1/13/2024 0 Comments Research studiesThe rapid growth in the number of robot-assisted surgery research coupled with the major investments of trial resources compounds the need for ensuring trials complete and dissemination of results and is still a crucial issue in the field of robot-assisted surgery. 15 Those resources will not go to waste only when clinical trial findings can foster scientific advances. 14 A lack of timely dissemination of research findings may influence clinical practice, have major effects on the development of evidence-based clinical policies and even have the potential for a large impact on public health. 12 13 By September 2016, the National Institutes of Health (NIH) and the Department of Health and Human Services expanded mandatory reporting of results to the in the Final Rule. Certain interventional trials listed there are required to report results within 1 year of the primary completion date, according to the Food and Drug Administration Amendments Act (FDAAA) of 2007. 9–11Ĭ is a study registration system developed for greater transparency and less risk of bias. 7 8 Nevertheless, plenty of examples exist of selective non-publication of trials with negative results or potentially harmful findings, especially those that were stopped early or with severe adverse effects, and publication bias (negative results are less likely to be published than positive results). 6īecause unreported trials represent a human rights violation, researchers have a potential obligation to make research results publicly available, particularly findings of human clinical trials. ![]() ![]() 4 A large number of observational studies and randomised controlled trials costing a lot of human, physical and financial resources 5 compared robot-assisted surgery with laparoscopic surgery, video-assisted surgery or open surgery, but the results have been inconsistent. 2 3 Robot-assisted surgery has become more and more widely applied in surgical specialties, and massive clinical studies were triggered. 1 The use of robots had an increase of 13% (about US$3200) on the average total cost of a procedure in 2007 for 20 different robot-assisted surgery interventions. In recent decades, the number of robot-assisted surgery interventions has increased exponentially, achievihng 570 000 cases in 2014 for the da Vinci surgical system.
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