Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000821998
Ethics application status
Approved
Date submitted
24/06/2020
Date registered
17/08/2020
Date last updated
16/02/2023
Date data sharing statement initially provided
17/08/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility trial of pelvic floor rehabilitation for bowel function issues after colorectal cancer surgery.
Scientific title
A pelvic floor rehabilitation program for patients with bowel dysfunction after sphincter- preserving surgery for colorectal cancer: a feasibility study
Secondary ID [1] 301613 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bowel cancer 317995 0
Bowel dysfunction 317997 0
Condition category
Condition code
Cancer 316028 316028 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Physical Medicine / Rehabilitation 316031 316031 0 0
Other physical medicine / rehabilitation
Oral and Gastrointestinal 316246 316246 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
Name: Pelvic floor rehabilitation program
Rationale: Patients after anterior resection +/- radiochemotherapy for colorectal cancer can suffer from bowel dysfunction that includes faecal incontinence and defaecatory problems. A structured pelvic floor rehabilitation program on pelvic floor muscle strengthening, anorectal sensory and coordination training can improve bowel function after surgery. This study will also examine the feasibility of the intervention in an outpatient setting.
Intervention: A 15 minutes of education session will be provided at the commencement of the program at first week. Participants will be provided education on normal bowel function and the bowel issues associated with colorectal cancer surgery. They will also receive information on good bladder and bowel habits, dietary advice, and pelvic floor exercises.The educational information and home exercise pamphlet is specifically designed for this study. Each participant will be assessed on their anorectal physiology by a colorectal surgeon and pelvic floor physiotherapist. Patient reported outcomes on bladder, bowel, sexual function and quality of life will be examined with questionnaires before and after the intervention. The intervention is a 10 week face to face program of weekly attendance to the outpatient clinic for 1 hour under supervision (ie 1 hour session, once per week for 10 weeks in an outpatient clinic). The program includes: pelvic floor muscle strengthening with use of transperineal ultrasound for visual biofeedback, anorectal sensory and coordination retraining using rectal balloon catheter biofeedback. Visual feedback will be provided via the application of a transperineal ultrasound. The patient will be able to visualise the pelvic floor muscle activity on the screen during the training session. A rectal balloon catheter will be used to provide sensory feedback in order to train pelvic floor muscle strength, rectal sensation and coordination. Verbal instruction will be given during the supervising session and a home exercise pamphlet explaining the exercises will be given to the patient. The pelvic floor exercises involve the contraction and relaxation of pelvic floor muscle together with diaphragmatic breathing. Pelvic floor exercises: two times per day with one for strength and one for endurance training. Strength training: 70%o of maximal pelvic floor muscle contraction, 10 reps x 3 sets with 1 minute rest in between. Endurance training: 50% of maximal pelvic floor muscle contraction 15 reps x5 sets with 2 minutes rest in between. This pelvic floor rehabilitation program will be delivered by a physiotherapist in the area of pelvic floor disorders with minimum 5 years experience. Participants will also be instructed to practise home exercises and to complete a daily pelvic floor exercise diary. Patients' satisfaction survey and attendance record will be evaluated at the end of the program for intervention adherence.
Due to the recent global pandemic outbreaks, a telehealth option will be included in the study procedure to minimise the risk of exposure to coronavirus in both staff and participants.
The telehealth consultation may replace face-to-face training sessions at any timepoint during the 10-weeks training. For the 10 weeks pelvic floor rehabilitation, participants will receive 5 mandatory face-to-face training sessions for biofeedback and 5 sessions for progressive pelvic floor exercise training which can be either face to face or via telehealth. Where possible the rehabilitation program will be carried out over 10 consecutive weeks whether it’s face-to-face or telehealth session.
Intervention code [1] 317918 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324243 0
Adherence to pelvic floor rehabilitation program.Proportion with >80% attendance of supervised sessions. >80% of completion for weekly home exercises. This will be assessed by an attendance log and home exercise diary completion.
Timepoint [1] 324243 0
Post intervention program (12 weeks)
Secondary outcome [1] 384134 0
Bowel function using Low Anterior resection syndrome score
Timepoint [1] 384134 0
0 month (baseline), 3 months (after intervention): 9 months (6 months after intervention)
Secondary outcome [2] 384135 0
Bowel Function using Memorial Sloan Kettering Cancer Centre – Bowel Function Instrument
Timepoint [2] 384135 0
0 month (baseline), 3 months (after intervention), 9 months (6 months after intervention)
Secondary outcome [3] 384136 0
Bladder function using International Consultation of Incontinence – Lower Urinary Tract
Timepoint [3] 384136 0
0 month (baseline), 3 months (after intervention), 9 months (6 months after intervention)
Secondary outcome [4] 384137 0
Sexual function using International Index of Erectile Function (IIEF) (male patient only)
Timepoint [4] 384137 0
0 month (baseline), 3 months (after intervention), 9 months (6 months after intervention)
Secondary outcome [5] 384138 0
Sexual function using Female Sexual Function Index (FSFI) (female patient only)
Timepoint [5] 384138 0
0 month (baseline), 3 months (after intervention), 9 months (6 months after intervention)
Secondary outcome [6] 384139 0
Quality of life using Fecal Incontinence Quality of Life (FIQOL)
Timepoint [6] 384139 0
0 month (baseline), 3 months (after intervention), 9 months (6 months after intervention)
Secondary outcome [7] 384140 0
Quality of life using Functional Assessment of Cancer Therapy – Colorectal (FACT-C)
Timepoint [7] 384140 0
0 month (baseline), 3 months (after intervention), 9 months (6 months after intervention)
Secondary outcome [8] 384141 0
Symptoms of anxiety and depression using Hospital Anxiety and Depression Scale (HADS)
Timepoint [8] 384141 0
0 month (baseline), 3 months (after intervention), 9 months (6 months after intervention)
Secondary outcome [9] 384142 0
Bowel function investigation with anorectal physiology assessment
Timepoint [9] 384142 0
0 months (baseline) and 3 months (after intervention)
Secondary outcome [10] 384143 0
Bowel function using endoanal ultrasound
Timepoint [10] 384143 0
0 months (baseline) and 3 months (after intervention)
Secondary outcome [11] 384144 0
Bowel function using Bristol Stool Chart
Timepoint [11] 384144 0
0 months (Baseline), 3 months (after intervention), 9 months (6 months after intervention)
Secondary outcome [12] 384145 0
Pelvic floor muscle strength using Modified Oxford Scale grading 0 -5
Timepoint [12] 384145 0
0 month (baseline), 3 months (after intervention)
Secondary outcome [13] 418630 0
Qualitative outcome measures with 15 minutes semi-structured interview conducted via telephone. The qualitative information will provide additional information on the impact of bowel symptoms in people's day to day lives, and more nuanced information regarding any changes noticed from participating in the pelvic floor rehabilitation program. The exit interview will be conducted at 3 months (on the completion of intervention).
Timepoint [13] 418630 0
Qualitative outcome measures with 15 minutes semi-structured interview conducted via telephone. The qualitative information will provide additional information on the impact of bowel symptoms in people's day to day lives, and more nuanced information regarding any changes noticed from participating in the pelvic floor rehabilitation program. The exit interview will be conducted at 3 months (on the completion of intervention).

Eligibility
Key inclusion criteria
• Underwent anterior resection with sphincter preservation for colorectal cancer with or without neoadjuvant/adjuvant therapy
• Initial onset of bowel dysfunction symptoms after surgery and treatment, with a LARS score >20.
• Bowel continuity restored without stoma for at least 6 months
• No clinical evidence of recurrence of colorectal cancer or distant metastasis
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Aged <18
• Unable to give informed consent or follow instructions due to cognitive or English language difficulties
• Neurological disorders or acute exacerbation of inflammatory bowel disease.

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)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary outcome, which is the adherence to the pelvic floor rehabilitation program, will be reported descriptively detailing attendance. The secondary outcomes, which are the completion of exercise, bowel function and QOL questionnaires measured at baseline, 3 months and 9 months after completion of the program will be analysed using paired sample t-tests, with 95% Confidence Interval (CI). Due to the small sample size, measures of significance will not be reported.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/05/2021
Actual
5/05/2021
Date of last participant enrolment
Anticipated
31/12/2023
Actual
Date of last data collection
Anticipated
30/06/2024
Actual
Sample size
Target
15
Accrual to date
8
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 16975 0
Concord Repatriation Hospital - Concord
Recruitment postcode(s) [1] 30637 0
2139 - Concord

Funding & Sponsors
Funding source category [1] 306044 0
Other Collaborative groups
Name [1] 306044 0
Digestive Pelvic Floor Centre
Country [1] 306044 0
Australia
Primary sponsor type
Hospital
Name
Concord Repatriation General Hospital
Address
Concord Repatriation General Hospital
Hospital Road
Concord NSW 2139
Country
Australia
Secondary sponsor category [1] 306506 0
None
Name [1] 306506 0
Address [1] 306506 0
Country [1] 306506 0
Other collaborator category [1] 281373 0
Other Collaborative groups
Name [1] 281373 0
Digestive Pelvic Floor Centre
Address [1] 281373 0
107/3 Railway Parade
Burwood NSW 2134
Country [1] 281373 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306271 0
Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 306271 0
Concord Repatriation General Hospital (CRGH)
Hospital Road
Concord NSW 2139
Ethics committee country [1] 306271 0
Australia
Date submitted for ethics approval [1] 306271 0
Approval date [1] 306271 0
31/03/2020
Ethics approval number [1] 306271 0
2019/PID15308

Summary
Brief summary
This study aims to determine the possibility and to examine if a short- term pelvic floor rehabilitation program can improve bowel issues after bowel cancer surgery with or without radiochemotherapy.

Who is it for?
You may be eligible for this study if you are an adult experiencing bowel issues after surgery for colorectal cancer.

Study details
Participants in this study will receive:
1. Education on normal bowel function and the bowel issues associated with colorectal cancer surgery. They will also receive information on good bladder and bowel habits, dietary advice, and pelvic floor exercises.
2. A 10 week face to face program of weekly attendance to the outpatient clinic for 1 hour under supervision (ie 1 hour session, once per week for 10 weeks in an outpatient clinic). The program includes: pelvic floor muscle strength training with use of an non- invasive technique called transperineal ultrasound for visual biofeedback, and anorectal sensory and coordination retraining using an minimally invasive technique called rectal balloon catheter biofeedback. Participants will also be instructed to practise home exercises and to complete a daily pelvic floor exercise diary.

It is hoped that this research will determine the possibility of a short-term pelvic floor rehabilitation program for patients with bowel dysfunction after colorectal cancer surgery and treatment in an outpatient setting as well as identify the signals of benefit of pelvic floor rehabilitation for the improvement of bowel function and quality of life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103314 0
Prof Janette Vardy
Address 103314 0
Concord Cancer Centre
Concord Repatriation & General Hospital
Hospital Rd
Concord, NSW, 2139
Country 103314 0
Australia
Phone 103314 0
+61 2 9767 5000
Fax 103314 0
Email 103314 0
[email protected]
Contact person for public queries
Name 103315 0
Prof Janette Vardy
Address 103315 0
Concord Cancer Centre
Concord Repatriation & General Hospital
Hospital Rd
Concord, NSW, 2139
Country 103315 0
Australia
Phone 103315 0
+61 2 9767 5000
Fax 103315 0
Email 103315 0
[email protected]
Contact person for scientific queries
Name 103316 0
Prof Janette Vardy
Address 103316 0
Concord Cancer Centre
Concord Repatriation & General Hospital
Hospital Rd
Concord, NSW, 2139
Country 103316 0
Australia
Phone 103316 0
+61 2 9767 5000
Fax 103316 0
Email 103316 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Under the SLHD ethics committee privacy act, individual participant data will not be disclosed and shared.


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.