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The challenges of surgical research in children

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It is generally agreed that advances in surgical care are accelerated by high-quality research, and in particular RCTs. BJS is seldom sent papers reporting controlled trials in children, perhaps reflecting… Click to show full abstract

It is generally agreed that advances in surgical care are accelerated by high-quality research, and in particular RCTs. BJS is seldom sent papers reporting controlled trials in children, perhaps reflecting the particular difficulties of conducting research in this age group. These include the ethics of research in children, and issues with the consent process. It is suggested that the interests of individual children should be balanced with the necessity to conduct research on specific children to benefit children more generally; thus, research in children need not be personally beneficial or in the child’s best interests. Parents/carers have legitimate authority to make non-harmful decisions about their child in line with their own values, but children have a right to be respected in their own right. These two obligations are balanced by seeking consensus with children and their parents about the child’s involvement in research: that neither the parent nor child strongly opposes involvement. In the UK, The Clinical Trials Regulations (Medicines for Human Use (Clinical Trial) Regulations 2004) (amended in 2006) define a child (minor) as someone under the age of 16 years. The regulations specify that, for a minor to participate in a clinical trial, a person with parental responsibility must give informed consent. For parents who want only the best for their child, it must be difficult to hear that a clinician has equipoise about two different intervention options. Informed consent may be tricky when trying to explain these concepts to both parent and child, but it is good practice to gain the child’s agreement to take part in the clinical trial, where possible, regardless of age. This month’s issue of BJS features four articles of topical interest to paediatric surgeons and the allied surgical specialty communities. They cover four major themes in paediatric surgery research. First, and perhaps most obvious, children and adults are different. Diederen and colleagues1 from the Netherlands highlight outcome metrics for paediatric and adult patients undergoing restorative ileoanal pouch surgery. It was thought that outcomes of restorative surgery were worse in children, but in fact this large Dutch study suggests that late failure and pouch outcome are similar in children and adults. The paediatric cohort had more anastomotic pouch strictures, suggesting that focusing on a surgical technique specific to children, such as handsewn anastomosis, rather than stapling, could optimize their outcomes. Other suggestions include paediatric and adult colorectal surgeons working in partnership, and in high-volume centres, particularly for rare conditions such as inflammatory bowel disease in children. This structure also facilitates transitional care, when children pass from paediatric to adult surgeons, robustly coordinated by gastroenterologists, surgeons, nursing staff/stoma therapists and psychologists in multidisciplinary clinics2. Technical papers are also rare in paediatric practice. Gastrostomy is a valuable adjunct in the nutritional management of adults and children, traditionally placed using endoscopic assistance. Percutaneous endoscopic gastrostomy (PEG) was pioneered by Dr Michael Gauderer, a paediatric surgeon working at the Rainbow Babies and Children’s Hospital, Cleveland, Ohio, USA, in the 1980s3,4. In the second paper this month, surgeons and radiologists working at Great Ormond Street Hospital, London, UK, compared PEG with radiologically inserted gastrostomy in an RCT5. Both techniques were similarly effective, with low complication rates when outcomes were examined critically. Thus, decisions about which technique to use, with appropriately trained staff (surgeon or radiologist), may depend more on resource availability, mindful that the occasional complication (pneumoperitoneum, inadvertent colonic puncture, gastrocolic fistula, abdominal sepsis) would require paediatric surgical expertise. Hand injuries are common in childhood, particularly traumatic nail-bed injury when, for example, a finger is trapped in a door. Hand surgeons have long debated the merits, or otherwise, of retaining the injured nail plate to protect the underlying nail matrix. Greig and colleagues6 report early clinical outcomes of a feasibility study to compare these alternatives (Nail bed INJury Analysis (NINJA) trial). This pilot randomized study has shown that a definitive trial is possible, and has led to modifications in design that should encourage research funders. The final paediatric paper this month does not involve clinical outcomes, but equally important communication issues. Young patients coming

Keywords: clinical trial; research; surgery; child; research children

Journal Title: British Journal of Surgery
Year Published: 2017

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