Improvement of Russian clinical guidelines and reduction of mortality in perforated ulcers / O perspektivakh sovershenstvovaniya rossiiskikh klinicheskikh rekomendatsii i snizheniya letal'nosti pri probodnoi yazve.

ABSTRACT

OBJECTIVE: To analyze the results of laparoscopic surgery in patients with perforated ulcers using evidence-based medicine approaches. MATERIAL AND METHODS: 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. RESULTS: 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. CONCLUSION: 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.