POLARIS TRIAL · UK public procurement notice

14,000 cases of rectal cancer are diagnosed in the UK per year. The treatment for advanced rectal

cancer is often radiotherapy+/-chemotherapy treatment followed by surgery. This provides good

outcomes, with the cancer returning in less than 10% of people. However, the surgery can cause significant long-lasting problems, including problems with bowel, sexual and urinary function. Low

anterior resection syndrome (LARS) is a collection of symptoms that people who have undergone a

partial or total removal of the rectum may experience, including bowel incontinence or leakage,

frequency or urgency of stools, loose stools and incomplete bowel emptying. These symptoms can

have a considerable negative impact on patient quality of life and daily functioning. As a result, there is

a need to focus efforts on survivorship.

LARS symptoms are present in 75% of the patients up to 12 months after surgery and remain in up to

50% of patients for more than 10 years with a major impact on quality of life. There is little evidence to

support treatment options for patients with LARS. Despite more acceptance of LARS amongst

clinicians, with increased subspecialisation of surgeons and poor reporting of LARS, many centres do

not have a clear management pathway and/or are unaware of the treatments available.

Transanal irrigation (TAI) is a method of managing conditions such as bowel incontinence or

constipation. It involves introducing water through the anus to flush faeces (poo) from the bowel.

Sacral Neuromodulation (SNM) involves a small battery powered unit being implanted into the lower

back. This is connected to electrodes which rest on the nerves in the lower spine.

These two treatment options may improve quality of life for patients with LARS, however supportive

evidence is currently lacking. The POLARiS trial will investigate the clinical and cost benefit of two

treatments for patients with major LARS who have previously undergone standard non-surgical

treatment without improvement. Patients who are not randomised to SNM or TAI will be offered

optimised medical management.

The study will monitor the bowel function and quality of life in patients who have undergone rectal

cancer surgery in the hospitals involved within the last 10 years of the trial commencing. Those

patients found to have poor bowel function (major LARS) will be randomised to one of the treatment

options and followed up for 2 years after randomisation.

The results of the study will be presented at conferences raising awareness of effective treatment

options to clinicians, as well as through publication in peer reviewed journals. Patient material will be

developed as part of the output of POLARiS which will offer self-management strategies and

explanation of treatment options for patients with LARS. The findings of the study will be highlighted

through social media to patient groups and relevant charities. This will inform patients and the public

that LARS is treatable and which treatment options are potentially available.