NCT02661750

Brief Summary

The purpose of this study is to document the safety and effectiveness of high doses of liquids to clean the colon for colonoscopy in patients who had a previous colonoscopy with a poorly cleaned colon.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 22, 2016

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

July 27, 2021

Status Verified

July 1, 2021

Enrollment Period

5 years

First QC Date

January 19, 2016

Last Update Submit

July 26, 2021

Conditions

Preparation for Colonoscopy

Keywords

Cleansing the colon

Outcome Measures

Primary Outcomes (1)

  • Bowel Cleanliness

    Measured by the Chicago Bowel Preparation Scale

    at colonoscopy

Secondary Outcomes (4)

  • Bowel Cleanliness

    at colonoscopy

  • Bowel Cleanliness

    at colonoscopy

  • Patient tolerance

    1-2 days before colonoscopy measured at colonoscopy

  • Electrolyte changes

    at colonoscopy

Study Arms (5)

Step 1

Patients who had inadequate preparations for colonoscopy with a standard dose of bowel cleansing agent.

Drug: Bowel Preparation

Step 2

Patients who had inadequate preparations for colonoscopy with a step 1 dose of bowel cleansing agent.

Drug: Bowel Preparation

Step 3

Patients who had inadequate preparations for colonoscopy with a step 2 dose of bowel cleansing agent.

Drug: Bowel Preparation

Step 4

Patients who had inadequate preparations for colonoscopy with a step 3 dose of bowel cleansing agent.

Drug: Bowel Preparation

Step 5

Patients who had inadequate preparations for colonoscopy with a step 4 dose of bowel cleansing agent.

Drug: Bowel Preparation

Interventions

Bowel PreparationDRUG

Standard 1/2 Dose: 153 g MiraLAX + 32 oz Gatorade 2 liters, 2 liters NuLYTELY, 1 liter MoviPrep, 16 oz (1 bottle) SuPREP, 10 oz (1 bottle) MagCitrate. Standard Full Dose: 306 g MiraLAX + 64 oz Gatorade, 4 liters NuLYTELY, 2 liters MoviPrep, 32 oz (2 bottles) SuPREP, 20 oz (2 bottles) MagCitrate. Step 1: 51 g MiraLAX\* noon the day-prior; Full dose - 51 g MiraLAX 6 PM day-prior; 1/2 dose 4 hours before the colonoscopy. Step 2: 1/2 dose noon the day-prior; Full dose 6 PM the day-prior; 1/2 dose 4 hours before the colonoscopy. Step 3: Full dose noon the day-prior; Full dose 6 PM the day-prior; 1/2 dose 4 hours before the colonoscopy. Step 4: 1/2 dose 6 PM 2 days-prior; Full dose noon the day-prior; Full dose 6 PM the day-prior; 1/2 dose 4 hours before the colonoscopy. Step 5: Full dose 6 PM 2 days-prior; Full dose noon the day-prior; Full dose 6 PM the day-prior; 1/2 dose 4 hours before the colonoscopy.

Step 1Step 2Step 3Step 4Step 5

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients in our practice who are undergoing a routine colonoscopy who had an inadequate preparation for colonoscopy in the past

You may not qualify if:

  • Patients who are pregnant.
  • Patients with ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or toxic megacolon would not be considered elective colonoscopies and are excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gastroenterology Services

Downers Grove, Illinois, 60515, United States

Location

Related Publications (1)

  • Gerard DP, Gerard SF, Raiser MW. High-dose polyethylene glycol-3350 and gatorade solutions for patients with previous inadequate bowel preparations for colonoscopy are safe and effective. BMC Gastroenterol. 2023 May 11;23(1):146. doi: 10.1186/s12876-023-02663-0.

    PMID: 37170191DERIVED

MeSH Terms

Interventions

Cathartics

Intervention Hierarchy (Ancestors)

Gastrointestinal AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2016

First Posted

January 22, 2016

Study Start

January 1, 2016

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

July 27, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)