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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03119168
Other study ID # E17034
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date March 15, 2017
Est. completion date April 10, 2019

Study information

Verified date June 2019
Source Texas Tech University Health Sciences Center, El Paso
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 268
Est. completion date April 10, 2019
Est. primary completion date April 10, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 80 Years
Eligibility Inclusion Criteria:

1. Patients between the ages of 30-80 scheduled for screening colonoscopy.

2. Male and female patients

3. Ambulatory patients

4. Signed informed consent form

Exclusion Criteria:

1. Previous colonic surgery

2. Patient with mental/physical condition that impairs oral ingestion of preparation

3. Allergy or hypersensitivity to simethicone

4. Patients with limited mobility (bedridden patients)

5. Patients with gastrointestinal obstruction

6. Patients with gastroparesis

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Simethicone Solution
Patients will be assigned randomly to take Simethicone Solution plus polyethylenglycol
Other:
Polyethylenglycol
Patients in this arm will be randomly assigned to take polyethylenglycol as their regular bowel preparation

Locations

Country Name City State
United States Texas Tech university Health Sciences Center El Paso El Paso Texas

Sponsors (1)

Lead Sponsor Collaborator
Texas Tech University Health Sciences Center, El Paso

Country where clinical trial is conducted

United States, 

References & Publications (4)

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 identif — View Citation

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. — View Citation

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. Review. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Adenoma Detection Rate The number of adenomatous polyps removed at colonoscopy 25 minutes
Secondary Withdrawal Times Amount spent withdrawing the scope during the colonoscopy 6-10 minutes
Secondary 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.
25 minutes
Secondary Intraprocedural Use of Simethicone The number of colonoscopies during which the endoscopist requested simethicone to be flushed through the endoscope. 6-10 minutes
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