Hospitalized PatientsPhase 4NCT02119000
Comparison of Two Types of Bowel Preparation for Inpatient Colonoscopy
A Phase 4 study testing PEG/electrolytes 2L/2L split dose and Bisacodyl 15 mg and PEG/electrolytes 1L/1L split dose in people with Hospitalized Patients, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 2 sites in Canada.
Trial summary
Bowel preparation is a crucial step prior to colonoscopy to help with the optimal assessment of the colonic mucosa. Inadequate bowel preparation increases the length of the procedure, and is associated with decreased lesional detection rates. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hospitalized Patients
- What is being tested?
- PEG/electrolytes 2L/2L split dose and Bisacodyl 15 mg and PEG/electrolytes 1L/1L split dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 2 sitesCanada
- Study dates
- Aug 2015to Jan 2020
- Phase
- Phase 4
- 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
- 18 years or older
- Be able to comprehend the trial and provide written informed consent in French or English, or a close relative with power of attorney
- Have a recognised indication for full colonoscopy after evaluation by a gastroenterologist or surgeon
- Be hospitalized or in the ED of a participating hospital center.
- Need to receive a bowel preparation during hospitalization or the ED stay.
- Be able to complete the follow-up patient response form in French or English
Who cannot join
- Patient refusal
- A suspected or diagnosed bowel obstruction
- A toxic megacolon
- Ileus
- Decompensated heart failure
- Severe acute renal failure
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- Severe electrolyte imbalance
- Previous bowel preparation in the last 7 days
- Pregnancy
- Time of randomization before 9h00 or after 22h00
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
McGill University Health Centre
Montreal, Quebec, H3G1A4
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, J1G 2E8
About this study
Bowel preparation is a crucial step prior to colonoscopy to help with the optimal assessment of the colonic mucosa. Inadequate bowel preparation increases the length of the procedure, and is associated with decreased lesional detection rates. The ideal bowel preparation formulation should be able to completely clean the bowel, without leaving solid or liquid residues, and without modifying the mucosal appearance.
Bowel preparation may be administered in hospitalised patients or in the ER. Patients have less control on their environment and the intake of the bowel preparation. For example, there may be a delay in pharmacy delivery or inadequate supervision by the treating personnel. Hospitalised patients have more comorbidities, are usually less autonomous and mobile - both can add to the barriers leading to an adequate bowel preparation. Multiple studies have identified hospitalization status as an independent risk factor for poor bowel preparation.
The objective of this study is to access which bowel preparation regimen, between PEG 3350 with electrolytes 2L the day before and 2L the day of the colonoscopy vs bisacodyl + PEG 3350 with electrolytes 1L the day before and 1L the day of the colonoscopy, results in the cleanest bowel preparation in hospitalised patients.
- Conditions
- Hospitalized Patients
- Being tested
- PEG/electrolytes 2L/2L split dose, Bisacodyl 15 mg and PEG/electrolytes 1L/1L split dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG/electrolytes 2L/2L split doseDrug
Polyethylene glycol 17gm X 4 At 18h00 the day prior the colonoscopy, dilute 2 sachets in 2 L of water and drink 240 mL every 10 minutes On the day of the procedure, 4-5 hours prior the colonoscopy, dilute 2 sachets in 2 L of water and drink 240 mL every 10 minutes
Bisacodyl 15 mg and PEG/electrolytes 1L/1L split doseDrug
Bisacodyl 15 mg x 3
At 14h00 the day prior the endoscopic procedure: take 3 tablets of Bisacodyl ER (15 mg) orally then 5 hr later:
PEG/electrolytes 1L/1L Polyethylene glycol 17gm Dilute one sachet of Polyethylene glycol 17gm in 1 L of water Start drinking at around 19h00 the night prior the colonoscopy Drink 240 ml every 10 minutes The day of the colonoscopy. At (4 hrs prior the procedure). Dilute on sachet of PEG and drink 240 ml every 10 minutes
| Study group | Role | What they receive |
|---|---|---|
| PEG electrolytes 2L/2L split dose | Experimental | Not described Receives: Drug: PEG/electrolytes 2L/2L split dose |
| Bisacodyl 15 mg and PEG/electrolytes 1L/1L split dose | Active comparator | Not described Receives: Drug: Bisacodyl 15 mg and PEG/electrolytes 1L/1L split dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Which bowel preparation regimen, between PEG 3350 with electrolytes 2L the day before and 2L the day of the colonoscopy vs bisacodyl + PEG 3350 with electrolytes 1L the day before and 1L the day of the colonoscopy, results in the cleanest bowel preparation in hospitalised patients.
Measured: following colonoscopy
Secondary outcomes (4)
Tolerability
A questionnaire will be used to assess which is the most tolerable and acceptable to patients between the two bowel preparation regimens
Measured: Before colonoscopy
Clinical quality standards
Does the bowel preparation given prior to in-hospital colonoscopy result in an excellent or good preparation rate that falls within the required clinical quality standards?
Measured: After colonoscopy
Cecal/ileal intubation rate
What is the cecal/ileal intubation rate for colonoscopies performed in hospitalized patients?
Measured: Following colonoscopy
Polyp detection rate
What is the polyp detection rate for colonoscopies performed in hospitalized patients?
Measured: Following colonosopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startAug 2015
- Primary completionJan 2020
- Study completionJan 2020
Why it stopped: Difficulty in recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hospitalized PatientsStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alan Barkun, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02119000
- Sponsor's protocol ID
- GEN 13-148
- Other IDs
- GEN 13-148
- Status last verified
- Feb 2021
- First submitted
- 26 Jan 2014
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Types of Bowel Preparation for Inpatient Colonoscopy
- ClinicalTrials.gov ID
- NCT02119000
- Acronym / sponsor ID
- GEN 13-148
- Conditions
- Hospitalized Patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in recruitment
- Enrolment
- 82 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 21 Apr 2014 (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.
Bowel preparation is a crucial step prior to colonoscopy to help with the optimal assessment of the colonic mucosa. Inadequate bowel preparation increases the length of the procedure, and is associated with decreased lesional detection rates. The ideal bowel preparation formulation should be able to completely clean the bowel, without leaving solid or liquid residues, and without modifying the mucosal appearance.
Bowel preparation may be administered in hospitalised patients or in the ER. Patients have less control on their environment and the intake of the bowel preparation. For example, there may be a delay in pharmacy delivery or inadequate supervision by the treating personnel. Hospitalised patients have more comorbidities, are usually less autonomous and mobile - both can add to the barriers leading to an adequate bowel preparation. Multiple studies have identified hospitalization status as an independent risk factor for poor bowel preparation.
The objective of this study is to access which bowel preparation regimen, between PEG 3350 with electrolytes 2L the day before and 2L the day of the colonoscopy vs bisacodyl + PEG 3350 with electrolytes 1L the day before and 1L the day of the colonoscopy, results in the cleanest bowel preparation in hospitalised patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEG electrolytes 2L/2L split dose | Experimental | Drug: PEG/electrolytes 2L/2L split dose |
| Bisacodyl 15 mg and PEG/electrolytes 1L/1L split dose | Active comparator | Drug: Bisacodyl 15 mg and PEG/electrolytes 1L/1L split dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years or older
- Be able to comprehend the trial and provide written informed consent in French or English, or a close relative with power of attorney
- Have a recognised indication for full colonoscopy after evaluation by a gastroenterologist or surgeon
- Be hospitalized or in the ED of a participating hospital center.
- Need to receive a bowel preparation during hospitalization or the ED stay.
Key exclusion criteria (10 listed)
- Patient refusal
- A suspected or diagnosed bowel obstruction
- A toxic megacolon
- Ileus
- Decompensated heart failure
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 |
|---|---|---|
| PEG/electrolytes 2L/2L split dosePolyethylene glycol 17gm X 4 At 18h00 the day prior the colonoscopy, dilute 2 sachets in 2 L of water and drink 240 mL every 10 minutes On the day of the procedure, 4-5 hours prior the colonoscopy, dilute 2 sachets in 2 L of water and drink 240 mL every 10 minutes | Drug | PEG electrolytes 2L/2L split dose |
| Bisacodyl 15 mg and PEG/electrolytes 1L/1L split doseBisacodyl 15 mg x 3 At 14h00 the day prior the endoscopic procedure: take 3 tablets of Bisacodyl ER (15 mg) orally then 5 hr later: PEG/electrolytes 1L/1L Polyethylene glycol 17gm Dilute one sachet of Polyethylene glycol 17gm in 1 L of water Start drinking at around 19h00 the night prior the colonoscopy Drink 240 ml every 10 minutes The day of the colonoscopy. At (4 hrs prior the procedure). Dilute on sachet of PEG and drink 240 ml every 10 minutes | Drug | Bisacodyl 15 mg and PEG/electrolytes 1L/1L split dose |
Primary outcome
Efficacy
Time frame: following colonoscopy
Which bowel preparation regimen, between PEG 3350 with electrolytes 2L the day before and 2L the day of the colonoscopy vs bisacodyl + PEG 3350 with electrolytes 1L the day before and 1L the day of the colonoscopy, results in the cleanest bowel preparation in hospitalised patients.
4 secondary outcomes
Tolerability
Time frame: Before colonoscopy
Clinical quality standards
Time frame: After colonoscopy
Cecal/ileal intubation rate
Time frame: Following colonoscopy
Polyp detection rate
Time frame: Following colonosopy
Results and safety
The study was stopped early (reason given: Difficulty in recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PEG/electrolytes 2L/2L split dose and Bisacodyl 15 mg and PEG/electrolytes 1L/1L split dose in people with Hospitalized Patients, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 2 sites in Canada.
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 6 inclusion and 10 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: stopped early, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulty in recruitment). Results are not available in the source record.
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?
Efficacy (time frame: following colonoscopy). 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 24 Feb 2021.