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A prospective randomized controlled trial comparing simethicone, N-acetylcysteine, sodium bicarbonate and peppermint for visualization in upper gastrointestinal endoscopy.
Mahawongkajit, P, Kanlerd, A
Surgical endoscopy. 2021;(1):303-308
Abstract
OBJECTIVES Early cancer detection is crucial in improving the patients' quality of life and upper gastrointestinal endoscopy (EGD) plays a key role in this detection. Many clearing mechanisms may be applied to create good endoscopic visualizations for the upper gastrointestinal tract using mucolytic agents, antifoaming agents, proteolytic enzymes and neutralizers. The aim of this study is to compare the effects of simethicone, N-acetylcysteine (NAC), sodium bicarbonate and peppermint as pre-medications for visualization of esophagogastroduodenoscopy (EGD). METHODS This study was a single center prospective randomized controlled trial. The patients were randomly allocated to one of four treatment groups. Group A: water; Group B: water with simethicone; Group C: water with simethicone plus NAC 600 mg; Group D: water with simethicone, NAC, sodium bicarbonate and peppermint. RESULTS A total of 128 patients were enrolled and evaluated in this study. Total visibility score (TVS) of Groups A, B, C, and D were 13.4 ± 1.86, 10.5 ± 1.45, 7.15 ± 0.98 and 6.4 ± 1.43, respectively. Group D showed lower TVS than other groups. The procedural durations of Groups C and D were significantly shorter than Group A. The volume of solution for mucosal cleansing of Groups C and D was significantly lower than Groups A and B. CONCLUSIONS The application of simethicone plus NAC is safe, improves endoscopic visualization and requires a minimal amount of mucosal cleansing solution. The addition of sodium bicarbonate and peppermint further improved visualization for the upper and lower gastric body. Thai Clinical Trials Registry (TCTR) with a reference number; TCTR20190501002.
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Protocol for a randomised trial evaluating the effect of applying gamification to simulation-based endoscopy training.
Scaffidi, MA, Khan, R, Walsh, CM, Pearl, M, Winger, K, Kalaichandran, R, Lin, P, Grover, SC
BMJ open. 2019;(2):e024134
Abstract
BACKGROUND Simulation-based training (SBT) provides a safe environment and effective means to enhance skills development. Simulation-based curricula have been developed for a number of procedures, including gastrointestinal endoscopy. Gamification, which is the application of game-design principles to non-game contexts, is an instructional strategy with potential to enhance learning. No studies have investigated the effects of a comprehensive gamification curriculum on the acquisition of endoscopic skills among novice endoscopists. METHODS AND ANALYSIS Thirty-six novice endoscopists will be randomised to one of two endoscopy SBT curricula: (1) the Conventional Curriculum Group, in which participants will receive 6 hours of one-on-one simulation training augmented with expert feedback and interlaced with 4 hours of small group teaching on the theory of colonoscopy or (2) the Gamified Curriculum Group, in which participants will receive the same curriculum with integration of the following game-design elements: a leaderboard summarising participants' performance, game narrative, achievement badges and rewards for top performance. In line with a progressive learning approach, simulation training for participants will progress from low to high complexity simulators, starting with a bench-top model and then moving to the EndoVR virtual reality simulator. Performance will be assessed at three points: pretraining, immediately post-training and 4-6 weeks after training. Assessments will take place on the simulator at all three time points and transfer of skills will be assessed during two clinical colonoscopies 4-6 weeks post-training. Mixed factorial ANOVAs will be used to determine if there is a performance difference between the two groups during simulated and clinical assessments. ETHICS AND DISSEMINATION Ethical approval was obtained at St. Michael's Hospital. Results of this trial will be submitted for presentation at academic meetings and for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER NCT03176251.
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Use of N-acetylcysteine plus simethicone to improve mucosal visibility during upper GI endoscopy: a double-blind, randomized controlled trial.
Monrroy, H, Vargas, JI, Glasinovic, E, Candia, R, Azúa, E, Gálvez, C, Rojas, C, Cabrera, N, Vidaurre, J, Álvarez, N, et al
Gastrointestinal endoscopy. 2018;(4):986-993
Abstract
BACKGROUND AND AIM Upper GI endoscopy (UGE) is essential for the diagnosis of gastrointestinal diseases. Mucus and bubbles may decrease mucosal visibility. The use of mucolytics could improve visualization. Our aim was to determine whether premedication with simethicone or simethicone plus N-acetylcysteine is effective in improving visibility during UGE. METHODS This was a randomized, double-blinded, placebo-controlled trial with 2 control groups: no intervention and water 100 mL (W); and 3 intervention groups: simethicone 200 mg (S); S + N-acetylcysteine (NAC) 500 mg (S+NAC500); and S + NAC 1000 mg (S+NAC1000). The solution was ingested 20 minutes before UGE. Gastric visibility was evaluated in 4 segments with a previously described scale. A score of less than 7 points was defined as adequate visibility (AV). Water volume was used to improve visibility, and adverse reactions were evaluated as a secondary outcome. Multiple group comparison was performed using non-parametric one-way analysis of variance (ANOVA). RESULTS Two hundred thirty patients were included in the study, 68% female, mean age 49 years. The most common indication for UGE was epigastric pain/dyspepsia (33%). AV was more frequent in the S+NAC500 and S+NAC1000 groups (65% and 67%) compared with no intervention (44%, P = .044) and water (41%, P = .022). The gastric total visibility scale (TVS) was significantly better in the S+NAC500 and S+NAC1000 groups compared with water (P = .03 and P = .008). Simethicone was not different from no intervention and water. S+NAC1000 required less water volume to improve visibility. No adverse reactions from the study drugs were observed. CONCLUSIONS Premedication with S+NAC500 and S+NAC1000 improves visibility during UGE. The use of simethicone did not show improvements in gastric visibility. TVS was worse in patients using water alone. (Clinical trial registration number: NCT 01653171.).
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Premedication with simethicone and N-acetylcysteine in improving visibility during upper endoscopy: a double-blind randomized trial.
Elvas, L, Areia, M, Brito, D, Alves, S, Saraiva, S, Cadime, AT
Endoscopy. 2017;(2):139-145
Abstract
Background and study aim Upper endoscopy is the most common method for the diagnosis of upper gastrointestinal tract diseases. The aim of this study was to determine whether premedication with simethicone or N-acetylcysteine improves mucosal visualization during upper endoscopy. Patients and methods This was a randomized, double-blind, placebo-controlled study of 297 patients scheduled for upper endoscopy who were premedicated 15 - 30 minutes before the procedure with: 100 mL of water (placebo, group A); water plus 100 mg simethicone (group B); water plus 100 mg simethicone plus 600 mg N-acetylcysteine (group C). The primary outcome measure was the quality of mucosal visualization (score: excellent, adequate or inadequate). Results The addition of simethicone (group B) or simethicone plus N-acetylcysteine to the water (group C) improved the visualization scores of endoscopies compared with water alone (group A). In particular, groups B and C produced a significantly higher percentage of endoscopies with excellent visualization for the esophagus (91.1 % and 86.7 %, respectively, vs. 71.4 % in group A; P < 0.001) and stomach (76.2 % and 74.5 % vs. 38.8 % in group A; P < 0.001). For the duodenum, the use of simethicone also showed an increase in the endoscopies with excellent visualization compared with water alone (85.1 % vs. 73.5 %; P = 0.042). There were no significant differences in scores between groups B and C or between gastric scores in patients with previous subtotal gastrectomy (B and C vs. A): 60.0 % and 42.1 % vs. 28.6 % (P = 0.14). The rate of reported lesions was higher in group B but without statistical significance. Conclusions Premedication with simethicone resulted in better mucosal visibility. Such premedication might improve diagnostic yield, and should be considered for standard practice. Trial registered at ClinicalTrials.gov (NCT02357303).
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Propofol-alfentanyl versus midazolam-alfentanyl in inducing procedural amnesia of upper gastrointestinal endoscopy in children--blind randomised trial.
Sienkiewicz, E, Albrecht, P, Ziółkowski, J, Dziechciarz, P
European journal of pediatrics. 2015;(11):1475-80
Abstract
UNLABELLED In paediatric patients, esophagogastroduodenoscopy (EGD) is commonly performed with the use of sedation. The aim of the study was to compare the effectiveness of propofol and midazolam in providing procedural amnesia and controlling behaviour in children undergoing diagnostic EGD. Children (9-16 years), classified to the first or second class of the American Society of Anaesthesiologists' physical status classification referred for EGD, were randomly assigned to receive propofol with alfentanyl or midazolam with alfentanyl for sedation during the procedure. Within 120 min after the procedure, patients were repeatedly investigated for memory of the procedure and for memory of pain intensity during EGD with the use of the visual analogue scale. Activity and cooperation of the patient during the procedure was assessed with the relative adequacy scale. Of the 51 children, 48 completed the study. Propofol was significantly better than midazolam in inducing amnesia of procedural pain (mean difference 11.53 mm; 95 % confidence interval [CI] 0.96 to 22.10), loss of memory of the procedure (relative risk 0.4; 95 % CI 0.21 to 0.59) and controlling behaviour (relative risk 2.12; 95 % CI 1.33 to 3.36). CONCLUSION In children sedated for EGD, propofol is significantly better than midazolam at providing procedural amnesia and controlling behaviour during the procedure.
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The effect of the endoscopic duodenal-jejunal bypass liner on obesity and type 2 diabetes mellitus, a multicenter randomized controlled trial.
Koehestanie, P, de Jonge, C, Berends, FJ, Janssen, IM, Bouvy, ND, Greve, JW
Annals of surgery. 2014;(6):984-92
Abstract
OBJECTIVE Investigate the safety and efficacy of 6 months' duodenal-jejunal bypass liner (DJBL) treatment in comparison with dietary intervention for obesity and type 2 diabetes mellitus (T2DM). BACKGROUND The DJBL is a bariatric procedure involving an impermeable sleeve that is delivered endoscopically in the proximal intestine. This procedure not only is less invasive than conventional surgical techniques but also has beneficial effects on obesity and T2DM. METHODS A multicenter randomized controlled trial was conducted. Seventy-seven patients with obesity and T2DM were included. Thirty-eight patients were randomized to 6 months' DJBL treatment in combination with dietary intervention (34 successfully implanted, 31 completed the study), 39 patients received only dietary intervention (controls, 35 completed the study). Total study duration for both groups was 12 months, including 6 months of post-DJBL removal follow-up. RESULTS After 6 months, just before DJBL removal, the DJBL group had lost 32.0% [22.0%-46.7%] of their excess weight versus 16.4% [4.1%-34.6%] in the control group (P < 0.05). Glycated hemoglobin A1c levels improved to 7.0% [6.4%-7.5%] in the DJBL group and to 7.9% [6.6%-8.3%] in the control group (P < 0.05). In addition, 85.3% of DJBL patients showed decreased postprandial glucose excursions versus 48.7% of control patients (P < 0.05). At 12 months, excess weight loss of the DJBL group was 19.8% [10.6%-45.0%] versus 11.7% [1.4%-25.4%] in the control group (P < 0.05). HbA1c was 7.3% [6.6%-8.0%] versus 8.0% [6.8%-8.8%], DJBL versus control respectively (P = ns). CONCLUSIONS The DJBL is a safe and effective alternative to invasive bariatric procedures. Six months of DJBL treatment combined with diet leads to superior weight loss and improvement of T2DM when compared with diet alone.
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Peroral endoscopic myotomy for idiopathic achalasia: randomized comparison of water-jet assisted versus conventional dissection technique.
Cai, MY, Zhou, PH, Yao, LQ, Xu, MD, Zhong, YS, Li, QL, Chen, WF, Hu, JW, Cui, Z, Zhu, BQ
Surgical endoscopy. 2014;(4):1158-65
Abstract
BACKGROUND Peroral endoscopic myotomy (POEM) has recently been introduced as a promising alternative to laparoscopic Heller myotomy for idiopathic achalasia. Several proposed technical modifications are yet to be tested in randomized trials. OBJECTIVE The objective of our study was to evaluate efficacy and safety of water-jet (WJ) assisted POEM versus the conventional (C) technique. The clinical trial registration number is NCT01742494. METHODS A prospective randomized trial was carried out in Zhongshan Hospital, Fudan University (Shanghai, China), in 100 consenting achalasia patients between August 2011 and April 2012. Patients eligible for POEM were randomized to use of either the HybridKnife (WJ group) or the conventional technique using injection and triangle tip knife interchangeably (C group). RESULTS A total of 100 patients with comparable characteristics between groups were included. Procedure time was significantly shorter for the WJ group (22.9 ± 6.7 vs. 35.9 ± 11.7 min; p < 0.0001), mostly due to less replacement of accessories (2.0 ± 2.4 vs. 19.2 ± 7.6; p < 0.0001). Injection volume was larger in the WJ group (45.3 ± 10.2 vs. 35.2 ± 9.5 ml; p < 0.0001) and was associated with fewer minor bleeding episodes (3.6 ± 1.8 vs. 6.8 ± 5.2; p < 0.0001). No severe complications occurred; one case of cutaneous emphysema occurred in the WJ group, and four cases occurred in the C group (p = 0.17), three cases of pneumonia were encountered in the C group and none in the WJ group (p = 0.24). Treatment success (Eckardt score ≤3) was achieved in 96.5 % of patients, with no significant differences between groups. CONCLUSIONS The use of the HybridKnife leads to a significant decrease in POEM procedure time and facilitates reinjection, possibly contributing to a lower rate of minor intra-procedural bleeding.
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Premedication with erythromycin improves endoscopic visualization of the gastric mucosa in patients with subtotal gastrectomy: a prospective, randomized, controlled trial.
Jun, BY, Choi, MG, Lee, JY, Baeg, MK, Moon, SJ, Lim, CH, Kim, JS, Cho, YK, Lee, IS, Kim, SW, et al
Surgical endoscopy. 2014;(5):1641-7
Abstract
BACKGROUND Food residue in the remnant stomach after subtotal gastrectomy (STG) interferes with endoscopic observation. We investigated whether intravenous erythromycin improves gastric mucosa visualization in patients with STG. METHODS This study was conducted from April 2012 to October 2012 as a double-blinded, placebo-controlled, randomized trial. Patients who received STG with complete resection (stage T1-2N0M0) were included. Exclusion criteria were diabetes mellitus, neurologic disease, myopathy, recent viral enteritis history, concomitant therapy influencing gastrointestinal motility and severe comorbidity. Patients were instructed to consume a soft diet for dinner between 1800 and 2000 h, and endoscopies were performed between 0900 and 1200 h. Patients were assigned randomly to receive either erythromycin (125 mg in normal saline 50 cc) or placebo saline. The endoscopy was performed 15 min after infusion. Grade of residual food was rated as follows: G0, no residual food; G1, a small amount of residual food; G2, a moderate amount of residual food; G3, a moderate amount of residual food that hinders observation of the entire surface, even with body rolling; G4, a great amount of residual food such that endoscopic observation is impossible. RESULTS When good visibility was defined as G0+G1, visibility was significantly better in the erythromycin group (61 + 19 %) than in the placebo group (38 + 12 %, p < 0.001). However, this effect was not seen in patients within 6 months after gastrectomy. The risk factor for food stasis in the placebo group (n = 58) was food stasis at last endoscopy. The only factor predicting erythromycin response in the erythromycin group (n = 56) was elapsed time since surgery. Adverse effects included nausea [11 (19.7 %)] and vomiting [1 (1.8 %)] in the erythromycin group and vomiting [3 (5.2 %)] in the placebo group. However, they were transient and tolerable. CONCLUSIONS Premedication with erythromycin improves mucosal visualization during endoscopy in patients with STG. ( CLINICAL TRIALS REGISTRATION NUMBER NCT01659619).
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Prospective randomized trial: endoscopic follow up 3 vs 6 months after esophageal variceal eradication by band ligation in cirrhosis.
Debernardi Venon, W, Elia, C, Stradella, D, Bruno, M, Fadda, M, DeAngelis, C, Rizzetto, M, Saracco, G, Marzano, A
European journal of internal medicine. 2014;(7):674-9
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Abstract
BACKGROUND AND OBJECTIVES Endoscopic variceal ligation (EVL) is recommended to treat esophageal varices (EV) in cirrhosis and portal hypertension. A program of endoscopic surveillance is not clearly established. The aim of this prospective randomized trial was to assess the most effective timing of endoscopic monitoring after variceal eradication and its impact on the patient's outcome and on the costs. METHODS A hundred and two cirrhotic patients with esophageal varices treated by EVL were evaluated. After variceal eradication patients were randomized to receive first endoscopic control at 3 (Group 1) and 6 (Group 2) months respectively. RESULTS Variceal obliteration was achieved in all patients. Variceal recurrence was observed in 28 cases at the first control (29.1%) without difference between the two groups (32% vs 29% in group 1 and 2 respectively, p=0.75). The incidence of large varices is similar in the two groups (33% vs 38% respectively). Using a multivariate analysis, medical therapy with B blockers was the only independent predictor of lowest risk of variceal recurrence [OR 2.30, 95% CI (1.68-3.26)]. Bleeding related to recurrent varices occurred in 3.1% of cases and was associated with portal thrombosis. Child Pugh score ≥8 was the only predictor of mortality (p=0.0002). CONCLUSIONS Recurrence of varices after banding ligation is not rare but it is associated with a low risk of variceal progression and bleeding. Accordingly, a first endoscopic control at 6 months after variceal eradication associated with a good risk stratification might be a cost-effective strategy of monitoring.
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Determination of the optimal time for premedication with pronase, dimethylpolysiloxane, and sodium bicarbonate for upper gastrointestinal endoscopy.
Woo, JG, Kim, TO, Kim, HJ, Shin, BC, Seo, EH, Heo, NY, Park, J, Park, SH, Yang, SY, Moon, YS, et al
Journal of clinical gastroenterology. 2013;(5):389-92
Abstract
GOALS AND BACKGROUND Premedication with pronase, dimethylpolysiloxane, and sodium bicarbonate improves visibility during upper gastrointestinal (UGI) endoscopy. However, the optimal time for this combination to take effect is unknown. We investigated the optimal time of pre-UGI endoscopy medication. STUDY A randomized, investigator-blind, controlled trial. The 300 patients who were to receive premedication were randomized into 3 groups according to the following medication time before UGI endoscopy: 10 minutes (group A, n=98), 10 to 30 minutes (group B, n=97), and 30 minutes premedication (group C, n=99). Visibility scores (range, 1 to 4, with lower scores indicating better gastric mucosal visibility) were assessed for the antrum, lower body, upper body, and fundus and compared, including the sum of the scores, between the 3 groups. RESULTS Group B had significantly lower visibility scores for the lower body, upper body, and fundus than group C (P=0.001, 0.009, and 0.002, respectively). Group A obtained significantly lower scores for the antrum and lower body than group C (P=0.007 and 0.005, respectively). The total visibility scores of groups A and B were significantly lower compared with those of group C (P=0.001, 0.003, respectively). CONCLUSIONS Administration of pronase, dimethylpolysiloxane, and sodium bicarbonate within 30 minutes before UGI endoscopy significantly improved endoscopic visualization. However, the optimal time to achieve the best visibility was between 10 to 30 minutes before UGI endoscopy.