Hughes Abdominal Repair Trial - abdominal wall closure techniques to reduce incidence of incisional hernias

ABSTRACT: Background and study aims 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. Who can participate? Patients must be 18 or over, and receive surgical treatment for colorectal cancer which requires a midline incision of 5 cm or more. What does the study involve? Patients who agree to take part in the study will be invited to consent to take part in the study. This study aims to compare two methods of closing abdominal wounds in the midline. The patients are randomly allocated to mass closure or Hughes repair. At the end of the study we will compare the two groups for pain, body image concerns and also complications. What are the possible benefits and risk of participating? There will be no direct benefits to those taking part. There should be benefits to future patients undergoing abdominal surgery as we think that the Hughes Repair will help to prevent condition that causes significant problems for patients. The patients we have selected to be part of the study will be undergoing CT scans as part of their normal follow up for colorectal cancer so there is no additional radiation exposure and they will also be routinely followed up as standard in all hospitals, so there is no additional time expenditure for patients or expense for the NHS. The abdomen closure techniques to be used in the study trial are already used in surgery so there is no danger to patients. Where will the study run from? The study has been set up to run from the University Hospital of Wales, Cardiff, involving the Welsh Barbers Research Group. Swansea Clinical Trials Unit are conducting the trial on behalf of sponsor Cardiff & Vale University Health Board. Participating centres will be UK wide. When is the study starting and how long is it expected to run for? Feasibility phase recruited from October 2013 till February 2014. The pilot phase that will run directly into the main phase started in August 2014 and is expected to recruit until February 2018. Who is funding the study? The Health Technology Assessment (HTA) programme (UK) Who is the main contact? Professor Jared Torkington [e-mail]

DISEASE(S): Abdominal Hernia/elective Colorectal Cancer Surgery

PROVIDER: 2414502 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR