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Fragility of statistically significant findings from randomized trials in comparing laparoscopic versus robotic
Yung Lee1,2, Yasith Samarasinghe1, Lucy H Chen1
1Division of General Surgery, McMaster University, Hamilton, ON, Canada.
Background:
Utility of robotic over laparoscopic approach has been an area of debate across all surgical specialties over the past decade. The fragility index (FI) is a metric that evaluates the frailty of randomized controlled trials (RCTs) findings by altering the status of patients from an event to non-event until significance is lost. This study aims to evaluate the robustness of RCTs comparing laparoscopic and robotic abdominopelvic surgeries through the FI.
Methods:
A search was conducted in MEDLINE and EMBASE for RCTs with dichotomous outcomes comparing laparoscopic and robot-assisted surgery in general surgery, gynecology, and urology. The FI and reverse fragility Index (RFI) metrics were used to assess the strength of findings reported by RCTs, and bivariate correlation was conducted to analyze relationships between FI and trial characteristics.
Results:
A total of 21 RCTs were included, with a median sample size of 89 participants (Interquartile range [IQR] 62-126). The median FI was 2 (IQR 0-15) and median RFI 5.5 (IQR 4-8.5). The median FI was 3 (IQR 1-15) for general surgery (n = 7), 2 (0.5-3.5) for gynecology (n = 4), and 0 (IQR 0-8.5) for urology RCTs (n = 4). Correlation was found between increasing FI and decreasing p-value, but not sample size, number of outcome events, journal impact factor, loss to follow-up, or risk of bias.
Conclusion:
RCTs comparing laparoscopic and robotic abdominal surgery did not prove to be very robust. While possible advantages of robotic surgery may be emphasized, it remains novel and requires further concrete RCT data.
