Single Center Comparison of 4 FDA Approved, Commercially Available Bowel Purgatives for Colonoscopy

Not Applicable

Withdrawn

• Conditions: Patients Undergoing Screening or Surveillance Colonoscopy
• Interventions: Drug: PEG+E; Drug: PEG+Asc; Drug: P+MC; Drug: sulfate

• Registration Number: NCT02124447
• Lead Sponsor: Medical College of Wisconsin

Brief Summary

This will be a 4-way comparison to prospectively evaluate the efficacy and patient tolerability of four commercially available bowel preparations among patients undergoing colonoscopy for screening and surveillance in a single tertiary academic medical center.

Detailed Description

We will randomize 300 consecutive patients undergoing colonoscopy for screening or surveillance purposes to receive one of four bowel purgatives. These purgatives include

1. Split dose 4 liter polyethylene glycol with electrolytes (PEG+E): Brand name GoLytely

2. Split dose 2 liter polyethylene glycol with ascorbic acid (PEG+Asc): Brand name: MoviPrep

3. Split dose sodium picosulfate, magnesium oxide, and anhydrous citric acid (P+MC): Brand name Prepopik

4. Split dose sodium sulfate, magnesium sulfate, and potassium sulfate solution (sulfate): Brand name Suprep

Study Timeline

• Study First Submitted: 2014-04-23
• Study First Submitted QC: 2014-04-24
• Study First Posted: 2014-04-28
• Study Start: 2014-06
• Primary Completion: 2014-08
• Study Completion: 2015-06
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-09
• Last Update Posted: 2015-07-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Age 18 years or greater
2. Ability to understand and complete questionnaires
3. Ability to speak and read English
4. Willingness to participate in study
5. Colonoscopy is being performed for routine screening (i.e. no prior personal history of polyps or cancer) or surveillance (i.e. follow up for a personal history of polyps) purposes

Exclusion Criteria

1. Previous bowel resection of any kind (small or large bowel)
2. End stage renal disease (ESRD)
3. Contraindication to bowel purgative
4. Necessity for inpatient admission to receive bowel preparation for any reason
5. Currently taking any narcotic/opiate pain or anticholinergic medication (since these may predispose to higher colon stool burden at baseline)
6. Currently taking stool softeners (e.g. Miralax, Amitiza, Linzess, lactulose) or stimulant laxatives (e.g. Dulcolax)
7. Subject did not follow appropriate dosing instructions for bowel purgative
8. Colonoscopy is being performed to evaluate a clinical symptom such as rectal bleeding, constipation, abdominal pain, or diarrhea
9. History of colon polyposis syndrome
10. Personal history of inflammatory bowel disease
11. History of inadequate colon preparation on any prior colonoscopies
12. Patient is pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEG+E	PEG+E	Split dose 4 liter polyethylene glycol with electrolytes
PEG+Asc	PEG+Asc	Split dose 2 liter polyethylene glycol with ascorbic acid
P+MC	P+MC	Split dose sodium picosulfate, magnesium oxide, and anhydrous citric acid
sulfate	sulfate	Split dose sodium sulfate, magnesium sulfate, and potassium sulfate solution

Primary Outcome Measures

Name	Time	Method
Efficacy of bowel cleansing according to the Boston Bowel Preparation Score (BPPS)	Patient outcome will be assessed at the time of the colonoscopy by the performing physician and ducomentation of this outcome will occur within 24 hours of the procedure

Secondary Outcome Measures

Name	Time	Method
Patient tolerability and satisfaction	Outcome of satisfaction will be assessed on a single survey that the patient will provide the day of their colonoscopy and will be recorded by study personnel up to 30 days thereafter	Will be assessed using a previously studied satisfaction questionnaire (7 items)

Trial Locations

Locations (1)

Froedtert Hospital & The Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States