Abstract
Paucity of data concerning many surgical procedures and its particular techniques often sustain utilization based on surgeon’s own preferences and/or experiences. Experts are also subjected to marketing strategies and persuasion. The hospital administration of a tertiary care teaching center in southern Brazil requested hospital-based Health Technology Assessment unit to provide the best current evidence for use of ultrasonic vessel sealing technology (harmonic scalpel) in laparoscopic fundoplication in children presenting with gastroesophageal reflux disease. Initial English-language database search using the Medical Subject Headings (MeSH) terms “child”, “gastroesophageal reflux” and “fundoplication” with all publication dates up to and including November 2019 was conducted. Then, a narrower research question was built with terms “child”, “laparoscopy”, “fundoplication”, “ultrasonic device”, “harmonic scalpel” in all their variants. Any additional articles identified in the references of relevant papers were also included. The original goal was to select only randomized clinical trials (RCT) and meta-analysis of RCTs. However, due to scarce data, non-interventional studies ended up being assessed as well. Database search did not return any RCT either comparing medical treatment versus fundoplication or assessing laparoscopic versus open surgery in pediatric patients. One meta-analysis of observational studies concluded that fundoplication did not improve symptoms or hospital admission rates. Specifically in children with neurological impairment, another meta-analysis of observational studies found that fundoplication after gastrostomy was related to increased perioperative morbidity and did not reduce gastroesophageal reflux symptoms. Likewise, none RCT was found regarding performance of ultrasonic vessel sealing technology on laparoscopic fundoplication among children. Current scientific knowledge raises serious concerns about effectiveness and safety of fundoplication in children with gastroesophageal reflux. To the extent of our knowledge, indication of such procedure is highly debatable. Limited data regarding ultrasonic vessel sealing technology (harmonic scalpel) compromise agreement and consensus of all parties.
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