Colon CancerPhase 3CCFNCT00687830
Efficacy of Morning-only Bowel Preparation for Afternoon Colonoscopy.
A Phase 3 study testing Polyethylene Glycol afternoon and Polyethylene Glycol morning in people with Colon Cancer, run by Cleveland Clinic Florida at 1 site in United States.
Trial summary
The study aims to study the adequacy of bowel preparation (colon cleansing) for afternoon colonoscopies. The conventional regimen of giving bowel prep on the evening prior to the day of the colonoscopy will be compared with that given on the morning of an afternoon colonoscopy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Polyethylene Glycol afternoon and Polyethylene Glycol morning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Nov 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients attending the GI Clinic at CCF who are prescribed colonoscopy and are willing to get the procedure done in the afternoon.
Who cannot join
- Colonoscopy is contraindicated
- Prior Colectomy or colon surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Endoscopist-blinded Clinical Trial Comparing the Bowel Cleansing Effect and Patient Tolerability of Same Day Polyethylene Glycol Bowel Preparation Regimen v Regimen Given on the Day Before Colonoscopy
The study aims to study the adequacy of bowel preparation (colon cleansing) for afternoon colonoscopies. The conventional regimen of giving bowel prep on the evening prior to the day of the colonoscopy will be compared with that given on the morning of an afternoon colonoscopy. Endoscopist scoring the bowel cleansing efficacy with an Ottawa Scale are blinded to the randomization process.
Read the detailed description
Two bowel preparation regimens of Polyethylene Glycol (PEG), commonly referred to as "Golytely" will be tested for their efficacy (bowel cleansing effect) and patient tolerability. The goal is to reduce the failure rates of afternoon colonoscopies, for which, one of the main reasons attributed is inadequate bowel preparation. For the afternoon colonoscopies, the conventional PEG regimen given on the evening prior to the day of the colonoscopy will be compared with the novel PEG regimen given on the morning of the day of the colonoscopy. The comparison will be drawn for two measures - bowel cleansing effect measured from the questionnaire given to the gastroenterologists performing the colonoscopy and the patient tolerability evaluated from the information gathered from the patient's questionnaire.
- Conditions
- Colon Cancer
- Being tested
- Polyethylene Glycol afternoon, Polyethylene Glycol morning
- Keywords
- Afternoon colonoscopy, Morning, Evening, Bowel Preparation, Efficacy, Satisfaction
- Medical subject headings
- Colonic Neoplasms, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyethylene Glycol afternoonDrug
Also called GoLytely
Prescribed the standard dose of 4L or 1 Gallon Polythylene Glycol to be taken over a period of 4 hours with water. For Evening prep, between 5PM and 9PM
Polyethylene Glycol morningDrug
Also called Golytely
Prescribed the standard dose of 4L or 1 Gallon Polythylene Glycol to be taken over a period of 4 hours with water. For Morning prep, between 6AM and 10AM
| Study group | Role | What they receive |
|---|---|---|
| Polythylene Glycol (PEG) in the evening | Active comparator | Bowel preparation with Polyethylene Glycol given in the evening prior to the day of the afternoon colonoscopy.
'Polyethylene Glycol afternoon' Receives: Drug: Polyethylene Glycol afternoon |
| Polythylene Glycol (PEG) in the Morning | Experimental | Bowel preparation with Polyethylene Glycol given on the morning of the day of the afternoon colonoscopy.
'Polyethylene Glycol morning' Receives: Drug: Polyethylene Glycol morning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing All Morning Bowel Prep to Evening Bowel Prep for Patients Undergoing Afternoon Colonoscopies. (Using Ottawa Scale Scores, Range 0-14) Lower Score Indicates a Better Outcome.
Measured: Within 1 hr after the colonoscopy procedure
Secondary outcomes (1)
Patient Satisfaction in the Two Groups, All Morning Prep vs. All Evening Bowel Prep.
Variable used to assess patient satisfaction: Loss of sleep. The numbers below depict the number of participants who experienced loss of sleep.
Measured: An hour 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 posted2 Jun 2008 (estimated)
- Study startFeb 2008
- Primary completionJul 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cleveland Clinic Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shibu Varughese, M.D., Principal investigator, Cleveland Clinic Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00687830
- Sponsor's protocol ID
- CCFL-8964
- Acronym
- CCF
- Status last verified
- Feb 2016
- First submitted
- 28 May 2008
- Last updated
- 17 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Varughese S, Kumar AR, George A, Castro FJ. Morning-only one-gallon polyethylene glycol improves bowel cleansing for afternoon colonoscopies: a randomized endoscopist-blinded prospective study. Am J Gastroenterol. 2010 Nov;105(11):2368-74. doi: 10.1038/ajg.2010.271. Epub 2010 Jul 6.
PubMed 20606677
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Endoscopist-blinded Clinical Trial Comparing the Bowel Cleansing Effect and Patient Tolerability of Same Day Polyethylene Glycol Bowel Preparation Regimen v Regimen Given on the Day Before Colonoscopy
- ClinicalTrials.gov ID
- NCT00687830
- Acronym / sponsor ID
- CCF / CCFL-8964
- Conditions
- Colon Cancer
- Keywords
- Afternoon colonoscopy, Morning, Evening, Bowel Preparation, Efficacy, Satisfaction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Cleveland Clinic FloridaUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 2 Jun 2008 (estimated)
- Results
- Posted 11 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to study the adequacy of bowel preparation (colon cleansing) for afternoon colonoscopies. The conventional regimen of giving bowel prep on the evening prior to the day of the colonoscopy will be compared with that given on the morning of an afternoon colonoscopy. Endoscopist scoring the bowel cleansing efficacy with an Ottawa Scale are blinded to the randomization process.
Detailed description
Two bowel preparation regimens of Polyethylene Glycol (PEG), commonly referred to as "Golytely" will be tested for their efficacy (bowel cleansing effect) and patient tolerability. The goal is to reduce the failure rates of afternoon colonoscopies, for which, one of the main reasons attributed is inadequate bowel preparation. For the afternoon colonoscopies, the conventional PEG regimen given on the evening prior to the day of the colonoscopy will be compared with the novel PEG regimen given on the morning of the day of the colonoscopy. The comparison will be drawn for two measures - bowel cleansing effect measured from the questionnaire given to the gastroenterologists performing the colonoscopy and the patient tolerability evaluated from the information gathered from the patient's questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polythylene Glycol (PEG) in the evening | Active comparator | Drug: Polyethylene Glycol afternoonBowel preparation with Polyethylene Glycol given in the evening prior to the day of the afternoon colonoscopy. 'Polyethylene Glycol afternoon' |
| Polythylene Glycol (PEG) in the Morning | Experimental | Drug: Polyethylene Glycol morningBowel preparation with Polyethylene Glycol given on the morning of the day of the afternoon colonoscopy. 'Polyethylene Glycol morning' |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients attending the GI Clinic at CCF who are prescribed colonoscopy and are willing to get the procedure done in the afternoon.
Key exclusion criteria (2 listed)
- Colonoscopy is contraindicated
- Prior Colectomy or colon surgery.
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 |
|---|---|---|
| Polyethylene Glycol afternoonAlso: GoLytelyPrescribed the standard dose of 4L or 1 Gallon Polythylene Glycol to be taken over a period of 4 hours with water. For Evening prep, between 5PM and 9PM | Drug | Polythylene Glycol (PEG) in the evening |
| Polyethylene Glycol morningAlso: GolytelyPrescribed the standard dose of 4L or 1 Gallon Polythylene Glycol to be taken over a period of 4 hours with water. For Morning prep, between 6AM and 10AM | Drug | Polythylene Glycol (PEG) in the Morning |
Primary outcome
Comparing All Morning Bowel Prep to Evening Bowel Prep for Patients Undergoing Afternoon Colonoscopies. (Using Ottawa Scale Scores, Range 0-14) Lower Score Indicates a Better Outcome.
Time frame: Within 1 hr after the colonoscopy procedure
1 secondary outcome
Patient Satisfaction in the Two Groups, All Morning Prep vs. All Evening Bowel Prep.
Time frame: An hour before the colonoscopy procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20606677Varughese S, Kumar AR, George A, Castro FJ. Morning-only one-gallon polyethylene glycol improves bowel cleansing for afternoon colonoscopies: a randomized endoscopist-blinded prospective study. Am J Gastroenterol. 2010 Nov;105(11):2368-74. doi: 10.1038/ajg.2010.271. Epub 2010 Jul 6.
- European society of GI endoscopy guidelines on bowel preparation. Reference 61, Page 145 : Same day regimen.Link provided by the sponsor.
- 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.
Shibu Varughese, 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 Phase 3 study testing Polyethylene Glycol afternoon and Polyethylene Glycol morning in people with Colon Cancer, run by Cleveland Clinic Florida 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 17 May 2017. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Comparing All Morning Bowel Prep to Evening Bowel Prep for Patients Undergoing Afternoon Colonoscopies. (Using Ottawa Scale Scores, Range 0-14) Lower Score Indicates a Better Outcome. (time frame: Within 1 hr after the colonoscopy procedure). 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 NCT00687830, 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 17 May 2017; AzTrials last refreshed its copy on 8 Nov 2026.