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

October 3, 2022 updated by: Mafalda Cainé João, Portuguese Oncology Institute, Coimbra

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

412

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Coimbra, Portugal, 3001-651
        • Portuguese Oncology Institute - Coimbra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 74 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion criteria:

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

Exclusion criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: PEG split-dose
Group A: PEG split dose ending 3 hours before colonoscopy
ACTIVE_COMPARATOR: 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
Drug: 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 Names:
  • Aero-OM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adequate bowel preparation rate
Time Frame: 1 day (during colonoscopy)
Total BBPS ≥6 and ≥2 in each segment (ascendent, transverse, descendent), presented as percentage.
1 day (during colonoscopy)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adenoma detection rate
Time Frame: Within 30 days from colonoscopy date
Colonoscopies with at least one adenoma identified, presented as percentage.
Within 30 days from colonoscopy date
Cecal intubation rate
Time Frame: 1 day (during colonoscopy)
Photo documentation of the cecum is a mark for effective total colonoscopy, presented as percentage.
1 day (during colonoscopy)
Compliance to the bowel cleansing regimen
Time Frame: 1 day (immediately before colonoscopy)
Patient assessment, by written questionnaire, of compliance of the bowel cleansing regimen.
1 day (immediately before colonoscopy)
Tolerability to the bowel cleansing regimen:questionnaire
Time Frame: 1 day (immediately before colonoscopy)
Patient assessment, by written questionnaire, of side effects of the bowel cleansing regimen.
1 day (immediately before colonoscopy)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of mucosal bubble
Time Frame: 1 day (during colonoscopy)
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).
1 day (during colonoscopy)
Withdrawal time
Time Frame: 1 day (during colonoscopy)
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.
1 day (during colonoscopy)
Polyp detection rate
Time Frame: Within 30 days from colonoscopy date
Colonoscopies with a detection of at least one polyp, presented as percentage.
Within 30 days from colonoscopy date
Patients characteristics questionnaire
Time Frame: 1 day (immediately before colonoscopy)
Evaluate, using proper data collecting sheet, patient relevant data (age, gender, chronic medication, risk factors for inappropriate preparation)
1 day (immediately before colonoscopy)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Portuguese Oncology Institute, Coimbra

Investigators

  • Study Director: Miguel Areia, PhD, Portuguese Oncology Institute, Coimbra

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 15, 2019

Primary Completion (ACTUAL)

September 17, 2022

Study Completion (ACTUAL)

September 17, 2022

Study Registration Dates

First Submitted

January 18, 2019

First Submitted That Met QC Criteria

January 22, 2019

First Posted (ACTUAL)

January 25, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 5, 2022

Last Update Submitted That Met QC Criteria

October 3, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PortugueseOIC 003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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