Pathway of Low Anterior Resection Syndrome Relief After Surgery: a Feasibility Study (POLARiS)
Low Anterior Resection Syndrome
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
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
No Intervention
Active Comparator
Active Comparator
Active Comparator
Cohort
Optimised Conservative Management
Trans-Anal Irrigation
Sacral NeuroModulation
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.