A randomized controlled trial of high volume simethicone to improve visualization during capsule endoscopy

Michael Sey, Brian Yan, Cassandra McDonald, Dan Segal, Joshua Friedland, Klajdi Puka, Vipul Jairath, Michael Sey, Brian Yan, Cassandra McDonald, Dan Segal, Joshua Friedland, Klajdi Puka, Vipul Jairath

Abstract

Background: The optimal dose of simethicone before capsule endoscopy is unknown. Prior studies have reported inconsistent cleansing, with some showing improved visualization only in the proximal small intestine. We hypothesized a higher volume of simethicone may improve cleansing and diagnostic yield, especially in the distal small bowel.

Methods: A phase III randomized controlled trial was conducted comparing high volume (1125 mg simethicone in 750 ml water) versus standard volume (300 mg simethicone in 200 ml water) solutions, both at 1.5 mg/ml. The primary outcome was adequate bowel preparation, defined as a KOrea-CanaDA (KODA) score >2.25, overall and stratified by the proximal and distal half of the small bowel. Secondary outcomes included mean KODA score, diagnostic yield, completion rate, and adverse events. All analyses were intention-to-treat.

Results: A total of 167 patients were randomized (mean (SD) age 58.7 (15.7), 54% female) and the most common indication was obscure gastrointestinal bleeding (71.7%). Adequate cleansing was achieved in 39 (50%) patients in the high volume group and in 39 (48%) patients in the standard volume group (RR 1.04, 95% CI 0.76-1.43, p = 0.82), with no differences observed in the proximal half (71% vs 64%, p = 0.40) or the distal half -of the small bowel (36% vs. 37%, p = 0.88). There was no differences in the mean (SD) KODA score (2.20 (0.41) vs. 2.18 (0.44), p = 0.73), diagnostic yields (53% vs. 56%, p = 0.71), or completion rates (both 95%). One adverse event, nausea, occurred in the control group.

Conclusion: High volume simethicone does not improve visualization during capsule endoscopy.

Clinical trial registration: Clinical trial: NCT02334631.

Conflict of interest statement

Dr. Michael Sey has received arms-length research grants from Pharmascience Inc and educational funding from Medtronic. Cassandra McDonald, Klajdi Puka, Drs. Yan and Friedland have no competing interests. Dr. Dan Segal has received consulting fees from AbbVie and Takeda. Dr. Vipul Jairath has received consulting fees from AbbVie, Eli Lilly, GlaxoSmithKline, Arena pharmaceuticals, BMS, Genentech, Pendopharm, Sandoz, Pfizer, Merck, Takeda, Janssen, Alimentiv Inc., Topivert, Celltrion, Applied Strategic, Sublimity Therapeutics, F. Hoffman-La Roche Ltd, Sigmatic Ltd.,; speaker’s fees from Takeda, Janssen, Ferring, Abbvie, Pfizer. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Figures

Fig 1. Poor cleansing of the distal…
Fig 1. Poor cleansing of the distal small bowel due to inadequate volume of simethicone solution used.
Fig 2. CONSORT flow diagram [26].
Fig 2. CONSORT flow diagram [26].

References

    1. Iddan G, Meron G, Glukhovsky A, Swain P. Wireless capsule endoscopy. Nature. 2000;405(6785):417. 10.1038/35013140
    1. Enns RA, Hookey L, Armstrong D, Bernstein CN, Heitman SJ, Teshima C, et al.. Clinical Practice Guidelines for the Use of Video Capsule Endoscopy. Gastroenterology. 2017;152(3):497–514. 10.1053/j.gastro.2016.12.032
    1. Rondonotti E, Spada C, Adler S, May A, Despott EJ, Koulaouzidis A, et al.. Small-bowel capsule endoscopy and device-assisted enteroscopy for diagnosis and treatment of small-bowel disorders: European Society of Gastrointestinal Endoscopy (ESGE) Technical Review. Endoscopy. 2018;50(4):423–46. 10.1055/a-0576-0566
    1. Liao Z, Gao R, Xu C, Li ZS. Indications and detection, completion, and retention rates of small-bowel capsule endoscopy: a systematic review. Gastrointestinal endoscopy. 2010;71(2):280–6. 10.1016/j.gie.2009.09.031
    1. Wu L, Cao Y, Liao C, Huang J, Gao F. Systematic review and meta-analysis of randomized controlled trials of Simethicone for gastrointestinal endoscopic visibility. Scandinavian journal of gastroenterology. 2011;46(2):227–35. 10.3109/00365521.2010.525714
    1. Kotwal VS, Attar BM, Gupta S, Agarwal R. Should bowel preparation, antifoaming agents, or prokinetics be used before video capsule endoscopy? A systematic review and meta-analysis. European journal of gastroenterology & hepatology. 2014;26(2):137–45. 10.1097/MEG.0b013e328365b9d4
    1. Lexicomp. Simethicone: Drug Information. Riverwoods, IL: Wolters Kluwer Health, Inc; [Available from: ].
    1. Yoo IK, Lee JS, Chun HJ, Jeen YT, Keum B, Kim ES, et al.. A randomized, prospective trial on efficacy and tolerability of low-volume bowel preparation methods for colonoscopy. Digestive and liver disease: official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver. 2015;47(2):131–7. 10.1016/j.dld.2014.10.019
    1. Yoo IK, Jeen YT, Kang SH, Lee JH, Kim SH, Lee JM, et al.. Improving of bowel cleansing effect for polyethylene glycol with ascorbic acid using simethicone: A randomized controlled trial. Medicine. 2016;95(28):e4163. 10.1097/MD.0000000000004163
    1. Fang YH, Chen CX, Zhang BL. Effect of small bowel preparation with simethicone on capsule endoscopy. Journal of Zhejiang University Science B. 2009;10(1):46–51. 10.1631/jzus.B0820148
    1. Wei W, Ge ZZ, Lu H, Gao YJ, Hu YB, Xiao SD. Purgative bowel cleansing combined with simethicone improves capsule endoscopy imaging. The American journal of gastroenterology. 2008;103(1):77–82. 10.1111/j.1572-0241.2007.01633.x
    1. Krijbolder MS, Grooteman KV, Bogers SK, de Jong DJ. Addition of simethicone improves small bowel capsule endoscopy visualisation quality. The Netherlands journal of medicine. 2018;76(1):27–31.
    1. Rosa BJ, Barbosa M, Magalhaes J, Rebelo A, Moreira MJ, Cotter J. Oral purgative and simethicone before small bowel capsule endoscopy. World journal of gastrointestinal endoscopy. 2013;5(2):67–73. 10.4253/wjge.v5.i2.67
    1. Spada C, Riccioni ME, Familiari P, Spera G, Pirozzi GA, Marchese M, et al.. Polyethylene glycol plus simethicone in small-bowel preparation for capsule endoscopy. Digestive and liver disease: official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver. 2010;42(5):365–70. 10.1016/j.dld.2009.07.017
    1. Chen HB, Huang Y, Chen SY, Song HW, Li XL, Dai DL, et al.. Small bowel preparations for capsule endoscopy with mannitol and simethicone: a prospective, randomized, clinical trial. Journal of clinical gastroenterology. 2011;45(4):337–41. 10.1097/MCG.0b013e3181f0f3a3
    1. Ge ZZ, Chen HY, Gao YJ, Hu YB, Xiao SD. The role of simeticone in small-bowel preparation for capsule endoscopy. Endoscopy. 2006;38(8):836–40. 10.1055/s-2006-944634
    1. Hounnou G, Destrieux C, Desme J, Bertrand P, Velut S. Anatomical study of the length of the human intestine. Surgical and radiologic anatomy: SRA. 2002;24(5):290–4. 10.1007/s00276-002-0057-y
    1. Ontario’s LHINs: Queen’s Printer for Ontario, 2014; 2020. [Available from: .
    1. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), ICH Harmonised Guideline, Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice, E6(R2), November 9, 2016.
    1. Albert J, Gobel CM, Lesske J, Lotterer E, Nietsch H, Fleig WE. Simethicone for small bowel preparation for capsule endoscopy: a systematic, single-blinded, controlled study. Gastrointestinal endoscopy. 2004;59(4):487–91. 10.1016/s0016-5107(04)00003-3
    1. Berger VW, Exner DV. Detecting selection bias in randomized clinical trials. Controlled clinical trials. 1999;20(4):319–27. 10.1016/s0197-2456(99)00014-8
    1. Mickenautsch S, Fu B, Gudehithlu S, Berger VW. Accuracy of the Berger-Exner test for detecting third-order selection bias in randomised controlled trials: a simulation-based investigation. BMC medical research methodology. 2014;14:114. 10.1186/1471-2288-14-114
    1. Berger VW. De facto masking and other measures to prevent contamination. Journal of clinical epidemiology. 2012;65(11):1236; author reply -7. 10.1016/j.jclinepi.2012.04.016
    1. Alageeli M YB, Alshankiti S, Al-Zahrani M, Bahreini Z, Dang T, Friedland J, et al.. KODA score: an updated and validated bowel preparation scale for patients undergoing small bowel capsule endoscopy. Endoscopy international open. 2020;8(8):E1011–E7. 10.1055/a-1176-9889
    1. Park SC, Keum B, Hyun JJ, Seo YS, Kim YS, Jeen YT, et al.. A novel cleansing score system for capsule endoscopy. World journal of gastroenterology: WJG. 2010;16(7):875–80. 10.3748/wjg.v16.i7.875
    1. Schulz KF, Altman DG, Moher D, Group C. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. Bmj. 2010;340:c332. 10.1136/bmj.c332
    1. Postgate A, Tekkis P, Patterson N, Fitzpatrick A, Bassett P, Fraser C. Are bowel purgatives and prokinetics useful for small-bowel capsule endoscopy? A prospective randomized controlled study. Gastrointestinal endoscopy. 2009;69(6):1120–8. 10.1016/j.gie.2008.06.044

Source: PubMed

Szponzorok és közreműködők

Egészségi állapot

Kábítószer-beavatkozások

3
Iratkozz fel