ColonoscopyNCT03011788
Polyethylene Glycol Cleansing in Patients at High Risk for Poor Bowel Preparation
A study testing Golytely Oral Solution in people with Colonoscopy, run by VA Connecticut Healthcare System at 1 site in United States.
Trial summary
The aim of this randomized trial is to compare the proportion of patients achieving an adequate bowel preparation after a 1-day split-dose 4-liter PEG-based bowel preparation regimen (Golytely, Braintree Laboratory Inc, MA, USA) vs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonoscopy
- What is being tested?
- Golytely Oral Solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Dec 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Risk factors that increase likelihood of poor bowel prep
Who cannot join
- prior colon resection
- Women of child bearing age
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
West Have VAMC
West Haven, Connecticut, 06516
anil nagar, MD, 203-932-5711 ext. 2830, anil.nagar@va.gov
About this study
Official title: A Randomized Study of Single vs Two-Day Polyethylene Glycol Cleansing in Patients at High Risk for Poor Bowel Preparation
The aim of this randomized trial is to compare the proportion of patients achieving an adequate bowel preparation after a 1-day split-dose 4-liter PEG-based bowel preparation regimen (Golytely, Braintree Laboratory Inc, MA, USA) vs. the same regimen given on 2 consecutive days in a population identified as high risk for an inadequate bowel preparation.
- Research Design: This study is a single-center prospective randomized study at the West Haven VAMC.
- Methodology:
- Primary endpoint: Adequate bowel preparation as defined by a Boston Bowel Preparation Scale (BBPS) score of 2 or 3 (on scale of 0-3) in all 3 colon segments (left, transverse, and right).
- Secondary endpoints: Adenoma detection rate, polyp detection rate, sessile serrated polyp/adenoma detection rate, patient tolerability of preparation using the validated Mayo clinic bowel prep tolerability questionnaire, adverse events potentially related to bowel preparation
Patients scheduled for routine outpatient colonoscopy will be eligible if they are at high risk for poor bowel preparation,
Read the detailed description
Group 1: One day of split-dose Golytely 4L (2 liters the evening before procedure, 2 liters the morning of procedure) Group 2: Two days of split-dose Golytely 4L (beginning 2 days before the procedure with 2 liters in the evening, 2 liters the morning of the day before the procedure, 2 liters the evening before the procedure, 2 liters the morning of the procedure) Patients will be instructed to ingest each of the 2-liter aliquots of Golytely over 2 hours.
Diet: Both groups will be instructed to ingest a low-residue diet beginning 2 days before the procedure, (attachment 2) the last low-residual meal at 4 pm on day prior to procedure, with no food on the day of the procedure. Clear liquid diet after 4 pm on day prior to procedure and clear liquids on the day of procedure up-to 4 hours prior to the procedure.
Education: Both groups will receive face to face, pre-procedure education 1 week prior to their procedure. Patient who cannot come for face-to-face education will not be included in the study.
Reminders: Both groups will receive a telephone call 2 days prior to their procedure to remind them of their procedure and to remind them to take the laxative preparation as prescribed.
Compliance: Patient will receive an educational handout about bowel preparation and colonoscopy. This practice is standard for all patients receiving colonoscopy at our institute. All Patients will get a copy of low residual diet and be asked to complete diet intake handout for 2 days prior to procedure. Patients will be requested to bring their unused Golytely prep medications to evaluate compliance.
Tolerability: The tolerability of the bowel preparation will be assessed using the validated Mayo clinic bowel prep tolerability questionnaire. (Attachment 3) On the day of the procedure, a member of the research team will review the patient's diet for the previous 2 days, the proportion of bowel prep solution ingested, and complications potentially related to the preparation (described above); the patient will also complete the Mayo tolerability questionnaire. Orthostatic vital signs will be checked prior to colonoscopy. Patient will undergo colonoscopy by an endoscopist following our standard protocols at WHVA MC. The bowel preparation will be scored using the BBPS and all polyps identified will be recorded and removed in the standard fashion.
Following discharge, patients will receive a telephone call within 2 days to document any post-procedure complications, including emergency room visits or hospitalizations.
- Conditions
- Colonoscopy
- Being tested
- Golytely Oral Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Golytely Oral SolutionDrug
Also called Bowel purge
Bowel purge prior to,colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Single day | Active comparator | Single day Golytely purge 4L purge Receives: Drug: Golytely Oral Solution |
| 2 day colon purge | Active comparator | Two days of Golytely purge 8L purge Receives: Drug: Golytely Oral Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boston Bowel Preparation Scale (BBPS)
Boston Bowel Preparation Scale (BBPS) score of 2 or 3 (on scale of 0-3) in all 3 colon segments
Measured: Day 1
Secondary outcomes (2)
Adenoma detection rate
Adenoma detection rates
Measured: Day 1
patient tolerability of preparation using the validated Mayo clinic bowel prep tolerability questionnaire
patient tolerability of preparation using the validated Mayo clinic bowel prep tolerability questionnaire
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Connecticut Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Anil Nagar, VA Connecticut Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03011788
- Sponsor's protocol ID
- AN0011
- Status last verified
- Dec 2019
- First submitted
- 3 Jan 2017
- Last updated
- 3 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of Single vs Two-Day Polyethylene Glycol Cleansing in Patients at High Risk for Poor Bowel Preparation
- ClinicalTrials.gov ID
- NCT03011788
- Acronym / sponsor ID
- AN0011
- Conditions
- Colonoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- VA Connecticut Healthcare SystemUS federal agency
- Study start
- Jan 2017
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 5 Jan 2017 (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 aim of this randomized trial is to compare the proportion of patients achieving an adequate bowel preparation after a 1-day split-dose 4-liter PEG-based bowel preparation regimen (Golytely, Braintree Laboratory Inc, MA, USA) vs. the same regimen given on 2 consecutive days in a population identified as high risk for an inadequate bowel preparation.
- Research Design: This study is a single-center prospective randomized study at the West Haven VAMC.
- Methodology:
- Primary endpoint: Adequate bowel preparation as defined by a Boston Bowel Preparation Scale (BBPS) score of 2 or 3 (on scale of 0-3) in all 3 colon segments (left, transverse, and right).
- Secondary endpoints: Adenoma detection rate, polyp detection rate, sessile serrated polyp/adenoma detection rate, patient tolerability of preparation using the validated Mayo clinic bowel prep tolerability questionnaire, adverse events potentially related to bowel preparation
Patients scheduled for routine outpatient colonoscopy will be eligible if they are at high risk for poor bowel preparation,
Detailed description
Group 1: One day of split-dose Golytely 4L (2 liters the evening before procedure, 2 liters the morning of procedure) Group 2: Two days of split-dose Golytely 4L (beginning 2 days before the procedure with 2 liters in the evening, 2 liters the morning of the day before the procedure, 2 liters the evening before the procedure, 2 liters the morning of the procedure) Patients will be instructed to ingest each of the 2-liter aliquots of Golytely over 2 hours.
Diet: Both groups will be instructed to ingest a low-residue diet beginning 2 days before the procedure, (attachment 2) the last low-residual meal at 4 pm on day prior to procedure, with no food on the day of the procedure. Clear liquid diet after 4 pm on day prior to procedure and clear liquids on the day of procedure up-to 4 hours prior to the procedure.
Education: Both groups will receive face to face, pre-procedure education 1 week prior to their procedure. Patient who cannot come for face-to-face education will not be included in the study.
Reminders: Both groups will receive a telephone call 2 days prior to their procedure to remind them of their procedure and to remind them to take the laxative preparation as prescribed.
Compliance: Patient will receive an educational handout about bowel preparation and colonoscopy. This practice is standard for all patients receiving colonoscopy at our institute. All Patients will get a copy of low residual diet and be asked to complete diet intake handout for 2 days prior to procedure. Patients will be requested to bring their unused Golytely prep medications to evaluate compliance.
Tolerability: The tolerability of the bowel preparation will be assessed using the validated Mayo clinic bowel prep tolerability questionnaire. (Attachment 3) On the day of the procedure, a member of the research team will review the patient's diet for the previous 2 days, the proportion of bowel prep solution ingested, and complications potentially related to the preparation (described above); the patient will also complete the Mayo tolerability questionnaire. Orthostatic vital signs will be checked prior to colonoscopy. Patient will undergo colonoscopy by an endoscopist following our standard protocols at WHVA MC. The bowel preparation will be scored using the BBPS and all polyps identified will be recorded and removed in the standard fashion.
Following discharge, patients will receive a telephone call within 2 days to document any post-procedure complications, including emergency room visits or hospitalizations.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single day | Active comparator | Drug: Golytely Oral SolutionSingle day Golytely purge 4L purge |
| 2 day colon purge | Active comparator | Drug: Golytely Oral SolutionTwo days of Golytely purge 8L purge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Risk factors that increase likelihood of poor bowel prep
Key exclusion criteria (2 listed)
- prior colon resection
- Women of child bearing age
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 |
|---|---|---|
| Golytely Oral SolutionAlso: Bowel purgeBowel purge prior to,colonoscopy | Drug | 2 day colon purge, Single day |
Primary outcome
Boston Bowel Preparation Scale (BBPS)
Time frame: Day 1
Boston Bowel Preparation Scale (BBPS) score of 2 or 3 (on scale of 0-3) in all 3 colon segments
2 secondary outcomes
Adenoma detection rate
Time frame: Day 1
patient tolerability of preparation using the validated Mayo clinic bowel prep tolerability questionnaire
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2019.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Golytely Oral Solution in people with Colonoscopy, run by VA Connecticut Healthcare System 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: status not confirmed, as of the sponsor's last update on 3 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anil Nagar, MD (2039325711 ext. 2830, anil.nagar@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Boston Bowel Preparation Scale (BBPS) (time frame: Day 1). 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 3 Dec 2019.