None listed
Conditions
Brief summary
Colorectal cancer is the third most common cancer globally, with rectal cancer accounting for over a third of colorectal cancer diagnoses and deaths. A common treatment for rectal cancer is surgery. While many patients who have undergone a low anterior resection report good outcomes, patients often experience a variety of disruptive bowel symptoms and poor bowel control following surgery. These symptoms can include painful bowel motions, diarrhoea and involuntary loss of stool and is collectively termed low anterior resection syndrome. One treatment for this condition is pelvic floor muscle training. This involves patients doing pelvic floor exercises aimed at improving the function of the pelvic floor and therefore reducing the symptoms of the condition. While this has proven to improve symptoms, there is limited research into the preventative role of pelvic floor muscle training on low anterior resection syndrome. Therefore, we aim to assess if pelvic floor muscle training can be used to prevent low anterior resection syndrome and improve quality of life. This study aims to assess if pelvic floor muscle training can be used to prevent low anterior resection syndrome following surgical treatment of colorectal cancer, and improve quality of life for patients. Who is it for? You may be eligible for this study if you are an adult colorectal cancer patient who has undergone a low anterior resection and received a diverting ileostomy, and are now waiting for an ileostomy reversal. Study details Participants at centres that do not have enough resources to provide the physiotherapy-based intervention, will be randomly assigned to one of two groups: app-based pelvic floor muscle training or standard care. Participants in the app-based pelvic floor muscle training group will be provided through a mobile application to guide them through exercises and record participation in these exercises. Standard care will not involve any pelvic floor muscle training. All participants will be asked to complete questionnaires at several timepoints following their ileostomy reversal regarding bowel function and quality of life. Information from this study will help inform clinical practice regarding optimisation of surgical treatment for colorectal cancer patients.
Interventions
Patients not recruited into COALA-1 will be included into COALA-2.
At centers where physiotherapists are unavailable, all patients will be directly recruited into COALA-2.
Electronic phone application based based physiotherapy intervention where patients download an electronic application on their phone with a preset pelvic floor exercise regimen and built in reminders to perform these exercises. Patients will be asked to complete these exercises three times a day for at least 12 weeks. This wil
Patients not recruited into COALA-1 will be included into COALA-2. At centers where physiotherapists are unavailable, all patients will be directly recruited into COALA-2. Electronic phone application based based physiotherapy intervention where patients download an electronic application on their phone with a preset pelvic floor exercise regimen and built in reminders to perform these exercises. Patients will be asked to complete these exercises three times a day for at least 12 weeks. This will begin at least 1 week before ileostomy reversal, but ideally 4-6 weeks prior to ileostomy reversal if they are able to be recruited in time. Adherence will be monitored through in app function which records exercise engagement and duration. Information about lifestyle modification, theory behind pelvic floor exercises, and how to perform these exercises will be available on the application in written, pictorial and video format. An example of the exercises prescribed in would be as follows: These exercises are a set prescription of repetitions Initially, muscle identification exercises - Position: Sitting forward in a chair, with knees and legs apart - Exercise: Squeeze pelvic floor and identify pelvic floor lift Rest 4 seconds, then repeat 3-4 times This will be repeated 3 times/day Then, an ongoing regime of this exercise will be prescribed as follows: Exercise 1- Hold 5-10sec, rest5-10sec ( pending on patient's ability)/5reps increase to 10 reps/3xday Exercise 2- Hold/Rest/ 10reps increase to 20 reps/3xday Follow exercise 3, 4 and daily application as above The duration of these exercises is variable as this depends on the repetitions rather than a specific time.
Sponsors
Austin Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The inclusion criteria for this study are: Adults aged 18 years and older, AND Have undergone a low anterior resection and received a diverting ileostomy, AND Who will have their ileostomies reversed in at least 1 weeks' time
Exclusion criteria
Are unable to provide informed consent, OR Are unable to perform the pelvic floor rehabilitation program Are unable to use or access the app due for any reason
Outcome results
None listed