II.2.2) Additional CPV code(s)
79314000
II.2.3) Place of performance
NUTS code:
UKL22
Main site or place of performance:
University Hospital of Wales
II.2.4) Description of the procurement
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.
II.2.11) Information about options
Options:
No
II.2.13) Information about European Union funds
The procurement is related to a project and/or programme financed by European Union funds:
No