Reconstructive surgery trial network
Clinical trials are the foundation for evidence-based medicine. In recognition, the NHS has allocated £1 billion per year until 2016 to support multicentre clinical trials research.
The Royal College of Surgeons has started an initiative to develop a nationwide surgical clinical trials portfolio. This is being facilitated by clinical trials units at Oxford, Bristol, Birmingham, Liverpool/Manchester and Barts/The London. Abhilash Jain has been jointly appointed by BSSH and BAPRAS as the Specialty Lead for Plastic and Hand Surgery. Over the next three years he will promote and encourage a culture of clinical trials and multicentre cooperation within these organisations.
The Reconstructive Surgery Trials Network gives members direct access to trial units. These units will provide support throughout the process from the initial project proposal through to analysis of trial data. This initiative is open to all levels of healthcare professional, especially trainees.
Visit the website to find out about current trials or suggest one yourself.
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- The BSSH have funded a pilot study of a randomized trial of steroid injection or surgery for moderate carpal tunnel syndrome. The trial is being run by Oxford SITU. The BSSH has approved £37,391 of the £50,000 initially awarded for this trial.
- The protocol is ready for submission for publication in Pilot & Feasibility Studies
- Recruitment started on 25th November 2015 in Canterbury and Gloucester and now stands at 20, The target recruitment for the Pilot study is 40
- Two of the planned sites – Bournemouth and Somerset – dropped out as their local CCG’s did not support the trial.
In Somerset this came to the attention of the CCG because the musculoskeletal interface services required the CCG’s approval to change from injecting Triamcinolone to Depo Medrone as per the protocol. It also happened that at this time Somerset CCG was in the process of restricting referrals for carpal tunnel surgery. Dorset CCG was asked whether they would fund surgery if patients have not received a steroid injection (as agreed in Gloucestershire). They would not, and were replaced by Plymouth, where the policy is less strict.
- This poses a problem for future sites in the main trial but one that we feel can be addressed by careful site selection.
- We anticipate reaching the recruitment target by the end of April. Analysis of the recruitment will commence then.
- We aim to apply for funding from the NIHR RfPB stream in early 2017, when we have had time to analyse the results of the pilot study.
- We are aware that a virtually identical trial in the Netherlands is also applying for funding as well as a similar trial in the UK (also from the NIHR).
Chief Investigator, INDICATE Pilot