ASTEROID
Research type
Research Study
Full title
Assessment of Surgeon Treatment Equipoise & Randomisation Opinion to Inform trial Design (ASTEROID)
IRAS ID
343722
Contact name
Matthew Lee
Contact email
Sponsor organisation
University of Birmingham
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Umbilical hernia is a swelling at the belly button. This can contain fat, or sometimes parts of the bowel. Around 2,700 people in England need an emergency operation each year for a hernia that has become stuck and painful. There is debate among surgeons on the best way to fix a hernia, so we need a trial to find the best method. However, there are some questions around how long it would take to find the patients for a trial, and whether surgeons would agree to use different ways to fix a hernia. The ASTEROID study will not change care in itself, but will answer these questions and help us design the planned trial. We will recruit 50-100 patients from several hospitals to the study, and ask them to complete patient reported outcome forms on quality of life and hernia symptoms prior to surgery (two questionnaires). The will complete questionnaires on quality of life, hernia symptoms, and wound health (three questionnaires) and at 7 and 30 days post surgery. After the operation, we will simulate a randomisation and ask the surgeon if they would have performed the method of repair allocated. We will then simulate a randomisation about post-operative antibiotics and ask the surgeon if they would accept this treatment allocation. This study will help to confirm how long it would take to deliver a trial, how many participants we might not get longer term outcomes for, and whether surgeons will accept randomisation.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
24/PR/1597
Date of REC Opinion
7 Mar 2025
REC opinion
Further Information Favourable Opinion