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Adenoma ColonPhase 4NCT03119168

Effect of Simethicone on Screening Colonoscopy

A Phase 4 study testing Simethicone Solution and Polyethylenglycol in people with Adenoma Colon, run by Texas Tech University Health Sciences Center, El Paso at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is evaluating the effect of adding a high dose of simethicone to the standard polyethylene glycol preparation for screening colonoscopy in the quality of the preparation , adenoma detection rate and withdrawal times. Read more about this study

Who is it for?
Ages 30 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Adenoma Colon
What is being tested?
Simethicone Solution and Polyethylenglycol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
268 participants
Where
1 siteUnited States
Study dates
15 Mar 2017to 10 Apr 2019
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients between the ages of 30-80 scheduled for screening colonoscopy.
  • Male and female patients
  • Ambulatory patients
  • Signed informed consent form

Who cannot join

  • Previous colonic surgery
  • Patient with mental/physical condition that impairs oral ingestion of preparation
  • Allergy or hypersensitivity to simethicone
  • Patients with limited mobility (bedridden patients)
  • Patients with gastrointestinal obstruction
  • Patients with gastroparesis

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Texas Tech university Health Sciences Center El Paso

    El Paso, Texas, 79905

Other trials in United States

About this study

Official title: The Effect Of Adding High Dose Simethicone To A Standard Polyethylene Glycol Preparation On Adenoma Detection Rate During Screening Colonoscopy: A Randomized Controlled Pilot Trial

This study is evaluating the effect of adding a high dose of simethicone to the standard polyethylene glycol preparation for screening colonoscopy in the quality of the preparation , adenoma detection rate and withdrawal times.

Read the detailed description

A proper bowel preparation is key to a thorough and safe colonoscopy. Several factors affect the mucosal visualization during colonoscopy, and consequently the quality of such evaluation. Undoubtedly, this can have unfavorable implications like missed lesions. One of the most commonly encountered scenarios is the presence of multiple bubbles that interfere with mucosal visualization. When this occurs, simethicone (an antifoam agent used to reduce bloating when ingested orally) is injected through the colonoscope to eliminate the bubbles and get a clear view of the mucosa. A few studies have used oral simethicone in conjunction with oral preparation agents (PEG, magnesium citrate, sodium phosphate) in an attempt to improve the quality of the preparation. Unfortunately these studies have not used the exact same preparation agent with and without simethicone, making it difficult to draw conclusions on its efficacy. However, it is important to understand that simethicone is not intended to decrease the amount of stool in the colon, and it's purpose is to decrease the amount of bubbles interfering with the visualization of the mucosa provided that there is no stool present . Furthermore, it is unclear if adding simethicone to a standard bowel preparation makes a significant difference in key aspects of screening colonoscopy such as adenoma detection rate or withdrawal times. This prospective randomized controlled, observer blinded study at Texas Tech University Health Sciences Center in El Paso, aims at studying the effect of simethicone on the overall colon preparation as well as on adenoma detection rate and withdrawal times.

Conditions
Adenoma Colon
Being tested
Simethicone Solution, Polyethylenglycol
Keywords
screening, adenoma detection rate, simethicone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Simethicone SolutionDrug

    Also called mylicon

    Patients will be assigned randomly to take Simethicone Solution plus polyethylenglycol

  • PolyethylenglycolOther

    Patients in this arm will be randomly assigned to take polyethylenglycol as their regular bowel preparation

Study groups in NCT03119168
Study groupRoleWhat they receive
Simethicone solution + PolyethylenglycolExperimentalThis arm of the study will include the patients assigned to take simethicone solution with their colon preparations ( 4L Polyethyleneglycol)
Receives: Drug: Simethicone Solution
PolyethylenglycolActive comparatorThis arm of the study will include the patients assigned to take a regular bowel preparation (4L Polyethylenglycol)
Receives: Other: Polyethylenglycol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adenoma Detection Rate

    The number of adenomatous polyps removed at colonoscopy

    Measured: 25 minutes

Secondary outcomes (3)

  1. Withdrawal Times

    Amount spent withdrawing the scope during the colonoscopy

    Measured: 6-10 minutes

  2. Colon Preparation

    Boston Bowel Preparation Scale (BBPS): scale that rates the quality of the colon preparation based on the amount of stool present. 0:solid stool that cannot be cleared; 1:areas not well seen due to residual stool and/or opaque liquid; 2:small fragments of stool and/or opaque liquid, but mucosa seen well; 3:no residual stool or opaque liquid seen. Score determined by adding the score of each individual segment of the colon (right side, transverse and left side). Scores range from 0 to 3 in each segment, therefore, a total composite score ranges from 0 (poor) to 9 (excellent).

    Bubble Score (BS): scale that rates the amount of bubbles present in the colon. 0:no or minimal bubbles; 1:bubbles covering up to half the luminal diameter; 2:bubbles covering the circumference of the lumen; 3:bubbles filling the entire lumen. Score determined the same way as BBPS score but in this case a total score of 0 is excellent and 9 is poor.

    Measured: 25 minutes

  3. Intraprocedural Use of Simethicone

    The number of colonoscopies during which the endoscopist requested simethicone to be flushed through the endoscope.

    Measured: 6-10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2017
  2. Study start15 Mar 2017
  3. Primary completion10 Apr 2019
  4. Study completion10 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Investigator
Enrolment
268 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03119168
Sponsor's protocol ID
E17034
Status last verified
Jun 2019
First submitted
10 Apr 2017
Last updated
5 Jun 2019
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Park JJ, Lee SK, Jang JY, Kim HJ, Kim NH. The effectiveness of simethicone in improving visibility during colonoscopy. Hepatogastroenterology. 2009 Sep-Oct;56(94-95):1321-5.

    PubMed 19950784

  • 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.

    PubMed 27428209

  • 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. Quality indicators for colonoscopy. Gastrointest Endosc. 2006 Apr;63(4 Suppl):S16-28. doi: 10.1016/j.gie.2006.02.021. No abstract available.

    PubMed 16564908

  • Hassan C, Fuccio L, Bruno M, Pagano N, Spada C, Carrara S, Giordanino C, Rondonotti E, Curcio G, Dulbecco P, Fabbri C, Della Casa D, Maiero S, Simone A, Iacopini F, Feliciangeli G, Manes G, Rinaldi A, Zullo A, Rogai F, Repici A. A predictive model identifies patients most likely to have inadequate bowel preparation for colonoscopy. Clin Gastroenterol Hepatol. 2012 May;10(5):501-6. doi: 10.1016/j.cgh.2011.12.037. Epub 2012 Jan 10.

    PubMed 22239959

  • Moraveji S, Casner N, Bashashati M, Garcia C, Dwivedi A, Zuckerman MJ, Carrion A, Ladd AM. The role of oral simethicone on the adenoma detection rate and other quality indicators of screening colonoscopy: a randomized, controlled, observer-blinded clinical trial. Gastrointest Endosc. 2019 Jul;90(1):141-149. doi: 10.1016/j.gie.2019.03.018. Epub 2019 Mar 26.

    PubMed 30926430

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Simethicone Solution and Polyethylenglycol in people with Adenoma Colon, run by Texas Tech University Health Sciences Center, El Paso at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adenoma Detection Rate (time frame: 25 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03119168, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2019.

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