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Completed

NCT Number: NCT00953017

A Trial Comparing Split-Dose Miralax With Amitiza Pretreatment Versus Dulcolax Pretreatment Versus Golytely for Bowel Cleansing Prior to Colonoscopy

Miralax (PEG 3350) has been shown to be a safe and uncomplicated bowel preparation prior to colonoscopy in pediatric populations. This study seeks to confirm the efficacy of this bowel cleansing regimen in adults and to determine the benefit of adding a pretreatment medication to this bowel preparation. The tolerability of Miralax will hopefully improve patient satisfaction with colonoscopy and decrease their reluctance to be screened because of the uncomfortable taste and side effects of bowel preparation regimens.

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Key information

Conditions

Colonoscopy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Brooke Army Medical Center

San Antonio, Texas, 78248, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • adult patients referred to our clinic for average or increased risk screening for colorectal cancer

Exclusion criteria

  • elevated serum creatinine (Men >1.4mg/dL, Women >1.3mg/dL)
  • previous diagnosis of congestive heart failure
  • history of bowel obstruction
  • history of solid organ transplant
  • current pregnancy
  • lactating mother
  • participants allergic to either polyethylene glycol (Miralax), lubiprostone (Amitiza), or bisacodyl (Dulcolax)

Treatment and study plan

Miralax (PEG 3350)

Drug

Miralax 255gm bottle

Amitiza (Lubiprostone)

Drug

Amitiza 24mcg gelcap

Dulcolax (Bisacodyl)

Drug

Bisacodyl 5mg tab x2

Golytely (polyethylene glycol)

Drug

Golytely 1 gallon

Primary outcomes

  1. The Cleanliness of the Prep as Measured by the Ottawa Scale

    Time frame: measured at the time of colonoscopy

    Bowel cleansing was evaluated with the Ottawa bowel preparation scale by each endoscopist during the endoscopy. Neither the endoscopist nor the endoscopy nurse was aware of the bowel preparation used prior to the colonoscopy. The Ottawa bowel preparation scale is a validated tool and was used in this study to provide a reliable quality assessment of the bowel preparation used for colonoscopy. This validated scale rates each section of the colon, the right, the mid, and the rectosigmoid colon, on a 5-point scale (0-4), as well as a global 3-point rating for overall colonic fluid (0-2). The total score ranges from 0 to 14. An excellent preparation with little fluid would score 0-3, a good preparation 4-6, while scores higher than 7 would indicate progressively worsening bowel preparations. A completely unprepared colon would score 11-14, depending on the amount of colonic fluid.

Secondary outcomes

  1. Patient Satisfaction With the Prep Measured by 5 Point Likert Scale

    Time frame: measured at check in to colonoscopy

    patient satisfaction based on a Likert Scale from 0-5 (5 being completely satisfied and 0 being not satisfied)

  2. Procedure Time

    Time frame: measured at the time of colonoscopy

    total colonoscopy procedure time

  3. Polyps Detected

    Time frame: measured at the time of colonoscopy

    Number of polyps

Sponsors and collaborators

Lead sponsor

Brooke Army Medical Center

Fed

Registry information

Official study title

A Randomized, Blinded Trial Comparing Miralax With Amitiza Pretreatment Versus Miralax With Dulcolax Pretreatment Versus Miralax Alone Without Pretreatment Versus Golytely for Bowel Cleansing Prior to Colonoscopy

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 6, 2009
Registry last updated
Nov 30, 2012

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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