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Efficacy and Patient Satisfaction of Miralax and Gatorade Versus Movi Prep

Phase 4
Completed
Conditions
Colorectal Cancer
Interventions
Drug: comparing 2 drugs on their effect on the bowel preparation for colonoscopy
Registration Number
NCT01695863
Lead Sponsor
Rush University Medical Center
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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
150
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
miralaxcomparing 2 drugs on their effect on the bowel preparation for colonoscopymiralax with dulcolax and gatorade efficacy evaluated by colonoscopy and patient satisfaction evaluated by patient questionnaire
moviprep split dosecomparing 2 drugs on their effect on the bowel preparation for colonoscopyEfficacy of split dose moviprep on cleansing colon for colonoscopy and patient satisfaction with the regimen
Primary Outcome Measures
NameTimeMethod
Bowel Prep Efficacy - Boston Bowel Preparation Scale (BBPS)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

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
NameTimeMethod
Renal Function Pre and Post Bowel Prep (mg/dL)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).

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)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).

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)

Trial Locations

Locations (1)

Rush Unversity Medical Center

🇺🇸

Chicago, Illinois, United States

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