Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001178639
Ethics application status
Approved
Date submitted
20/10/2023
Date registered
14/11/2023
Date last updated
14/11/2023
Date data sharing statement initially provided
14/11/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
A prospective pilot study of biofeedback training with “Contrain” in patients with major Low Anterior Resection Syndrome (LARS) and faecal incontinence symptoms after anterior resection for rectal cancer
Scientific title
A prospective pilot study of biofeedback training with “Contrain” in patients with major LARS and faecal incontinence symptoms after anterior resection for rectal cancer
Secondary ID [1] 310823 0
Nil Known
Universal Trial Number (UTN)
UTN: U1111-1252-3652
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low anterior resection syndrome 331817 0
Faecal Incontinence 331818 0
Condition category
Condition code
Cancer 328564 328564 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each participant allocated to treatment will be given a training programme with the Contrain® multifunction trainer (Procon GmbH, Hamburg, Germany). Patients will undergo two 20-minute sessions per day for nine months, with encouragement to do this morning and evening. The initial session is supervised by a physiotherapist, and subsequent sessions are performed at home, with remote support from the study’s physiotherapist as required. The participant will be asked to perform exercises while standing, with the probe inserted into their anus or with skin pads surrounding the anus depending on patient preference. They will select the routines and intensity of the electrical stimulation. The Contrain gives immediate on-screen feedback, which includes clearly documenting the strength of the contraction of the pelvic floor and anal sphincters. Feedback on contraction strength is given in microvolts, and participants are encouraged to contract at >80% of their capacity, which is determined by maximal contractions with the device. This will assist participants to correctly perform the exercises as they can see what their values are. In certain routines the timing of the electrical stimulation can be co-ordinated with the electromyography (EMG) readings to help increase the strength of the maximal achieved muscle contraction, as well as improve neurological feedback to the brain. This is known as "triple target therapy", combining biofeedback, stimulation, and pelvic floor exercises.
The number of exercises per day, and the performance in each exercise, will be recorded by the Contrain device. In addition to this, an intermittent clinical review (once every three months, for 30 minutes a session) will be performed by the study’s physiotherapist. At this time the performance in terms of frequency of exercise sessions and improvement in the strength of contraction will be reviewed. The ability of the participant to coordinate contraction, as well as relax the pelvic floor on bearing down, will also be reviewed. During the intervention, participants will not receive pelvic floor physiotherapy.
Intervention code [1] 327236 0
Treatment: Devices
Comparator / control treatment
Participants will undergo either standard care or biofeedback treatment, depending on patient preference. Those not allocated to treatment will be offered pelvic floor biofeedback with the Contrain once the study is completed. Standard care will involve guidance to patients, but no publicly funded pelvic floor physiotherapy. We will record whether the participants receive private pelvic floor physiotherapy.
Control group
Active

Outcomes
Primary outcome [1] 336370 0
Change in bowel function as assessed using the Low Anterior Resection score over the treatment period from baseline.
Timepoint [1] 336370 0
The LARS score will be measured at baseline, twelve weeks from the start of treatment, and after completion of training (nine months from the start of treatment).
Secondary outcome [1] 428057 0
change in faecal incontinence severity index score
Timepoint [1] 428057 0
baseline, twelve weeks from the start of treatment, and at the completion of training (nine months from the start of treatment).
Secondary outcome [2] 428059 0
Change in the Faecal incontinence severity index score
Timepoint [2] 428059 0
Performed at baseline, twelve weeks from the start of treatment, and at the completion of training (nine months from the start of treatment).
Secondary outcome [3] 428061 0
Change in quality of life scores
Timepoint [3] 428061 0
This will be performed at baseline, twelve weeks from the start of treatment, and at the completion of training (nine months from the start of treatment).

Eligibility
Key inclusion criteria
1. Previous rectal cancer surgery
2. Full continuity of the gastrointestinal tract (If a stoma was formed it has subsequently been closed at least a year prior to enrolment in this study)
3. Major LARS (score > 30)
4. Previous treatment has been given for LARS, including medications such as loperamide, dietary advice and treatment for bile acid malabsorption (BAM).
5. Aged 18-80
6. Able to give informed consent
7. Participant is available to commit to up to 36 weeks of biofeedback training.
8. Participant is sufficiently motivated to commit to two training sessions a day for 6-9 months.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cognitive disorders impeding pelvic floor rehabilitation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
This is a pragmatic prospective pilot study to assess the impact of Contrain on major LARS. As there are no reported studies assessing this, an a priori power calculation is not possible. However, the results of this pilot will inform a power calculation for a larger, randomised controlled trial of biofeedback in patients with LARS.
Outcome measures will be summarised with descriptive statistics, including mean and standard deviations or medians and interquartile ranges depending on the distribution of the data.
Comparison of LARS score before and after Contrain biofeedback will be assessed with either paired Student t tests or Wilcoxon Rank Sum test depending on distribution of the data.
We will compare the change in LARS score to potential predictors of response. This will include age, previous pelvic radiotherapy, time between rectal cancer surgery and closure of stoma, and time from closure of stoma to commencement of Contrain biofeedback. As this is a pilot study with only 10 patients in each group no linear regression analysis will be performed.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
10/10/2023
Date of last participant enrolment
Anticipated
10/10/2025
Actual
Date of last data collection
Anticipated
10/07/2026
Actual
Sample size
Target
20
Accrual to date
3
Final
Recruitment outside Australia
Country [1] 25914 0
New Zealand
State/province [1] 25914 0
otago

Funding & Sponsors
Funding source category [1] 315071 0
Charities/Societies/Foundations
Name [1] 315071 0
Maurice and Phyllis Paykel Trust
Country [1] 315071 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
201 Great King St, Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 317088 0
Hospital
Name [1] 317088 0
Dunedin Hospital
Address [1] 317088 0
201 Great King st, Dunedin 9016
Country [1] 317088 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314018 0
Southern Health and Disabilities Ethics Committee
Ethics committee address [1] 314018 0
PO Box 5013 Wellington 6140
Ethics committee country [1] 314018 0
New Zealand
Date submitted for ethics approval [1] 314018 0
27/05/2022
Approval date [1] 314018 0
15/07/2022
Ethics approval number [1] 314018 0
11277

Summary
Brief summary
This study is evaluating the efficacy of delivering pelvic floor physiotherapy using biofeedback and electrical stimulation techniques to help re-train the rectal muscles and improve faecal continence.

Who is it for?
You may be eligible for this study if you are aged 18 to 80 years old, and have major low anterior resection syndrome (LARS) after surgery for rectal cancer.

Study details
Participants will choose to either receive pelvic floor biofeedback stimulation or standard care. Pelvic floor biofeedback stimulation will involve using the Contrain multifunction trainer for up to two 20-minute sessions per day for nine months. Participants will be asked to complete questionnaires on their faecal incontinence symptoms and quality of life over the course of the nine-month study period.

It is hoped that results from this pilot study will help determine the feasibility of pelvic floor biofeedback stimulation after rectal cancer surgery, to help develop a larger study in the future.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130138 0
Dr John Woodfield
Address 130138 0
Department of Surgical Sciences, Dunedin School of Medicine, PO Box 56 Dunedin 9054
Country 130138 0
New Zealand
Phone 130138 0
+64 276085111
Fax 130138 0
Email 130138 0
john.woodfield@otago.ac.nz
Contact person for public queries
Name 130139 0
Dr Kari Clifford
Address 130139 0
Department of Surgical Sciences, Dunedin School of Medicine, PO Box 56 Dunedin 9054
Country 130139 0
New Zealand
Phone 130139 0
+64 210668369
Fax 130139 0
Email 130139 0
kari.clifford@otago.ac.nz
Contact person for scientific queries
Name 130140 0
Dr Kari Clifford
Address 130140 0
Department of Surgical Sciences, Dunedin School of Medicine, PO Box 56 Dunedin 9054
Country 130140 0
New Zealand
Phone 130140 0
+64 210668369
Fax 130140 0
Email 130140 0
kari.clifford@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
anonymised results from the questionnaire data collected
When will data be available (start and end dates)?
Data will be available from the date we publish the results (anticipated 12/2026) for ten years.
Available to whom?
Available to researchers upon reasonable request to the corresponding author.
Available for what types of analyses?
Available for use in meta analyses
How or where can data be obtained?
by contacting the corresponding investigator. Kari.clifford@otago.ac.nz


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.