Clinical trial NCT05319054: Pathway of Low Anterior Resection Syndrome Relief After Surgery: a Feasibility Study
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
Overall status: UNKNOWN
Phase: NA
Conditions: Low Anterior Resection Syndrome
Keywords: Sacral Neuromodulation
Transanal Irrigation
Trials within cohorts
Colorectal cancer
Quality of Life
Lead sponsor: Cardiff and Vale University Health Board
Sponsor class: OTHER_GOV
Collaborators: name: University of Leeds
name: Aneurin Bevan University Health Board
name: University Hospital Southampton NHS Foundation Trust
name: Bowel Research UK
name: The Leeds Teaching Hospitals NHS Trust
First posted: 2022-04-08
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Trials within Cohorts
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Recruitment rate of to cohort arm of study
timeFrame: 9 months
measure: Assess characteristics of patients recruited to the cohort
timeFrame: 9 months
measure: Prevalence of 'major LARS' in the patient cohort
timeFrame: 12 months
measure: Onset of 'major LARS' symptoms in relation to surgery
timeFrame: Time from surgery to onset of major LARS, up to 10 years.
measure: Onset of 'major LARS' symptoms in relation to radiotherapy treatment
timeFrame: Time from ending radiotherapy treatment to onset of major LARS, up to 10 years.
measure: Recruitment rate to randomised trial part of the study
timeFrame: 9 months
measure: Proportion of randomised participants that are allocated to each trial arm
timeFrame: 9 months
measure: Describe variation in clinical practice across UK sites
timeFrame: Up to 10 years prior to recruitment
measure: Compliance of participants to the study programme
timeFrame: 12 months
measure: Adherence of participants to the treatment programme
timeFrame: 12 months
Secondary outcomes:
measure: Change in LARS score
timeFrame: 12 months.
measure: Change in EuroQuol 5-Dimension Health-related Quality of Life instrument (5-level) (EQ-5D-5L)
timeFrame: 12 months
measure: Change in European Organisation for Research and Treatment of Cancer Colorectal Quality of Life Questionnaire
timeFrame: 12 months
measure: Change in European Organisation for Research and Treatment of Cancer Cancer Quality of Life Questionnaire
timeFrame: 12 months
measure: Change in medical outcome profile score
timeFrame: 12 months
measure: Patient-reported adverse events
timeFrame: 12 months
measure: LARS treatment history
timeFrame: 12 months
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust
state: Hampshire
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospital NHS Trust
state: Yorkshire
city: Cardiff
country: United Kingdom
facility: Julie Cornish
city: Newport
country: United Kingdom
facility: Royal Gwent Hospital
Study officials:
affiliation: Cardiff and Vale University Health Board
name: Julie A Cornish
role: PRINCIPAL_INVESTIGATOR
References: