ABSTRACT
BACKGROUND: The reformulated simethicone emulsion from Berlin Chemical AG might develop white flocculate precipitate covering the gastric mucosa when used before esophagogastroduodenoscopy (EGD). We aim to investigate whether combining the reformulated simethicone emulsion with 5% sodium bicarbonate solution could prevent the development of white precipitate and improve visibility during EGD. METHODS: Our clinical study involved 523 patients. They were randomly assigned to two groups. In Group A, patients received a warm solution containing 30 ml 5% sodium bicarbonate solution and 15 ml reformulated simethicone emulsion. In Group B, patients received 45 ml 40 °C lukewarm water. Visibility scores were recorded and analyzed. Flushes, volume of flush water, overall time taken for EGD and complications during or after the procedure were also recorded. RESULTS: We found that no white precipitate was observed during EGD in Group A. Moreover, visibility scores in Group A were significantly lower (P < 0.01). Patients in Group A had fewer flushes (P < 0.01) and smaller volume of flush water (P < 0.01). In addition, the overall time taken for the EGD procedure was significantly shorter in Group A (P < 0.01). The percentage of patients who had no adverse response was significantly higher in Group A than in Group B (P < 0.01). CONCLUSIONS: Premedication with a mixed solution of 15 ml reformulated simethicone emulsion and 30 ml 5% sodium bicarbonate solution can prevent the development of white precipitate, substantially enhancing mucosal visibility safely. TRIAL REGISTRATION: The registered name of the trial is "Efficacy of using premedication with reformulated simethicone emulsion during upper gastrointestinal endoscopy examination". Its Current Controlled Trials number is ChiCTR1900021689. Its date of registration is 11 September 2019. Retrospectively registered, http://www.medresman.org.cn/uc/sindex.aspx .
Subject(s)
Simethicone , Sodium Bicarbonate , Double-Blind Method , Endoscopy, Gastrointestinal , Humans , PremedicationABSTRACT
Objective To investigate the clinical effects of four different bowel preparation methods for colonoscopy.Methods 620 patients examined by coloscopy were randomized into four groups (group A,B,C and D),with each group in 155 cases.Group A received magnesium sulfate.Group B received compound polyethylene glycol.Group C received magnesium sulfate combined with simethicone.Group D received compound polyethylene glycol combined with simethicone.The quality and influencing factors,the detection of polyps and adverse events were compared between the four groups.Results The good bowel cleaning rate of group A,B,C and D were respectively 84.52％,91.61％,85.81％ and 94.19％.The good bowel cleaning rates of group A and C were higher than those of group B and D (x2 =4.32,P ＜ 0.05;x2 =7.63,P ＜ 0.05;x2 =4.10,P ＜ 0.05;x2 =6.06,P ＜ 0.05.).The bubble free rate of group A,B,C and D were 86.45 ％,87.74％,92.26％ and 90.96％.The bubble free rates of group C and D were higher than those of group A and B (x2 =4.17,P ＜ 0.05;x2 =4.76,P ＜ 0.05;x2 =5.02,P ＜ 0.05;x2 =4.23,P ＜ 0.05).The polyp detection rates of group A,B,C and D were 35.4％,36.8％,51.6％ and 54.2％.Group C and D showed higher quality of foam eliminating and detection rate of polyps as compared with group A and B (x2 =8.24,P ＜0.05;x2 =11.04,P ＜0.05;x2 =6.95,P ＜0.05;x2 =9.53,P ＜0.05).The incidence of adverse reactions of group A and C (21.3％ and 19.4％) were higher than group B and D (7.8％ and 6.5％) (x2 =11.86,P＜0.05;x2 =14.95,P ＜0.05;x2 =9.18,P ＜0.05;x2 =11.95,P ＜0.05).The frequency of colonoscopy,constipation,medication and examination time interval,bowel preparation methods and adverse events were the the influ ence factors of bowel preparation.Conclusion The quality of bowel preparation of compound polyethylene glycol electrolyte powder is better than magnesium sulfate with high security.Treatment of combination with simethicone can improve bowel preparation quality.Many factors can affect bowel preparation,which need to be paid attention to.
