ANZCTR - Registration

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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Bowel cancer

Bowel dysfunction

Condition category

Condition code

Cancer

Bowel - Back passage (rectum) or large bowel (colon)

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Oral and Gastrointestinal

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]

Rehabilitation

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Post intervention program (12 weeks)

Secondary outcome [1]

Bowel function using Low Anterior resection syndrome score

Timepoint [1]

0 month (baseline), 3 months (after intervention): 9 months (6 months after intervention)

Secondary outcome [2]

Bowel Function using Memorial Sloan Kettering Cancer Centre – Bowel Function Instrument

Timepoint [2]