The DYNAMIC Study

• Research type

  Research Study

• Full title

  A Randomised Controlled Feasibility Trial of a Novel Polyvinylideneflouride (PVDF) Mesh (Dynamesh®-HIATUS) Cruroplasty versus Suture only Repair of Large Hiatus Hernia – The DYNAMIC Study

• IRAS ID

  231788

• Contact name

  Simon Khay Chuan Toh

• Contact email

  simon.toh@porthosp.nhs.uk

• Sponsor organisation

  Portsmouth Hospitals NHS Trust

• ISRCTN Number

  ISRCTN76437720

• Duration of Study in the UK

  3 years, 0 months, 1 days

• Research summary

  This study is looking at heartburn patients who have a large hiatus hernia defect. Standard surgery to stitch the defect only works in up to half of these patients, as the hernia recurs. We therefore need a way of making the repair more long-lasting. A new type of mesh has been made that could improve patient outcomes. Small studies have already been done with the mesh, and it appears to be safe and effective. Similar mesh is used every day in other locations (e.g. groin) effectively.
  This study will look at how feasible it is to carry out a larger trial of this mesh, in many different hospitals. This initial study will take place in a small number of patients in one hospital, and assess whether the mesh is safe and effective. We will include 40 patients, of whom 20 will be randomly allocated to have the current method of surgery (stitches only) and 20 will have stitches plus a mesh to reinforce the repair. The risks of mesh repair are rare, including mesh infection and erosion. However, this new mesh (made from a different material to others) has been designed to prevent these complications. In order to reduce bias in the study, patients and assessors will not know if the patient has a mesh inserted or not for one year. All patient will keep a diary of their symptoms, and complete a quality of life questionnaire at 3, 6 & 12 months, 2yrs and 3yrs, after surgery. They will also be asked to do a barium swallow test after one year to see how well the operation has worked. Patients who received the mesh will also be asked to have an MRI scan to check how well the mesh is staying in place one year after surgery.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  19/SC/0161

• Date of REC Opinion

  10 Jun 2019

• REC opinion

  Further Information Favourable Opinion