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

Phase 4

Completed

Conditions: Colonoscopy

Interventions: Drug: Amitiza (Lubiprostone)
Drug: Dulcolax (Bisacodyl)
Drug: Miralax (PEG 3350)
Drug: Golytely (polyethylene glycol)

Registration Number: NCT00953017

Lead Sponsor: Brooke Army Medical Center

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 425

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Miralax plus Amitiza	Amitiza (Lubiprostone)	106 patients randomized to Miralax plus Amitiza will take one 24mcg gelcap of Amitiza at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
Miralax plus Dulcolax	Dulcolax (Bisacodyl)	107 patients randomized to Miralax plus Dulcolax will take two 5mg tablets of Dulcolax at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
Miralax	Miralax (PEG 3350)	106 patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
Golytely (polyethylene glycol)	Golytely (polyethylene glycol)	106 patients will take 1 gallon of golytley (Polyethylene glycol) and drink 1/2 of the solution at 4 p.m. The remaining 1/2 of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy

Primary Outcome Measures

Name	Time	Method
The Cleanliness of the Prep as Measured by the Ottawa Scale	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 Outcome Measures

Name	Time	Method
Procedure Time	measured at the time of colonoscopy	total colonoscopy procedure time
Polyps Detected	measured at the time of colonoscopy	Number of polyps
Patient Satisfaction With the Prep Measured by 5 Point Likert Scale	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)