Section one: Contracting authority/entity
one.1) Name and addresses
NHS Wales Shared Services Partnership-Procurement Services (hosted by Velindre University NHS Trust)
4-5 Charnwood Court,, Heol Billingsley, Parc Nantgarw
Cardiff
CF15 7QZ
Telephone
+44 1443848585
Country
United Kingdom
NUTS code
UK - United Kingdom
Internet address(es)
Main address
http://nwssp.nhs.wales/ourservices/procurement-services/
Buyer's address
https://www.sell2wales.gov.wales/search/Search_AuthProfile.aspx?ID=AA0221
one.4) Type of the contracting authority
Body governed by public law
one.5) Main activity
Health
Section two: Object
two.1) Scope of the procurement
two.1.1) Title
POLARIS TRIAL
Reference number
CAV-STA (22-23) 211
two.1.2) Main CPV code
- 79314000 - Feasibility study
two.1.3) Type of contract
Services
two.1.4) Short description
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.
two.1.6) Information about lots
This contract is divided into lots: No
two.1.7) Total value of the procurement (excluding VAT)
Value excluding VAT: £1,833,550.84
two.2) Description
two.2.2) Additional CPV code(s)
- 79314000 - Feasibility study
two.2.3) Place of performance
NUTS codes
- UKL22 - Cardiff and Vale of Glamorgan
Main site or place of performance
University Hospital of Wales
two.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.
two.2.11) Information about options
Options: No
two.2.13) Information about European Union Funds
The procurement is related to a project and/or programme financed by European Union funds: No
Section four. Procedure
four.1) Description
four.1.1) Type of procedure
Award of a contract without prior publication of a call for competition in the cases listed below
- The procurement falls outside the scope of application of the regulations
Explanation:
This contract will be awarded to the University of Leeds, who’s Clinical Trials Research Unit (CTRU_ have been involved in trial design, application development and implementation plan for this research proposal and have experience of day-to-day management of a trail of this size previously.
four.1.8) Information about the Government Procurement Agreement (GPA)
The procurement is covered by the Government Procurement Agreement: Yes
Section five. Award of contract/concession
Contract No
CAV-STA (22-23) 211
A contract/lot is awarded: Yes
five.2) Award of contract/concession
five.2.1) Date of conclusion of the contract
11 May 2023
five.2.2) Information about tenders
The contract has been awarded to a group of economic operators: No
five.2.3) Name and address of the contractor/concessionaire
University of Leeds
St James's University Hospital
Leeds
LS97TF
Country
United Kingdom
NUTS code
- UK - United Kingdom
The contractor/concessionaire is an SME
No
five.2.4) Information on value of contract/lot/concession (excluding VAT)
Total value of the contract/lot/concession: £1,833,550.84
Section six. Complementary information
six.3) Additional information
This VEAT will be in place for 10 calendar days from 11th May 2023 until 22nd May 2023.
NOTE: To register your interest in this notice and obtain any additional information please visit the Sell2Wales Web Site at
https://www.sell2wales.gov.wales/Search/Search_Switch.aspx?ID=131124.
NOTE: To register your interest in this notice and obtain any additional information please visit the Sell2Wales Web Site at https://www.sell2wales.gov.wales/Search/Search_Switch.aspx?ID=131474.
(WA Ref:131474)
six.4) Procedures for review
six.4.1) Review body
High Court
Royal Courts of Justice, The Strand
London
WC2A 2LL
Telephone
+44 2079477501
Country
United Kingdom