Notice Information
Notice Title
POLARIS TRIAL
Notice 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.
Lot Information
Lot 1
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.
Procurement Information
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.
Notice Details
Publication & Lifecycle
- Open Contracting ID
- ocds-kuma6s-131474
- Publication Source
- Sell2Wales
- Latest Notice
- https://www.sell2wales.gov.wales/search/search_switch.aspx?ID=131474
- Current Stage
- Award
- All Stages
- Award
Procurement Classification
- Notice Type
- OJEU - F15 - Voluntary Ex Ante Transparency Notice
- Procurement Type
- Standard
- Procurement Category
- Services
- Procurement Method
- Limited
- Procurement Method Details
- Award procedure without prior publication of a call for competition
- Tender Suitability
- Not specified
- Awardee Scale
- Large
Common Procurement Vocabulary (CPV)
- CPV Divisions
79 - Business services: law, marketing, consulting, recruitment, printing and security
-
- CPV Codes
79314000 - Feasibility study
Notice Value(s)
- Tender Value
- Not specified
- Lots Value
- Not specified
- Awards Value
- Not specified
- Contracts Value
- £1,833,550 £1M-£10M
Notice Dates
- Publication Date
- 11 May 20232 years ago
- Submission Deadline
- Not specified
- Future Notice Date
- Not specified
- Award Date
- 11 May 20232 years ago
- Contract Period
- Not specified - Not specified
- Recurrence
- Not specified
Notice Status
- Tender Status
- Complete
- Lots Status
- Complete
- Awards Status
- Not Specified
- Contracts Status
- Active
Buyer & Supplier
Contracting Authority (Buyer)
- Main Buyer
- NHS WALES SHARED SERVICES PARTNERSHIP-PROCUREMENT SERVICES (HOSTED BY VELINDRE UNIVERSITY NHS TRUST)
- Contact Name
- Rob Hollands
- Contact Email
- robert.d.hollands@wales.nhs.uk
- Contact Phone
- Not specified
Buyer Location
- Locality
- CARDIFF
- Postcode
- CF15 7QZ
- Post Town
- Cardiff
- Country
- Wales
-
- Major Region (ITL 1)
- TLL Wales
- Basic Region (ITL 2)
- TLL5 South East Wales
- Small Region (ITL 3)
- TLL51 Central Valleys and Bridgend
- Delivery Location
- TLL22 Cardiff and Vale of Glamorgan
-
- Local Authority
- Rhondda Cynon Taf
- Electoral Ward
- Taff's Well
- Westminster Constituency
- Cardiff North
Further Information
Notice Documents
-
https://www.sell2wales.gov.wales/search/show/search_view.aspx?ID=MAY437034
POLARIS TRIAL - 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.
Open Contracting Data Standard (OCDS)
View full OCDS Record for this contracting process
The Open Contracting Data Standard (OCDS) is a framework designed to increase transparency and access to public procurement data in the public sector. It is widely used by governments and organisations worldwide to report on procurement processes and contracts.
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