Improvement of Russian clinical guidelines and reduction of mortality in perforated ulcers

Abstract

To analyze the results of laparoscopic surgery in patients with perforated ulcers using evidence-based medicine approaches. We compared the efficacy and effectiveness of laparoscopic and open surgeries in patients with perforated ulcers. Meta-analysis of mortality after laparoscopic surgeries (randomized controlled trials) and trial sequential analysis were carried out. We clarified the differences between the efficacy and effectiveness of laparoscopic surgeries regarding postoperative mortality. In the Russian Federation, mortality after laparoscopic surgery is 9-11 times lower compared to open procedures. According to evidence-based researches (efficacy of laparoscopic interventions in 10 meta-analyses), these differences are less obvious (1.4-3.0 times) and not significant. The diversity-adjusted required information size to draw reasonable conclusions about differences in mortality in trial sequential analysis was 68 181 participants. Meta-analyses of RCTs also demonstrate lower incidence of wound complications (1.8-5.0% after laparoscopic surgery and 6.3-13.3% after laparotomy), shorter hospital-stay (mean difference from -0.13 to -2.84) and less severe pain syndrome (mean difference in VAS score from -2.08 to -2.45) after laparoscopic technologies. The obvious advantage of laparoscopic surgery in patients with perforated ulcers is fast-truck recovery following shorter hospital-stay, mild pain and rarer wound complications. Comparison of postoperative mortality regarding efficacy and effectiveness is difficult due to insufficient introduction of laparoscopic technologies in clinical practice and diversity-adjusted required information size.