An interventional study of Sacral NeuroModulation and Trans-Anal Irrigation in Low Anterior Resection Syndrome, sponsored by Cardiff and Vale University Health Board. Status unknown at 4 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-20.
Sponsored by Cardiff and Vale University Health Board · Not applicable, Interventional, and Other
Currently, no standard exists for the treatment and management of Low Anterior Resection Syndrome (LARS)- a common disorder that affects patients who have had part of their bowel removed due to colorectal cancer. Decisions about which treatment patients receive is at the discretion of local clinicians, leading to a variation in both clinical practice and the outcomes of these patients. As a result, there is a need for research to assess what treatments are most effective in treating or managing LARS to establish a consensus and develop a treatment pathway in the UK. This study aims to assess the feasibility of undertaking such a trial utilising a novel 'trial within cohorts (TWiCs)' study design, with a view to informing the design of a full-scale trial.
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.
85 studies on the registry are indexed under Low Anterior Resection Syndrome; 36 are open to participants now.
This study's enrollment of 187 is above the median of 67 across 57 interventional studies indexed under Low Anterior Resection Syndrome.
Browse Low Anterior Resection Syndrome studies →Cardiff and Vale University Health Board is the lead sponsor of 44 studies on the registry; 11 are open to participants now.
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For cohort:
For randomisation:
Exclusion Criteria:
For cohort
For randomised control trial
For TAI randomisation:
For SNM randomisation:
Patients who have undergone colonic resection for colorectal cancer in the last 10 years. Patient reported outcome measures collected at 3-monthly intervals.
Cohort participants who are identified as having 'major LARS' at any point are treated with Optimised Conservative Managements, consisting of medication, dietary advice, lifestyle advice and physiotherapy.
Other: Optimised Conservative Management
Cohort participants who are identified as having 'major LARS' at any point are treated with Trans-anal irrigation, in additional to receiving optimised conservative management. Transanal irrigation system will be decided upon with the participant and procured locally.
Device: Trans-Anal Irrigation · Other: Optimised Conservative Management
Cohort participants who are identified as having 'major LARS' at any point are treated with Sacral Neuromodulation system, in addition to receiving optimised conservative management. Medtronic Interstim system will be used.
Device: Sacral NeuroModulation · Other: Optimised Conservative Management
Sacral Neuromodulation group will include up-to 20 patients with major LARS. Medtronic Interstim system will be used, including 2 week trial device.
Trans-Anal irrigation group will include up-to 20 patients with major LARS. Specific system will be agreed with the patient, depending on eligibility and preference.
Optimised conservative management will include up-to 30 patients with major LARS. They will be provided with a resource booklet which includes dietary and lifestyle advice as well as exercises that can be undertaken independently.
Recruitment rate of to cohort arm of study
The total number of participants enrolled into the study over the recruitment period.
Time frame: 9 months
Assess characteristics of patients recruited to the cohort
We will record basic demographics, medical history and prevalence of relative symptoms of participants enrolled in the cohort study to describe the characteristics of no- minor- and major- LARS patients
Time frame: 9 months
Prevalence of 'major LARS' in the patient cohort
The number of participants in the cohort that meet the criteria for 'major low anterior resection syndrome (LARS)', as measured by the LARS scoring tool. LARS scoring tool produces a score from 0 - 42, which represents the severity of symptoms, where 0 is least severe and 42 is most severe. Score =\>30 is considered 'major LARS'. LARS score will be measured at 5 times at 3-monthly intervals over 12 months.
Time frame: 12 months
Onset of 'major LARS' symptoms in relation to surgery
The time (in months) from resection surgery to onset of 'major LARS' symptoms, as reported by the LARS scoring tool.
Time frame: Time from surgery to onset of major LARS, up to 10 years.
Onset of 'major LARS' symptoms in relation to radiotherapy treatment
The time (in months) from completing radiotherapy treatment to onset of 'major LARS' symptoms, as reported by the LARS scoring tool.
Time frame: Time from ending radiotherapy treatment to onset of major LARS, up to 10 years.
Recruitment rate to randomised trial part of the study
The total number of cohort participants that are enrolled into the randomised trial part of the study, over the recruitment period.
Time frame: 9 months
Proportion of randomised participants that are allocated to each trial arm
The proportion of randomised participants that meet the criteria for, and are allocated to, each of the three trial arms (transanal irrigation; sacral neuromodulation; optimised conservative management).
Time frame: 9 months
Describe variation in clinical practice across UK sites
Where possible, we will record patient's previous treatments and interactions with health services in relation to their bowel dysfunction symptoms. This will be used to describe the variation in UK clinical practice in terms of diagnosis, management and treatment pathways.
Time frame: Up to 10 years prior to recruitment
Compliance of participants to the study programme
The proportion of participants that complete and return follow-up questionnaires (four questionnaires at 3-month intervals).
Time frame: 12 months
Adherence of participants to the treatment programme
The proportion of patients that continue to receive the treatment assigned to them at the end of the follow-up period.
Time frame: 12 months
Change in LARS score
LARS score will be measured at 5 time points (at 3-monthly intervals from baseline to 12 months) to assess severity of bowel dysfunction. Self-reported by participants using the LARS scoring tool (min 0, max 42) where higher score denotes greater severity of symptoms.
Time frame: 12 months.
Change in EuroQuol 5-Dimension Health-related Quality of Life instrument (5-level) (EQ-5D-5L)
Patient-reported quality of life will be measured using the EuroQuol 5-Dimension Health-related Quality of Life instrument (5-level) (EQ-5D-5L) at 5 time-points (3-monthly intervals from baseline to 12 months). Quality of life total score will be calculated (min 5; max 25), where reduction in total score represents improvement in quality of life.
Time frame: 12 months
Change in European Organisation for Research and Treatment of Cancer Colorectal Quality of Life Questionnaire
Quality of life will be self-reported by participants using the European Organisation for Research and Treatment of Cancer Colorectal Quality of Life Questionnaire (EORTC QLQ-CR29) at 5 time-points (3-monthly intervals, from baseline to 12 months). Quality of life total score will be calculated (min 26; max 104) where reduction in total score represents improvement in quality of life.
Time frame: 12 months
Change in European Organisation for Research and Treatment of Cancer Cancer Quality of Life Questionnaire
Quality of life will be self-reported by participants using the European Organisation for Research and Treatment of Cancer Cancer Quality of Life Questionnaire (EORTC QLQ-C30). This will be recorded at 5 time-points (3-monthly intervals, from baseline to 12 months). Total score will be calculated (min 30; max 128), where reduction in total score represents improvement in quality of life.
Time frame: 12 months
Change in medical outcome profile score
Measure Yourself Medical Outcome Profile (MYMOP) 2 will be used to record patient-reported medical outcome profile at 5 time-points (3-montly intervals from baseline to 12 months). Change in patient-reported severity (min 0; max 5) will be measured, where change ≥ 1.0 is considered clinically significant.
Time frame: 12 months
Patient-reported adverse events
We will record any adverse events reported by randomised patients in relation to each of the treatments they receive, which impairs their adherence to the study protocol, treatment programme or safety.
Time frame: 12 months
LARS treatment history
Treatments offered to manage individual patient's LARS symptoms will be recorded, along with duration of treatment and reasons for stopping. This will be used to support the description of standard care variation and patient characteristics.
Time frame: 12 months
Plan to share: No
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Low Anterior Resection Syndrome→
Cardiff and Vale University Health Board