PLUG: a single-arm feasibility study
Research type
Research Study
Full title
Feasibility study investigating the Prevention of post-operative gastro-oesophageal anastomotic Leaks with the Use of a surgical adhesive, BioGlue – the PLUG trial: a single-arm trial
IRAS ID
272680
Contact name
Nicholas Carter
Contact email
Sponsor organisation
Portsmouth Hospital Trust
ISRCTN Number
ISRCTN26729280
Duration of Study in the UK
1 years, 5 months, 25 days
Research summary
For people who have cancer of the oesophagus (gullet), one possible treatment is surgery to remove the cancer. The operation is an oesophagectomy which involves the removal of the tumour and then re-connecting the stomach to the healthy oesophagus. A risk in this operation is a leak from that join. Surgeons are always working hard to reduce the risks of operations and we hope that our research can help to reduce the number of people who suffer a leak after their operation.
This study will investigate the ease of application and the safety of a type of surgical glue (called BioGlue) when applied to the join during an oesophagectomy. We hope that this study will pave the way for a larger trial across many hospitals which will look at the effect of the glue on the number of leaks. We will use the glue in addition to the normal way of making the join. As well as looking at how to best apply the glue and its safety we will also look at other outcomes. We will see the effect of the glue on the number of leaks and the number of other complications after surgery. We already collect baseline information on patients and carefully monitor their progress after their operation. We will do the same for those people who will be part of the study.
We will offer all patients who will have an oesophagectomy the option of being involved. Other than the use of the glue, all other parts of a patient’s care will be the same as a patient who is not part of the trial.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
20/SC/0005
Date of REC Opinion
20 Jan 2020
REC opinion
Favourable Opinion