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15 Voluntary ex ante Transparency (VEAT) Notice

POLARIS TRIAL

  • First published: 11 May 2023
  • Last modified: 11 May 2023
  • Record interest

     

  • This file may not be fully accessible.

  •  

Contents

Summary

OCID:
ocds-kuma6s-131474
Published by:
NHS Wales Shared Services Partnership-Procurement Services (hosted by Velindre University NHS Trust)
Authority ID:
AA0221
Publication date:
11 May 2023
Deadline date:
-
Notice type:
15 Voluntary ex ante Transparency (VEAT) Notice
Has documents:
No
Has SPD:
No
Has Carbon Reduction Plan:
N/A

Abstract

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. CPV: 79314000, 79314000.

Full notice text

Voluntary ex ante transparency notice

Directive 2014/24/EU

Section I: Contracting entity

I.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

UK

Telephone: +44 1443848585

E-mail: rhodri.poacher@wales.nhs.uk

NUTS: UK

Internet address(es)

Main address: http://nwssp.nhs.wales/ourservices/procurement-services/

Address of the buyer profile: https://www.sell2wales.gov.wales/search/Search_AuthProfile.aspx?ID=AA0221

I.4) Type of the contracting authority

Body governed by public law

I.5) Main activity

Health

Section II: Object

II.1) Scope of the procurement

II.1.1) Title

POLARIS TRIAL

Reference number: CAV-STA (22-23) 211

II.1.2) Main CPV code

79314000

 

II.1.3) Type of contract

Services

II.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.

II.1.6) Information about lots

This contract is divided into lots: No

II.1.7) Total value of the procurement

Value excluding VAT: 1 833 550.84  GBP

II.2) Description

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

Section IV: Procedure

IV.1) Description

IV.1.1) Type of procedure

Award of a contract without prior publication of a call for competition

Justification for selected award procedure:

The procurement falls outside the scope of application of the Directive

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.

IV.1.8) Information about Government Procurement Agreement (GPA)

The procurement is covered by the Government Procurement Agreement: Yes

Section V: Award of contract/concession

Contract No: CAV-STA (22-23) 211

V.2 Award of contract/concession

V.2.1) Date of conclusion of the contract/concession

11/05/2023

V.2.2) Information about tenders

The contract has been awarded to a group of economic operators: No

V.2.3) Name and address of the contractor

University of Leeds

St James's University Hospital

Leeds

LS97TF

UK

NUTS: UK

The contractor is an SME: No

V.2.4) Information on value of the concession and main financing terms (excluding VAT)

Total value of the concession/lot: 1 833 550.84  GBP

V.2.5) Information about subcontracting

Section VI: Complementary information

VI.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 http://www.sell2wales.gov.wales/Search/Search_Switch.aspx?ID=131474.

(WA Ref:131474)

VI.4) Procedures for review

VI.4.1) Review body

High Court

Royal Courts of Justice, The Strand

London

WC2A 2LL

UK

Telephone: +44 2079477501

VI.5) Date of dispatch of this notice

11/05/2023

Coding

Commodity categories

ID Title Parent category
79314000 Feasibility study Market research services

Delivery locations

ID Description
1022 Cardiff and Vale of Glamorgan

Alert region restrictions

The buyer has restricted the alert for this notice to suppliers based in the following regions.

ID Description
There are no alert restrictions for this notice.

About the buyer

Main contact:
rhodri.poacher@wales.nhs.uk
Admin contact:
N/a
Technical contact:
N/a
Other contact:
N/a

Further information

Date Details
No further information has been uploaded.

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