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Hughes abdominal repair trial (HART) - Complete

Lay summary

Incisional hernias are a common complication of abdominal surgery and can be defined as gaps in the wall through which abdominal contents can come through. They can cause patients significant pain, affect body image and also complications, including further major abdominal surgery. This study aims to compare two methods of closing abdominal wounds in the midline. There is the traditional technique of mass closure, involving all layers of the abdominal wall being closed symmetrically at regular points along the wound, and the Hughes repair, which involves closing all layers of the abdominal wall being closed at regular points in a near and far distribution (i.e two sutures close to the midline and two sutures further apart). The idea of the Hughes repair is to distribute tension of the suture closing along different points in the wound and therefore reducing the rate of 'cut through' and development of hernias.

This study has now been completed.

Cedar's role

Cedar’s role is of Trial Manager. As recruitment is now finished, this role primarily includes chasing and collating outstanding data (primary endpoint and safety), the organising of oversight committee meetings, production of reports to oversight committees, the funding body and REC and dealing with any site issues that arise during the course of the study. Cedar prepared the final study report to NIHR. 

Publications

Cornish, J., Harries, R. L., Bosanquet, D., Rees, B., Ansell, J., Frewer, N., ... & Torkington, J. (2016). Hughes Abdominal Repair Trial (HART)–Abdominal wall closure techniques to reduce the incidence of incisional hernias: study protocol for a randomised controlled trial. Trials17(1), 1-6.

Harries, R. L., Cornish, J., Bosanquet, D., Rees, B., Horwood, J., Islam, S., ... & Torkington, J. (2017). Hughes Abdominal Repair Trial (HART)—abdominal wall closure techniques to reduce the incidence of incisional hernias: feasibility trial for a multicentre, pragmatic, randomised controlled trial. BMJ open7(12), e017235.

ISRCTN 25616490: Hughes Abdominal Repair Trial - abdominal wall closure technique to reduce incidence of incisional hernias: multi-centre pragmatic randomised trial. https://www.journalslibrary.nihr.ac.uk/programmes/hta/123529/#/

Study details

  • Full title of clinical trial: Hughes Abdominal Repair Trial - abdominal wall closure techniques to reduce incidence of incisional hernias: a multi-centre pragmatic randomised trial
  • Study design: Multi-centre randomised controlled trial
  • Chief Investigator: Prof Jared Torkington
  • Sponsor: Cardiff and Vale University Health Board
  • Funding: NIHR Health Technology Assessment Programme, HTA
  • ISRCTN: ISRCTN25616490
  • Ethical approval: Wales REC 3, ref:12/WA/0374