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Pathway of Low Anterior Resection Syndrome Relief After Surgery: a Feasibility Study (POLARiS)

Primary Purpose

Low Anterior Resection Syndrome

Status
Active
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Sacral NeuroModulation
Trans-Anal Irrigation
Optimised Conservative Management
Sponsored by
Cardiff and Vale University Health Board
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Low Anterior Resection Syndrome focused on measuring Sacral Neuromodulation, Transanal Irrigation, Trials within cohorts, Colorectal cancer, Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • For cohort:

    • Diagnosis of rectal or sigmoid cancer
    • Low or high anterior resection (colorectal resection with anastomosis to the rectum)
    • Functioning anastomosis
    • Aged 18 years and older
    • Primary surgery/reversal of ileostomy less than 10 years before recruitment
    • Reversal of ileostomy at least 12 weeks prior to recruitment with at least a further 12 weeks of standard care to manage symptoms following reversal
    • Willing and able to provide valid informed consent

  • For randomisation:

    • Recruited to cohort study
    • Willing and able to provide valid informed consent for randomisation
    • Major LARS symptoms (Defined as score of 30+ on LARS scoring tool)
    • Previous unsuccessful conservative treatment determined by treating clinician and patient

Exclusion Criteria:

  • For cohort

    - Inability to understand and complete study questionnaires independently. (Due to cognitive or intellectual impairment, Due to insufficient English language skills)

  • For randomised control trial

    • Pregnancy
    • No previous conservative treatment plan for the management of LARS
    • Does not meet any treatment-specific criteria

  • For TAI randomisation:

    • Unable to perform TAI
    • History of anastomotic leak with evidence of ongoing leak/sinus
    • Previous use of TAI for LARS
    • Site unable to offer TAI as a treatment
    • Any other contraindications advised by the care team, product manufacturer or distributor

  • For SNM randomisation:

    • <12months since primary cancer surgery
    • Palliative disease
    • Site unable to offer SNM as a treatment
    • Previous SNM
    • Specific contraindications to implantation
    • Any other contraindications advised by the care team, product manufacturer or distributor.

Sites / Locations

  • University Hospital Southampton NHS Foundation Trust
  • Leeds Teaching Hospital NHS Trust
  • Julie Cornish
  • Royal Gwent Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Active Comparator

Active Comparator

Active Comparator

Arm Label

Cohort

Optimised Conservative Management

Trans-Anal Irrigation

Sacral NeuroModulation

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Recruitment rate of to cohort arm of study
The total number of participants enrolled into the study over the recruitment period.
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
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.
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.
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.
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.
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).
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.
Compliance of participants to the study programme
The proportion of participants that complete and return follow-up questionnaires (four questionnaires at 3-month intervals).
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
April 1, 2022
Last Updated
July 19, 2023
Sponsor
Cardiff and Vale University Health Board
Collaborators
University of Leeds, Aneurin Bevan University Health Board, University Hospital Southampton NHS Foundation Trust, Bowel Research UK, The Leeds Teaching Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT05319054
Brief Title
Pathway of Low Anterior Resection Syndrome Relief After Surgery: a Feasibility Study
Acronym
POLARiS
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 23, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cardiff and Vale University Health Board
Collaborators
University of Leeds, Aneurin Bevan University Health Board, University Hospital Southampton NHS Foundation Trust, Bowel Research UK, The Leeds Teaching Hospitals NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Anterior Resection Syndrome
Keywords
Sacral Neuromodulation, Transanal Irrigation, Trials within cohorts, Colorectal cancer, Quality of Life

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Trials within Cohorts
Masking
None (Open Label)
Allocation
Randomized
Enrollment
187 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort
Arm Type
No Intervention
Arm Description
Patients who have undergone colonic resection for colorectal cancer in the last 10 years. Patient reported outcome measures collected at 3-monthly intervals.
Arm Title
Optimised Conservative Management
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Trans-Anal Irrigation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sacral NeuroModulation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Sacral NeuroModulation
Intervention Description
Sacral Neuromodulation group will include up-to 20 patients with major LARS. Medtronic Interstim system will be used, including 2 week trial device.
Intervention Type
Device
Intervention Name(s)
Trans-Anal Irrigation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Optimised Conservative Management
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recruitment rate of to cohort arm of study
Description
The total number of participants enrolled into the study over the recruitment period.
Time Frame
9 months
Title
Assess characteristics of patients recruited to the cohort
Description
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
Title
Prevalence of 'major LARS' in the patient cohort
Description
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
Title
Onset of 'major LARS' symptoms in relation to surgery
Description
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.
Title
Onset of 'major LARS' symptoms in relation to radiotherapy treatment
Description
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.
Title
Recruitment rate to randomised trial part of the study
Description
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
Title
Proportion of randomised participants that are allocated to each trial arm
Description
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
Title
Describe variation in clinical practice across UK sites
Description
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
Title
Compliance of participants to the study programme
Description
The proportion of participants that complete and return follow-up questionnaires (four questionnaires at 3-month intervals).
Time Frame
12 months
Title
Adherence of participants to the treatment programme
Description
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
Secondary Outcome Measure Information:
Title
Change in LARS score
Description
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.
Title
Change in EuroQuol 5-Dimension Health-related Quality of Life instrument (5-level) (EQ-5D-5L)
Description
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
Title
Change in European Organisation for Research and Treatment of Cancer Colorectal Quality of Life Questionnaire
Description
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
Title
Change in European Organisation for Research and Treatment of Cancer Cancer Quality of Life Questionnaire
Description
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
Title
Change in medical outcome profile score
Description
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
Title
Patient-reported adverse events
Description
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
Title
LARS treatment history
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: For cohort: Diagnosis of rectal or sigmoid cancer Low or high anterior resection (colorectal resection with anastomosis to the rectum) Functioning anastomosis Aged 18 years and older Primary surgery/reversal of ileostomy less than 10 years before recruitment Reversal of ileostomy at least 12 weeks prior to recruitment with at least a further 12 weeks of standard care to manage symptoms following reversal Willing and able to provide valid informed consent For randomisation: Recruited to cohort study Willing and able to provide valid informed consent for randomisation Major LARS symptoms (Defined as score of 30+ on LARS scoring tool) Previous unsuccessful conservative treatment determined by treating clinician and patient Exclusion Criteria: For cohort - Inability to understand and complete study questionnaires independently. (Due to cognitive or intellectual impairment, Due to insufficient English language skills) For randomised control trial Pregnancy No previous conservative treatment plan for the management of LARS Does not meet any treatment-specific criteria For TAI randomisation: Unable to perform TAI History of anastomotic leak with evidence of ongoing leak/sinus Previous use of TAI for LARS Site unable to offer TAI as a treatment Any other contraindications advised by the care team, product manufacturer or distributor For SNM randomisation: <12months since primary cancer surgery Palliative disease Site unable to offer SNM as a treatment Previous SNM Specific contraindications to implantation Any other contraindications advised by the care team, product manufacturer or distributor.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie A Cornish
Organizational Affiliation
Cardiff and Vale University Health Board
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Southampton NHS Foundation Trust
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Leeds Teaching Hospital NHS Trust
City
Leeds
State/Province
Yorkshire
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Julie Cornish
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
Royal Gwent Hospital
City
Newport
ZIP/Postal Code
NP20 2UB
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Pathway of Low Anterior Resection Syndrome Relief After Surgery: a Feasibility Study

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