J.Jpn. Surg. Soc.. 125(2): 146-153, 2024

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Feature topic

RANDOMIZED, CONTROLLED TRIALS IN PEDIATRIC SURGERY: THE ROAD TO TOP JOURNALS

Randomized, controlled trials (RCTs) are the gold standard for demonstrating evidence for diagnoses and treatments, but there are only a few reports of RCTs in pediatric surgery. RCTs are difficult because they require significant manpower and efforts. An insufficient number of cases, lack of an established standard treatment for comparison of results, and unwillingness to allocate patients to new treatment arms due to excessive expectations are common issues. Especially in the pediatric surgical field, a single-arm study is often chosen with the expectation of a new treatment, which often prevents publication of reports in top journals. In this field, RCTs were accepted early in international collaborative malignant tumor treatment trials since diseases such as liver tumors and germ cell tumors are rare. To promote RCTs in pediatric surgery, an understanding of the importance of obtaining solid evidence is necessary, and RCTs must be developed with adequate preparation and appropriate design, especially for diseases with relatively small numbers of patients, and choosing national and international collaborative trials might be a shortcut to publication in top journals. In addition, it is also necessary to take the right approach to the clinical questions to be clarified.

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