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Efficacy and Patient Satisfaction of Miralax and Gatorade Versus Movi Prep

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
comparing 2 drugs on their effect on the bowel preparation for colonoscopy
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Cancer focused on measuring Miralax with gatorade and dulcolax, Movi pre, Patient satisfaction and efficacy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • outpatient colonoscopy for screening for other Gi related problems

Exclusion Criteria:

  • Severe CHF,
  • CKD,
  • less than age 18 or more than 80 years

Sites / Locations

  • Rush Unversity Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

miralax

moviprep split dose

Arm Description

miralax with dulcolax and gatorade efficacy evaluated by colonoscopy and patient satisfaction evaluated by patient questionnaire

Efficacy of split dose moviprep on cleansing colon for colonoscopy and patient satisfaction with the regimen

Outcomes

Primary Outcome Measures

Bowel Prep Efficacy - Boston Bowel Preparation Scale (BBPS)
To assess the bowel prep efficacy in cleansing the colon for colonoscopy - Scale used is the Boston Bowel Preparation Scale (BBPS), Integer Scale from 0-3, where 3 indicated the best outcome and 0 the worst. The BBPS was estimated during the procedure (Colonoscopy) by an endoscopist and a nurse and retrospectively by a second endoscopist postoperatively. Scores were averaged by for each subject by location (Right colon, Transverse colon, and Left colon) and then for each group/arm by location.

Secondary Outcome Measures

Renal Function Pre and Post Bowel Prep (mg/dL)
Changes in electrolytes pre and post bowel preparation administration. Pre bowel prep measures were taken at study randomization (up to one week before surgery) and post bowel prep measures were taken prior to the procedure (less than 5 hours before start of procedure on day of procedure). Change is electrolytes are presented as pre bowel prep value minus post bowel prep value but prior to procedure (Pre-Post). Units = Milligrams/deciLiter (mg/dL)
Renal Function Pre and Post Bowel Prep - Continued (mmol/L)
Changes in electrolytes pre and post bowel preparation administration. Pre bowel prep measures were taken at study randomization (up to one week before surgery) and post bowel prep measures were taken prior to the procedure (less than 5 hours before start of procedure on day of procedure). Change is electrolytes are presented as pre bowel prep value minus post bowel prep value, but prior to procedure (Pre-Post). Units=Millimoles per Liter (mmol/L)

Full Information

First Posted
August 10, 2012
Last Updated
August 1, 2023
Sponsor
Rush University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01695863
Brief Title
Efficacy and Patient Satisfaction of Miralax and Gatorade Versus Movi Prep
Official Title
Phase 4 of Efficacy and Patient Satisfaction of Miralax and Gatorade Versus Movi Prep
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rush University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will be comparing patient satisfaction, efficacy comparing miralax with gatorade versus Movi Prep for outpatient colonoscopy.
Detailed Description
Study is the purpose of evaluating patient satisfaction and at the same time efficacy of the bowel regimen in cleansing the colon

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Miralax with gatorade and dulcolax, Movi pre, Patient satisfaction and efficacy

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
miralax
Arm Type
Experimental
Arm Description
miralax with dulcolax and gatorade efficacy evaluated by colonoscopy and patient satisfaction evaluated by patient questionnaire
Arm Title
moviprep split dose
Arm Type
Experimental
Arm Description
Efficacy of split dose moviprep on cleansing colon for colonoscopy and patient satisfaction with the regimen
Intervention Type
Drug
Intervention Name(s)
comparing 2 drugs on their effect on the bowel preparation for colonoscopy
Intervention Description
the effects of the drug on the colon preparation for colonoscopy
Primary Outcome Measure Information:
Title
Bowel Prep Efficacy - Boston Bowel Preparation Scale (BBPS)
Description
To assess the bowel prep efficacy in cleansing the colon for colonoscopy - Scale used is the Boston Bowel Preparation Scale (BBPS), Integer Scale from 0-3, where 3 indicated the best outcome and 0 the worst. The BBPS was estimated during the procedure (Colonoscopy) by an endoscopist and a nurse and retrospectively by a second endoscopist postoperatively. Scores were averaged by for each subject by location (Right colon, Transverse colon, and Left colon) and then for each group/arm by location.
Time Frame
Outcome BBPS was measured during surgery for endoscopist #1 and nurse raters and post-operatively (at any time before the end of the study) by endoscopist #2
Secondary Outcome Measure Information:
Title
Renal Function Pre and Post Bowel Prep (mg/dL)
Description
Changes in electrolytes pre and post bowel preparation administration. Pre bowel prep measures were taken at study randomization (up to one week before surgery) and post bowel prep measures were taken prior to the procedure (less than 5 hours before start of procedure on day of procedure). Change is electrolytes are presented as pre bowel prep value minus post bowel prep value but prior to procedure (Pre-Post). Units = Milligrams/deciLiter (mg/dL)
Time Frame
Pre bowel prep measures were taken at study randomization (up to one week before surgery) and post bowel prep measures were taken prior to the procedure (less than 5 hours before start of procedure on day of procedure).
Title
Renal Function Pre and Post Bowel Prep - Continued (mmol/L)
Description
Changes in electrolytes pre and post bowel preparation administration. Pre bowel prep measures were taken at study randomization (up to one week before surgery) and post bowel prep measures were taken prior to the procedure (less than 5 hours before start of procedure on day of procedure). Change is electrolytes are presented as pre bowel prep value minus post bowel prep value, but prior to procedure (Pre-Post). Units=Millimoles per Liter (mmol/L)
Time Frame
Pre bowel prep measures were taken at study randomization (up to one week before surgery) and post bowel prep measures were taken prior to the procedure (less than 5 hours before start of procedure on day of procedure).
Other Pre-specified Outcome Measures:
Title
Non-Serious Adverse Events on Self Report Scale
Description
Non-Serious Adverse Events on self report scale - 5 point scale from "No Complaints (0)" to "Very Severe (4)" with 4 indicating the worst outcome and 0 the best.
Time Frame
During Bowel Preparation (Pre-Operative)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: outpatient colonoscopy for screening for other Gi related problems Exclusion Criteria: Severe Congestive Heart Failure (CHF), Chronic Kidney Disease (CKD), less than age 18 or more than 80 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maqsood A Khan, MD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ali Keshavarzian, MD
Organizational Affiliation
RUMC
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Michael D Brown, MD
Organizational Affiliation
RUMC
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
John losurdo, MD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush Unversity Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12135020
Citation
Rex DK, Imperiale TF, Latinovich DR, Bratcher LL. Impact of bowel preparation on efficiency and cost of colonoscopy. Am J Gastroenterol. 2002 Jul;97(7):1696-700. doi: 10.1111/j.1572-0241.2002.05827.x.
Results Reference
background
PubMed Identifier
17299615
Citation
Hookey LC, Vanner S. A review of current issues underlying colon cleansing before colonoscopy. Can J Gastroenterol. 2007 Feb;21(2):105-11. doi: 10.1155/2007/634125.
Results Reference
background
PubMed Identifier
14572566
Citation
DiPalma JA, Wolff BG, Meagher A, Cleveland Mv. Comparison of reduced volume versus four liters sulfate-free electrolyte lavage solutions for colonoscopy colon cleansing. Am J Gastroenterol. 2003 Oct;98(10):2187-91. doi: 10.1111/j.1572-0241.2003.07690.x.
Results Reference
background
Links:
URL
http://rush.edu
Description
rush university medical center website

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Efficacy and Patient Satisfaction of Miralax and Gatorade Versus Movi Prep

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