POLARiS

• Research type

  Research Study

• Full title

  Pathway of Low Anterior Resection Syndrome relief after Surgery (POLARiS) trial

• IRAS ID

  324576

• Contact name

  Julie Cornish

• Contact email

  julie.cornish@wales.nhs.uk

• Sponsor organisation

  Cardiff and Vale University Health Board

• ISRCTN Number

  ISRCTN12834598

• Duration of Study in the UK

  4 years, 7 months, 1 days

• Research summary

  Rectal cancer (cancer of the lower part of the bowel) is one of the most common forms of cancer, affecting around 14,000 people each annually in the UK. The mainstay of treatment for rectal cancer is surgery to remove the affected area of bowel, for cancers which are more advanced patients may also require radiotherapy and chemotherapy. One consequence of bowel cancer treatment is major Low Anterior Resection Syndrome (LARS). LARS is a collection of symptoms including incontinence to stool, urgency and frequency of bowel movements and incomplete evacuation. Major LARS is the most severe form of LARS, and can have a huge impact on the person’s quality of life and daily functioning. There is little evidence to support treatment options for patients with LARS. Despite more acceptance of LARS amongst clinicians, many centres don’t have a clear management pathway and/or are unaware of available treatments. The POLARiS study will investigate three treatments for major LARS:
  • Optimised conservative management: a combination of diet, medication, bowel retraining and pelvic floor exercises
  • Trans-anal irrigation: washing out the back passage of stool with warmed water
  • Sacral nerve stimulation: insertion of a small device which delivers an electrical impulse to the sacral nerve in the lower back

  The study will recruit consenting adults who have had surgery for rectal cancer (called an anterior resection), who don’t have a stoma, into a cohort of up to 1500 participants, and then follow up those patients every 3 months with bowel function and quality of life assessments. The aim of the cohort study is to better understand how LARS and major LARS develop over time. Patients found to have major LARS will be invited into the randomised control trial in which the above treatments will be tested for effectiveness and safety. The trial will recruit 600 participants.

• REC name

  Wales REC 4

• REC reference

  23/WA/0171

• Date of REC Opinion

  14 Jun 2023

• REC opinion

  Favourable Opinion