Effect of Adding Simethicone to Split-dose Polyethylene Glycol for Bowel Preparation in a Screening Colonoscopy Setting
NCT ID: NCT03816774
Last Updated: 2022-10-05
Study Results
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Basic Information
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COMPLETED
NA
412 participants
INTERVENTIONAL
2019-06-15
2022-09-17
Brief Summary
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The quality of colonoscopy is greatly dependent on the quality of the bowel preparation. Standard bowel cleansing includes a low-fibre diet on the day preceding the exam and a split regimen of 4 litres of polyethylene glycol (PEG) solution.
In order to improve bowel cleansing some additional measures are available. Simethicone is an inexpensive and safe antifoaming agent that reduces the surface tension of air bubbles, theoretically presenting several benefits such as increased tolerability to the preparation, thereby improving the quality of the preparation and, secondly, adenoma detection (ADR) and cecal intubation rates (CIR). However, its role remains controversial, with some publications supporting its administration and others failing to demonstrate clear benefits.
The main aim of this study is to assess if addition of simethicone to a split-dose cleansing regimen of 4 litres of PEG improves adequate bowel preparation rate.
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Detailed Description
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ii. Randomization by computer generated tables. iii. Allocation concealment by sealed, opaque envelopes. iv. Endoscopist-blinded: endoscopist blinded to the group allocation. v. Patient informed about its bowel cleansing regimen.
b. Selection participant method: i. Inclusion by invitation of patients aged between 50 and 74 years, inclusive, scheduled for colonoscopy by nationwide CRC screening program after a positive faecal immunochemical test. ii. Exclusion criteria for nationwide CRC screening program: previous diagnosis of CRC, presence of known genetic susceptibility syndromes related with CRC, personal history of inflammatory bowel disease, presence of gastrointestinal complaints (significant changes in gastrointestinal transit in the last 6 months or evidence of gastrointestinal bleeding), a normal colonoscopy in the last 10 years and a normal flexible sigmoidoscopy in the last 5 years. Exclusion criteria of this study also include: known or suspected gastrointestinal obstruction or perforation, toxic megacolon, major colonic resection, pregnant or at risk of becoming pregnant and lactating women, known or suspected hypersensitivity to the active or other ingredients.
c. Sample size: i. 412 (2 groups of 206 patients). ii. To improve adequate bowel preparation rate (primary outcome) from 85% (value from the investigator's own database) to 95% (target standard suggested by ESGE) and assuming a normal distribution and a power of 90% (α=0.05), the calculated sample size of each of the 2 groups was 188; allowing for a 10% dropout rate, the sample size is 206 per group (412 patients overall). Adequate bowel preparation is defined as total. Boston Bowel Preparation Scale ≥6 and ≥2 in each segment. The chosen scale is the most systematically validated and appropriate for the clinical setting.
d. Procedures and data collection methods: Form sheets filled by the endoscopist about intraprocedural measures and by the nurse about patient compliance and tolerability to the prescribed cleansing regimen.
e. Analysed variables: i. Primary outcome: adequate bowel preparation rate. ii. Secondary outcomes: ADR, CIR, compliance and tolerability related to the bowel cleansing regimen. iii. Patient characteristics and other variables: age, gender, degree of mucosal bubble reported by a comprehensive scoring used by previous studies (grade 0: no bubbles; 1: minimal or occasional bubbles (must be actively sought); 2: moderate or obviously present; 3: severe or so many bubbles that vision is obscured), withdrawal time, polyp detection rate and complications rate.
f. Statistical analysis: i. Performed using statistical software IBM SPSS Statistics, Version 25.0. Armonk, NY: IBM Corp. ii. Continuous variables are reported as mean and standard deviation or median and interquartile range, if they have normal or not normal distribution, respectively; categorical variables as absolute and relative frequency. iii. Continuous variables are compared between two groups using Student's T test if they have a normal distribution and homogeneity of variance or Mann-Whitney U if these conditions are not met. Categorical variables are compared using Pearson's X2 test or Fisher test. iv. All hypotheses are two-tailed and a P-value\<0.05 is considered statistically significant.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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PEG split-dose
Group A: PEG split dose ending 3 hours before colonoscopy
No interventions assigned to this group
PEG split-dose and simethicone
Group B: 250mg simethicone pill 15 minutes before PEG dose on the previous evening plus 250mg simethicone pill 15 minutes before PEG dose ending 3 hours before colonoscopy
PEG split-dose and simethicone
Patients in active comparator arm are instructed to take 250mg simethicone pill 15 minutes before PEG dose on the previous evening plus 250mg simethicone pill 15 minutes before PEG dose ending 3 hours before colonoscopy
Interventions
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PEG split-dose and simethicone
Patients in active comparator arm are instructed to take 250mg simethicone pill 15 minutes before PEG dose on the previous evening plus 250mg simethicone pill 15 minutes before PEG dose ending 3 hours before colonoscopy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* signed informed consent.
Exclusion Criteria
* presence of known genetic susceptibility syndromes related with CRC,
* personal history of inflammatory bowel disease,
* presence of gastrointestinal complaints (significant changes in gastrointestinal transit in the last 6 months or evidence of gastrointestinal bleeding),
* a normal colonoscopy in the last 10 years and a normal flexible sigmoidoscopy in the last 5 years,
* known or suspected gastrointestinal obstruction or perforation, toxic megacolon, major colonic resection,
* pregnant or at risk of becoming pregnant and lactating women,
* known or suspected hypersensitivity to the active or other ingredients.
50 Years
74 Years
ALL
Yes
Sponsors
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Portuguese Oncology Institute, Coimbra
OTHER
Responsible Party
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Mafalda Cainé João
Principal Investigator
Principal Investigators
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Miguel Areia, PhD
Role: STUDY_DIRECTOR
Portuguese Oncology Institute, Coimbra
Locations
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Portuguese Oncology Institute - Coimbra
Coimbra, , Portugal
Countries
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References
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Hassan C, Quintero E, Dumonceau JM, Regula J, Brandao C, Chaussade S, Dekker E, Dinis-Ribeiro M, Ferlitsch M, Gimeno-Garcia A, Hazewinkel Y, Jover R, Kalager M, Loberg M, Pox C, Rembacken B, Lieberman D; European Society of Gastrointestinal Endoscopy. Post-polypectomy colonoscopy surveillance: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2013 Oct;45(10):842-51. doi: 10.1055/s-0033-1344548. Epub 2013 Sep 12.
Hassan C, Bretthauer M, Kaminski MF, Polkowski M, Rembacken B, Saunders B, Benamouzig R, Holme O, Green S, Kuiper T, Marmo R, Omar M, Petruzziello L, Spada C, Zullo A, Dumonceau JM; European Society of Gastrointestinal Endoscopy. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy. 2013;45(2):142-50. doi: 10.1055/s-0032-1326186. Epub 2013 Jan 18.
Kaminski MF, Thomas-Gibson S, Bugajski M, Bretthauer M, Rees CJ, Dekker E, Hoff G, Jover R, Suchanek S, Ferlitsch M, Anderson J, Roesch T, Hultcranz R, Racz I, Kuipers EJ, Garborg K, East JE, Rupinski M, Seip B, Bennett C, Senore C, Minozzi S, Bisschops R, Domagk D, Valori R, Spada C, Hassan C, Dinis-Ribeiro M, Rutter MD. Performance measures for lower gastrointestinal endoscopy: a European Society of Gastrointestinal Endoscopy (ESGE) quality improvement initiative. United European Gastroenterol J. 2017 Apr;5(3):309-334. doi: 10.1177/2050640617700014. Epub 2017 Mar 16.
Parmar R, Martel M, Rostom A, Barkun AN. Validated Scales for Colon Cleansing: A Systematic Review. Am J Gastroenterol. 2016 Feb;111(2):197-204; quiz 205. doi: 10.1038/ajg.2015.417. Epub 2016 Jan 19.
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. Scand J Gastroenterol. 2011 Feb;46(2):227-35. doi: 10.3109/00365521.2010.525714. Epub 2010 Oct 26.
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 Nov 29;3(11):e26. doi: 10.1038/ctg.2012.16.
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 Sep 16;5(9):433-9. doi: 10.4253/wjge.v5.i9.433.
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 Jul;95(28):e4163. doi: 10.1097/MD.0000000000004163.
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 May;34(5):830-836. doi: 10.1111/jgh.14508. Epub 2018 Nov 4.
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 Apr;50(4):412-422. doi: 10.1055/s-0043-121337. Epub 2017 Nov 13.
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 Feb;34(2):314-320. doi: 10.1111/jgh.14401. Epub 2018 Aug 27.
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, endoscopist-blinded randomized controlled trial. Endoscopy. 2018 Feb;50(2):128-136. doi: 10.1055/s-0043-119213. Epub 2017 Oct 6.
Despacho n.o 8254/2017. Diário da República, 2.a série - N.o 183 - 21 de setembro de 2017. 2017;20788-9.
Lazzaroni M, Petrillo M, Desideri S, Bianchi Porro G. Efficacy and tolerability of polyethylene glycol-electrolyte lavage solution with and without simethicone in the preparation of patients with inflammatory bowel disease for colonoscopy. Aliment Pharmacol Ther. 1993 Dec;7(6):655-9. doi: 10.1111/j.1365-2036.1993.tb00148.x.
Other Identifiers
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PortugueseOIC 003
Identifier Type: -
Identifier Source: org_study_id
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