Clinical trial NCT01695863: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colorectal Cancer
Keywords: Miralax with gatorade and dulcolax
Movi pre
Patient satisfaction and efficacy
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2012-09-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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

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

Primary outcomes:
measure: Bowel Prep Efficacy - Boston Bowel Preparation Scale (BBPS)
timeFrame: 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 outcomes:
measure: Renal Function Pre and Post Bowel Prep (mg/dL)
timeFrame: 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).
measure: Renal Function Pre and Post Bowel Prep - Continued (mmol/L)
timeFrame: 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 outcomes:
measure: Non-Serious Adverse Events on Self Report Scale
timeFrame: During Bowel Preparation (Pre-Operative)
Locations:
city: Chicago
country: United States
facility: Rush Unversity Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Maqsood A Khan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: RUMC
name: Ali Keshavarzian, MD
role: STUDY_CHAIR
affiliation: RUMC
name: Michael D Brown, MD
role: STUDY_DIRECTOR
affiliation: Rush University Medical Center
name: John losurdo, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.