Condition category
Cancer
Date applied
06/11/2017
Date assigned
02/01/2018
Last edited
15/12/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Julie Cornish

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2.0

Study information

Scientific title

Physiotherapy and Anterior Resection Syndrome

Acronym

PARiS

Study hypothesis

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

Wales REC 6, 21/04/2016, ref: REC 16/WA/0124

Study design

Feasibility non randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request patient information sheet

Condition

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

Phase

Drug names

Primary outcome measure

Proportion of eligible patients approached who consent and attend the educational session are measured using the screening log and attendance record at each site.

Secondary outcome measures

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

Overall trial start date

01/09/2016

Overall trial end date

01/10/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. 18 years old
2. Rectal cancer
3. Undergoing Anterior Resection procedure with planned intestinal continuity
4. Able to complete physiotherapy programme

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Unable to give informed consent
2. Not physically capable of performing the PFR programme

Recruitment start date

01/09/2017

Recruitment end date

01/09/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Glamorgan Hospital
Llantrisant
CF728XR
United Kingdom

Trial participating centre

University Hospital of Wales
Cardiff
CF144XW
United Kingdom

Trial participating centre

Prince Charles Hospital
Gurnos Roadd
Merthyr Tydfil
CF47 9DT
United Kingdom

Sponsor information

Organisation

Cwm Taf University Health Board

Sponsor details

Royal Glamorgan Hospital
Llantrisant
CF728XR
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Tenovus

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high impact peer reviewed journal. Planned publication of the protocol.

IPD sharing statement:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

30/09/2019

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes