Timing of Stoma Closure in Neonates (ToSCiN)
Research type
Research Study
Full title
Timing of Stoma Closure in Neonates (ToSCiN)
IRAS ID
278331
Contact name
Nick Lansdale
Contact email
Sponsor organisation
Manchester University NHS Foundation Trust
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Research Summary
Some babies require emergency surgery on their tummy in the first few months of life. This is most commonly because they were born prematurely and developed a bowel problem (called NEC) or a blockage of the bowel. As part of this surgery, the ends of the bowel may be brought to the skin surface (called a stoma) to divert stool into a bag. The stoma allows time for the bowel to rest and recover and is intended to be temporary with reversal later on. The best time to reverse or “close” the stoma is unknown. Stomas may cause dehydration, poor growth and skin problems so earlier closure may be better; however surgery is safer when babies are older and bigger so later closure may be better.
The ideal way to study which approach is better, is to conduct a clinical trial; randomly assigning babies to ‘early’ or ‘late’ stoma closure and see what happens. However, a clinical trial like this may not be acceptable to parents or health professionals, may be expensive, challenging and may not be possible. We therefore plan to do this initial study (ToSCiN) to look into all these things.
Our study will take place in six specialist neonatal surgical units across the UK. We are asking parents and health professionals for their views and whether they would take part in a future trial. We will also collect information about babies who have recently had a stoma to find out which factors influence the timing of closure. We will also analyse 6 years of data from an existing database, the National Neonatal Research Database to estimate the numbers of babies affected, understand current practice and outcomes for these babies.
We will put this information together to help us decide whether a clinical trial is possible.Summary of Results
ToSCiN (Timing of Stoma Closure in Neonates) was a research project sponsored by Manchester University NHS Foundation Trust. It was funded by the National Institute for Health Research (NIHR, the research arm of the NHS). It was managed by researchers at the University of Liverpool and the National Perinatal Epidemiology Unit Clinical Trials Unit at the University of Oxford. It took place between August 2020 and December 2022.
What was the question?
Some babies require a stoma because they were born early and developed a bowel problem, or because they were born with a bowel blockage. A stoma is where the ends of the bowel are brought out of the body to allow the baby to poo into a bag. They can be life-saving but cause skin or growth problems. So “closing” the stoma with a second operation is important. We don’t know the best time to close a stoma. Different hospitals do it at different times.To find out the best time to close a stoma, we would need to do a type of research study called a clinical trial. We would sign up babies to the trial and, using a computer, then put them into one of two groups. Then, we would close the stomas of the babies in one group “early”, and one group “later”, and see which group did better.
ToSCiN wanted to find out if this was possible by:
- Finding out what doctors in the UK currently think about when to close babies’ stomas and when they actually do this
- Designing a trial: decide the “early” and “later” times to close a stoma, which types of babies to recruit, what sort of data about them to collect, and whether we could use data routinely collected in the NHS when a baby receives care as part of a trial
- Finding out whether parents and doctors would be willing to enrol babies in a trial and why/why notIt did this through different workstreams:
Workstream 1: an online survey sent out to healthcare professionals. It asked when stomas in their hospital were closed, whether they would choose “early” or “late” closure for different types of baby, and what types of babies they thought should be included in a trial
Workstream 2.1: recruiting babies with stomas from eight hospitals in the UK and collecting information on how they did when they were in hospital
Workstream 2.2: asking the lead surgeon and lead neonatologist (doctor who works with newborn babies) of each baby in Workstream 2.1 whether they would consider recruiting the baby to a clinical trial of “early” and “late” closure, if one existed. Then, at six and at twelve weeks after the babies’ stomas were made, asking whether the doctors would be willing to close their stoma at this point as part of a clinical trial. (The doctors did not change how they cared for the babies or what they decided. We simply asked them to tell us what they would do if the baby were in a trial)
Workstream 2.3: interviews with parents whose children had had a stoma within the past three years. This included some of the parents whose babies had been recruited to Workstream 2.1. Also, focus groups with staff working at the hospitals where Workstream 2.1 was taking place.
Workstream 3: Analysis of data from three national databases. This was to see how many babies in the UK each year have a stoma, when their stoma is made and closed, and what sort of illnesses they have
Consensus meeting: a meeting with doctors, nurses, surgeons, and parents to tell them what we had found out and ask them what they thought
The two groups developing and monitoring ToSCiN both included a parent of a child who had had a stoma as a baby. We also had a group of parents of this kind who told us how best to plan the study and what they thought of the documents that we prepared for it. In particular, we asked for their thoughts on the materials that would be given to parents whose babies were recruited to Workstream 2.1.
Results:
The parents and doctors that we spoke to agreed that this question is important.A trial comparing closure at six weeks after the stoma was made to twelve weeks after (our original plan) might be difficult to carry out. A different trial design may need to be planned. This could include having a rule that the most premature babies in the trial would only have their stoma closed when they were old enough.
The trial could investigate which group of babies gains the most weight, or which spends the greatest number of days in hospital.
The NIHR will use the results of the study to decide if they would like to do a trial, and how to plan one.
More information is at https://www.npeu.ox.ac.uk/toscinREC name
London - Dulwich Research Ethics Committee
REC reference
20/LO/1227
Date of REC Opinion
13 Jan 2021
REC opinion
Further Information Favourable Opinion