Effect of Adding Simethicone to Split-dose Polyethylene Glycol for Bowel Preparation in a Screening Colonoscopy Setting

NCT03816774 | Completed

• 1 other identifier: PortugueseOIC 003
• Study Type: interventional
• Target: 412
• Locations: 1 country
• Sites: 1

Brief Summary

Colonoscopy is currently accepted as the gold standard in screening, surveillance and prevention for colorectal cancer (CRC), and therefore, its quality is a major priority. 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.

Conditions

Colo-rectal Cancer; Colonic Neoplasms

Keywords

screening colonoscopy; colo-rectal cancer; simethicone; split-dose polyethylene glycol; adequate bowel preparation

Outcome Measures

Primary Outcomes (1)

• Adequate bowel preparation rate

  Total BBPS ≥6 and ≥2 in each segment (ascendent, transverse, descendent), presented as percentage.

  1 day (during colonoscopy)

Secondary Outcomes (4)

• Adenoma detection rate

  Within 30 days from colonoscopy date

• Cecal intubation rate

  1 day (during colonoscopy)

• Compliance to the bowel cleansing regimen

  1 day (immediately before colonoscopy)

• Tolerability to the bowel cleansing regimen:questionnaire

  1 day (immediately before colonoscopy)

Other Outcomes (4)

• Degree of mucosal bubble

  1 day (during colonoscopy)

• Withdrawal time

  1 day (during colonoscopy)

• Polyp detection rate

  Within 30 days from colonoscopy date

Study Arms (2)

PEG split-dose

NO INTERVENTION

Group A: PEG split dose ending 3 hours before colonoscopy

PEG split-dose and simethicone

ACTIVE COMPARATOR

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

Drug: PEG split-dose and simethicone

Interventions

PEG split-dose and simethicone DRUG

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

Also known as: Aero-OM

PEG split-dose and simethicone

Eligibility Criteria

• Age: 50 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• consecutive patients scheduled for colonoscopy by nationwide CRC screening program after a positive faecal immunochemical test,
• signed informed consent.

You may not qualify if:

• 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,
• 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.

Sponsors & Collaborators

• Portuguese Oncology Institute, Coimbra: lead

Study Sites (1)

Portuguese Oncology Institute - Coimbra

Coimbra, 3001-651, Portugal

Location

Related Publications (14)

• 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.

  PMID: 24030244 BACKGROUND

• 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.

  PMID: 23335011 BACKGROUND

• 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.

  PMID: 28507745 BACKGROUND

• 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.

  PMID: 26782820 BACKGROUND

• 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.

  PMID: 20977386 BACKGROUND

• 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.

  PMID: 23238113 BACKGROUND

• 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.

  PMID: 24044042 BACKGROUND

• 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.

  PMID: 27428209 BACKGROUND

• 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.

  PMID: 30311262 BACKGROUND

• 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.

  PMID: 29132175 BACKGROUND

• 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.

  PMID: 30069899 BACKGROUND

• 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.

  PMID: 28985630 BACKGROUND

• Despacho n.o 8254/2017. Diário da República, 2.a série - N.o 183 - 21 de setembro de 2017. 2017;20788-9.

  BACKGROUND

• 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.

  PMID: 8161673 BACKGROUND

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Simethicone

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Dimethylpolysiloxanes; Silicones; Siloxanes; Organosilicon Compounds; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Miguel Areia, PhD

  Portuguese Oncology Institute, Coimbra

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 18, 2019
• First Posted: January 25, 2019
• Study Start: June 15, 2019
• Primary Completion: September 17, 2022
• Study Completion: September 17, 2022
• Last Updated: October 5, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)