Bowel Preparation for ColonoscopyNCT01765491
Comparison of Two Methods of Bowel Preparation for Colonoscopy in Hospitalized Patients
A study testing Split-dose polyethylene glycol and Morning-only polyethylene glycol in people with Bowel Preparation for Colonoscopy, run by Cook County Health at 1 site in United States.
Trial summary
Morning-only colonoscopy preparation may improve efficiency by allowing same-day patient preparation and colonoscopy. The aim of the investigators study is to compare the efficacy and tolerability of morning-only Polyethylene Glycol (PEG) to split-dose preparation in hospitalized patients undergoing colonoscopy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bowel Preparation for Colonoscopy
- What is being tested?
- Split-dose polyethylene glycol and Morning-only polyethylene glycol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Dec 2012
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients scheduled to undergo diagnostic colonoscopy during hospitalization
Who cannot join
- Critically ill/Intensive Care Unit patients
- Suspected bowel obstruction/perforation
- History of colon resection
- Patients with altered mental status/inability to provide informed consent
- Incarcerated patients
- Pregnant females
Trial locations and contacts
1 site in 1 country.
United States1 site
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612
About this study
Official title: Comparison of Morning-only With Split-dose Polyethylene Glycol for Colonoscopy Preparation in Hospitalized Patients: A Randomized Controlled Non-Inferiority Study
Morning-only colonoscopy preparation may improve efficiency by allowing same-day patient preparation and colonoscopy. The aim of the investigators study is to compare the efficacy and tolerability of morning-only Polyethylene Glycol (PEG) to split-dose preparation in hospitalized patients undergoing colonoscopy.
Read the detailed description
This is a single-center, prospective, endoscopist-blinded study in which hospitalized patients scheduled to undergo diagnostic colonoscopy were randomly assigned to receive one gallon of PEG either the morning of colonoscopy or as a split-dose (evening-morning). The primary end point is efficacy of colonoscopy preparation measured by the Ottawa scale. The investigators pre-specified a non-inferiority margin of 1.5 for the difference in Ottawa scale between arms. Secondary end points are patient compliance and tolerance. N: 120 hospitalized patients scheduled for diagnostic colonoscopy.
- Conditions
- Bowel Preparation for Colonoscopy
- Being tested
- Split-dose polyethylene glycol, Morning-only polyethylene glycol
- Keywords
- colonoscopy, bowel preparation, polyethylene glycol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Split-dose polyethylene glycolOther
Half gallon of polyethylene glycol to be taken between 7-9 pm on the day before colonoscopy and the remaining half between 7-9 am on the day of colonoscopy
Morning-only polyethylene glycolOther
One gallon of polyethylene glycol to be taken between 5am and 9am on the day of colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Morning-only polyethylene glycol | Experimental | One gallon of polyethylene glycol to be taken between 5am and 9am on the day of colonoscopy. Receives: Other: Morning-only polyethylene glycol |
| Split-dose polyethylene glycol | Active comparator | Half gallon of polyethylene glycol to be taken between 7-9 pm on the day before colonoscopy and the remaining half between 7-9 am on the day of colonoscopy. Receives: Other: Split-dose polyethylene glycol |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the efficacy of colonoscopy preparation measured by the Ottawa scale
Colonoscopy was performed by gastroenterology fellows under the supervision of attending physicians and both were blinded to the type of preparation taken by the study patients. Bowel cleansing was evaluated by the Ottawa scale. Scoring of each part of the colon (right, middle and left) was done separately and the total amount of fluid was noted. The scores were then added to calculate the total score out of 14.
Measured: Day of procedure
Secondary outcomes (2)
Patient compliance
Before the patients were taken to the endoscopy suite, they completed a questionnaire, asking the amount of preparation that was taken to evaluate compliance.
Measured: Day of procedure
Patient tolerance
Before the patients were taken to the endoscopy suite, they completed a questionnaire to evaluate tolerance for taking the preparation. Patients were asked about side-effects like nausea, vomiting, abdominal pain and bloating.
Measured: Same day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2013 (estimated)
- Study startAug 2012
- Primary completionNov 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook County Health
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Bashar Attar MD, Cook County Health
- Investigators
- Bashar Attar, MD, PhD, Study director, Cook County Health & Hospitals System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01765491
- Sponsor's protocol ID
- 11-206
- Status last verified
- Jun 2023
- First submitted
- 7 Jan 2013
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Morning-only With Split-dose Polyethylene Glycol for Colonoscopy Preparation in Hospitalized Patients: A Randomized Controlled Non-Inferiority Study
- ClinicalTrials.gov ID
- NCT01765491
- Acronym / sponsor ID
- 11-206
- Conditions
- Bowel Preparation for Colonoscopy
- Keywords
- colonoscopy, bowel preparation, polyethylene glycol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Cook County HealthOther government
- Study start
- Aug 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 10 Jan 2013 (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.
Morning-only colonoscopy preparation may improve efficiency by allowing same-day patient preparation and colonoscopy. The aim of the investigators study is to compare the efficacy and tolerability of morning-only Polyethylene Glycol (PEG) to split-dose preparation in hospitalized patients undergoing colonoscopy.
Detailed description
This is a single-center, prospective, endoscopist-blinded study in which hospitalized patients scheduled to undergo diagnostic colonoscopy were randomly assigned to receive one gallon of PEG either the morning of colonoscopy or as a split-dose (evening-morning). The primary end point is efficacy of colonoscopy preparation measured by the Ottawa scale. The investigators pre-specified a non-inferiority margin of 1.5 for the difference in Ottawa scale between arms. Secondary end points are patient compliance and tolerance. N: 120 hospitalized patients scheduled for diagnostic colonoscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morning-only polyethylene glycol | Experimental | Other: Morning-only polyethylene glycolOne gallon of polyethylene glycol to be taken between 5am and 9am on the day of colonoscopy. |
| Split-dose polyethylene glycol | Active comparator | Other: Split-dose polyethylene glycolHalf gallon of polyethylene glycol to be taken between 7-9 pm on the day before colonoscopy and the remaining half between 7-9 am on the day of colonoscopy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients scheduled to undergo diagnostic colonoscopy during hospitalization
Key exclusion criteria (6 listed)
- Critically ill/Intensive Care Unit patients
- Suspected bowel obstruction/perforation
- History of colon resection
- Patients with altered mental status/inability to provide informed consent
- Incarcerated patients
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 |
|---|---|---|
| Split-dose polyethylene glycolHalf gallon of polyethylene glycol to be taken between 7-9 pm on the day before colonoscopy and the remaining half between 7-9 am on the day of colonoscopy | Other | Split-dose polyethylene glycol |
| Morning-only polyethylene glycolOne gallon of polyethylene glycol to be taken between 5am and 9am on the day of colonoscopy | Other | Morning-only polyethylene glycol |
Primary outcome
To compare the efficacy of colonoscopy preparation measured by the Ottawa scale
Time frame: Day of procedure
Colonoscopy was performed by gastroenterology fellows under the supervision of attending physicians and both were blinded to the type of preparation taken by the study patients. Bowel cleansing was evaluated by the Ottawa scale. Scoring of each part of the colon (right, middle and left) was done separately and the total amount of fluid was noted. The scores were then added to calculate the total score out of 14.
2 secondary outcomes
Patient compliance
Time frame: Day of procedure
Patient tolerance
Time frame: Same day
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 18 Jun 2023.
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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.
Bashar Attar, MD, PhD study director
Cook County Health & Hospitals System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Split-dose polyethylene glycol and Morning-only polyethylene glycol in people with Bowel Preparation for Colonoscopy, run by Cook County Health 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 6 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 18 Jun 2023. 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?
To compare the efficacy of colonoscopy preparation measured by the Ottawa scale (time frame: Day of procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2023.