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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.

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.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000591257
Acronym
PFME in RC
Enrollment
12
Registered
2018-04-17
Start date
2018-04-17
Completion date
Unknown
Last updated
2022-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

Calvary Mater Newcastle
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026