Randomized, double-blinded, placebo-controlled trial evaluating simethicone pretreatment with bowel preparation during colonoscopy
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摘要
BACKGROUND The presence of small air bubbles and foam are an impediment to a successful colonoscopy. They impair an endoscopist's view and diminish the diagnostic accuracy of the study. This has been particularly noted to be of concern with the switch to lower volume polyethylene glycol(PEG) and bisacodyl combination preparation.AIM To evaluate the effect of oral simethicone addition to bowel preparation on intraluminal bubbles reduction during colonoscopy.METHODS Described is a prospective, randomized, multi-center, double-blinded, placebocontrolled study to evaluate the use of premixed simethicone formulation with split-regimen, low-volume PEG-bisacodyl combination bowel preparation for 168 outpatients undergoing screening, surveillance, and diagnostic colonoscopies.Primary outcome includes evaluation of bubbles during colonoscopy graded using the Intraluminal Bubbles Scale. Secondary outcomes include evaluation ofthe Boston Bowel Preparation Scale(BBPS), total number of polyps, polyp size differentiation, polyp laterality, adenoma detection, mass detection, cecal insertion time, withdrawal time, and patient-reported adverse events.RESULTS Higher Intraluminal Bubbles grades III and IV(less than 75% of the mucosa cleared of bubbles/foam requiring intervention with simethicone infused wash)were detected in the placebo group [Simethicone n = 4/84 vs Placebo n = 20/84(P= 0.007)]. BBPS total score was 7.42 [standard deviation(SD) = ± 1.51] in the simethicone group and 7.28(SD = ± 1.44) in the placebo group(P = 0.542) from a total of 9. Significantly higher number of adenomas were detected in the simethicone group(P = 0.001).CONCLUSION The addition of simethicone to bowel preparation is well advised for its antifoaming properties. The results of this study suggest that addition of oral simethicone can improve bowel wall visibility.
BACKGROUND The presence of small air bubbles and foam are an impediment to a successful colonoscopy. They impair an endoscopist's view and diminish the diagnostic accuracy of the study. This has been particularly noted to be of concern with the switch to lower volume polyethylene glycol(PEG) and bisacodyl combination preparation.AIM To evaluate the effect of oral simethicone addition to bowel preparation on intraluminal bubbles reduction during colonoscopy.METHODS Described is a prospective, randomized, multi-center, double-blinded, placebocontrolled study to evaluate the use of premixed simethicone formulation with split-regimen, low-volume PEG-bisacodyl combination bowel preparation for 168 outpatients undergoing screening, surveillance, and diagnostic colonoscopies.Primary outcome includes evaluation of bubbles during colonoscopy graded using the Intraluminal Bubbles Scale. Secondary outcomes include evaluation ofthe Boston Bowel Preparation Scale(BBPS), total number of polyps, polyp size differentiation, polyp laterality, adenoma detection, mass detection, cecal insertion time, withdrawal time, and patient-reported adverse events.RESULTS Higher Intraluminal Bubbles grades III and IV(less than 75% of the mucosa cleared of bubbles/foam requiring intervention with simethicone infused wash)were detected in the placebo group [Simethicone n = 4/84 vs Placebo n = 20/84(P= 0.007)]. BBPS total score was 7.42 [standard deviation(SD) = ± 1.51] in the simethicone group and 7.28(SD = ± 1.44) in the placebo group(P = 0.542) from a total of 9. Significantly higher number of adenomas were detected in the simethicone group(P = 0.001).CONCLUSION The addition of simethicone to bowel preparation is well advised for its antifoaming properties. The results of this study suggest that addition of oral simethicone can improve bowel wall visibility.
BACKGROUND The presence of small air bubbles and foam are an impediment to a successful colonoscopy. They impair an endoscopist's view and diminish the diagnostic accuracy of the study. This has been particularly noted to be of concern with the switch to lower volume polyethylene glycol(PEG) and bisacodyl combination preparation.AIM To evaluate the effect of oral simethicone addition to bowel preparation on intraluminal bubbles reduction during colonoscopy.METHODS Described is a prospective, randomized, multi-center, double-blinded, placebocontrolled study to evaluate the use of premixed simethicone formulation with split-regimen, low-volume PEG-bisacodyl combination bowel preparation for 168 outpatients undergoing screening, surveillance, and diagnostic colonoscopies.Primary outcome includes evaluation of bubbles during colonoscopy graded using the Intraluminal Bubbles Scale. Secondary outcomes include evaluation ofthe Boston Bowel Preparation Scale(BBPS), total number of polyps, polyp size differentiation, polyp laterality, adenoma detection, mass detection, cecal insertion time, withdrawal time, and patient-reported adverse events.RESULTS Higher Intraluminal Bubbles grades III and IV(less than 75% of the mucosa cleared of bubbles/foam requiring intervention with simethicone infused wash)were detected in the placebo group [Simethicone n = 4/84 vs Placebo n = 20/84(P= 0.007)]. BBPS total score was 7.42 [standard deviation(SD) = ± 1.51] in the simethicone group and 7.28(SD = ± 1.44) in the placebo group(P = 0.542) from a total of 9. Significantly higher number of adenomas were detected in the simethicone group(P = 0.001).CONCLUSION The addition of simethicone to bowel preparation is well advised for its antifoaming properties. The results of this study suggest that addition of oral simethicone can improve bowel wall visibility.
引文
1 Wexner SD,Beck DE,Baron TH,Fanelli RD,Hyman N,Shen B,Wasco KE;American Society of Colon and Rectal Surgeons;American Society for Gastrointestinal Endoscopy;Society of American Gastrointestinal and Endoscopic Surgeons.A consensus document on bowel preparation before colonoscopy:prepared by a task force from the American Society of Colon and Rectal Surgeons(ASCRS),the American Society for Gastrointestinal Endoscopy(ASGE),and the Society of American Gastrointestinal and Endoscopic Surgeons(SAGES).Gastrointest Endosc 2006;63:894-909[PMID:16733101 DOI:10.1016/j.gie.2006.03.918]
2 Harrison NM,Hjelkrem MC.Bowel cleansing before colonoscopy:Balancing efficacy,safety,cost and patient tolerance.World J Gastrointest Endosc 2016;8:4-12[PMID:26788258 DOI:10.4253/wjge.v8.i1.4]
3 Toledo TK,DiPalma JA.Review article:colon cleansing preparation for gastrointestinal procedures.Aliment Pharmacol Ther 2001;15:605-611[PMID:11328253 DOI:10.1046/j.1365-2036.2001.00966.x]
4 da Silva MM,Briars GL,Patrick MK,Cleghorn GJ,Shepherd RW.Colonoscopy preparation in children:safety,efficacy,and tolerance of high-versus low-volume cleansing methods.J Pediatr Gastroenterol Nutr 1997;24:33-37[PMID:9093983 DOI:10.1097/00005176-199701000-00009]
5 Adams WJ,Meagher AP,Lubowski DZ,King DW.Bisacodyl reduces the volume of polyethylene glycol solution required for bowel preparation.Dis Colon Rectum 1994;37:229-33;discussion 233-4[PMID:8137669 DOI:10.1007/BF02048160]
6 Kojecky V,Matous J,Keil R,Dastych M,Kroupa R,Zadorova Z,Varga M,Dolina J,Kment M,Hep A.A head-to-head comparison of 4-L polyethylene glycol and low-volume solutions before colonoscopy:which is the best?A multicentre,randomized trial.Int J Colorectal Dis 2017;32:1763-1766[PMID:28944412 DOI:10.1007/s00384-017-2901-x]
7 Brecevi?L,Bosan-Kilibarda I,Strajnar F.Mechanism of antifoaming action of simethicone.J Appl Toxicol 1994;14:207-211[PMID:8083482 DOI:10.1002/jat.2550140311]
8 Tongprasert S,Sobhonslidsuk A,Rattanasiri S.Improving quality of colonoscopy by adding simethicone to sodium phosphate bowel preparation.World J Gastroenterol 2009;15:3032-3037[PMID:19554657DOI:10.3748/wjg.15.3032]
9 Ofstead CL,Wetzler HP,Johnson EA,Heymann OL,Maust TJ,Shaw MJ.Simethicone residue remains inside gastrointestinal endoscopes despite reprocessing.Am J Infect Control 2016;44:1237-1240[PMID:27497824 DOI:10.1016/j.ajic.2016.05.016]
10 Yoo IK,Jeen YT,Kang SH,Lee JH,Kim SH,Lee JM,Choi HS,Kim ES,Keum B,Chun HJ,Lee HS,Kim CD.Improving of bowel cleansing effect for polyethylene glycol with ascorbic acid using simethicone:A randomized controlled trial.Medicine(Baltimore)2016;95:e4163[PMID:27428209DOI:10.1097/MD.0000000000004163]
11 Matro R,Tupchong K,Daskalakis C,Gordon V,Katz L,Kastenberg D.The effect on colon visualization during colonoscopy of the addition of simethicone to polyethylene glycol-electrolyte solution:a randomized single-blind study.Clin Transl Gastroenterol 2012;3:e26[PMID:23238113 DOI:10.1038/ctg.2012.16]
12 Lai EJ,Calderwood AH,Doros G,Fix OK,Jacobson BC.The Boston bowel preparation scale:a valid and reliable instrument for colonoscopy-oriented research.Gastrointest Endosc 2009;69:620-625[PMID:19136102 DOI:10.1016/j.gie.2008.05.057]
13 Parente F,Vailati C,Bargiggia S,Manes G,Fontana P,Masci E,Arena M,Spinzi G,Baccarin A,Mazzoleni G,Testoni PA.2-Litre polyethylene glycol-citrate-simethicone plus bisacodyl versus 4-litre polyethylene glycol as preparation for colonoscopy in chronic constipation.Dig Liver Dis 2015;47:857-863[PMID:26232311 DOI:10.1016/j.dld.2015.06.008]
14 Repici A,Cestari R,Annese V,Biscaglia G,Vitetta E,Minelli L,Trallori G,Orselli S,Andriulli A,Hassan C.Randomised clinical trial:low-volume bowel preparation for colonoscopy-a comparison between two different PEG-based formulations.Aliment Pharmacol Ther 2012;36:717-724[PMID:22924336 DOI:10.1111/apt.12026]
15 Bai Y,Fang J,Zhao SB,Wang D,Li YQ,Shi RH,Sun ZQ,Sun MJ,Ji F,Si JM,Li ZS.Impact of preprocedure simethicone on adenoma detection rate during colonoscopy:a multicenter,endoscopistblinded randomized controlled trial.Endoscopy 2018;50:128-136[PMID:28985630 DOI:10.1055/s-0043-119213]
16 Alexander W.The uphill path to successful clinical trials:keeping patients enrolled.P T 2013;38:225-227[PMID:23785228]
17 Sakpal TV.Sample size estimation in clinical trial.Perspect Clin Res 2010;1:67-69[PMID:21829786]
18 Cohen J.A Coefficient of Agreement for Nominal Scales.Educ Psychol Meas 1960;20:37-46[DOI:10.1177/001316446002000104]
19 Rex DK,Petrini JL,Baron TH,Chak A,Cohen J,Deal SE,Hoffman B,Jacobson BC,Mergener K,Petersen BT,Safdi MA,Faigel DO,Pike IM;ASGE/ACG Taskforce on Quality in Endoscopy.Quality indicators for colonoscopy.Am J Gastroenterol 2006;101:873-885[PMID:16635231 DOI:10.1111/j.1572-0241.2006.00673.x]
20 Zhang S,Zheng D,Wang J,Wu J,Lei P,Luo Q,Wang L,Zhang B,Wang H,Cui Y,Chen M.Simethicone improves bowel cleansing with low-volume polyethylene glycol:a multicenter randomized trial.Endoscopy 2018;50:412-422[PMID:29132175 DOI:10.1055/s-0043-121337]
21 Pontone S,Angelini R,Standoli M,Patrizi G,Culasso F,Pontone P,Redler A.Low-volume plus ascorbic acid vs high-volume plus simethicone bowel preparation before colonoscopy.World J Gastroenterol 2011;17:4689-4695[PMID:22180711 DOI:10.3748/wjg.v17.i42.4689]
22 Kump P,Hassan C,Spada C,Brownstone E,Datz C,Haefner M,Renner F,Schoefl R,Schreiber F.Efficacy and safety of a new low-volume PEG with citrate and simethicone bowel preparation for colonoscopy(Clensia):a multicenter randomized observer-blind clinical trial vs.a low-volume PEG with ascorbic acid(PEG-ASC).Endosc Int Open 2018;6:E907-E913[PMID:30083580 DOI:10.1055/a-0624-2266]
23 de Leone A,Tamayo D,Fiori G,Ravizza D,Trovato C,De Roberto G,Fazzini L,Dal Fante M,Crosta C.Same-day 2-L PEG-citrate-simethicone plus bisacodyl vs split 4-L PEG:Bowel cleansing for late-morning colonoscopy.World J Gastrointest Endosc 2013;5:433-439[PMID:24044042 DOI:10.4253/wjge.v5.i9.433]
24 Barakat MT,Huang RJ,Banerjee S.Simethicone is retained in endoscopes despite reprocessing:impact of its use on working channel fluid retention and adenosine triphosphate bioluminescence values(with video).Gastrointest Endosc 2019;89:115-123[PMID:30125574 DOI:10.1016/j.gie.2018.08.012]
25 Alagappan M,Brown JRG,Mori Y,Berzin TM.Artificial intelligence in gastrointestinal endoscopy:The future is almost here.World J Gastrointest Endosc 2018;10:239-249[PMID:30364792 DOI:10.4253/wjge.v10.i10.239]
26 Wang Y,Tavanapong W,Wong J,Oh JH,de Groen PC.Polyp-Alert:near real-time feedback during colonoscopy.Comput Methods Programs Biomed 2015;120:164-179[PMID:25952076 DOI:10.1016/j.cmpb.2015.04.002]
27 Yeh JH,Hsu MH,Tseng CM,Chen TH,Huang RY,Lee CT,Lin CW,Wang WL.The benefit of adding oral simethicone in bowel preparation regimen for the detection of colon adenoma:A systematic review and meta-analysis.J Gastroenterol Hepatol 2019;34:830-836[PMID:30311262 DOI:10.1111/jgh.14508]
28 Pan P,Zhao SB,Li BH,Meng QQ,Yao J,Wang D,Li ZS,Bai Y.Effect of supplemental simethicone for bowel preparation on adenoma detection during colonoscopy:A meta-analysis of randomized controlled trials.J Gastroenterol Hepatol 2019;34:314-320[PMID:30069899 DOI:10.1111/jgh.14401]
2 Harrison NM,Hjelkrem MC.Bowel cleansing before colonoscopy:Balancing efficacy,safety,cost and patient tolerance.World J Gastrointest Endosc 2016;8:4-12[PMID:26788258 DOI:10.4253/wjge.v8.i1.4]
3 Toledo TK,DiPalma JA.Review article:colon cleansing preparation for gastrointestinal procedures.Aliment Pharmacol Ther 2001;15:605-611[PMID:11328253 DOI:10.1046/j.1365-2036.2001.00966.x]
4 da Silva MM,Briars GL,Patrick MK,Cleghorn GJ,Shepherd RW.Colonoscopy preparation in children:safety,efficacy,and tolerance of high-versus low-volume cleansing methods.J Pediatr Gastroenterol Nutr 1997;24:33-37[PMID:9093983 DOI:10.1097/00005176-199701000-00009]
5 Adams WJ,Meagher AP,Lubowski DZ,King DW.Bisacodyl reduces the volume of polyethylene glycol solution required for bowel preparation.Dis Colon Rectum 1994;37:229-33;discussion 233-4[PMID:8137669 DOI:10.1007/BF02048160]
6 Kojecky V,Matous J,Keil R,Dastych M,Kroupa R,Zadorova Z,Varga M,Dolina J,Kment M,Hep A.A head-to-head comparison of 4-L polyethylene glycol and low-volume solutions before colonoscopy:which is the best?A multicentre,randomized trial.Int J Colorectal Dis 2017;32:1763-1766[PMID:28944412 DOI:10.1007/s00384-017-2901-x]
7 Brecevi?L,Bosan-Kilibarda I,Strajnar F.Mechanism of antifoaming action of simethicone.J Appl Toxicol 1994;14:207-211[PMID:8083482 DOI:10.1002/jat.2550140311]
8 Tongprasert S,Sobhonslidsuk A,Rattanasiri S.Improving quality of colonoscopy by adding simethicone to sodium phosphate bowel preparation.World J Gastroenterol 2009;15:3032-3037[PMID:19554657DOI:10.3748/wjg.15.3032]
9 Ofstead CL,Wetzler HP,Johnson EA,Heymann OL,Maust TJ,Shaw MJ.Simethicone residue remains inside gastrointestinal endoscopes despite reprocessing.Am J Infect Control 2016;44:1237-1240[PMID:27497824 DOI:10.1016/j.ajic.2016.05.016]
10 Yoo IK,Jeen YT,Kang SH,Lee JH,Kim SH,Lee JM,Choi HS,Kim ES,Keum B,Chun HJ,Lee HS,Kim CD.Improving of bowel cleansing effect for polyethylene glycol with ascorbic acid using simethicone:A randomized controlled trial.Medicine(Baltimore)2016;95:e4163[PMID:27428209DOI:10.1097/MD.0000000000004163]
11 Matro R,Tupchong K,Daskalakis C,Gordon V,Katz L,Kastenberg D.The effect on colon visualization during colonoscopy of the addition of simethicone to polyethylene glycol-electrolyte solution:a randomized single-blind study.Clin Transl Gastroenterol 2012;3:e26[PMID:23238113 DOI:10.1038/ctg.2012.16]
12 Lai EJ,Calderwood AH,Doros G,Fix OK,Jacobson BC.The Boston bowel preparation scale:a valid and reliable instrument for colonoscopy-oriented research.Gastrointest Endosc 2009;69:620-625[PMID:19136102 DOI:10.1016/j.gie.2008.05.057]
13 Parente F,Vailati C,Bargiggia S,Manes G,Fontana P,Masci E,Arena M,Spinzi G,Baccarin A,Mazzoleni G,Testoni PA.2-Litre polyethylene glycol-citrate-simethicone plus bisacodyl versus 4-litre polyethylene glycol as preparation for colonoscopy in chronic constipation.Dig Liver Dis 2015;47:857-863[PMID:26232311 DOI:10.1016/j.dld.2015.06.008]
14 Repici A,Cestari R,Annese V,Biscaglia G,Vitetta E,Minelli L,Trallori G,Orselli S,Andriulli A,Hassan C.Randomised clinical trial:low-volume bowel preparation for colonoscopy-a comparison between two different PEG-based formulations.Aliment Pharmacol Ther 2012;36:717-724[PMID:22924336 DOI:10.1111/apt.12026]
15 Bai Y,Fang J,Zhao SB,Wang D,Li YQ,Shi RH,Sun ZQ,Sun MJ,Ji F,Si JM,Li ZS.Impact of preprocedure simethicone on adenoma detection rate during colonoscopy:a multicenter,endoscopistblinded randomized controlled trial.Endoscopy 2018;50:128-136[PMID:28985630 DOI:10.1055/s-0043-119213]
16 Alexander W.The uphill path to successful clinical trials:keeping patients enrolled.P T 2013;38:225-227[PMID:23785228]
17 Sakpal TV.Sample size estimation in clinical trial.Perspect Clin Res 2010;1:67-69[PMID:21829786]
18 Cohen J.A Coefficient of Agreement for Nominal Scales.Educ Psychol Meas 1960;20:37-46[DOI:10.1177/001316446002000104]
19 Rex DK,Petrini JL,Baron TH,Chak A,Cohen J,Deal SE,Hoffman B,Jacobson BC,Mergener K,Petersen BT,Safdi MA,Faigel DO,Pike IM;ASGE/ACG Taskforce on Quality in Endoscopy.Quality indicators for colonoscopy.Am J Gastroenterol 2006;101:873-885[PMID:16635231 DOI:10.1111/j.1572-0241.2006.00673.x]
20 Zhang S,Zheng D,Wang J,Wu J,Lei P,Luo Q,Wang L,Zhang B,Wang H,Cui Y,Chen M.Simethicone improves bowel cleansing with low-volume polyethylene glycol:a multicenter randomized trial.Endoscopy 2018;50:412-422[PMID:29132175 DOI:10.1055/s-0043-121337]
21 Pontone S,Angelini R,Standoli M,Patrizi G,Culasso F,Pontone P,Redler A.Low-volume plus ascorbic acid vs high-volume plus simethicone bowel preparation before colonoscopy.World J Gastroenterol 2011;17:4689-4695[PMID:22180711 DOI:10.3748/wjg.v17.i42.4689]
22 Kump P,Hassan C,Spada C,Brownstone E,Datz C,Haefner M,Renner F,Schoefl R,Schreiber F.Efficacy and safety of a new low-volume PEG with citrate and simethicone bowel preparation for colonoscopy(Clensia):a multicenter randomized observer-blind clinical trial vs.a low-volume PEG with ascorbic acid(PEG-ASC).Endosc Int Open 2018;6:E907-E913[PMID:30083580 DOI:10.1055/a-0624-2266]
23 de Leone A,Tamayo D,Fiori G,Ravizza D,Trovato C,De Roberto G,Fazzini L,Dal Fante M,Crosta C.Same-day 2-L PEG-citrate-simethicone plus bisacodyl vs split 4-L PEG:Bowel cleansing for late-morning colonoscopy.World J Gastrointest Endosc 2013;5:433-439[PMID:24044042 DOI:10.4253/wjge.v5.i9.433]
24 Barakat MT,Huang RJ,Banerjee S.Simethicone is retained in endoscopes despite reprocessing:impact of its use on working channel fluid retention and adenosine triphosphate bioluminescence values(with video).Gastrointest Endosc 2019;89:115-123[PMID:30125574 DOI:10.1016/j.gie.2018.08.012]
25 Alagappan M,Brown JRG,Mori Y,Berzin TM.Artificial intelligence in gastrointestinal endoscopy:The future is almost here.World J Gastrointest Endosc 2018;10:239-249[PMID:30364792 DOI:10.4253/wjge.v10.i10.239]
26 Wang Y,Tavanapong W,Wong J,Oh JH,de Groen PC.Polyp-Alert:near real-time feedback during colonoscopy.Comput Methods Programs Biomed 2015;120:164-179[PMID:25952076 DOI:10.1016/j.cmpb.2015.04.002]
27 Yeh JH,Hsu MH,Tseng CM,Chen TH,Huang RY,Lee CT,Lin CW,Wang WL.The benefit of adding oral simethicone in bowel preparation regimen for the detection of colon adenoma:A systematic review and meta-analysis.J Gastroenterol Hepatol 2019;34:830-836[PMID:30311262 DOI:10.1111/jgh.14508]
28 Pan P,Zhao SB,Li BH,Meng QQ,Yao J,Wang D,Li ZS,Bai Y.Effect of supplemental simethicone for bowel preparation on adenoma detection during colonoscopy:A meta-analysis of randomized controlled trials.J Gastroenterol Hepatol 2019;34:314-320[PMID:30069899 DOI:10.1111/jgh.14401]