Back to resultsEfficacy and Tolerability of Suprep With and Without Simethicone for Routine Colonoscopy for Colorectal Cancer Screening
Primary Purpose
Colorectal Cancer
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Simethicone
Placebo
sodium sulfate/potassium sulfate/magnesium sulfate solution
Sponsored by
About this trial
This is an interventional screening trial for Colorectal Cancer focused on measuring Suprep, Simethicone, Colorectal cancer screening, Routine colonoscopy, sodium sulfate/potassium sulfate/magnesium sulfate, Bowel cleansing, Mass screening
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
Sites / Locations
- UF Health Jacksonville
- Iowa Endoscopy Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Simethicone Group
Placebo Group
Arm Description
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.
Outcomes
Primary Outcome Measures
Overall bowel cleansing
To be assessed during removal of the colonoscope during the procedure and blinded endoscopist will score using a written questionnaire
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT02523911
First Posted
August 12, 2015
Last Updated
February 10, 2020
Sponsor
MercyOne Des Moines Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02523911
Brief Title
Efficacy and Tolerability of Suprep With and Without Simethicone for Routine Colonoscopy for Colorectal Cancer Screening
Official Title
Sodium Sulfate/Potassium Sulfate/Magnesium Sulfate Bowel Preparation With and Without Simethicone for Routine Colonoscopy: A Double-blinded Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Withdrawn
Why Stopped
investigator graduated and is not longer at this institution
Study Start Date
March 2016 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MercyOne Des Moines Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Suprep, Simethicone, Colorectal cancer screening, Routine colonoscopy, sodium sulfate/potassium sulfate/magnesium sulfate, Bowel cleansing, Mass screening
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Simethicone Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Simethicone
Other Intervention Name(s)
Gas-X Infant Drops, Infants Gas Relief, Infants Simethicone, Infants' Mylicon
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Inert solution
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
sodium sulfate/potassium sulfate/magnesium sulfate solution
Other Intervention Name(s)
Suprep Bowel Prep Kit
Intervention Description
Both arms will receive sodium sulfate/potassium sulfate/magnesium sulfate solution for bowel preparation
Primary Outcome Measure Information:
Title
Overall bowel cleansing
Description
To be assessed during removal of the colonoscope during the procedure and blinded endoscopist will score using a written questionnaire
Time Frame
During procedure
Secondary Outcome Measure Information:
Title
Number of patients with adverse effects
Description
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.
Time Frame
Day prior to and day of colonoscopy
Title
Number of patients completing the bowel preparation
Description
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.
Time Frame
Day prior to and day of colonoscopy
Other Pre-specified Outcome Measures:
Title
Presence of bubbles
Description
To be assessed during removal of the colonoscope during the procedure and blinded endoscopist will score using a written questionnaire
Time Frame
During procedure
Title
Degree of haziness
Description
To be assessed during removal of the colonoscope during the procedure and blinded endoscopist will score using a written questionnaire
Time Frame
During procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tercio Lopes, MD
Organizational Affiliation
Iowa Digestive Disease Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Silvio de Melo, MD
Organizational Affiliation
University of Florida Health Systems, Jacksonville
Official's Role
Principal Investigator
Facility Information:
Facility Name
UF Health Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Iowa Endoscopy Center
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
12. IPD Sharing Statement
Citations:
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24023492
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Efficacy and Tolerability of Suprep With and Without Simethicone for Routine Colonoscopy for Colorectal Cancer Screening
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