal Balloon Training in Obstructive Defaecation: A Randomised Controlled Trial
Scientific title
A Randomised controlled Trial to assess the effectiveness of rectal balloon training in Biofeedback for Obstructive defaecation patients.
Secondary ID [1] 252968 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive defecation 258494 0
Condition category
Condition code
Oral and Gastrointestinal 258664 258664 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
Education sessions on the role of fluid, fibre, fitness and maintaining a correct posture during defecation plus a rectal balloon training.

For the rectal balloon trainig, the nurse will insert a deflated balloon into the rectum and inflate it with 50mL of warm water using a syringe. This provides the sensation of a full rectum and the need to defaecate. The biofeedback nurse will monitor your abdominal movements, relaxation and breathing during the attempt to expel the balloon and give you instant feedback on proper defecating technique.

The biofeedback treatment will be facilitated by a specialised biofeedback nurse. Participants will received 1 hr sessions once a month for a total of 4 months.
Intervention code [1] 257492 0
Treatment: Devices
Intervention code [2] 257558 0
Behaviour
Intervention code [3] 257559 0
Lifestyle
Comparator / control treatment
education sessions only on the role of fluid, fibre, fitness and maintaining a correct posture during defecation.

The biofeedback treatment will be facilitated by a specialised biofeedback nurse. Participants will received 1 hr sessions once a month for a total of 4 months.
Control group
Active

Outcomes
Primary outcome [1] 259516 0
Change in QOL for obstructive defecation patients as determined using CR QOL (constipation related quality of life) and DQOT (Direct questioning of objectives).
Timepoint [1] 259516 0
Baseline data will be collected prior to patients receiving the treatment.
The treatment involves 4 sessions with 1month interval between each sessions. Questionnaire will be administered to patients at each session.
Patients will be followed up 3,6 and 12 months post completion of treatment.
Secondary outcome [1] 266127 0
Improved psychological sate as determined using DASS (depression, anxiety and stress scale).
Timepoint [1] 266127 0
Baseline data will be collected prior to patients receiving the treatment.
The treatment involves 4 sessions with 1month interval between each sessions. Questionnaire will be administered to patients at each session.
Patients will be followed up 3,6 and 12 months post completion of treatment.
Secondary outcome [2] 266230 0
Improved symptoms as determined using CSI (constipation severity instrument)
Timepoint [2] 266230 0
Baseline data will be collected prior to patients receiving the treatment.
The treatment involves 4 sessions with 1month interval between each sessions. Questionnaire will be administered to patients at each session.
Patients will be followed up 3,6 and 12 months post completion of treatment.

Eligibility
Key inclusion criteria
1) prior assessment by a doctor, nurse specialist or physiotherapist;
2) fulfill the ROME criteria of obstructive defecation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) structural causes such as colorectal malignancy, full thickness rectal prolapse or a non-emptying rectocoele;
2) previous treatment with biofeedback;
3) poor command of English;
4) an underlying organic brain lesion that may limit a patient’s ability to understand or follow instructions for biofeedback;
5) unable to consent for other reasons.

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e., computerised sequence generation)
Masking / blinding
Blinded (masking 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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3400 0
2050

Funding & Sponsors
Funding source category [1] 257940 0
Self funded/Unfunded
Name [1] 257940 0
Colorectal Research Department
Country [1] 257940 0
Australia
Primary sponsor type
Individual
Name
A/Prof Christopher Young
Address
Suite 415, RPAH Medical Centre, 100 Carillon Ave, Newtown, NSW 2042
Country
Australia
Secondary sponsor category [1] 257132 0
Individual
Name [1] 257132 0
Dr Cherry Koh
Address [1] 257132 0
Source, PO Box M157, Missenden Road, Camperdown, NSW 2050
Country [1] 257132 0
Australia
Secondary sponsor category [2] 257133 0
Individual
Name [2] 257133 0
Professor Michael Solomon
Address [2] 257133 0
Suite 415, RPAH Medical Centre, 100 Carillon Ave, Newtown, NSW 2042
Country [2] 257133 0
Australia
Secondary sponsor category [3] 257134 0
Individual
Name [3] 257134 0
Dr Christopher Byrne
Address [3] 257134 0
Suite 415, RPAH Medical Centre, 100 Carillon Ave, Newtown, NSW 2042
Country [3] 257134 0
Australia
Secondary sponsor category [4] 257135 0
Individual
Name [4] 257135 0
Prof Anthony Eyers
Address [4] 257135 0
Suite 202, RPAH Medical Centre, 100 Carillon Ave, Newtown, NSW 2042
Country [4] 257135 0
Australia
Secondary sponsor category [5] 257136 0
Individual
Name [5] 257136 0
Dr Peter Lee
Address [5] 257136 0
Suite 415, RPAH Medical Centre, 100 Carillon Ave, Newtown, NSW 2042
Country [5] 257136 0
Australia
Secondary sponsor category [6] 257137 0
Individual
Name [6] 257137 0
Dr Caroline Wright
Address [6] 257137 0
Suite 415, RPAH Medical Centre, 100 Carillon Ave, Newtown, NSW 2042
Country [6] 257137 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 259950 0
SSWAHS Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 259950 0
c/- Research Development Office
Level 3, Building 92
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [1] 259950 0
Australia
Date submitted for ethics approval [1] 259950 0
29/09/2010
Approval date [1] 259950 0
Ethics approval number [1] 259950 0
HREC/10/RPAH/506

Summary
Brief summary
Obstructive defaecation (OD) is a challenging clinical problem not uncommonly encountered in colorectal practice. OD is associated with depression, anxiety and impaired quality of life (QOL).1 Unfortunately, because the underlying anatomic and pathophysiology of OD is poorly understood, large number of medical, surgical and behavioural treatment have been described with no panacea. A recent meta-analysis suggests that biofeedback is effective in the treatment of OD, although only a handful of randomized trials, each with different biofeedback regime have been completed to date.2 Most trials have also focused on symptomatic improvement with relative neglect of impact of treatment on QOL or psychological state.2 In amongst the seemingly vast literature surrounding OD and its treatment, some fundamental questions remain unanswered: 1) is it the counselling and support that makes biofeedback effective; 2) is balloon retraining effective as a biofeedback modality; 3) does treatment improve QOL or psychological state.

The biofeedback protocol at Royal Prince Alfred Hospital (RPAH) for OD is a comprehensive program entailing education, counselling (conservative management) and balloon retraining. Balloon retraining has only been evaluated in 1 randomised trial in 1995 (Koutsoumanis et al)3 and although improved treatment success have been noted since it was introduced at RPAH, whether or not this represents a biased observation remains unclear.

A randomized controlled trial (RCT) is proposed to: 1) determine if biofeedback improves QOL and psychological state of patients with OD; 2) to determine if balloon retraining as a biofeedback modality is effective; 3) to determine if balloon retraining confers any additional benefit to patient receiving conservative management.
Trial website
None
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 31838 0
Address 31838 0
Country 31838 0
Phone 31838 0
Fax 31838 0
Email 31838 0
Contact person for public queries
Name 15085 0
Emily Chew
Address 15085 0
Colorectal Research Department
Level 9 East Ambulatory Care,
Royal Prince Alfred Hospital
Missenden Road, Camperdown 2050 NSW
Country 15085 0
Australia
Phone 15085 0
+61 2 9515 3209
Fax 15085 0
+61 2 9515 3222
Email 15085 0
[email protected]
Contact person for scientific queries
Name 6013 0
Dr Cherry Koh
Address 6013 0
Colorectal Research Department
Level 9 East Ambulatory Care,
Royal Prince Alfred Hospital
Missenden Road, Camperdown 2050 NSW
Country 6013 0
Australia
Phone 6013 0
+61 2 9515 6111
Fax 6013 0
Email 6013 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

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