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

Cardiff and Vale University Health Board

Status: Active, not recruiting

Conditions: Low Anterior Resection Syndrome

Treatments: Device: Trans-Anal Irrigation; Device: Sacral NeuroModulation; Other: Optimised Conservative Management

Study type: Interventional

Funder types: Other

Identifiers

NCT05319054

8238

307764 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 187 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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187 participants in 4 patient groups

Cohort

No Intervention group

Description:

Patients who have undergone colonic resection for colorectal cancer in the last 10 years. Patient reported outcome measures collected at 3-monthly intervals.

Optimised Conservative Management

Active Comparator group

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.

Treatment:

Other: Optimised Conservative Management

Trans-Anal Irrigation

Active Comparator group

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.

Treatment:

Other: Optimised Conservative Management

Device: Trans-Anal Irrigation

Sacral NeuroModulation

Active Comparator group

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.

Treatment:

Other: Optimised Conservative Management

Device: Sacral NeuroModulation