Title: Timing of Stoma Closure in Neonates (ToSCiN) Study
Funder: Department of Health and Social Care

Abstract: 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 related to this (called NEC) or they were born with a problem that caused a blockage of the bowel. As part of this surgery, a stoma is frequently required temporarily. A stoma is where ends of the bowel are brought to the skin surface to allow the baby to poo into a bag. Although a stoma can be life-saving, there are problems associated with them. Babies may get dehydrated, have poor growth and have problems with their skin. Reversing (closing) the stoma with a second operation is therefore a key part of the baby’s care._x000D_ _x000D_ The time when the stoma is closed is important as it may affect: i) when the baby can feed with milk without a drip; ii) how well the baby grows and iii) when the baby can go home (as well as treatment cost). However, the time of this stoma closure is known to vary between hospitals and between different surgeons. The best time to do this operation is uncertain and a clinical trial is needed to find this out. A clinical trial like this though, is likely to be expensive, challenging and may not be possible. It also may not be acceptable to parents or doctors. We therefore plan to do an initial study to look into all these things._x000D_ _x000D_ This study aims to find out if it is possible to do a future clinical trial. To do this we plan to: _x000D_ 1. Find out what is currently happening in the UK for stoma closure in babies _x000D_ 2. Find out whether surgeons, neonatal doctors and other professionals like dieticians are genuinely uncertain about when it is best for stomas to be closed _x000D_ 3. Find out if parents, surgeons and neonatal doctors would be willing to include babies in a trial that would randomly allocate them (like tossing a coin) to ‘early’ or ‘late’ stoma closure _x000D_ 4. Decide what is meant by ‘early’ and ‘late’ stoma closure for a potential trial _x000D_ 5. Identify a group of babies for inclusion in a trial and find out how many of these babies could be included in the UK. _x000D_ 6. Find the most appropriate design for a potential trial _x000D_ 7. Find out if current national databases could be used for gathering the required information for a potential trial _x000D_ _x000D_ Our study will take place in specialist neonatal surgical units across the UK and has a number of parts that will help us get the information we need. We will ask parents and doctors about their views; we will collect information about babies who have recently had a stoma to find out which factors influence the decision of when to close it and we will talk to their parents and doctors to find out whether they would take part in a future trial and the reasons for this. Finally, we will analyse anonymous data already collected by the NHS to find out how many babies may be suitable for a trial. _x000D_ _x000D_ Once we have all this information, we will arrange a meeting of everyone involved, as well as other doctors who we would like to take part in a future trial. We will use the information firstly to decide if a future trial is feasible. If it is, we will use the information to help us design such a trial. By collecting this information, we will be well placed to create a trial that is acceptable to parents and doctors; that will focus on the most appropriate babies; that will measure things important to parents and doctors and ultimately will help us to answer the question: when is the best time to close a baby’s stoma?

Lay abstract: Background_x000D_ Neonates undergoing emergency abdominal surgery frequently require stoma formation. Reversing (closing) these stomas with a second operation is an essential part of the infant’s recovery. The timing of this closure is highly variable around the UK and the best time remains unclear. Current evidence is of low methodological quality and presents mixed conclusions: determining the best time has significant potential benefits for: (i) infant health outcomes (short-term e.g. avoiding complications and long-term e.g. growth and neurodevelopment); ii) families (e.g. reduced NICU stay); and iii) healthcare providers (e.g. reduced costs). Ideally, a clinical trial to compare early and late closure would be conducted but this is likely to be challenging and may not be feasible or acceptable to parents and clinicians._x000D_ _x000D_ Aims and objectives _x000D_ This study aims to answer the question, ‘is it feasible to conduct a clinical trial comparing ‘early’ vs. ‘late’ stoma closure in neonates?’ It has a series of specific objectives which incorporate: (i) describing current UK practice; (ii) establishing whether or not a clinical trial (and exactly what form of trial) is acceptable to parents and clinicians; and (iii) establishing the design of a potential trial, including defining the intervention (‘early vs. late’) and the population of infants to be included, how infants should be recruited and what information should be collected (outcomes)._x000D_ _x000D_ Methods_x000D_ We will use a mixed-methods approach comprising three parallel work-streams (WS). WS 1 will be a national survey of clinician perspectives of neonatal stoma closure. WS 2 will use interviews, questionnaires and focus groups to establish parent and clinician perspectives regarding a clinical trial of neonatal stoma closure. WS 3 will analyse three existing large databases (NNRD, HES and BAPS-CASS). The findings of these WS will be combined and presented at a final, trial design meeting where conclusions about trial feasibility will be reached and if appropriate, an outline of a trial protocol agreed._x000D_ _x000D_ Anticipated impact and dissemination_x000D_ The principal impact will be determining whether or not a definitive trial can go ahead: if we demonstrate that a trial is feasible then we would use our findings to design a trial that is acceptable to parents and clinicians; that includes the most appropriate infants; that measures outcomes important to parents and clinicians and ultimately, answers the question: when is the best time to close an infant’s stoma? Our findings will be disseminated at national meetings of relevant professionals, through social media (including patient groups), to funding bodies and in open access publications.

Research activity codes: 2.4 SURVEILLANCE AND DISTRIBUTION;7.1 INDIVIDUAL CARE NEEDS;7.3 MANAGEMENT AND DECISION MAKING
Health categories: ORAL AND GASTROINTESTINAL;REPRODUCTIVE HEALTH AND CHILDBIRTH