Efficacy and Patient Satisfaction of Miralax and Gatorade Versus Movi Prep

Phase 4 of Efficacy and Patient Satisfaction of Miralax and Gatorade Versus Movi Prep

This study will be comparing patient satisfaction, efficacy comparing miralax with gatorade versus Movi Prep for outpatient colonoscopy.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: comparing 2 drugs on their effect on the bowel preparation for 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

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush Unversity Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: miralax; miralax with dulcolax and gatorade efficacy evaluated by colonoscopy and patient satisfaction evaluated by patient questionnaire	Drug: comparing 2 drugs on their effect on the bowel preparation for colonoscopy; the effects of the drug on the colon preparation for colonoscopy
Experimental: moviprep split dose; Efficacy of split dose moviprep on cleansing colon for colonoscopy and patient satisfaction with the regimen	Drug: comparing 2 drugs on their effect on the bowel preparation for colonoscopy; the effects of the drug on the colon preparation for colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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 Measures

Outcome Measure	Measure Description	Time Frame
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)	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).
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)	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-Serious Adverse Events on Self Report Scale	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.	During Bowel Preparation (Pre-Operative)

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Investigators: Principal Investigator: Maqsood A Khan, MD, Rush University Medical Center; Study Chair: Ali Keshavarzian, MD, RUMC; Study Director: Michael D Brown, MD, RUMC; Principal Investigator: John losurdo, MD, Rush University Medical Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• rush university medical center website

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: August 10, 2012
• First Submitted That Met QC Criteria: September 27, 2012
• First Posted (Estimated): September 28, 2012

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Miralax with gatorade and dulcolax; Movi pre; Patient satisfaction and efficacy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 11042705