DISC: Dupuytren's Interventions Surgery vs. Collagenase. A pragmatic multi-centre randomised controlled non-inferiority, cost effectiveness trial comparing injections of collagenase into the cord to surgical correction in the treatment of moderate Dupuytren's contracture in adult patients

Record ID 32017000102
English
Authors' objectives: Dupuytren's contracture is the fourth most common problem affecting the hand in the UK. The disorder occurs in adults, mainly affecting men, and is caused by fibrous tissue, which forces the finger to bend down into the palm. Although it is rarely painful, patients cannot straighten the finger and this increasingly interferes with hand function. In England around 17,000 patients have surgery to straighten the bent finger by removing the fibrous tissue causing Dupuytren's contracture each year, at a cost of over £60 million. This is the common and accepted treatment. An alternative to surgery is a newly introduced collagenase injection, which softens the fibrous tissue that causes the condition, given in the clinic. The patient is followed up a few days later in clinic and the finger is manipulated, in an attempt to straighten it. Both these treatments are offered on the NHS in England and are used in the USA and Europe. It is currently not known if the injection is as good as surgery at correcting finger deformity and if the correction is maintained in the long term. We also do not know whether the complication rates are similar. Early findings suggest that patients who have collagenase treatment might be more likely to have the condition return in the longer term. However, if proven effective, the injection does have the advantage of avoiding surgery, and provides an alternative for those who cannot have surgery. The DISC study will investigate if an injection of collagenase is as good as surgery at treating this condition, and whether the effects of treatment are sustained in the short term. The best way to investigate these questions is by doing a randomised study. This means that, as part of the study, the patient and surgeon agree to use whatever treatment (surgery or collagenase injection) is allocated to them by chance (randomly). This is the best way to make sure that two comparable groups are created at the start, thereby allowing reasonably objective conclusions to be made from the study. After treatment, patients will be seen at regular intervals. Our patient advisors have confirmed that these intervals are appropriate for their condition. Questionnaires will be used to assess how patients taking part in the study feel about their hand over a 2 year period, and the bend in the finger will be measured at intervals after treatment. Our patients have advised us that these forms are clear and easy to complete, and that if they were taking part they would be happy to fill these in at regular intervals. They also confirmed that the forms we propose would adequately capture the impact of their condition and the impact of treatment including that of any complications. The study will also find out the cost of both treatments, both at 1 year and 2 years, to find out which is better value for money. It will look at the impact of these two treatments on hospital resources, including beds and operating theatre time. We will also talk to our patients to discover what they think about the different treatments, to see if they have any preference for treatment, and to see if they can help us to develop more effective services for the future.
Details
Project Status: Ongoing
Anticipated Publish Date: 2021
English language abstract: An English language summary is available
Publication Type: Not Assigned
Country: England
MeSH Terms
  • Fasciotomy
  • Adult
  • Collagenases
  • Cost-Benefit Analysis
  • Dupuytren Contracture
  • Injections
  • Microbial Collagenase
Contact
Organisation Name: NIHR Health Technology Assessment programme
Contact Address: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK
Contact Name: journals.library@nihr.ac.uk
Contact Email: journals.library@nihr.ac.uk
Copyright: Queen's Printer and Controller of HMSO
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