Use of physiotherapy to improve bowel function after rectal cancer surgery

ISRCTN	ISRCTN77383505
DOI	https://doi.org/10.1186/ISRCTN77383505
Protocol serial number	2.0
Sponsor	Cwm Taf University Health Board
Funder	Tenovus

Submission date: 06/11/2017
Registration date: 02/01/2018
Last edited: 24/02/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Up to 75% of patients experience difficulty controlling their bowels for up to 12 months following surgery for rectal cancer and 1 in 4 will continue to do so for more than a year. The introduction of an education session from specialist nurses and physiotherapists prior to surgery to teach patients how to improve their bowel function using a pelvic floor programme could be helpful. By assessing muscle tone in the pelvis before and after surgery to see if the introduction of pelvic floor training will determine if the programme is acceptable to patients and if they are able to comply with the programme at may be a stressful time for themselves and their family. In addition to evaluating the programme patients are interviewed to assess their satisfaction with the elements of the programme. This study is hoped to initiate further studies in future to look at the impact of introducing this intervention on bowel function and the effect on quality of life and function for bowel cancer survivors. The aim of this study is to test the feasibility of a simple intervention to improve bowel function following surgery for rectal cancer.

Who can participate?
Adults aged 18 and older with rectal cancer.

What does the study involve?
Patients recruited into this study are given an educational session to inform patients of bowel problems that can occur after surgery, simple measures to improve them and also education around pelvic floor exercises. Following this patients have an assessment of their pelvic floor by a physiotherapist and are given a tailored programme of exercises to follow for 12 weeks following their surgery, with two appointments at six and 12 weeks to assess progress. They are asked to complete questionnaires on quality of life and bowel function before surgery and after surgery (six and 12 weeks).

What are the possible benefits and risks of participating?
Participants may benefit from increased education and the potential for improvements in bowel function after rectal cancer surgery. There are no direct risks to patients involved in the study.

Where is the study run from?
1. Royal Glamorgan Hospital (UK)
2. University Hospital of Wales (UK)
3. Prince Charles Hospital (UK)

When is the study starting and how long is it expected to run for?
September 2016 to October 2018

Who is funding the study?
Tenovus (UK)

Who is the main contact?
Mrs Julie Cornish

Contact information

Mrs Julie Cornish
Scientific

Department of Surgery
Cwm Taf University Health Board
Llantrisant
CF728XR
United Kingdom

Study information

Primary study design	Interventional
Study design	Feasibility non randomised study
Secondary study design	Non randomised study
Study type	Participant information sheet
Scientific title	Physiotherapy and Anterior Resection Syndrome
Study acronym	PARiS
Study objectives	The aim of this study is to test the feasibility of introducing a simple intervention in an attempt to improve bowel function following surgery for rectal cancer. We propose the introduction of an educational session from specialist nurses and physiotherapists prior to surgery to teach patients how to strengthen their pelvic floor using this programme. The primary aim of this study is to see if the introduction of pelvic floor training is acceptable to patients and if they are able to comply with the programme at what may be a stressful time for themselves and their family.
Ethics approval(s)	Wales REC 6, 21/04/2016, ref: REC 16/WA/0124
Health condition(s) or problem(s) studied	Rectal Cancer
Intervention	Participants undergo an educational Session and Pelvic Floor Rehabilitation programme. Patients recruited into this study are given an educational session to inform patients of bowel problems that can occur after surgery, simple measures to improve them and also education around pelvic floor exercises. Following this participants have an assessment of their pelvic floor by a physiotherapist and be given a tailored programme of exercises to follow for 12 weeks following their surgery, with two appointments at six and 12 weeks to assess progress. They are asked to complete questionnaires on quality of life and bowel function before surgery and after surgery (six and 12 weeks).
Intervention type	Behavioural
Primary outcome measure(s)	Proportion of eligible patients approached who consent and attend the educational session are measured using the screening log and attendance record at each site.
Key secondary outcome measure(s)	1. Compliance with PFR programme is measured using Squeezy app +/-patient diaries for 12 weeks. Data will be collected at 6 and 12 weeks from the patients records 2. Acceptability of the intervention to the patient is measured using qualitative interviews for a proportion of patients (8-12) following the educational session and following the pelvic floor programme as 12 weeks 3. Pelvic floor tone measured using the Oxford Grading System, ICS grading system at the baseline assessment, 6 weeks and 12 weeks postoperatively 4. Patient bowel function is measured using LARS score and St Marks Faecal Incontinence Score at the baseline assessment, 6 weeks and 12 weeks postoperatively 5. Patient quality of life is measured using EQ5D, EORTC QLQ C30 and CR29, qualitative interviews at the baseline assessment, 6 weeks and 12 weeks postoperatively 6. Opinion on physiotherapy programme DVD are measured using focus groups following completion of the 12 week programme
Completion date	01/10/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	40
Total final enrolment	9
Key inclusion criteria	1. 18 years old 2. Rectal cancer 3. Undergoing Anterior Resection procedure with planned intestinal continuity 4. Able to complete physiotherapy programme
Key exclusion criteria	1. Unable to give informed consent 2. Not physically capable of performing the PFR programme
Date of first enrolment	01/09/2017
Date of final enrolment	01/09/2018

Locations

Countries of recruitment

United Kingdom
Wales

Study participating centres

Royal Glamorgan Hospital

Llantrisant
CF728XR
United Kingdom

University Hospital of Wales

Cardiff
CF144XW
United Kingdom

Prince Charles Hospital

Gurnos Roadd
Merthyr Tydfil
CF47 9DT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The dataset generated during the study is available upon request until 01/03/2028. Anonymised demographic, medical, patient-reported outcome and study-specific metric data may be shared with bonafide researchers, for use in research projects carried out in the public interest within the context of medical care or treatment. Access requests are processed according to local NHS policy and procedure and access may be granted at the discretion of the Chief Investigator/ Data Controller, who reserves the right to fully or partially withhold data. Further information, including application enquiries, should be made in writing to Mrs Julie Cornish at ColorectalResearch.CAV@wales.nhs.uk.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		26/09/2022	24/02/2023	Yes	No
Protocol article	protocol	30/06/2018	18/10/2019	Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

24/02/2023: IPD sharing statement, publication reference and total final enrolment added.
18/10/2019: Publication reference added.