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CC BY-NC-ND 4.0 · Endosc Int Open 2023; 11(10): E992-E1000
DOI: 10.1055/a-2157-5034
Original article

Optimal timing of simethicone administration prior to upper endoscopy: A multicenter, single-blind, randomized controlled trial

I.N. Beaufort
1   Department of Gastroenterology and Hepatology, Sint Antonius Hospital, Nieuwegein, the Netherlands (Ringgold ID: RIN6028)
2   Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, the Netherlands (Ringgold ID: RIN8124)
,
R.E. Verbeek
3   Department of Gastroenterology and Hepatology, Groene Hart Hospital, Gouda, the Netherlands (Ringgold ID: RIN3573)
,
J.H. Bosman
3   Department of Gastroenterology and Hepatology, Groene Hart Hospital, Gouda, the Netherlands (Ringgold ID: RIN3573)
,
A. Al-Toma 
1   Department of Gastroenterology and Hepatology, Sint Antonius Hospital, Nieuwegein, the Netherlands (Ringgold ID: RIN6028)
,
A. Bogte
2   Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, the Netherlands (Ringgold ID: RIN8124)
,
L. Alvarez Herrero
1   Department of Gastroenterology and Hepatology, Sint Antonius Hospital, Nieuwegein, the Netherlands (Ringgold ID: RIN6028)
,
B.L.A.M. Weusten
1   Department of Gastroenterology and Hepatology, Sint Antonius Hospital, Nieuwegein, the Netherlands (Ringgold ID: RIN6028)
2   Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, the Netherlands (Ringgold ID: RIN8124)
› InstitutsangabenGefördert durch: Sint Antonius Research Fund NA

TRIAL REGISTRATION: Registration number (trial ID): NL8383, Trial registry: Netherlands National Trial Register (http://www.trialregister.nl), Type of Study: Prospective, randomized, multicenter study
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Abstract

Background and study aims Simethicone is useful as premedication for upper endoscopy because of its antifoaming effects. We aimed to evaluate the effect of timing of simethicone administration on mucosal visibility.

Patients and methods In this multicenter, randomized, endoscopist-blinded study, patients scheduled for upper endoscopy were randomized to receive 40 mg simethicone at the following time points prior to the procedure: 20 to 30 minutes (early group), 0 to 10 minutes (late group) or 20 mg simethicone at both time points (split-dose group). Images were taken from nine predefined locations in the esophagus, stomach, and duodenum before endoscopic flushing. Each image was scored on mucosal visibility by three independent endoscopists on a 4-point scale (lower scores indicating better visibility), with adequate mucosal visibility defined as a score ≤ 2. Primary outcome was the percentage of patients with adequate total mucosal visibility (TMV), reached if all median subscores for each location were ≤ 2.

Results A total of 386 patients were included (early group: 132; late group: 128; split-dose group: 126). Percentages of adequate TMV were 55%, 42%, and 61% in the early, late, and split-dose group, respectively (P < 0.01). Adequate TMV was significantly higher in the split-dose group compared to the late group (P < 0.01), but not compared to the early group (P = 0.29). Differences between groups were largest in the stomach, where percentages of adequate mucosal visibility were higher in the early (68% vs 53%, P = 0.03) and split-dose group (69% vs 53%, P = 0.02) compared to the late group.

Conclusions Mucosal visibility can be optimized with early simethicone administration, either as a single administration or in a split-dose regimen.

Keywords

Precancerous conditions & cancerous lesions (displasia and cancer) stomach - Barrett's and adenocarcinoma - Preparation, quality and logistical aspects - Quality management - Diagnosis and imaging (inc chromoendoscopy, NBI, iSCAN, FICE, CLE)

Supporting information



Publikationsverlauf

Eingereicht: 12. Mai 2023

Angenommen nach Revision: 25. Juli 2023

Artikel online veröffentlicht:
17. Oktober 2023

© 2023. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).

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Kommentar zu diesem Artikel:

Endoscopy International Open – recently publishedEndoscopy 2024; 56(01): 85-85
DOI: 10.1055/a-2167-8169

 

  • References

  • 1 Beck M, Bringeland EA, Qvigstad G. et al. Gastric cancers missed at upper endoscopy in central Norway 2007 to 2016 – a population-based study. Cancers (Basel) 2021; 13: 5628
    CrossrefPubMedSuche in Google Scholar
  • 2 Januszewicz W, Witczak K, Wieszczy P. et al. Prevalence and risk factors of upper gastrointestinal cancers missed during endoscopy: A nationwide registry-based study. Endoscopy 2022; 54: 653-660
    Thieme ConnectPubMedSuche in Google Scholar
  • 3 Pimenta-Melo AR, Monteiro-Soares M, Libânio D. et al. Missing rate for gastric cancer during upper gastrointestinal endoscopy: A systematic review and meta-analysis. Eur J Gastroenterol Hepatol 2016; 28: 1041-1049
    Suche in Google Scholar
  • 4 Rodríguez de Santiago E, Hernanz N, Marcos-Prieto HM. et al. Rate of missed oesophageal cancer at routine endoscopy and survival outcomes: A multicentric cohort study. United European Gastroenterol J 2019; 7: 189-198
    CrossrefPubMedSuche in Google Scholar
  • 5 van Putten M, Johnston BT, Murray LJ. et al. ‘Missed’ oesophageal adenocarcinoma and high-grade dysplasia in Barrett’s oesophagus patients: A large population-based study. United European Gastroenterol J 2018; 6: 519-528
    CrossrefPubMedSuche in Google Scholar
  • 6 Yalamarthi S, Witherspoon P, McCole D. et al. Missed diagnoses in patients with upper gastrointestinal cancers. Endoscopy 2004; 36: 874-879
    Thieme ConnectPubMedSuche in Google Scholar
  • 7 Manfredi G, Pedaci M, Iiritano E. et al. Impact of improved upper endoscopy quality on detection of gastric precancerous lesions. Eur J Gastroenterol Hepatol 2023; 35: 285-287
    CrossrefPubMedSuche in Google Scholar
  • 8 Early DS, Lightdale JR, Vargo JJ. et al. Guidelines for sedation and anesthesia in GI endoscopy. Gastrointest Endosc 2018; 87: 327-337
    Suche in Google Scholar
  • 9 Bisschops R, Areia M, Coron E. et al. Performance measures for upper gastrointestinal endoscopy: A European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative. Endoscopy 2016; 48: 843-864
    Suche in Google Scholar
  • 10 Gotoda T, Uedo N, Yoshinaga S. et al. Basic principles and practice of gastric cancer screening using high-definition white-light gastroscopy: Eyes can only see what the brain knows. Digestive Endoscopy 2016; 28: 2-15
    CrossrefPubMedSuche in Google Scholar
  • 11 Chiu PWY, Uedo N, Singh R. et al. An Asian consensus on standards of diagnostic upper endoscopy for neoplasia. Gut 2019; 68: 186-197
    CrossrefPubMedSuche in Google Scholar
  • 12 Chang WK, Yeh MK, Hsu HC. et al. Efficacy of simethicone and N-acetylcysteine as premedication in improving visibility during upper endoscopy. Journal of Gastroenterology and Hepatology (Australia) 2014; 29: 769-774
    CrossrefPubMedSuche in Google Scholar
  • 13 Elvas L, Areia M, Brito D. et al. Premedication with simethicone and N-acetylcysteine in improving visibility during upper endoscopy: A double-blind randomized trial. Endoscopy 2017; 49: 139-145
    PubMedSuche in Google Scholar
  • 14 Song M, Kwek ABE, Law NM. et al. Efficacy of small-volume simethicone given at least 30 min before gastroscopy. World J Gastrointest Pharmacol Ther 2016; 7: 572-578
    CrossrefPubMedSuche in Google Scholar
  • 15 Krishnamurthy V, Joseph A, Venkataraman S. et al. Simethicone and N-acetyl cysteine combination as premedication before esophagogastroduodenoscopy: Double-blind randomized controlled trial. Endosc Int Open 2022; 10: E585-E592
    Thieme ConnectPubMedSuche in Google Scholar
  • 16 Keeratichananont S, Sobhonslidsuk A, Kitiyakara T. et al. The role of liquid simethicone in enhancing endoscopic visibility prior to esophagogastroduodenoscopy ( EGD):. J Med Assoc Thai 2010; 93: 892-897
    PubMedSuche in Google Scholar
  • 17 Ahsan M, Babaei L, Gholamrezaei A. et al. Simethicone for the preparation before esophagogastroduodenoscopy. Diagn Ther Endosc 2011; 2011: 484532
    CrossrefPubMedSuche in Google Scholar
  • 18 Asl SMKH, Sivandzadeh GR. Efficacy of premedication with activated Dimethicone or N-acetylcysteine in improving visibility during upper endoscopy. World J Gastroenterol 2011; 17: 4213-4217
    Suche in Google Scholar
  • 19 Banerjee B, Parker J, Waits W. et al. Effectiveness of preprocedure simethicone drink in improving visibility during esophagogastroduodenoscopy: a double-blind, randomized study. J Clin Gastroenterol 1992; 15: 264-265
    PubMedSuche in Google Scholar
  • 20 Basford P, Brown J, Gadeke L. et al. A randomized controlled trial of pre-procedure simethicone and N-acetylcysteine to improve mucosal visibility during gastroscopy – NICEVIS. Endosc Int Open 2016; 04: E1197-E1202
    Thieme ConnectPubMedSuche in Google Scholar
  • 21 Mahawongkajit P, Kanlerd A. A prospective randomized controlled trial comparing simethicone, N-acetylcysteine, sodium bicarbonate and peppermint for visualization in upper gastrointestinal endoscopy. Surg Endosc 2021; 35: 303-308
    CrossrefPubMedSuche in Google Scholar
  • 22 Sajid MS, Rehman S, Chedgy F. et al. Improving the mucosal visualization at gastroscopy: a systematic review and meta-analysis of randomized, controlled trials reporting the role of Simethicone ± N-acetylcysteine. Transl Gastroenterol Hepatol 2018; 3: 1-8
    CrossrefPubMedSuche in Google Scholar
  • 23 Bertoni G, Gumina C, Conigliaro R. et al. Randomized placebo-controlled trial of oral liquid simethicone prior to upper gastrointestinal endoscopy. Endoscopy 1992; 24: 268-270
    Suche in Google Scholar
  • 24 Blanco C, Barreto-Guevara MI, Walteros-Gordillo YL. et al. Cohorts of premedication for endoscopy of the upper gastrointestinal tract with simethicone, n-acetylcysteine, hedera helix and visual scale validation. Rev Colomb Gastroenterol 2021; 36: 39-50
    CrossrefPubMedSuche in Google Scholar
  • 25 Manfredi G, Bertè R, Iiritano E. et al. Premedication with simethicone and N-acetylcysteine for improving mucosal visibility during upper gastrointestinal endoscopy in a Western population. Endosc Int Open 2021; 9: E190-E194
    Suche in Google Scholar
  • 26 Monrroy H, Vargas JI, Glasinovic E. et al. Use of N-acetylcysteine plus simethicone to improve mucosal visibility during upper GI endoscopy: a double-blind, randomized controlled trial. Gastrointest Endosc 2018; 87: 986-993
    CrossrefPubMedSuche in Google Scholar
  • 27 Schulz KF, Altman DG, Moher D. CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomised trials. BMJ 2010; 340: 698-702
    CrossrefPubMedSuche in Google Scholar
  • 28 Vickerstaff V, Omar RZ, Ambler G. Methods to adjust for multiple comparisons in the analysis and sample size calculation of randomised controlled trials with multiple primary outcomes. BMC Med Res Methodol 2019; 19: 1-13
    CrossrefPubMedSuche in Google Scholar
  • 29 Harris PA, Taylor R, Thielke R. et al. Research electronic data capture (REDCap) – a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 2009; 42: 377-381
    Suche in Google Scholar
  • 30 Hommel G. A stagewise rejective multiple test procedure based on a modified Bonferroni test. Biometrika 1988; 75: 383-386
    CrossrefPubMedSuche in Google Scholar
  • 31 Hassan C, East J, Radaelli F. et al. Bowel preparation for colonoscopy: European society of gastrointestinal endoscopy (ESGE) guideline-update 2019. Endoscopy 2019; 51: 775-794
    Thieme ConnectPubMedSuche in Google Scholar
  • 32 Saltzman JR, Cash BD, Pasha SF. et al. Bowel preparation before colonoscopy. Gastrointest Endosc 2015; 81: 781-794
    CrossrefPubMedSuche in Google Scholar
  • 33 Sun X, Xu Y, Zhang X. et al. Simethicone administration improves gastric cleanness for esophagogastroduodenoscopy: a randomized clinical trial. Trials 2021; 22: 4-10
    CrossrefPubMedSuche in Google Scholar
  • 34 Woo JG, Kim TO, Kim HJ. et al. Determination of the optimal time for premedication with pronase, dimethylpolysiloxane, and sodium bicarbonate for upper gastrointestinal endoscopy. J Clin Gastroenterol 2013; 47: 389-392
    CrossrefPubMedSuche in Google Scholar
  • 35 Khan R, Gimpaya N, Vargas JI. et al. The Toronto Upper Gastrointestinal Cleaning Score: a prospective validation study. Endoscopy 2023; 55: 121-128
    Suche in Google Scholar