<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03816774</url>
  </required_header>
  <id_info>
    <org_study_id>PortugueseOIC 003</org_study_id>
    <nct_id>NCT03816774</nct_id>
  </id_info>
  <brief_title>Effect of Adding Simethicone to Split-dose Polyethylene Glycol for Bowel Preparation in a Screening Colonoscopy Setting</brief_title>
  <official_title>Effect of Adding Simethicone to a Split Regimen of Polyethylene Glycol for Bowel Preparation in a Colorectal Cancer Screening Colonoscopy Setting: an Endoscopist-blinded Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Portuguese Oncology Institute, Coimbra</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Portuguese Oncology Institute, Coimbra</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Colonoscopy is currently accepted as the gold standard in screening, surveillance and&#xD;
      prevention for colorectal cancer (CRC), and therefore, its quality is a major priority.&#xD;
&#xD;
      The quality of colonoscopy is greatly dependent on the quality of the bowel preparation.&#xD;
      Standard bowel cleansing includes a low-fibre diet on the day preceding the exam and a split&#xD;
      regimen of 4 litres of polyethylene glycol (PEG) solution.&#xD;
&#xD;
      In order to improve bowel cleansing some additional measures are available. Simethicone is an&#xD;
      inexpensive and safe antifoaming agent that reduces the surface tension of air bubbles,&#xD;
      theoretically presenting several benefits such as increased tolerability to the preparation,&#xD;
      thereby improving the quality of the preparation and, secondly, adenoma detection (ADR) and&#xD;
      cecal intubation rates (CIR). However, its role remains controversial, with some publications&#xD;
      supporting its administration and others failing to demonstrate clear benefits.&#xD;
&#xD;
      The main aim of this study is to assess if addition of simethicone to a split-dose cleansing&#xD;
      regimen of 4 litres of PEG improves adequate bowel preparation rate.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      a. Study type: Endoscopist-blinded randomized controlled trial i. Prospective inclusion of&#xD;
      patients scheduled for a colonoscopy by nationwide CRC screening program after a positive&#xD;
      faecal immunochemical test.&#xD;
&#xD;
      ii. Randomization by computer generated tables. iii. Allocation concealment by sealed, opaque&#xD;
      envelopes. iv. Endoscopist-blinded: endoscopist blinded to the group allocation. v. Patient&#xD;
      informed about its bowel cleansing regimen.&#xD;
&#xD;
      b. Selection participant method: i. Inclusion by invitation of patients aged between 50 and&#xD;
      74 years, inclusive, scheduled for colonoscopy by nationwide CRC screening program after a&#xD;
      positive faecal immunochemical test. ii. Exclusion criteria for nationwide CRC screening&#xD;
      program: previous diagnosis of CRC, presence of known genetic susceptibility syndromes&#xD;
      related with CRC, personal history of inflammatory bowel disease, presence of&#xD;
      gastrointestinal complaints (significant changes in gastrointestinal transit in the last 6&#xD;
      months or evidence of gastrointestinal bleeding), a normal colonoscopy in the last 10 years&#xD;
      and a normal flexible sigmoidoscopy in the last 5 years. Exclusion criteria of this study&#xD;
      also include: known or suspected gastrointestinal obstruction or perforation, toxic&#xD;
      megacolon, major colonic resection, pregnant or at risk of becoming pregnant and lactating&#xD;
      women, known or suspected hypersensitivity to the active or other ingredients.&#xD;
&#xD;
      c. Sample size: i. 412 (2 groups of 206 patients). ii. To improve adequate bowel preparation&#xD;
      rate (primary outcome) from 85% (value from the investigator's own database) to 95% (target&#xD;
      standard suggested by ESGE) and assuming a normal distribution and a power of 90% (α=0.05),&#xD;
      the calculated sample size of each of the 2 groups was 188; allowing for a 10% dropout rate,&#xD;
      the sample size is 206 per group (412 patients overall). Adequate bowel preparation is&#xD;
      defined as total. Boston Bowel Preparation Scale ≥6 and ≥2 in each segment. The chosen scale&#xD;
      is the most systematically validated and appropriate for the clinical setting.&#xD;
&#xD;
      d. Procedures and data collection methods: Form sheets filled by the endoscopist about&#xD;
      intraprocedural measures and by the nurse about patient compliance and tolerability to the&#xD;
      prescribed cleansing regimen.&#xD;
&#xD;
      e. Analysed variables: i. Primary outcome: adequate bowel preparation rate. ii. Secondary&#xD;
      outcomes: ADR, CIR, compliance and tolerability related to the bowel cleansing regimen. iii.&#xD;
      Patient characteristics and other variables: age, gender, degree of mucosal bubble reported&#xD;
      by a comprehensive scoring used by previous studies (grade 0: no bubbles; 1: minimal or&#xD;
      occasional bubbles (must be actively sought); 2: moderate or obviously present; 3: severe or&#xD;
      so many bubbles that vision is obscured), withdrawal time, polyp detection rate and&#xD;
      complications rate.&#xD;
&#xD;
      f. Statistical analysis: i. Performed using statistical software IBM SPSS Statistics, Version&#xD;
      25.0. Armonk, NY: IBM Corp. ii. Continuous variables are reported as mean and standard&#xD;
      deviation or median and interquartile range, if they have normal or not normal distribution,&#xD;
      respectively; categorical variables as absolute and relative frequency. iii. Continuous&#xD;
      variables are compared between two groups using Student's T test if they have a normal&#xD;
      distribution and homogeneity of variance or Mann-Whitney U if these conditions are not met.&#xD;
      Categorical variables are compared using Pearson's X2 test or Fisher test. iv. All hypotheses&#xD;
      are two-tailed and a P-value&lt;0.05 is considered statistically significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 15, 2019</start_date>
  <completion_date type="Actual">September 17, 2022</completion_date>
  <primary_completion_date type="Actual">September 17, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adequate bowel preparation rate</measure>
    <time_frame>1 day (during colonoscopy)</time_frame>
    <description>Total BBPS ≥6 and ≥2 in each segment (ascendent, transverse, descendent), presented as percentage.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adenoma detection rate</measure>
    <time_frame>Within 30 days from colonoscopy date</time_frame>
    <description>Colonoscopies with at least one adenoma identified, presented as percentage.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cecal intubation rate</measure>
    <time_frame>1 day (during colonoscopy)</time_frame>
    <description>Photo documentation of the cecum is a mark for effective total colonoscopy, presented as percentage.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compliance to the bowel cleansing regimen</measure>
    <time_frame>1 day (immediately before colonoscopy)</time_frame>
    <description>Patient assessment, by written questionnaire, of compliance of the bowel cleansing regimen.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tolerability to the bowel cleansing regimen:questionnaire</measure>
    <time_frame>1 day (immediately before colonoscopy)</time_frame>
    <description>Patient assessment, by written questionnaire, of side effects of the bowel cleansing regimen.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Degree of mucosal bubble</measure>
    <time_frame>1 day (during colonoscopy)</time_frame>
    <description>Degree of mucosal bubble in each colonic segment (ascendent, transverse, descendent) 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).</description>
  </other_outcome>
  <other_outcome>
    <measure>Withdrawal time</measure>
    <time_frame>1 day (during colonoscopy)</time_frame>
    <description>Time spent on withdrawal of the endoscope from cecum to anal canal and inspection of the entire bowel mucosa at negative (no biopsy or therapy) colonoscopy, presented in minutes.</description>
  </other_outcome>
  <other_outcome>
    <measure>Polyp detection rate</measure>
    <time_frame>Within 30 days from colonoscopy date</time_frame>
    <description>Colonoscopies with a detection of at least one polyp, presented as percentage.</description>
  </other_outcome>
  <other_outcome>
    <measure>Patients characteristics questionnaire</measure>
    <time_frame>1 day (immediately before colonoscopy)</time_frame>
    <description>Evaluate, using proper data collecting sheet, patient relevant data (age, gender, chronic medication, risk factors for inappropriate preparation)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">412</enrollment>
  <condition>Colo-rectal Cancer</condition>
  <condition>Colonic Neoplasms</condition>
  <arm_group>
    <arm_group_label>PEG split-dose</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Group A: PEG split dose ending 3 hours before colonoscopy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PEG split-dose and simethicone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PEG split-dose and simethicone</intervention_name>
    <description>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</description>
    <arm_group_label>PEG split-dose and simethicone</arm_group_label>
    <other_name>Aero-OM</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  consecutive patients scheduled for colonoscopy by nationwide CRC screening program&#xD;
             after a positive faecal immunochemical test,&#xD;
&#xD;
          -  signed informed consent.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  previous diagnosis of CRC,&#xD;
&#xD;
          -  presence of known genetic susceptibility syndromes related with CRC,&#xD;
&#xD;
          -  personal history of inflammatory bowel disease,&#xD;
&#xD;
          -  presence of gastrointestinal complaints (significant changes in gastrointestinal&#xD;
             transit in the last 6 months or evidence of gastrointestinal bleeding),&#xD;
&#xD;
          -  a normal colonoscopy in the last 10 years and a normal flexible sigmoidoscopy in the&#xD;
             last 5 years,&#xD;
&#xD;
          -  known or suspected gastrointestinal obstruction or perforation, toxic megacolon, major&#xD;
             colonic resection,&#xD;
&#xD;
          -  pregnant or at risk of becoming pregnant and lactating women,&#xD;
&#xD;
          -  known or suspected hypersensitivity to the active or other ingredients.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>74 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Miguel Areia, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Portuguese Oncology Institute, Coimbra</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Portuguese Oncology Institute - Coimbra</name>
      <address>
        <city>Coimbra</city>
        <zip>3001-651</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Portugal</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>24030244</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>23335011</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>28507745</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>26782820</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>20977386</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>23238113</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>24044042</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>27428209</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>30311262</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>29132175</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>30069899</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>28985630</PMID>
  </reference>
  <reference>
    <citation>Despacho n.o 8254/2017. Diário da República, 2.a série - N.o 183 - 21 de setembro de 2017. 2017;20788-9.</citation>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>8161673</PMID>
  </reference>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>October 3, 2022</last_update_submitted>
  <last_update_submitted_qc>October 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Portuguese Oncology Institute, Coimbra</investigator_affiliation>
    <investigator_full_name>Mafalda Cainé João</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>screening colonoscopy</keyword>
  <keyword>colo-rectal cancer</keyword>
  <keyword>simethicone</keyword>
  <keyword>split-dose polyethylene glycol</keyword>
  <keyword>adequate bowel preparation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rectal Neoplasms</mesh_term>
    <mesh_term>Colonic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Simethicone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03816774
org study id: PortugueseOIC 003
nct id: NCT03816774
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
a. Study type: Endoscopist-blinded randomized controlled trial i. Prospective inclusion of
      patients scheduled for a colonoscopy by nationwide CRC screening program after a positive
      faecal immunochemical test.

      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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Care Provider)
measure: Adequate bowel preparation rate
time frame: 1 day (during colonoscopy)
description: Total BBPS ≥6 and ≥2 in each segment (ascendent, transverse, descendent), presented as percentage.
measure: Adenoma detection rate
time frame: Within 30 days from colonoscopy date
description: Colonoscopies with at least one adenoma identified, presented as percentage.
measure: Cecal intubation rate
time frame: 1 day (during colonoscopy)
description: Photo documentation of the cecum is a mark for effective total colonoscopy, presented as percentage.
measure: Compliance to the bowel cleansing regimen
time frame: 1 day (immediately before colonoscopy)
description: Patient assessment, by written questionnaire, of compliance of the bowel cleansing regimen.
measure: Tolerability to the bowel cleansing regimen:questionnaire
time frame: 1 day (immediately before colonoscopy)
description: Patient assessment, by written questionnaire, of side effects of the bowel cleansing regimen.
measure: Degree of mucosal bubble
time frame: 1 day (during colonoscopy)
description: Degree of mucosal bubble in each colonic segment (ascendent, transverse, descendent) 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).
measure: Withdrawal time
time frame: 1 day (during colonoscopy)
description: Time spent on withdrawal of the endoscope from cecum to anal canal and inspection of the entire bowel mucosa at negative (no biopsy or therapy) colonoscopy, presented in minutes.
measure: Polyp detection rate
time frame: Within 30 days from colonoscopy date
description: Colonoscopies with a detection of at least one polyp, presented as percentage.
measure: Patients characteristics questionnaire
time frame: 1 day (immediately before colonoscopy)
description: Evaluate, using proper data collecting sheet, patient relevant data (age, gender, chronic medication, risk factors for inappropriate preparation)
arm group label: PEG split-dose
arm group type: No Intervention
description: Group A: PEG split dose ending 3 hours before colonoscopy
arm group label: PEG split-dose and simethicone
arm group type: Active Comparator
description: 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
intervention type: Drug
intervention name: PEG split-dose and simethicone
description: 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
arm group label: PEG split-dose and simethicone
other name: Aero-OM
criteria: 
gender: All
minimum age: 50 Years
maximum age: 74 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Miguel Areia, PhD
role: Study Director
affiliation: Portuguese Oncology Institute, Coimbra
facility: 
country: Portugal
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PMID: 8161673
responsible party type: Principal Investigator
investigator affiliation: Portuguese Oncology Institute, Coimbra
investigator full name: Mafalda Cainé João
investigator title: Principal Investigator
mesh term: Rectal Neoplasms
mesh term: Colonic Neoplasms
mesh term: Simethicone
sharing ipd: No