Neoplasms

All Conditions

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pharmaceutical Solutions

All Drugs and Chemicals

Dermatologic Agents

Herbal and Botanical

Simethicone

Emollients

Cola

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

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

Patients will be assigned randomly to take Simethicone Solution plus polyethylenglycol

Simethicone Solution

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

Polyethylenglycol

Antonio H Mendoza-Ladd, MD

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.

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.

Effect of Simethicone on Screening Colonoscopy

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

The number of adenomatous polyps removed at colonoscopy

Amount spent withdrawing the scope during the colonoscopy

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.

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

Texas Tech University Health Sciences Center, El Paso

Assistant Professor of Medicine

Simethicone solution + Polyethylenglycol were received as a bowel prep regimen

Simethicone Solution + Polyethylenglycol

Polyethylenglycol was received as a bowel prep regimen

This arm of the study will include the patients assigned to take simethicone solution with their colon preparations

Simethicone Solution: Patients will be assigned randomly to take Simethicone Solution plus polyethylenglycol

This arm of the study will include the patients assigned to take a regular bowel preparation with Polyethylenglycol

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

Total

Age, Continuous

Sex: Female, Male

Hispanic

Non Hispanic

Race/Ethnicity, Customized

United States

Region of Enrollment

Count of participants

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

The Effect Of Adding High Dose Simethicone To A Standard Polyethylene Glycol Preparation On Adenoma

Adenoma Detection Rate

Withdrawal Times

Boston Bowel Preparation Scale

Bubble Scale

Colon Preparation

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

Intraprocedural Use of Simethicone

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

Simethicone Solution: Patients will be assigned randomly to take Simethicone Solution plus 4 L of polyethylenglycol

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

Polyethylenglycol: All patients were assigned to take 4L polyethylenglycol as their regular bowel preparation

Overall Study

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Genital Neoplasms, Female

Urogenital Neoplasms

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

women take 6 tablets (2 tablets after each meal) and to fast overnight before the operation

women take 3 rectal Enema (8:00 pm, 12:00 am \& 8:00 am) and to fast over night before the operation.

sodium dihydrogen phosphate dihydrate 19.2 gram \& disodium hydrogen phosphate dodecahydrate 7.2 gram, in addition to purified water

Enema

Altayeb Mostafa, MBBCh

Altayeb Mostafa

Mechanical bowel preparation aims to decrease the volume fecal content in the colon, which thereby decreases the total colony count of bacteria, thus, decreasing peritoneal contamination in case of bowel injury, improving the access to the surgical field and facilitating intraoperative bowel manipulation

Does Simethicone Improve Operative Field in Gynecological Operations

Assiut University

Digestive System Diseases

Rare Diseases

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Anti-Infective Agents

Respiratory System Agents

Acetylcysteine

N-monoacetylcystine

Antiviral Agents

Expectorants

Antioxidants

Protective Agents

Antidotes

Standard upper endoscopy withouth premedication

100 mL of water, 20 minutes before upper endoscopy

Simethicone 200 mg, in water for up to 100 mL, to take 20 minutes prior to examination

N-acetylcysteine 500 mg + Simethicone 200 mg in water for up to 100 mL, to take 20 minutes prior to examination

N-acetylcysteine 1000 mg + Simethicone 200 mg in water for up to 100 mL, to take 20 minutes prior to examination

Water (Placebo)

200 mg (5 mL) in water for up to 100 mL, to take 20 minutes prior to examination

500 mg + Simethicone 200 mg in water for up to 100 mL, to take 20 minutes prior to examination

N-acetylcysteine 500 mg

1000 mg + Simethicone 200 mg in water for up to 100 mL, to take 20 minutes prior to examination

N-acetylcysteine 1000 mg

Adolfo Parra-Blanco, MD

Esteban Glasinovic, MD

Hugo Monrroy, MD

Roberto Candia, MD

The purpose of this study is to determine whether premedication with Simethicone or Simethicone plus N-acetylcysteine are effective improving visibility during Upper endoscopy compared with use of water or no preparation.

While globally there has been a downward trend in the incidence of gastric cancer, it remains the second leading cause of cancer mortality in the world. In Chile is the leading cause of death from malignant tumors in both sexes, and is recognized as a problem and public health priority in our country. Detection of gastric cancer in early stages has a huge impact on healing and therefore the prognosis of patients. In countries like Japan, where the incidence of this neoplasm is one of the highest in the world, mass screening programs have failed to demonstrate significant impact at the population level, there is a body of evidence to support endoscopic screening especially with the advent of new minimally invasive procedures such as endoscopic mucosal resection for gastric cancers detected in early stages. In our country, it is estimated that about half of the patients already have lymph node metastases or involvement of adjacent organs at diagnosis. The best way to reduce disease burden from this disease would be through primary prevention interventions or effective early detection. For this purpose the upper gastrointestinal endoscopy is the method of choice to examine the gastric mucosa in search of early lesions, and this is the point where adequate visibility of the mucosa is overriding. Mucus, foam and bubbles accumulated in the gastrointestinal tract mucosa interfere with adequate endoscopic visualization and thus represent risk of failing to diagnose early lesions. For this reason is that various anti-foam agents, anti-bubbles are widely used in endoscopic centers mainly in Japan, where its use is almost a rule, unlike the West where its use is limited by the theoretical risk of aspiration. Simethicone has been proven as a good anti-foam agent prior to endoscopy to remove mucus and bubbles. It has also been studied in other scenarios such as colonoscopy as an additive in the preparation of the colon to eliminate bubbles in endoscopic capsule for small bowel preparation as well as Endoscopic Ultrasound which reduces artifacts and increases the accuracy of the study. Currently N-acetylcysteine, a mucolytic agent, either alone or in combination with Simethicone has proven effective in removing mucus and gastric bubbles when used 20 minutes prior to the upper endoscopy, improving the visualization of the gastric mucosa. Other agents such as pronase have also been described as useful in this task are not yet available in our area. In the context of the relevance of gastric cancer in our environment, our low rate of early cancer detection and the absence of national policies on the preparation and agents that may improve visualization of the mucosa, this study aims to compare the effect of products available in our country in preparation for an endoscopy in order to improve visualization of the mucosa and increase the chance of recognizing early lesions.

Premedication With Simethicone or Simethicone Plus N-acetylcysteine in Improving Visibility During Upper Endoscopy

Effectiveness of Premedication With Simethicone or Simethicone Plus N-acetylcysteine vs. Placebo in Improving Visibility During Upper Endoscopy.

The antrum, proximal part of the greater curvature, distal part of the greater curvature and the gastric fundus were assessed separately in terms of visibility mucosa. He scored from 1 to 4 each zone according to a score of visibility, as defined in previous publications by Chang et al. The sum of the scores from the four locations was defined as the total mucosal visibility score (TMVS) for each patient

Pontificia Universidad Catolica de Chile

Internal Medicine Physician, Gastroenterology Residency Training Program

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Anti-Arrhythmia Agents

Channel Blockers

Analgesics

Anticonvulsants

Central Nervous System Depressants

Reproductive Control Agents

Gastrointestinal Agents

Bone Density Conservation Agents

Magnesium Sulfate

Sodium sulfate

Anesthetics

Calcium

Calcium Channel Blockers

Calcium, Dietary

Hormones

Tocolytic Agents

Laxatives

Cathartics

Early in the evening prior to colonoscopy, patients will be instructed to consume one 6 ounce bottle of oral sodium sulfate/potassium sulfate/magnesium sulfate (Suprep) solution (containing sodium sulfate 17.5 grams, potassium sulfate 3.13 grams, and magnesium sulfate 1.6 grams) diluted with 16 ounces of water over one hour. Over the next hour, the patient will be instructed to drink an additional 32 ounces of water. On the day of colonoscopy, the same procedure will be repeated. Patients will take 2.4 mL simethicone in a half glass of water immediately after consuming each dose of the Suprep. All of the bowel preparation solution and required water should be consumed at least 2 hours prior to colonoscopy.

Early in the evening prior to colonoscopy, patients will be instructed to consume one 6 ounce bottle of oral sodium sulfate/potassium sulfate/magnesium sulfate (Suprep) solution (containing sodium sulfate 17.5 grams, potassium sulfate 3.13 grams, and magnesium sulfate 1.6 grams) diluted with 16 ounces of water over one hour. Over the next hour, the patient will be instructed to drink an additional 32 ounces of water. On the day of colonoscopy, the same procedure will be repeated. Patients will take 2.4 mL of placebo (identical in appearance to simethicone) in a half glass of water immediately after consuming each dose of the Suprep. All of the bowel preparation solution and required water should be consumed at least 2 hours prior to colonoscopy.

Patients will be randomized to receive either simethicone or placebo in addition to oral sodium sulfate/potassium sulfate/magnesium sulfate solution (Suprep), and will be blinded to whether they are in the simethicone arm or the placebo arm of the trial. Simethicone and placebo will be prepared as identically-appearing liquid solution (2.4 mL) with the assistance of a pharmacist. The simethicone or placebo solution will then be assigned to patients according to the randomization scheme and samples will be labeled with patient information prior to distribution. Only the pharmacist will participate in the labeling process and know which patients receive simethicone or placebo; administering staff, nurses, physicians, and patients will be blinded to this.

Placebo

Both arms will receive sodium sulfate/potassium sulfate/magnesium sulfate solution for bowel preparation

sodium sulfate/potassium sulfate/magnesium sulfate solution

Tercio Lopes, MD

Silvio de Melo, MD

The purpose of this study is to investigate Suprep bowel preparation, with and without the anti-gas medication simethicone, in terms of efficacy and patient tolerability in the preparation of patients undergoing routine colonoscopy for colorectal cancer screening.

The study will investigate sodium sulfate/potassium sulfate/magnesium sulfate (Suprep), with and without simethicone, in terms of efficacy and patient tolerability in the preparation of patients undergoing routine colonoscopy. Adult ambulatory outpatients who are scheduled for elective routine colonoscopy for colorectal cancer screening will be recruited to participate in the trial. Patients will be randomized to receive either simethicone or placebo in addition to oral sodium sulfate/potassium sulfate/magnesium sulfate solution (Suprep) and will receive verbal and written instruction on administration of solutions. During colonoscopy, three areas of the colon (right colon, transverse colon, and left colon) will be assessed during removal of the colonoscope for overall colon cleansing, presence of bubbles, and degree of haziness; this will be scored by a blinded endoscopist. A separate written patient questionnaire will be used to assess acceptability and tolerability of the preparation, as well as any adverse events.

Efficacy and Tolerability of Suprep With and Without Simethicone for Routine Colonoscopy for Colorectal Cancer Screening

Sodium Sulfate/Potassium Sulfate/Magnesium Sulfate Bowel Preparation With and Without Simethicone for Routine Colonoscopy: A Double-blinded Randomized Controlled Trial

To be assessed during removal of the colonoscope during the procedure and blinded endoscopist will score using a written questionnaire

A written patient questionnaire will be used to assess patient acceptability and tolerability by recording any adverse effects experienced, including nausea, vomiting, headache, insomnia, bloating, abdominal pain, abdominal discomfort, abdominal cramps or any others.

A written patient questionnaire will be used to assess compliance by asking if the total prescribed volume of solution was ingested and by recording number of evacuations.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Simethicone on Screening Colonoscopy	NCT03119168	Adenoma Colon	Simethicone Sol... Polyethylenglyc...	30 Years - 80 Years	Texas Tech University Health Sciences Center, El Paso
Does Simethicone Improve Operative Field in Gynecological Operations	NCT03009604	Benign Gynecolo...	Simethicone Enema	20 Years - 60 Years	Assiut University
Premedication With Simethicone or Simethicone Plus N-acetylcysteine in Improving Visibility During Upper Endoscopy	NCT01653171	Stomach Neoplas...	Water (Placebo) Simethicone N-acetylcystein... N-acetylcystein...	18 Years -	Pontificia Universidad Catolica de Chile
Does Simethicone Improve Operative Field in Gynecological Operations	NCT03009604	Benign Gynecolo...	Simethicone Enema	20 Years - 60 Years	Assiut University
Efficacy and Tolerability of Suprep With and Without Simethicone for Routine Colonoscopy for Colorectal Cancer Screening	NCT02523911	Colorectal Canc...	Simethicone Placebo sodium sulfate/...	18 Years -	MercyOne Des Moines Medical Center
Does Simethicone Improve Operative Field in Gynecological Operations	NCT03009604	Benign Gynecolo...	Simethicone Enema	20 Years - 60 Years	Assiut University

Spots Global Cancer Trial Database for simethicone

Every month we try and update this database with for simethicone cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for simethicone

Every month we try and update this database with for simethicone cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for simethicone cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.