ColonoscopyPOOPSCOPENCT05368792
Prospective Trial Of Osmolar Protocol Solution on Colonoscopy Outcomes and Patient Experience
A study testing Complex Carbohydrate (PREcovery) in people with Colonoscopy, run by St. Joseph's Health Centre Toronto.
Trial summary
Fasting is the current standard of care for colonoscopies. Recent changes to anesthesia guidelines have allowed for clear fluids to be provided up to 2 hours before procedures, including colonoscopies. Read more about this study
- Who is it for?
- Ages 18 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy
- What is being tested?
- Complex Carbohydrate (PREcovery)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 31 May 2022to 1 Dec 2022
- 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 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- referred for a routine colonoscopy for cancer screening
- Physician indicates a bowel preparation of split dose 2L PEG ± bisacodyl (iso-osmolar) solution
Who cannot join
- patients with colonic resection, inflammatory bowel disease; any condition that would preclude colonoscopy of the whole colon;
- patients with lower gastrointestinal bleeding, patients with ileus, gastric retention, intestinal perforation, gastrointestinal obstruction;
- patients with significant heart disease, impaired renal function, decompensated liver disease
- patients who have diabetes
- patients on opioid medications.
- Patients with a corn allergy, or allergy to any ingredient in the complex CHO drink
Trial locations and contacts
No sites are listed yet.
About this study
Fasting is the current standard of care for colonoscopies. Recent changes to anesthesia guidelines have allowed for clear fluids to be provided up to 2 hours before procedures, including colonoscopies.
This study will compare fasting to a 12.5% carbohydrate solution 2 hours before colonoscopy on patient-reported measures of discomfort, hydration, and colon visibility.
The investigators hypothesize that the carbohydrate solution will improve patient-reported measures of discomfort, hydration, and colon visibility.
Read the detailed description
Fasting and bowel preparation before colonoscopy procedures has been the clinical protocol for decades. Evidence suggests that patients undergoing this traditional standard of care before procedures may be associated with common undesirable outcomes, including anxiety, thirst, and poor patient experience. The impacts of fasting and poor satisfaction can create a cascade of challenges regarding communication between clinicians and patients.
The new standard of care utilizes an innovative clear fluid protocol, allowing patients to consume clear fluids up to 2-3 hours prior to their procedure. The consumption of a complex carbohydrate (CHO) drink may reduce dehydration, improve patient-reported outcomes, enhance patient communication and clinician workflow, ultimately resulting in improved patient experience and cancer screening/detection. Although clinical validation and implementation of a complex CHO drink have already been completed in surgical patients within clear fluid protocols, this needs to be expanded to patients undergoing colonoscopy procedures.
A prospective, single-blinded, single-centre, randomized control design will be used to compare fasting from midnight the day of the colonoscopy [the current standard of care] to a clear fluid protocol [a complex CHO drink consumed the night before and 2 hours before the colonoscopy]. The physician performing the colonoscopy will be blinded to the group allocation. The primary outcome of the present study is pre and post-procedure patient-reported measures of discomfort in adults undergoing routine colonoscopy for cancer screening. Secondary outcome measures are compliance, hydration, and bowel visibility.
Hypotheses
- Patient-reported measures of discomfort pre and post colonoscopy will be lower in patients in the clear fluid group than the standard of care group.
- Hydration status will be greater in the clear fluids group than the fasting group.
- Colon visibility score (BBPS) will be higher in the clear fluids group
- Conditions
- Colonoscopy
- Being tested
- Complex Carbohydrate (PREcovery)
- Keywords
- Fasting, Pre-Operative Carbohydrate, Discomfort, Hydration, Bowel preparation, Bowel visibility
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complex Carbohydrate (PREcovery)Dietary supplement
Each serving of the complex carbohydrate drink is a clear, colorless, 12.5% maltodextrin drink with a citrus taste, prepared by mixing 54 g of powder (50g carbohydrate) with 400mL of cold water. Participants will consume 2 servings of the complex carbohydrate drink the evening before colonoscopy (100g carbohydrate, 800mL fluid), and 1 serving 2 hours before their colonoscopy (50g carbohydrate, 400mL fluid)
| Study group | Role | What they receive |
|---|---|---|
| Complex Carbohydrate | Experimental | Participants in the intervention group will be instructed to follow standard bowel preparation guidance AND consume two servings of the complex CHO (12.5% maltodextrin) drink (PREcovery®, Enhanced Medical Nutrition, Toronto, Canada) the evening prior to the procedure, and one serving 2-3 hours prior to the colonoscopy. Participants should not consume anything within 2 hours prior to the procedure's start time. One serving consists of one package (50 g maltodextrin) stirred into 400 mL of cold water.
Standard bowel preparation guidance is as follows a split-dose 2L PEG ± bisacodyl (iso-osmolar) solution (Bi-PegLyte®, Pendopharm, Montreal, Canada) taken according to the physician's order. All participants will be instructed to follow a clear fluid diet starting the day before the procedure. Participants will also be verbally instructed to consume 2L of clear liquids the day before their colonoscopy in addition to the PREcovery. Receives: Dietary Supplement: Complex Carbohydrate (PREcovery) |
| Fasting | No intervention | The Fasting arm will follow the current standard of care for colonoscopy preparations in Ontario, Canada. This includes fasting from midnight before the procedure and following a PEG bowel preparation All participants will follow a standard bowel preparation guidance, a split-dose 2L PEG ± bisacodyl (iso-osmolar) solution (Bi-PegLyte®, Pendopharm, Montreal, Canada) taken according to the physician's order. All participants will be instructed to follow a clear fluid diet starting the day before the procedure. Participants will also be verbally instructed to consume 2L of clear liquids the day before their colonoscopy. Participants in the fasting arm will be instructed to not have any oral intake after 00:00 of the day of their colonoscopy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-procedure Patient Reported Discomfort
Domains of discomfort will be evaluated by digital VAS: anxiety, depression, hunger, inability to concentrate, malaise, nausea, pain, thirst, tiredness, unfitness, and weakness. Visual analogue scales (VAS) will be used to measure each domain. the VAS will be measured from 1-10 representing "not at all _____" and "Very ____" respectively.
Measured: 30 minutes before the colonoscopy
Secondary outcomes (4)
Hydration
Plasma osmolality will be used to measure hydration status.
Measured: Blood samples will be collected from participants immediately after the colonoscopy has ended (time point 30 minutes) and they are cleared to leave the clinic
Compliance
Patients in the Treatment group will report the number of 50g maltodextrin packets they consumed before the procedure. Those having consumed all 3 packets provided will be reported as having 100% compliance. If the consumed none of the packets they will get a score of 0% compliance. 1 packet will result in a compliance score of 33%. 2 packets will result in a compliance score of 66%.
Measured: 30 minutes before the colonoscopy
Bowel Visibility
The Boston Bowel Preparation Scale (BBPS) will be used to evaluate visibility during the colonoscopy. The scale uses a 0-3 rating where 0 is the worst visibility rating ("inadequate") and 3 is the best visibility rating ("excellent"). Each of the 3 sections of the colon (left, transverse, and right) are rated using this scale and a cumulative score is determined from the sum of these three ratings.
Measured: During the colonoscopy (Time point 0)
Post-procedure Patient Reported Discomfort
Domains of discomfort will be evaluated by digital VAS: anxiety, depression, hunger, inability to concentrate, malaise, nausea, pain, thirst, tiredness, unfitness, and weakness. Visual analogue scales (VAS) will be used to measure each domain. the VAS will be measured from 1-10 representing "not at all _____" and "Very ____" respectively.
Measured: up to 6 hours after the colonoscopy visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start31 May 2022 (estimated)
- Primary completion30 Sep 2022 (estimated)
- Study completion1 Dec 2022 (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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Health Centre Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Enhanced Medical Nutrition
- Responsible party
- Principal investigator, Ian Bookman, St. Joseph's Health Centre Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05368792
- Sponsor's protocol ID
- REB 21-198
- Acronym
- POOPSCOPE
- Status last verified
- May 2022
- First submitted
- 29 Oct 2021
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Trial Of Osmolar Protocol Solution on Colonoscopy Outcomes and Patient Experience
- ClinicalTrials.gov ID
- NCT05368792
- Acronym / sponsor ID
- POOPSCOPE / REB 21-198
- Conditions
- Colonoscopy
- Keywords
- Fasting, Pre-Operative Carbohydrate, Discomfort, Hydration, Bowel preparation, Bowel visibility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- St. Joseph's Health Centre TorontoUniversity, hospital or other
- Collaborators
- Enhanced Medical Nutrition
- Study start
- 31 May 2022 (estimated)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 10 May 2022 (actual)
- 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.
Fasting is the current standard of care for colonoscopies. Recent changes to anesthesia guidelines have allowed for clear fluids to be provided up to 2 hours before procedures, including colonoscopies.
This study will compare fasting to a 12.5% carbohydrate solution 2 hours before colonoscopy on patient-reported measures of discomfort, hydration, and colon visibility.
The investigators hypothesize that the carbohydrate solution will improve patient-reported measures of discomfort, hydration, and colon visibility.
Detailed description
Fasting and bowel preparation before colonoscopy procedures has been the clinical protocol for decades. Evidence suggests that patients undergoing this traditional standard of care before procedures may be associated with common undesirable outcomes, including anxiety, thirst, and poor patient experience. The impacts of fasting and poor satisfaction can create a cascade of challenges regarding communication between clinicians and patients.
The new standard of care utilizes an innovative clear fluid protocol, allowing patients to consume clear fluids up to 2-3 hours prior to their procedure. The consumption of a complex carbohydrate (CHO) drink may reduce dehydration, improve patient-reported outcomes, enhance patient communication and clinician workflow, ultimately resulting in improved patient experience and cancer screening/detection. Although clinical validation and implementation of a complex CHO drink have already been completed in surgical patients within clear fluid protocols, this needs to be expanded to patients undergoing colonoscopy procedures.
A prospective, single-blinded, single-centre, randomized control design will be used to compare fasting from midnight the day of the colonoscopy [the current standard of care] to a clear fluid protocol [a complex CHO drink consumed the night before and 2 hours before the colonoscopy]. The physician performing the colonoscopy will be blinded to the group allocation. The primary outcome of the present study is pre and post-procedure patient-reported measures of discomfort in adults undergoing routine colonoscopy for cancer screening. Secondary outcome measures are compliance, hydration, and bowel visibility.
Hypotheses
- Patient-reported measures of discomfort pre and post colonoscopy will be lower in patients in the clear fluid group than the standard of care group.
- Hydration status will be greater in the clear fluids group than the fasting group.
- Colon visibility score (BBPS) will be higher in the clear fluids group
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Complex Carbohydrate | Experimental | Dietary Supplement: Complex Carbohydrate (PREcovery)Participants in the intervention group will be instructed to follow standard bowel preparation guidance AND consume two servings of the complex CHO (12.5% maltodextrin) drink (PREcovery®, Enhanced Medical Nutrition, Toronto, Canada) the evening prior to the procedure, and one serving 2-3 hours prior to the colonoscopy. Participants should not consume anything within 2 hours prior to the procedure's start time. One serving consists of one package (50 g maltodextrin) stirred into 400 mL of cold water. Standard bowel preparation guidance is as follows a split-dose 2L PEG ± bisacodyl (iso-osmolar) solution (Bi-PegLyte®, Pendopharm, Montreal, Canada) taken according to the physician's order. All participants will be instructed to follow a clear fluid diet starting the day before the procedure. Participants will also be verbally instructed to consume 2L of clear liquids the day before their colonoscopy in addition to the PREcovery. |
| Fasting | No intervention | –The Fasting arm will follow the current standard of care for colonoscopy preparations in Ontario, Canada. This includes fasting from midnight before the procedure and following a PEG bowel preparation All participants will follow a standard bowel preparation guidance, a split-dose 2L PEG ± bisacodyl (iso-osmolar) solution (Bi-PegLyte®, Pendopharm, Montreal, Canada) taken according to the physician's order. All participants will be instructed to follow a clear fluid diet starting the day before the procedure. Participants will also be verbally instructed to consume 2L of clear liquids the day before their colonoscopy. Participants in the fasting arm will be instructed to not have any oral intake after 00:00 of the day of their colonoscopy. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- referred for a routine colonoscopy for cancer screening
- Physician indicates a bowel preparation of split dose 2L PEG ± bisacodyl (iso-osmolar) solution
Key exclusion criteria (6 listed)
- patients with colonic resection, inflammatory bowel disease; any condition that would preclude colonoscopy of the whole colon;
- patients with lower gastrointestinal bleeding, patients with ileus, gastric retention, intestinal perforation, gastrointestinal obstruction;
- patients with significant heart disease, impaired renal function, decompensated liver disease
- patients who have diabetes
- patients on opioid medications.
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 |
|---|---|---|
| Complex Carbohydrate (PREcovery)Each serving of the complex carbohydrate drink is a clear, colorless, 12.5% maltodextrin drink with a citrus taste, prepared by mixing 54 g of powder (50g carbohydrate) with 400mL of cold water. Participants will consume 2 servings of the complex carbohydrate drink the evening before colonoscopy (100g carbohydrate, 800mL fluid), and 1 serving 2 hours before their colonoscopy (50g carbohydrate, 400mL fluid) | Dietary supplement | Complex Carbohydrate |
Primary outcome
Pre-procedure Patient Reported Discomfort
Time frame: 30 minutes before the colonoscopy
Domains of discomfort will be evaluated by digital VAS: anxiety, depression, hunger, inability to concentrate, malaise, nausea, pain, thirst, tiredness, unfitness, and weakness. Visual analogue scales (VAS) will be used to measure each domain. the VAS will be measured from 1-10 representing "not at all _____" and "Very ____" respectively.
4 secondary outcomes
Hydration
Time frame: Blood samples will be collected from participants immediately after the colonoscopy has ended (time point 30 minutes) and they are cleared to leave the clinic
Compliance
Time frame: 30 minutes before the colonoscopy
Bowel Visibility
Time frame: During the colonoscopy (Time point 0)
Post-procedure Patient Reported Discomfort
Time frame: up to 6 hours after the colonoscopy visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Complex Carbohydrate (PREcovery) in people with Colonoscopy, run by St. Joseph's Health Centre Toronto.
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 2 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: status not confirmed, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Ian Bookman, MD (14162262777, Office@gibookman.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-procedure Patient Reported Discomfort (time frame: 30 minutes before the 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 10 May 2022; AzTrials last refreshed its copy on 6 Nov 2026.