POLARiS feasibility
Research type
Research Study
Full title
A feasibility, multicentre randomised control trial assessing the treatment options for patient with major low anterior resection syndrome to establish a Pathway Of Low Anterior Resection syndrome relief after Surgery
IRAS ID
307764
Contact name
Julie Cornish
Contact email
Sponsor organisation
Cardiff and Vale University Health Board
ISRCTN Number
ISRCTN10442425
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
RESEARCH SUMMARY
Rectal cancer (cancer of the lower part of the bowel) is one of the most prevalent forms of cancer, and affects approximately 14,000 people each year in the UK. The treatment for the majority of these patients is surgical removal of the affected part of the bowel, following which the bowel is joined back together. Some patients may also require chemotherapy and radiotherapy. One consequence of the treatment of bowel cancer is a severe form of bowel dysfunction called major Low Anterior Resection Syndrome (LARS).
LARS is a constellation of symptoms including incontinence to stool, urgency and frequency of bowel movements and incomplete evacuation; it is diagnosed using the LARS scoring tool. Major LARS can have a huge impact on the persons quality of life resulting in social isolation.
Currently there are no guidelines for the management of LARS. The aim of the POLARiS study is to investigate three different treatments for major LARS; optimised conservative management, a combination of diet, medication, bowel retraining and pelvic floor exercises; transanal irrigation, washing out the back passage of stool with warmed water; and sacral nerve stimulation where an electrical impulse delivered to the sacral nerve to help with bowel function. This feasibility study aims to test the study design ahead of a larger fully powered randomised control trial. The study will firstly recruit any consenting adult who has had surgery for rectal cancer (called an anterior resection) and who does not have a stoma, into a cohort and then follow up those patients every 3 months with bowel function and quality of life assessments. Any patient found to have major LARS (LARS score over 30) will be invited into the randomised control trial where the above three treatments will be tested. The study will run at 4 NHS Hospital sites over an 18 month period.SUMMARY OF RESULTS
Low Anterior Resection Syndrome (LARS) is a common outcome of bowel cancer treatment, causing symptoms like unpredictable bowel habits, incontinence (to wind or stool), and urgency. Despite its impact on quality of life, there are no guidelines on treatments.
This study explored the feasibility of running a randomised controlled trial (RCT) to assess treatment options for LARS, using a "Trial within a Cohort" (TWiC) design. Patients treated for bowel cancer in the past 10 years were recruited from NHS sites and screened for LARS. Those with severe symptoms were invited to join the RCT.
Participants were randomly assigned to one of three treatments:
Optimised Conservative Management: Tailored medication, physiotherapy, and lifestyle advice Transanal Irrigation: Water-based bowel cleansing Sacral Neuromodulation: An implantable device to retrain the pelvic floor The study focused on recruitment, conversion to the RCT, and retention in treatment programmes-not on evaluating the treatments themselves.Findings showed that 75% of rectal cancer surgery patients had LARS symptoms, even after 10 years. 40% of those with severe symptoms joined the RCT, with non-participation due to treatment eligibility or personal choice-highlighting a gap between symptom scores and patient experiences.
The study confirms that the TWiC design is feasible for LARS research, but future trials may benefit from directly recruiting patients already diagnosed with LARS into the RCT.REC name
Wales REC 1
REC reference
22/WA/0025
Date of REC Opinion
16 Feb 2022
REC opinion
Further Information Favourable Opinion