Small evidence for small incisions: pediatric laparoscopy and the need for more rigorous evaluation of novel surgical therapies.

BACKGROUND/PURPOSE: Laparoscopic surgery has been widely adopted for many pediatric surgical diseases for its potential to reduce morbidity and hospital stay. To date, no study has examined the qualitative state of evidence supporting the use of these techniques in children. The authors present a systematic and objective review of this evidence.

METHODS: The authors identified all clinical reports during the last 10 years for the 3 most common pediatric surgical diseases managed laparoscopically (appendicitis, gastroesophageal reflux, and conditions requiring splenectomy). Standardized and previously validated quality assessment instruments were used to examine individual studies in 4 areas: (1) clinical relevance, (2) generalizability to clinical practice, (3) reporting methodology, and (4) strength of conclusions.

RESULTS: The authors evaluated a total of 131 clinical reports (39 to 48 per disease). Ninety-three percent of all studies were retrospective, with single institution case reports accounting for the majority of evidence. Only 23% of studies used a control group of any kind. Randomized trials comprised 3% of all evidence (4 studies). Forty-five percent of nonrandomized studies were found to be of poor quality, and 55% were of fair quality by epidemiologic standards. The distribution of quality scores was not significantly different between the 3 operative indications examined (analysis of variance P =0.10). Randomized studies also were found to be of poor methodologic quality by standardized assessment criteria.

CONCLUSIONS: The current body of evidence is of insufficient quality to justify the widespread adoption of laparoscopic techniques into accepted standards of care. Wider use of prospective studies such as multicenter databases and randomized trials are needed to clarify the indications and outcomes for these innovative techniques. Significant improvement in the quality of published observational studies is also warranted, and this may be facilitated by the adoption of standardized reporting guidelines specific to nonrandomized data.