Timing of Stoma Closure in Neonates (ToSCiN)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Feasibility of a future trial comparing early and late stoma closure
研究概览
简要总结
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.
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).
The investigators will ask parents and health professionals for their views and whether they would take part in a future trial and information about babies who have recently had a stoma to find out which factors influence the timing of closure. They 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 to help decide whether a clinical trial is possible.
详细描述
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 United Kingdom (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 Neonatal Intensive Care Unit (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.
Aims and objectives:
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).
Methods:
The study will use a mixed-methods approach comprising three parallel workstreams (WS). WS 1 will be a national survey of clinician perspectives of neonatal stoma closure. WS 2 will use an observational cohort study, interviews, questionnaires and focus groups. WS 3 will analyse three existing large databases (National Neonatal Research Database (NNRD), Health Episode Statistics (HES) and British Association of Paediatric Surgeons Congenital Anomalies Surveillance System (BAPS-CASS)).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Feasibility of a future trial comparing early and late stoma closure
时间窗: through study completion, an average of 1 year
The key research question 'Is it feasible to conduct a clinical trial comparing 'early' vs. 'late' stoma closure in neonates?' will be answered by completing the series of secondary outcome measures using qualitative mixed research methods
次要结局
- To establish current UK practice for stoma closure in neonates(through study completion, an average of 1 year)
- To determine the willingness of parents, neonatal surgeons and neonatologists to include neonates in a trial that would randomise to 'early' or 'late' stoma closure and identify potential barriers to recruitment.(through study completion, an average of 1 year)
- Find the most appropriate design for a potential trial(through study completion, an average of 1 year)
- To assess the suitability of using routinely collected data for gathering clinical information for a trial.(through study completion, an average of 1 year)
- To define 'early' and 'late' stoma closure for a potential trial.(through study completion, an average of 1 year)
- To determine whether there is equipoise amongst clinicians (neonatal surgeons, and neonatologists) and allied health professionals (specialist nurses and dieticians) over when it is best to close stomas in neonates(through study completion, an average of 1 year)
- Identify a group of babies for inclusion in a trial and find out how many of these babies could be included in the UK.(through study completion, an average of 1 year)