Preparation for ColonoscopyNCT02661750
Safety and Efficacy of High Dose Bowel Preparation Solutions for Patients With Difficult To Clean Colons For Colonoscopy
An observational study of Preparation for Colonoscopy, run by Gastroenterology Services, Ltd. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Preparation for Colonoscopy
- What is being tested?
- Bowel Preparation
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in our practice who are undergoing a routine colonoscopy who had an inadequate preparation for colonoscopy in the past
Who may be able to join
- Patients at least 18 years old planning to undergo an elective colonoscopy will be eligible for inclusion in our study if they had a previous colonoscopy with an inadequate preparation.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Gastroenterology Services
Downers Grove, Illinois, 60515
About this study
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.
Read the detailed description
Most of our patients use a standard dose of Gatorade (64 oz) and a tasteless laxative powder called MiraLAX (306 g) to clean their colons out for a colonoscopy. Occasionally, patients have chosen to use other FDA approved solutions to clean their colons including NuLYTELY, GoLytely, MoviPrep and SuPREP. Rarely patients choose to use high doses of MagCitrate.
Despite drinking all their liquid to clean their colon, a few patients have difficult to clean out colons and the quality of their colonoscopy preparation was not good. No one has ever studied what liquids to give these patients when they have another colonoscopy. Most doctors recommend using higher than standard doses of bowel cleaning liquids, but the safety and effectiveness of these higher doses has never been studied.
Patients will already have been assigned a higher than standard dose of a bowel cleaning liquid of their choice for their planned colonoscopy. This is our standard of care for cleaning out the colons of patients who previous had colonoscopies with colons that were not adequately cleaned. If the patient chooses to participate in this study, the plans to clean their colon will remain unchanged.
Before and during the study: The subject will clean out thier colon in the days before their colonoscopy just as they would have if they were not part of the study. They will be asked to fill out a short questionnaire before the colonoscopy about their experience with the liquid and the clean out process.
We would like to obtain a blood test (basic metabolic profile) that looks at each subject's kidney function within 3 months before their colonoscopy and before the IV is started for the colonoscopy. This involves a simple needle stick to draw 1 teaspoon (5 ml) of blood. If the subject had had blood tests done for other reasons within 3 months of their colonoscopy, these results can be used in place of the first blood sample.
The only research activity is the collection of patient's blood and the questionnaire the subject will fill out before the colonoscopy. The preparation to clean their colon and the actually colonoscopy will be unaffected by this research.
- Conditions
- Preparation for Colonoscopy
- Being tested
- Bowel Preparation
- Keywords
- Cleansing the colon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Step 1 | Patients who had inadequate preparations for colonoscopy with a standard dose of bowel cleansing agent. Receives: Drug: Bowel Preparation | |
| Step 2 | Patients who had inadequate preparations for colonoscopy with a step 1 dose of bowel cleansing agent. Receives: Drug: Bowel Preparation | |
| Step 3 | Patients who had inadequate preparations for colonoscopy with a step 2 dose of bowel cleansing agent. Receives: Drug: Bowel Preparation | |
| Step 4 | Patients who had inadequate preparations for colonoscopy with a step 3 dose of bowel cleansing agent. Receives: Drug: Bowel Preparation | |
| Step 5 | Patients who had inadequate preparations for colonoscopy with a step 4 dose of bowel cleansing agent. Receives: Drug: Bowel Preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel Cleanliness
Measured by the Chicago Bowel Preparation Scale
Measured: at colonoscopy
Secondary outcomes (4)
Bowel Cleanliness
Measured by the Boston Bowel Preparation Scale
Measured: at colonoscopy
Bowel Cleanliness
Measured by an adequate/inadequate bowel preparation scale
Measured: at colonoscopy
Patient tolerance
subject questionnaire
Measured: 1-2 days before colonoscopy measured at colonoscopy
Electrolyte changes
measured using a BMP before and after the colonoscopy preparation
Measured: at colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2021
- Study completionJan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preparation for ColonoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gastroenterology Services, Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02661750
- Sponsor's protocol ID
- 2015-0004-02
- Status last verified
- Jul 2021
- First submitted
- 19 Jan 2016
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 37170191
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of High Dose Bowel Preparation Solutions for Patients With Difficult To Clean Colons For Colonoscopy
- ClinicalTrials.gov ID
- NCT02661750
- Acronym / sponsor ID
- 2015-0004-02
- Conditions
- Preparation for Colonoscopy
- Keywords
- Cleansing the colon
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Gastroenterology Services, Ltd.University, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Jan 2021 (actual)
- Study completion
- Jan 2021 (actual)
- First posted
- 22 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Most of our patients use a standard dose of Gatorade (64 oz) and a tasteless laxative powder called MiraLAX (306 g) to clean their colons out for a colonoscopy. Occasionally, patients have chosen to use other FDA approved solutions to clean their colons including NuLYTELY, GoLytely, MoviPrep and SuPREP. Rarely patients choose to use high doses of MagCitrate.
Despite drinking all their liquid to clean their colon, a few patients have difficult to clean out colons and the quality of their colonoscopy preparation was not good. No one has ever studied what liquids to give these patients when they have another colonoscopy. Most doctors recommend using higher than standard doses of bowel cleaning liquids, but the safety and effectiveness of these higher doses has never been studied.
Patients will already have been assigned a higher than standard dose of a bowel cleaning liquid of their choice for their planned colonoscopy. This is our standard of care for cleaning out the colons of patients who previous had colonoscopies with colons that were not adequately cleaned. If the patient chooses to participate in this study, the plans to clean their colon will remain unchanged.
Before and during the study: The subject will clean out thier colon in the days before their colonoscopy just as they would have if they were not part of the study. They will be asked to fill out a short questionnaire before the colonoscopy about their experience with the liquid and the clean out process.
We would like to obtain a blood test (basic metabolic profile) that looks at each subject's kidney function within 3 months before their colonoscopy and before the IV is started for the colonoscopy. This involves a simple needle stick to draw 1 teaspoon (5 ml) of blood. If the subject had had blood tests done for other reasons within 3 months of their colonoscopy, these results can be used in place of the first blood sample.
The only research activity is the collection of patient's blood and the questionnaire the subject will fill out before the colonoscopy. The preparation to clean their colon and the actually colonoscopy will be unaffected by this research.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Step 1 | – | Drug: Bowel PreparationPatients who had inadequate preparations for colonoscopy with a standard dose of bowel cleansing agent. |
| Step 2 | – | Drug: Bowel PreparationPatients who had inadequate preparations for colonoscopy with a step 1 dose of bowel cleansing agent. |
| Step 3 | – | Drug: Bowel PreparationPatients who had inadequate preparations for colonoscopy with a step 2 dose of bowel cleansing agent. |
| Step 4 | – | Drug: Bowel PreparationPatients who had inadequate preparations for colonoscopy with a step 3 dose of bowel cleansing agent. |
| Step 5 | – | Drug: Bowel PreparationPatients who had inadequate preparations for colonoscopy with a step 4 dose of bowel cleansing agent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in our practice who are undergoing a routine colonoscopy who had an inadequate preparation for colonoscopy in the past
Key inclusion criteria (1 listed)
- Patients at least 18 years old planning to undergo an elective colonoscopy will be eligible for inclusion in our study if they had a previous colonoscopy with an inadequate preparation.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bowel PreparationStandard 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. | Drug | Step 1, Step 2, Step 3, Step 4, Step 5 |
Primary outcome
Bowel Cleanliness
Time frame: at colonoscopy
Measured by the Chicago Bowel Preparation Scale
4 secondary outcomes
Bowel Cleanliness
Time frame: at colonoscopy
Bowel Cleanliness
Time frame: at colonoscopy
Patient tolerance
Time frame: 1-2 days before colonoscopy measured at colonoscopy
Electrolyte changes
Time frame: at colonoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- Derived from this study: PubMed 37170191Gerard 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preparation for Colonoscopy, run by Gastroenterology Services, Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bowel Cleanliness (time frame: at colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02661750, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2021.