Simethicone use during gastrointestinal endoscopy: Position statement of the Gastroenterological Society of Australia
Abstract
Concern has been raised regarding the use of simethicone, a de-foaming agent, during endoscopic procedures. Following reports of simethicone residue in endoscope channels despite high level disinfection, an endoscope manufacturer recommended that it not be used due to concerns of biofilm formation and a possible increased risk of microorganism transmission. However, a detailed mucosal assessment is essential in performing high-standard endoscopic procedures. This is impaired by bubbles within the gastrointestinal lumen. The Gastroenterological Society of Australia's Infection Control in Endoscopy Guidelines (ICEG) Committee conducted a literature search utilizing the MEDLINE database. Further references were sourced from published paper bibliographies. Following a review of the available evidence, and drawing on extensive clinical experience, the multidisciplinary ICEG committee considered the risks and benefits of simethicone use in formulating four recommendations. Published reports have documented residual liquid or crystalline simethicone in endoscope channels after high level disinfection. There are no data confirming that simethicone can be cleared from channels by brushing. Multiple series report benefits of simethicone use during gastroscopy and colonoscopy in improving mucosal assessment, adenoma detection rate, and reducing procedure time. There are no published reports of adverse events related specifically to the use of simethicone, delivered either orally or via any endoscope channel. An assessment of the risks and benefits supports the continued use of simethicone during endoscopic procedures. Strict adherence to instrument reprocessing protocols is essential.
Introduction and background
In performing endoscopic procedures to the highest standard, it is essential that a detailed mucosal assessment is undertaken. Bubbles within the gastrointestinal lumen can significantly impair mucosal assessment, lesion detection, and lengthen procedural duration. Simethicone is commonly used as a de-foaming agent during endoscopic procedures. Concerns regarding simethicone use during gastrointestinal endoscopy have been circulating for several years. Despite this, there is no comparable, alternative substance. Recently, Olympus Corporation distributed a letter to customers in the USA warning of the use of simethicone during gastrointestinal endoscopic procedures.1 This has resulted in heightened focus on the use of simethicone. The letter stated, “Olympus does not recommend the use of non-water-soluble additives with our flexible endoscopes or ancillary equipment. These products may be difficult to remove during manual cleaning and may reduce the efficacy of the reprocessing procedure. Simethicone and petroleum/oil/silicone-based lubricants are non-water soluble and thus not recommended for use by Olympus.” Olympus America had earlier raised concern regarding the use of simethicone in a letter to customers in 2009.2 Peak international gastroenterology bodies have published position statements on the use of simethicone. The European Society of Gastrointestinal Endoscopy recommends adding simethicone to standard bowel preparation for colonoscopy.3 The American Society for Gastrointestinal Endoscopy, in an update on the use of simethicone in 2016, concluded there was insufficient evidence to recommend a change to current clinical practice.4 The British Society of Gastroenterology advised in 2017 that the concentration of simethicone be kept to a minimum and that it be administered orally or via the biopsy port and not via the water bottle or flushing pump.5 Most recently, the Canadian Association of Gastroenterology concluded it was unable to make clear recommendations on the use of simethicone at this time.6
Methods
Computerized medical literature searches were undertaken using MEDLINE, utilizing search terms “endoscopy,” “gastrointestinal endoscopy,” “gastroscopy,” “colonoscopy,” “adenoma detection rate,” and “simethicone” up until September 2018. Cross referencing was performed using the “similar articles” function, and further references were sourced from published paper bibliographies and recommendations from Committee members. Following this review of the available evidence, and drawing on extensive clinical experience, the multidisciplinary Infection Control in Endoscopy Guidelines Committee of the Gastroenterological Society of Australia considered the risks and benefits of simethicone use in formulating four recommendations (Table 1). B. D. conducted the literature search, formulated the initial recommendation statements, wrote the first draft of the manuscript, and chaired the Infection Control in Endoscopy Committee. The recommendations were reviewed and discussed at face to face meetings and electronically by all authors (B.D., A.T., E.A., D.W., R.B., S.G., F.B., K.V., E.W., and D.J.). An iterative process was used to reach agreement on the final recommendations and the content and structure of the manuscript. B.D. and A.T. revised the document to achieve the final version. The evidence level was determined for each recommendation as was the recommendation grade (Appendix A).7 The recommendations were reviewed and approved by the relevant committees and boards of the Gastroenterological Society of Australia (September 2018), the Gastroenterological Nurses College of Australia (September 2018), and the Australasian College of Infection Prevention and Control (February 2019).
1. The continued use of simethicone is considered reasonable as it improves mucosal inspection during gastroscopy and colonoscopy and likely facilitates adenoma detection at colonoscopy. Evidence Level: IA, Recommendation Grade: A |
2. The smallest effective quantity of simethicone should be added to lavage fluid. A suggested, yet untested concentration, would be 2–3 mL of 120 mg/mL simethicone added to 1 L of sterile water (0.024−0.036% (g/100ml, w/v)). Evidence Level: IV, Recommendation Grade: D |
3. Simethicone may be administered orally or through any endoscope irrigating channel. Evidence Level: IV, Recommendation Grade: D |
4. Strict adherence to instrument reprocessing protocols is essential. We highlight the importance of immediate bedside pre-clean endoscope decontamination that includes post-procedure flushing and prompt commencement of manual or machine cleaning. Evidence Level: IIB, Recommendation Grade: B |
Recommendations
- 1 The continued use of simethicone is considered reasonable as it improves mucosal inspection during gastroscopy and colonoscopy and likely facilitates adenoma detection at colonoscopy. Evidence Level: IA, Recommendation Grade: A
- 2 The smallest effective quantity of simethicone should be added to lavage fluid. A suggested, yet untested concentration, would be 2–3 mL of 120 mg/mL simethicone added to 1 L of sterile water-(0.024-0.036% (g/100ml, w/v)). Evidence Level: IV, Recommendation Grade: D
- 3 Simethicone may be administered orally or through any endoscope irrigating channel. Evidence Level: IV, Recommendation Grade: D
- 4 Strict adherence to instrument reprocessing protocols is essential. We highlight the importance of immediate bedside pre-clean endoscope decontamination that includes post-procedure flushing and prompt commencement of manual or machine cleaning. Evidence Level: IIB, Recommendation Grade: B
Conclusion
Given the evidence of improved quality of endoscopic imaging and polyp detection, without evidence of clinical adverse events over decades of use, we believe that continued use of simethicone is appropriate, and it can be administered through any endoscope channel. We also emphasize that strict adherence to instrument reprocessing protocols is essential.
Disclaimer
This Position Statement is based on a careful assessment of the current literature regarding the benefits and potential risks of the use of simethicone in endoscopy. Each endoscopy facility should make its own determination regarding the use of simethicone during endoscopic procedures and the route of administration. Furthermore, endoscopy facilities should have regard to any information, research or other material which may have been published or become available subsequently and reassess their position accordingly. It is not implied that the Statement is applicable in all cases, or in any particular case, but is a general policy document that may provide guidance for users. Users should use their own judgment and consider the particular circumstances of each case. The user should have regard to any information, research or other material which may have been published or become available subsequently. This Statement is current at the time at which the endorsement is expressed. The Statement may be reviewed and updated from time to time. GESA does not necessarily take responsibility for reviewing its endorsements, and it is the responsibility of the user to ensure that they have obtained the current version, or are aware of more recent or more appropriate Statements.
Acknowledgments
This manuscript has the endorsement of the Gastroenterological Society of Australia, Gastroenterological Nurses College of Australia, and Australasian College for Infection Prevention and Control.
Appendix A: Classification of evidence levels and recommendation grades
Level/grade | Description |
---|---|
Evidence level | |
IA | Evidence from meta-analysis of RCT's |
IB | Evidence from at least 1 RCT |
IIA | Evidence from at least 1 controlled study without randomization |
IIB | Evidence from at least one other type of quasi-experimental study |
III | Evidence from non-experimental descriptive studies, such as comparative studies, correlation studies, and case-controlled studies |
IV | Evidence from expert committee reports or opinions or clinical experience of respected authorities, or both |
Recommendation grade | |
A | Directly based on category I evidence |
B | Directly based on category II evidence or extrapolated recommendation from category I evidence |
C | Directly based on category III evidence or extrapolated recommendation from category I or II evidence |
D | Directly based on category IV evidence or extrapolated recommendation from category I, II, or III evidence |
- Adapted from Shekelle et al.7