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Completed

NCT Number: NCT01695863

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.

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Key information

Conditions

Colorectal Cancer Behavior Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Health Behavior Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Patient Satisfaction Rectal Diseases Treatment Adherence and Compliance

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rush Unversity Medical Center

Chicago, Illinois, 60612, United States

About this study

Study is the purpose of evaluating patient satisfaction and at the same time efficacy of the bowel regimen in cleansing the colon

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

comparing 2 drugs on their effect on the bowel preparation for colonoscopy

Drug

the effects of the drug on the colon preparation for colonoscopy

Primary outcomes

  1. Bowel Prep Efficacy - Boston Bowel Preparation Scale (BBPS)

    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

    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 outcomes

  1. Renal Function Pre and Post Bowel Prep (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).

    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)

  2. Renal Function Pre and Post Bowel Prep - Continued (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).

    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)

Other outcomes

  1. Non-Serious Adverse Events on Self Report Scale

    Time frame: During Bowel Preparation (Pre-Operative)

    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.

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2014
First posted
Sep 28, 2012
Registry last updated
Aug 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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