Effect of Simethicone on Screening Colonoscopy

NCT03119168 | Completed Phase 4 Results FDA Drug

• 1 other identifier: E17034
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adenoma Colon

Keywords

screening; adenoma detection rate; simethicone

Outcome Measures

Primary Outcomes (1)

• Adenoma Detection Rate

  The number of adenomatous polyps removed at colonoscopy

  25 minutes

Secondary Outcomes (3)

• Withdrawal Times

  6-10 minutes

• Colon Preparation

  25 minutes

• Intraprocedural Use of Simethicone

  6-10 minutes

Study Arms (2)

Simethicone solution + Polyethylenglycol

EXPERIMENTAL

This arm of the study will include the patients assigned to take simethicone solution with their colon preparations ( 4L Polyethyleneglycol)

Drug: Simethicone Solution

Polyethylenglycol

ACTIVE COMPARATOR

This arm of the study will include the patients assigned to take a regular bowel preparation (4L Polyethylenglycol)

Other: Polyethylenglycol

Interventions

Simethicone Solution DRUG

Patients will be assigned randomly to take Simethicone Solution plus polyethylenglycol

Also known as: mylicon

Simethicone solution + Polyethylenglycol

Polyethylenglycol OTHER

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

Polyethylenglycol

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas Tech University Health Sciences Center, El Paso: lead

Study Sites (1)

Texas Tech university Health Sciences Center El Paso

El Paso, Texas, 79905, United States

Location

Related Publications (5)

• 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.

  PMID: 19950784 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

• 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.

  PMID: 16564908 RESULT

• 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.

  PMID: 22239959 RESULT

• 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.

  PMID: 30926430 DERIVED

MeSH Terms

Interventions

Simethicone; alginate-polyethylene glycol acrylate

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

The study was done at our hospital setting, generalizability can be examined in larger studies

Results Point of Contact

• Title: The Effect Of Adding High Dose Simethicone To A Standard Polyethylene Glycol Preparation On Adenoma
• Organization: Texas Tech University Health Sciences Center at El Paso

antonio.mendoza-ladd@ttuhsc.edu

915-215-4678

Study Officials

• Antonio H Mendoza-Ladd, MD

  Texas Tech University Health Sciences Center, El Paso

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: April 10, 2017
• First Posted: April 18, 2017
• Study Start: March 15, 2017
• Primary Completion: April 10, 2019
• Study Completion: April 10, 2019
• Last Updated: June 5, 2019
• Results First Posted: June 5, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)