Low anterior resection syndrome Digestive System
Conditions
Interventions
POLARiS is a Phase III randomised superiority trial within a cohort (TWiC), with qualitative sub-study and economic evaluation. The aim of the research is to explore the natural history of low anterio
Sponsors
Cardiff and Vale University Health Board
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: General inclusion criteria (cohort): 1. Diagnosis of rectal or sigmoid cancer 2. Low or high anterior resection (colorectal resection with anastomosis to the rectum) 3. Functioning anastomosis 4. Primary surgery less than 10 years before recruitment 5. At least 6 months since reversal of stoma or primary surgery if no stoma created 6. Aged =18 years old 7. Able to provide written informed consent RCT inclusion criteria - as above plus: 8. Major LARS symptoms within the last 3 months (defined as a LARS score of =30) 9. Clinically appropriate for randomisation as determined by the treating clinician
Exclusion criteria
Exclusion criteria: Cohort exclusion criteria: 1. Receiving ongoing chemotherapy, radiotherapy or immunotherapy treatment for cancer 2. Anterior exenteration RCT exclusion criteria: 3. Receiving ongoing chemotherapy, radiotherapy or immunotherapy treatment for cancer 4. Metastatic disease 5. Inflammatory bowel disease 6. Pregnancy 7. Use of TAI for LARS within 1 month prior to randomisation 8. Not eligible for SNM and not eligible for TAI 9. Anterior exenteration 10. Anastomotic stricture 11. History of anastomotic leak with evidence of ongoing leak/sinus Plus treatment-specific exclusions: Exclusion criteria for SNM: 12. History of spinal cord stimulator (added 28/11/2025) 13. Site unable to offer SNM as a treatment 14. Previous SNM 15. Specific contraindications to implantation 16. Any other contraindications advised by the care team, product manufacturer or distributor 17. Margin positive (R1) resection within 24 months prior to randomisation (added 09/10/2024) RCT exclusion – TAI specific: Exclusion criteria for TAI: 18. Unable to perform TAI 19. History of anastomotic leak with evidence of ongoing leak/sinus 20. Previous use of TAI for LARS 21. Site unable to offer TAI as a treatment 22. Any other contraindications advised by the care team, product manufacturer or distributor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LARS score measured using the LARS score questionnaire at baseline and every 3 months until 24 months post registration/randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| RCT and cohort study: 1. Health-related quality of life and physical, psychological and emotional functioning, is measured using the EORTC QLQ C30, EORTC CR29 and the LARS iCAT questionnaire at baseline and at 3, 6, 12 and 24 months after registration/randomisation 2. Incidence of adverse events related to the trial/trial procedures within 24 months of registration/randomisation, categorised using the CTCAE Grading (plus Clavien-Dindo or ClassIntra classification for adverse events relating to surgery) using medical notes Secondary outcome measures (RCT only) 1. Generic quality of life measured using EQ-5D-5L, at baseline 3, 6, 12 and 24 months after randomisation 2. Treatment compliance will be measured using medical records 3. Cost-effectiveness will be measured using a health resource use questionnaire at baseline, 3, 6, 12 and 24 months after randomisation and medical records | — |
Countries
Australia, England, United Kingdom, Wales
Contacts
Public ContactKatie Gordon
Outcome results
None listed