ColonoscopyNCT02643316
Morning-Only 4 L PEG vs Split Dose Prep for Afternoon Colonoscopies, Endoscopist-Blinded Prospective Study
A study testing Same day 4 L preparation (Polyethylene Glycol) and Split dose 4 L preparation (Polyethylene Glycol) in people with Colonoscopy, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Comparison of quality of preparation of colonoscopy in patients taking same day 4L preparation vs. 4 L split dose preparation in patients scheduled for an afternoon colonoscopy procedure. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy
- What is being tested?
- Same day 4 L preparation (Polyethylene Glycol) and Split dose 4 L preparation (Polyethylene Glycol)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Aug 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. All patients above 18 years of age undergoing elective outpatient colonoscopy at CCF Florida who are scheduled for an afternoon colonoscopy procedure. All patients must have been prescribed a 4 L PEG based bowel preparation.
Who cannot join
- Patients who had prior Colectomy or colon resection surgery.
- Patients with confirmed diagnosis of impaired GI motility.
- Chronic nausea or vomiting.
- Severe constipation (=/<1 bowel movement per week).
- Pregnancy.
- Breast feeding.
- Patients taking drugs which are known to influence GI motility.
- Hospital inpatients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Morning-Only 4 Liter Polyethylene Glycol vs. Split Dose for Afternoon Colonoscopies, a Randomized Endoscopist-Blinded Prospective Study
Comparison of quality of preparation of colonoscopy in patients taking same day 4L preparation vs. 4 L split dose preparation in patients scheduled for an afternoon colonoscopy procedure.
Read the detailed description
The aim of colorectal cancer screening is to reduce mortality. This can be effectively achieved by colonoscopy with direct visualization of the entire colon to detect preneoplastic lesions such as adenomatous polyps. Bowel preparation quality is critical for the accuracy of colonoscopy, time required to complete the procedure and its success. On the other hand, poor quality of bowel preparation was shown to be associated with a lower adenoma detection rate. Prior studies have shown that time of colonoscopy is one of the major factors influencing bowel preparation quality with the afternoon colonoscopies being notable for a high failure rate. This failure rate is related to poor bowel preparation quality. Given that, the number of afternoon colonoscopies performed is still high due to the increased need for colonoscopies. Therefore, it is suggested that improving the bowel preparation quality can reduce failure rate of afternoon colonoscopies. Several studies on split-dose bowel preparation have shown that it is superior to the conventional day-before regimen, in terms of preparation quality and patient's tolerability. Another study on split-dose bowel preparation also showed that it is associated with a better adenoma detection rate, better polyp detection rate and colonoscopy completion rate. There also have been few studies comparing same day dose vs. day-before for afternoon colonoscopies and showed that same day was superior to day before.There is no data comparing quality of preparation of colonoscopy in patients taking same day 4L preparation vs. 4 L split-dose preparation for an afternoon colonoscopy.
Using a 4L PEG-ELS solution, the investigators aim to evaluate the efficacy and patient's tolerability for the same day versus split-dose regimen.
- Conditions
- Colonoscopy
- Being tested
- Same day 4 L preparation (Polyethylene Glycol), Split dose 4 L preparation (Polyethylene Glycol)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Same day 4 L preparation (Polyethylene Glycol)Drug
Also called PEG bowel prep
Receive 1 gallon (4 L) of Polyethylene Glycol preparation on the morning of the colonoscopy.
Split dose 4 L preparation (Polyethylene Glycol)Drug
Also called PEG bowel prep
Receive the split-dose regimen. Will take half (2 L) the preparation the evening before colonoscopy and half (2 L) on the morning of the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Same day 4 L preparation of PEG | Active comparator | Receive 1 gallon (4 L) of Polyethylene Glycol (PEG) preparation on the morning of the colonoscopy. Receives: Drug: Same day 4 L preparation (Polyethylene Glycol) |
| Split dose 4 L preparation of of the PEG | Active comparator | Receive the split-dose regimen. Will take half (2 L) of the PEG preparation the evening before colonoscopy and half (2 L) of the PEG preparation on the morning of the procedure. Receives: Drug: Split dose 4 L preparation (Polyethylene Glycol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of preparation (Ottawa score)
The quality of bowel preparation will be assessed for the 2 groups at the time of the colonoscopy using the Ottawa score for quality of preparation.
Measured: During the colonoscopy
Secondary outcomes (1)
Patient satisfaction with the bowel preparation (questionnaire).
Patient satisfaction with the bowel preparation in the 2 groups will be assessed using an approved questionnaire at the time of pre-operative assessment of the patient.
Measured: Before the colonoscopy procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionAug 2019
- Study completionAug 2019
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 ColonoscopyStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernando Castro, The Cleveland Clinic
- Investigators
- Fernando Castro, M.D., Principal investigator, Cleveland Clinic Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02643316
- Sponsor's protocol ID
- FLA 15-092
- Status last verified
- Dec 2019
- First submitted
- 29 Dec 2015
- Last updated
- 4 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Castro FJ, Al-Khairi B, Singh H, Mohameden M, Tandon K, Lopez R. Randomized Controlled Trial: Split-dose and Same-day Large Volume Bowel Preparation for Afternoon Colonoscopy Have Similar Quality of Preparation. J Clin Gastroenterol. 2019 Nov/Dec;53(10):724-730. doi: 10.1097/MCG.0000000000001213.
PubMed 31021890
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morning-Only 4 Liter Polyethylene Glycol vs. Split Dose for Afternoon Colonoscopies, a Randomized Endoscopist-Blinded Prospective Study
- ClinicalTrials.gov ID
- NCT02643316
- Acronym / sponsor ID
- FLA 15-092
- Conditions
- Colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 31 Dec 2015 (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.
Comparison of quality of preparation of colonoscopy in patients taking same day 4L preparation vs. 4 L split dose preparation in patients scheduled for an afternoon colonoscopy procedure.
Detailed description
The aim of colorectal cancer screening is to reduce mortality. This can be effectively achieved by colonoscopy with direct visualization of the entire colon to detect preneoplastic lesions such as adenomatous polyps. Bowel preparation quality is critical for the accuracy of colonoscopy, time required to complete the procedure and its success. On the other hand, poor quality of bowel preparation was shown to be associated with a lower adenoma detection rate. Prior studies have shown that time of colonoscopy is one of the major factors influencing bowel preparation quality with the afternoon colonoscopies being notable for a high failure rate. This failure rate is related to poor bowel preparation quality. Given that, the number of afternoon colonoscopies performed is still high due to the increased need for colonoscopies. Therefore, it is suggested that improving the bowel preparation quality can reduce failure rate of afternoon colonoscopies. Several studies on split-dose bowel preparation have shown that it is superior to the conventional day-before regimen, in terms of preparation quality and patient's tolerability. Another study on split-dose bowel preparation also showed that it is associated with a better adenoma detection rate, better polyp detection rate and colonoscopy completion rate. There also have been few studies comparing same day dose vs. day-before for afternoon colonoscopies and showed that same day was superior to day before.There is no data comparing quality of preparation of colonoscopy in patients taking same day 4L preparation vs. 4 L split-dose preparation for an afternoon colonoscopy.
Using a 4L PEG-ELS solution, the investigators aim to evaluate the efficacy and patient's tolerability for the same day versus split-dose regimen.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Same day 4 L preparation of PEG | Active comparator | Drug: Same day 4 L preparation (Polyethylene Glycol)Receive 1 gallon (4 L) of Polyethylene Glycol (PEG) preparation on the morning of the colonoscopy. |
| Split dose 4 L preparation of of the PEG | Active comparator | Drug: Split dose 4 L preparation (Polyethylene Glycol)Receive the split-dose regimen. Will take half (2 L) of the PEG preparation the evening before colonoscopy and half (2 L) of the PEG preparation on the morning of the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. All patients above 18 years of age undergoing elective outpatient colonoscopy at CCF Florida who are scheduled for an afternoon colonoscopy procedure. All patients must have been prescribed a 4 L PEG based bowel preparation.
Key exclusion criteria (8 listed)
- Patients who had prior Colectomy or colon resection surgery.
- Patients with confirmed diagnosis of impaired GI motility.
- Chronic nausea or vomiting.
- Severe constipation (=/<1 bowel movement per week).
- Pregnancy.
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 |
|---|---|---|
| Same day 4 L preparation (Polyethylene Glycol)Also: PEG bowel prepReceive 1 gallon (4 L) of Polyethylene Glycol preparation on the morning of the colonoscopy. | Drug | Same day 4 L preparation of PEG |
| Split dose 4 L preparation (Polyethylene Glycol)Also: PEG bowel prepReceive the split-dose regimen. Will take half (2 L) the preparation the evening before colonoscopy and half (2 L) on the morning of the procedure. | Drug | Split dose 4 L preparation of of the PEG |
Primary outcome
Quality of preparation (Ottawa score)
Time frame: During the colonoscopy
The quality of bowel preparation will be assessed for the 2 groups at the time of the colonoscopy using the Ottawa score for quality of preparation.
1 secondary outcome
Patient satisfaction with the bowel preparation (questionnaire).
Time frame: Before the colonoscopy procedure.
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 4 Dec 2019.
- Derived from this study: PubMed 31021890Castro FJ, Al-Khairi B, Singh H, Mohameden M, Tandon K, Lopez R. Randomized Controlled Trial: Split-dose and Same-day Large Volume Bowel Preparation for Afternoon Colonoscopy Have Similar Quality of Preparation. J Clin Gastroenterol. 2019 Nov/Dec;53(10):724-730. doi: 10.1097/MCG.0000000000001213.
- 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.
Fernando Castro, M.D. principal investigator
Cleveland Clinic Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Same day 4 L preparation (Polyethylene Glycol) and Split dose 4 L preparation (Polyethylene Glycol) in people with Colonoscopy, run by The Cleveland Clinic 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 8 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 4 Dec 2019. 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?
Quality of preparation (Ottawa score) (time frame: During the 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 NCT02643316, 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 4 Dec 2019.