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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Drug: Simethicone
* Drug: Placebo
* Drug: sodium sulfate/potassium sulfate/magnesium sulfate solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than 18 years Outpatients who require elective colonoscopy for colorectal cancer screening at Iowa Endoscopy Center and at University of Florida - Jacksonville Exclusion Criteria: Allergy or hypersensitivity to any constituent of the lavage solution or to simethicone Presence of any contraindication to colonoscopy (i.e. uncontrolled congestive heart failure, New York Heart Association classification III-IV, history of myocardial infarction within 6 months, coagulopathy) Massive ascites Renal insufficiency Pregnancy History of colonic surgery History of anti-flatulence or laxative agent within one week Refusal/inability to give consent Patients undergoing colonoscopy for reasons other than colorectal cancer screening Mentally disabled Non-English-speaking patients

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Simethicone Group<br>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. | Drug: Simethicone<br>* 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.<br>* Other names: Infants' Mylicon;Drug: sodium sulfate/potassium sulfate/magnesium sulfate solution<br>* Both arms will receive sodium sulfate/potassium sulfate/magnesium sulfate solution for bowel preparation<br>* Other names: Suprep Bowel Prep Kit;|
| Placebo Comparator: Placebo Group<br>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. | Drug: Placebo<br>* 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.<br>* Other names: Inert solution;Drug: sodium sulfate/potassium sulfate/magnesium sulfate solution<br>* Both arms will receive sodium sulfate/potassium sulfate/magnesium sulfate solution for bowel preparation<br>* Other names: Suprep Bowel Prep Kit;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall bowel cleansing | To be assessed during removal of the colonoscope during the procedure and blinded endoscopist will score using a written questionnaire | During procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse effects | 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. | Day prior to and day of colonoscopy | 
| Number of patients completing the bowel preparation | 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. | Day prior to and day of colonoscopy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Suprep, Simethicone, Colorectal cancer screening, Routine colonoscopy, sodium sulfate/potassium sulfate/magnesium sulfate, Bowel cleansing, Mass screening