Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000591257
Ethics application status
Approved
Date submitted
7/03/2018
Date registered
17/04/2018
Date last updated
4/10/2022
Date data sharing statement initially provided
5/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised study of pelvic floor muscle exercises compared to standard care to improve bowel function following ileostomy/colostomy reversal following a diagnosis of rectal cancer.
Scientific title
A randomised study of pelvic floor muscle exercises compared to standard care to improve bowel function following ileostomy/colostomy reversal following a diagnosis of rectal cancer.
Secondary ID [1] 294235 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PFME in RC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
colorectal cancer 306906 0
reversal of stoma 306907 0
pelvic floor dysfunction 306909 0
Condition category
Condition code
Cancer 306001 306001 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Surgery 306002 306002 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants recruited to the intervention arm will receive Pelvic Floor Muscle (PFM) assessment and instruction about PFM exercises by qualified physiotherapists. This assessment with the physiotherapist should take 30 minutes and will be done at the following timepoints:
-6 weeks prior to to operation to reverse stoma
-2 weeks, 3 & 6 months after reversal
PFM assessment will be inclusive of peritron measurements and visual assessment. The assessment of PFM function involves patients laying on their left side, at this time a thin flexible catheter with a small anal sensor at the tip is passed through the anus and into the rectum. Participants will be asked to change into a hospital gown. The physiotherapist will explain the procedure to the participant and answer any questions they may have. Participants will be asked to lie down on their left side. A small anal sensor, connected by a tube to the peritron monitor will be inserted anally. The probe will be placed in a latex-free glove and a water based lubricant used to ensure this is as comfortable as possible for the participant. The Physiotherapist will ask the participant to squeeze, hold a contraction, and then relax three to four times. The anal sphincter muscle pressures are measured during each of these manoeuvres.
Based on the initial assessment by the physiotherapist, an individualised program will be designed and taught to the participant to undertake at home. The exercises will be designed to tighten the anal muscles as if trying to prevent anything from coming out of the rectum. The exercises are to be performed regularly by the participant as often as they choose pre-opertively and post-operatively and a patient diary will be used to monitor adherence with the intervention.
Intervention code [1] 300529 0
Treatment: Other
Comparator / control treatment
Standard of care - Patient able to do nothing or seek their own advice for pelvic floor exercise.
Control group
Active

Outcomes
Primary outcome [1] 305036 0
Low Anterior Resection Syndrome (LARS) score to assess bowel function and frequency
Timepoint [1] 305036 0
Measured at baseline, pre-operatively, post-operatively at surgical review, 3 months and 6 months. Primary time point is 3 months.
Secondary outcome [1] 343960 0
Frequency of bowel movements as recorded in participant diary.
Timepoint [1] 343960 0
2 weeks post operatively, 3 months, 6 months
Secondary outcome [2] 343962 0
Use of loperamide as recorded by participant daily amount of tablets used.
Timepoint [2] 343962 0
2 weeks post operatively
3 months post operatively
6 months post operatively:
Secondary outcome [3] 343963 0
Food diary as recorded by participant in diary to assess avarage daily energy intake.
Timepoint [3] 343963 0
2 weeks post operatively
3 months post operatively
6 months post operatively
Secondary outcome [4] 343964 0
Incontinence pad use following the reversal procedure as recorded by participant in diary.
Timepoint [4] 343964 0
2 weeks post operatively
3 months post operatively
6 months post operatively
Secondary outcome [5] 343965 0
Patient reported outcomes using the following:
Wexner score to assess and monitor faecal incontinence.
Timepoint [5] 343965 0
baseline (approximately 6 weeks preoperatively),
2 weeks post operatively
3 months post operatively
6 months post operatively
Secondary outcome [6] 344438 0
European Organisation for Research and treatment of cancer (EORTC) QLQC30 questionnaire Assessing generic aspects of quality of life.
Timepoint [6] 344438 0
baseline (approximately 6 weeks preoperatively),
2 weeks post operatively
3 months post operatively
6 months post operatively
Secondary outcome [7] 344439 0
EORTC colon cancer specific module QLQ CR29 for rectal cancer.
Timepoint [7] 344439 0
baseline (approximately 6 weeks preoperatively),
2 weeks post operatively
3 months post operatively
6 months post operatively

Eligibility
Key inclusion criteria
-Male or Female subjects aged>= 18 years
-Rectal cancer with a temporary ileostomy/ colostomy planned for a reversal procedure -Before study enrolment written informed consent to participate in the trial must be given according to ICH/GCP and national/local regulations Aboriginal Torres Strait Islander patients must be offered the option of having the Aboriginal Liaison Officer or a friend/relative be present during consenting process
-Patients with a primary language other than English must be offered an interpreter during the consenting process.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects are not eligible for the trial if they fulfil any of the following criteria:
-Pregnancy Any psychiatric condition that would prohibit the understanding or rendering of informed consent
-Patient unable to adhere to planned visit and treatment schedule

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)
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
Recruiting
Date of first participant enrolment
Anticipated
23/04/2018
Actual
17/04/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
12
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 10260 0
John Hunter Hospital - New Lambton
Recruitment hospital [2] 10261 0
Newcastle Private Hospital - New Lambton Heights
Recruitment hospital [3] 10318 0
Calvary Mater Newcastle - Waratah
Recruitment postcode(s) [1] 21926 0
2305 - New Lambton
Recruitment postcode(s) [2] 21927 0
2305 - New Lambton Heights
Recruitment postcode(s) [3] 21986 0
2298 - Waratah

Funding & Sponsors
Funding source category [1] 298875 0
Other Collaborative groups
Name [1] 298875 0
Hunter Cancer Research Alliance
Country [1] 298875 0
Australia
Primary sponsor type
Hospital
Name
Calvary Mater Newcastle
Address
Edith St
Waratah NSW 2298
Country
Australia
Secondary sponsor category [1] 298082 0
None
Name [1] 298082 0
none
Address [1] 298082 0
none
Country [1] 298082 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299815 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 299815 0
Locked Bag 1
New Lambton NSW 2305
Ethics committee country [1] 299815 0
Australia
Date submitted for ethics approval [1] 299815 0
Approval date [1] 299815 0
26/07/2017
Ethics approval number [1] 299815 0
17/06/21/3.03

Summary
Brief summary
This study aims to examine efficacy of pelvic floor muscle exercises compared to standard care to improve bowel function following ileostomy/colostomy reversal following a diagnosis of rectal cancer.

Who is it for?
You may be eligible for this study if you are aged 18 or older, have had/have rectal cancer and have a temporary ileostomy or colostomy planned for a reversal procedure.
Study details
Participants will be randomly assigned (by chance) to either continue standard care or continue standard care in addition to pelvic floor muscle exercises. Participants in the exercises group will perform the exercises daily as instructed by the physiotherapist after initial assessment 6 weeks prior to reversal of stoma. Following stoma reversal participants randomised to PFME will be assessed by a physiotherapist again at 2 weeks , 3 months and 6 months. All participants , including those randomised to standard of care, will complete patient diary and quality of life assessments at 2 weeks, 3 months and 6 months after stoma reversal.
It is hoped this research will contribute to improved quality of life in patients after their reversal surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81654 0
Ms Catherine Johnson
Address 81654 0
Calvary Mater Newcastle
Edith St,
Waratah, NSW, 2298.
Country 81654 0
Australia
Phone 81654 0
+61 2 40144748
Fax 81654 0
Email 81654 0
[email protected]
Contact person for public queries
Name 81655 0
Catherine Johnson
Address 81655 0
Calvary Mater Newcastle
Edith St,
Waratah, NSW, 2298.
Country 81655 0
Australia
Phone 81655 0
+61 2 40144748
Fax 81655 0
Email 81655 0
[email protected]
Contact person for scientific queries
Name 81656 0
Catherine Johnson
Address 81656 0
Calvary Mater Newcastle
Edith St,
Waratah, NSW, 2298.
Country 81656 0
Australia
Phone 81656 0
+61 2 40144748
Fax 81656 0
Email 81656 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
data submitted for analysis
When will data be available (start and end dates)?
Yet to be determined and will update when information available.
Available to whom?
Relevant researchers
Available for what types of analyses?
Meta-analyses
How or where can data be obtained?
Contact to CI via email


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.