ColonoscopyNCT03650725
Evaluation of Information on Bowel Preparation for Morning Colonoscopy
An observational study of Colonoscopy and Patient Compliance, run by Harminder Singh at 1 site in Canada.
Trial summary
Background: In randomized controlled trials, split-dose bowel preparation for colonoscopy has been shown to provide better bowel cleansing than day before bowel preparation. However, people who volunteer to be in clinical trials may be more adherent to a challenging bowel preparation regimen than people in the general… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy, Patient Compliance
- What is being tested?
- Mandatory Split bowel preparation
- How many people
- 1,000 participants
- Where
- 1 siteCanada
- Study dates
- 30 Jun 2018to 30 Jun 2023
- Phase
- Observational
- 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
Study population: Description of Population: We will enroll all persons who are scheduled to undergo colonoscopy by one of the four participating gastroenterologists at an outpatient hospital-based endoscopy centre in Winnipeg, Canada, in this trial. These four gastroenterologists have been in practice for 10 years or greater, and all perform over 400 colonoscopies annually. Patients are referred to these gastroenterologists by a centralized referral program, which is responsible for scheduling the procedure and for distributing the bowel preparation instructions- This program is randomly assigning to mandatory and optional split preparation as part of routine care; stratified randomization by early vs. later morning.
Who may be able to join
- Must be 18 years of age or older
- Must have colonoscopy appointment with any 4 of the participating GI doctors at Health Sciences Centre-Winnipeg
- Must use 4 liter type of bowel preparation
Who cannot join
- Has colonoscopy appointment with non-participating GI doctor and/or a non-participating endoscopy hospital/clinic
- Patient and/or referral doctor requested a non-4 liter bowel preparation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Information Provided to Patients Provided About Bowel Preparation for Morning Colonoscopy
Background: In randomized controlled trials, split-dose bowel preparation for colonoscopy has been shown to provide better bowel cleansing than day before bowel preparation. However, people who volunteer to be in clinical trials may be more adherent to a challenging bowel preparation regimen than people in the general community undergoing colonoscopy. This may be especially true for colonoscopies scheduled for the morning, when the later dose of the split-dose bowel preparation would be administered in the early morning hours. Hence the results of the available trials may not be applicable to patients undergoing morning colonoscopy in routine medical practices.
Aims: To compare the effectiveness of mandatory split-dose bowel preparation to optional split-dose bowel preparation protocols for morning colonoscopies in a non-inferiority pragmatic trial.
Anticipated results and significance: The study will produce a better understanding of the most effective approach to bowel preparation for early morning colonoscopies and suggest specific recommendations for colonoscopy practice.
Read the detailed description
Patient will be randomized by the central booking office. Patient experience survey will be administered prior to colonoscopy. Chart review will be done to obtain data from the medical records and endoscopy reports. Please see outcomes and planned analysis.
- Conditions
- Colonoscopy, Patient Compliance
- Being tested
- Mandatory Split bowel preparation
- Keywords
- Colonoscopy, bowel preparation
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandatory Split bowel preparationOther
Also called Instructions for Bowel preparation before colonoscopy
Intervention describes the standard of care patient split bowel preparation instructions as mandatory, instead of giving patient instructions with option of choice between split or day before bowel prep.
| Study group | Role | What they receive |
|---|---|---|
| Mandatory Split bowel preparation | Patients will be advised to take 4 liters of polyethylene glycol (PEG), split into two 2 liter doses. The first 2 liters are to be taken starting at 1800 hours the day before the colonoscopy, and the second dose is to be taken starting 4-5 hours prior to the scheduled time for the colonoscopy. Each dose will be taken within a 2-hour time span. Receives: Other: Mandatory Split bowel preparation | |
| Optional Split bowel preparation | Patients will be advised on split-dose bowel preparation (as per option 1), but will also receive instructions on day before bowel preparation. The instructions will indicate that split-dose bowel preparation is the optimal preparation for cleansing the bowel and for visualizing polyps, but they may choose day before bowel preparation if the split dose preparation is too difficult for them. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of bowel cleanliness as measured by Boston Bowel Preparation Scale Score (0-2) in all segments
Proportion with adequate cleansing as measured by Boston Bowel Preparation Scale Score ≥2 in all segments. Boston Bowel Preparation Scale Score is reported as score of 0 to 3 in 3 segments of the colon. The score is then summed for a total score of 0 to 9. Higher Boston score, better quality of bowel cleanliness.
Measured: At the scheduled colonoscopy procedure performed with the instructions provided, expected average within 3 months
Secondary outcomes (14)
Composite with any of the following: cancellations in the day before colonoscopy; no shows for colonoscopy appointment; phone calls for questions on the bowel preparation and/or rescheduling because of the bowel preparation.
Determine the proportion with any of the following: cancellations in the day before colonoscopy; no shows for colonoscopy appointment (composite and separate analysis for these 2 outcomes); phone calls for questions on the bowel preparation and/or rescheduling because of the bowel preparation (indicator of staff workload generated).. This is a composite measure of number of individuals in each of the listed categories. Each will also be reported separately.
Measured: Anytime before the scheduled colonoscopy procedure performed with the instructions provided, expected average within 3 months
Amount of laxative intake
Amount of laxative intake before colonoscopy will be compared in the two groups.
Measured: In the 24 hours before the scheduled colonoscopy,expected average within 3 months
Proportion with split dose laxative intake
Split dose refers to taking half the dose of the laxative day before colonoscopy and half on the day of the colonoscopy.
Measured: In the 24 hours before the scheduled colonoscopy,expected average within 3 months
Endoscopic Outcome 1: Cecal intubation (colonoscopy completion)
Compare cecal intubation rate between the groups.
Measured: At the scheduled colonoscopy procedure, expected average within 3 months
Endoscopic Outcome 2: Withdrawal time during colonoscopy performance
Compare withdrawal time between the groups.
Measured: At the scheduled colonoscopy procedure, expected average within 3 months
Endoscopic Outcome 3: total time for performance of colonoscopy
Compare total procedure time between the groups.
Measured: At the scheduled colonoscopy procedure, expected average within 3 months
Endoscopic Outcome 4: polyps during colonoscopy
Compare polyp detection (adenoma, sessile serrated polyps) detection rates between the groups.
Measured: At the scheduled colonoscopy procedure, expected average within 3 months
Patient experience data outcome 1: use of split dose bowel preparation
We will determine the proportion reporting: use of split dose and day before bowel preparation
Measured: Before scheduled colonoscopy procedure, expected average within 3 months
Patient experience data outcome 2: complete intake of all of the prescribed laxative
We will determine the proportion reporting consumption of all of the laxative
Measured: Before scheduled colonoscopy procedure, expected average within 3 months
Patient experience data outcome 3: incontinence episodes while preparing for colonoscopy
We will determine the proportion reporting incontinence episodes during bowel preparation and during travel to the colonoscopy appointment
Measured: Before scheduled colonoscopy procedure, expected average within 3 months
Patient experience data outcome 4: Sleep in night before colonoscopy
We will determine and compare the total duration of sleep
Measured: Before scheduled colonoscopy procedure, expected average within 3 months
Patient experience data outcome 5: willingness to repeat colonoscopy using same laxative preparation
We will determine the proportion reporting patient willingness to repeat colonoscopy using same preparation
Measured: Assessed immediately before scheduled colonoscopy procedure, expected average within 3 months
Patient experience data outcome 6: pre-colonoscopy anxiety (Likert scale 1-5)
We will determine and compare the pre-colonoscopy anxiety rating, assessed on 5 point Likert scale (1-5). Higher values represent higher anxiety.
Measured: Assessed immediately before scheduled colonoscopy procedure, expected average within 3 months
Patient experience data outcome 7: difficulty with bowel preparation (Likert scale 1-10)
We will determine and compare difficulty with bowel preparation rating, as reported by patients on a ten point Likert scale (1-10). Higher values represent less difficulty (i.e. more tolerance)
Measured: Assessed immediately before scheduled colonoscopy procedure, expected average within 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start30 Jun 2018
- Primary completion30 Jun 2022
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harminder Singh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Harminder Singh, University of Manitoba
- Investigators
- Harminder Singh, MD, MPH, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03650725
- Sponsor's protocol ID
- H2018:202
- Status last verified
- Jan 2024
- First submitted
- 15 Aug 2018
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rex DK. Optimal bowel preparation--a practical guide for clinicians. Nat Rev Gastroenterol Hepatol. 2014 Jul;11(7):419-25. doi: 10.1038/nrgastro.2014.35. Epub 2014 Apr 1.
PubMed 24686267Martel M, Barkun AN, Menard C, Restellini S, Kherad O, Vanasse A. Split-Dose Preparations Are Superior to Day-Before Bowel Cleansing Regimens: A Meta-analysis. Gastroenterology. 2015 Jul;149(1):79-88. doi: 10.1053/j.gastro.2015.04.004. Epub 2015 Apr 8.
PubMed 25863216Horton N, Garber A, Hasson H, Lopez R, Burke CA. Impact of Single- vs. Split-Dose Low-Volume Bowel Preparations on Bowel Movement Kinetics, Patient Inconvenience, and Polyp Detection: A Prospective Trial. Am J Gastroenterol. 2016 Sep;111(9):1330-7. doi: 10.1038/ajg.2016.273. Epub 2016 Jul 5.
PubMed 27377521Radaelli F, Paggi S, Hassan C, Senore C, Fasoli R, Anderloni A, Buffoli F, Savarese MF, Spinzi G, Rex DK, Repici A. Split-dose preparation for colonoscopy increases adenoma detection rate: a randomised controlled trial in an organised screening programme. Gut. 2017 Feb;66(2):270-277. doi: 10.1136/gutjnl-2015-310685. Epub 2015 Dec 9.
PubMed 26657900Bucci C, Rotondano G, Hassan C, Rea M, Bianco MA, Cipolletta L, Ciacci C, Marmo R. Optimal bowel cleansing for colonoscopy: split the dose! A series of meta-analyses of controlled studies. Gastrointest Endosc. 2014 Oct;80(4):566-576.e2. doi: 10.1016/j.gie.2014.05.320. Epub 2014 Jul 19.
PubMed 25053529Siddiqui AA, Yang K, Spechler SJ, Cryer B, Davila R, Cipher D, Harford WV. Duration of the interval between the completion of bowel preparation and the start of colonoscopy predicts bowel-preparation quality. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):700-6. doi: 10.1016/j.gie.2008.09.047.
PubMed 19251013Johnson DA, Barkun AN, Cohen LB, Dominitz JA, Kaltenbach T, Martel M, Robertson DJ, Boland CR, Giardello FM, Lieberman DA, Levin TR, Rex DK; US Multi-Society Task Force on Colorectal Cancer. Optimizing adequacy of bowel cleansing for colonoscopy: recommendations from the US multi-society task force on colorectal cancer. Gastroenterology. 2014 Oct;147(4):903-24. doi: 10.1053/j.gastro.2014.07.002. No abstract available.
PubMed 25239068Hassan C, Bretthauer M, Kaminski MF, Polkowski M, Rembacken B, Saunders B, Benamouzig R, Holme O, Green S, Kuiper T, Marmo R, Omar M, Petruzziello L, Spada C, Zullo A, Dumonceau JM; European Society of Gastrointestinal Endoscopy. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy. 2013;45(2):142-50. doi: 10.1055/s-0032-1326186. Epub 2013 Jan 18.
PubMed 23335011Ton L, Lee H, Taunk P, Calderwood AH, Jacobson BC. Nationwide variability of colonoscopy preparation instructions. Dig Dis Sci. 2014 Aug;59(8):1726-32. doi: 10.1007/s10620-014-3262-8. Epub 2014 Jul 2.
PubMed 24985353Clark BT, Protiva P, Nagar A, Imaeda A, Ciarleglio MM, Deng Y, Laine L. Quantification of Adequate Bowel Preparation for Screening or Surveillance Colonoscopy in Men. Gastroenterology. 2016 Feb;150(2):396-405; quiz e14-5. doi: 10.1053/j.gastro.2015.09.041. Epub 2015 Oct 9.
PubMed 26439436Calderwood AH, Schroy PC 3rd, Lieberman DA, Logan JR, Zurfluh M, Jacobson BC. Boston Bowel Preparation Scale scores provide a standardized definition of adequate for describing bowel cleanliness. Gastrointest Endosc. 2014 Aug;80(2):269-76. doi: 10.1016/j.gie.2014.01.031. Epub 2014 Mar 12.
PubMed 24629422Parmar R, Martel M, Rostom A, Barkun AN. Validated Scales for Colon Cleansing: A Systematic Review. Am J Gastroenterol. 2016 Feb;111(2):197-204; quiz 205. doi: 10.1038/ajg.2015.417. Epub 2016 Jan 19.
PubMed 26782820Menees SB, Kim HM, Wren P, Zikmund-Fisher BJ, Elta GH, Foster S, Korsnes S, Graustein B, Schoenfeld P. Patient compliance and suboptimal bowel preparation with split-dose bowel regimen in average-risk screening colonoscopy. Gastrointest Endosc. 2014 May;79(5):811-820.e3. doi: 10.1016/j.gie.2014.01.024. Epub 2014 Mar 13.
PubMed 24631492Singh H, Kaita L, Taylor G, Nugent Z, Bernstein C. Practice and documentation of performance of colonoscopy in a central Canadian health region. Can J Gastroenterol Hepatol. 2014 Apr;28(4):185-90. doi: 10.1155/2014/635932.
PubMed 24729991Porostocky P, Chiba N, Colacino P, Sadowski D, Singh H. A survey of sedation practices for colonoscopy in Canada. Can J Gastroenterol. 2011 May;25(5):255-60. doi: 10.1155/2011/783706.
PubMed 21647459
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Information Provided to Patients Provided About Bowel Preparation for Morning Colonoscopy
- ClinicalTrials.gov ID
- NCT03650725
- Acronym / sponsor ID
- H2018:202
- Conditions
- Colonoscopy, Patient Compliance
- Keywords
- Colonoscopy, bowel preparation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Harminder SinghUniversity, hospital or other
- Study start
- 30 Jun 2018 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 29 Aug 2018 (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.
Background: In randomized controlled trials, split-dose bowel preparation for colonoscopy has been shown to provide better bowel cleansing than day before bowel preparation. However, people who volunteer to be in clinical trials may be more adherent to a challenging bowel preparation regimen than people in the general community undergoing colonoscopy. This may be especially true for colonoscopies scheduled for the morning, when the later dose of the split-dose bowel preparation would be administered in the early morning hours. Hence the results of the available trials may not be applicable to patients undergoing morning colonoscopy in routine medical practices.
Aims: To compare the effectiveness of mandatory split-dose bowel preparation to optional split-dose bowel preparation protocols for morning colonoscopies in a non-inferiority pragmatic trial.
Anticipated results and significance: The study will produce a better understanding of the most effective approach to bowel preparation for early morning colonoscopies and suggest specific recommendations for colonoscopy practice.
Detailed description
Patient will be randomized by the central booking office. Patient experience survey will be administered prior to colonoscopy. Chart review will be done to obtain data from the medical records and endoscopy reports. Please see outcomes and planned analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mandatory Split bowel preparation | – | Other: Mandatory Split bowel preparationPatients will be advised to take 4 liters of polyethylene glycol (PEG), split into two 2 liter doses. The first 2 liters are to be taken starting at 1800 hours the day before the colonoscopy, and the second dose is to be taken starting 4-5 hours prior to the scheduled time for the colonoscopy. Each dose will be taken within a 2-hour time span. |
| Optional Split bowel preparation | – | –Patients will be advised on split-dose bowel preparation (as per option 1), but will also receive instructions on day before bowel preparation. The instructions will indicate that split-dose bowel preparation is the optimal preparation for cleansing the bowel and for visualizing polyps, but they may choose day before bowel preparation if the split dose preparation is too difficult for them. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Description of Population: We will enroll all persons who are scheduled to undergo colonoscopy by one of the four participating gastroenterologists at an outpatient hospital-based endoscopy centre in Winnipeg, Canada, in this trial. These four gastroenterologists have been in practice for 10 years or greater, and all perform over 400 colonoscopies annually. Patients are referred to these gastroenterologists by a centralized referral program, which is responsible for scheduling the procedure and for distributing the bowel preparation instructions- This program is randomly assigning to mandatory and optional split preparation as part of routine care; stratified randomization by early vs. later morning.
Key inclusion criteria (3 listed)
- Must be 18 years of age or older
- Must have colonoscopy appointment with any 4 of the participating GI doctors at Health Sciences Centre-Winnipeg
- Must use 4 liter type of bowel preparation
Key exclusion criteria (2 listed)
- Has colonoscopy appointment with non-participating GI doctor and/or a non-participating endoscopy hospital/clinic
- Patient and/or referral doctor requested a non-4 liter bowel preparation
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 |
|---|---|---|
| Mandatory Split bowel preparationAlso: Instructions for Bowel preparation before colonoscopyIntervention describes the standard of care patient split bowel preparation instructions as mandatory, instead of giving patient instructions with option of choice between split or day before bowel prep. | Other | Mandatory Split bowel preparation |
Primary outcome
Quality of bowel cleanliness as measured by Boston Bowel Preparation Scale Score (0-2) in all segments
Time frame: At the scheduled colonoscopy procedure performed with the instructions provided, expected average within 3 months
Proportion with adequate cleansing as measured by Boston Bowel Preparation Scale Score ≥2 in all segments. Boston Bowel Preparation Scale Score is reported as score of 0 to 3 in 3 segments of the colon. The score is then summed for a total score of 0 to 9. Higher Boston score, better quality of bowel cleanliness.
14 secondary outcomes
Composite with any of the following: cancellations in the day before colonoscopy; no shows for colonoscopy appointment; phone calls for questions on the bowel preparation and/or rescheduling because of the bowel preparation.
Time frame: Anytime before the scheduled colonoscopy procedure performed with the instructions provided, expected average within 3 months
Amount of laxative intake
Time frame: In the 24 hours before the scheduled colonoscopy,expected average within 3 months
Proportion with split dose laxative intake
Time frame: In the 24 hours before the scheduled colonoscopy,expected average within 3 months
Endoscopic Outcome 1: Cecal intubation (colonoscopy completion)
Time frame: At the scheduled colonoscopy procedure, expected average within 3 months
Endoscopic Outcome 2: Withdrawal time during colonoscopy performance
Time frame: At the scheduled colonoscopy procedure, expected average within 3 months
Endoscopic Outcome 3: total time for performance of colonoscopy
Time frame: At the scheduled colonoscopy procedure, expected average within 3 months
Endoscopic Outcome 4: polyps during colonoscopy
Time frame: At the scheduled colonoscopy procedure, expected average within 3 months
Patient experience data outcome 1: use of split dose bowel preparation
Time frame: Before scheduled colonoscopy procedure, expected average within 3 months
Patient experience data outcome 2: complete intake of all of the prescribed laxative
Time frame: Before scheduled colonoscopy procedure, expected average within 3 months
Patient experience data outcome 3: incontinence episodes while preparing for colonoscopy
Time frame: Before scheduled colonoscopy procedure, expected average within 3 months
Patient experience data outcome 4: Sleep in night before colonoscopy
Time frame: Before scheduled colonoscopy procedure, expected average within 3 months
Patient experience data outcome 5: willingness to repeat colonoscopy using same laxative preparation
Time frame: Assessed immediately before scheduled colonoscopy procedure, expected average within 3 months
Patient experience data outcome 6: pre-colonoscopy anxiety (Likert scale 1-5)
Time frame: Assessed immediately before scheduled colonoscopy procedure, expected average within 3 months
Patient experience data outcome 7: difficulty with bowel preparation (Likert scale 1-10)
Time frame: Assessed immediately before scheduled colonoscopy procedure, expected average within 3 months
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 9 Jan 2024.
- Background: PubMed 24686267Rex DK. Optimal bowel preparation--a practical guide for clinicians. Nat Rev Gastroenterol Hepatol. 2014 Jul;11(7):419-25. doi: 10.1038/nrgastro.2014.35. Epub 2014 Apr 1.
- Background: PubMed 25863216Martel M, Barkun AN, Menard C, Restellini S, Kherad O, Vanasse A. Split-Dose Preparations Are Superior to Day-Before Bowel Cleansing Regimens: A Meta-analysis. Gastroenterology. 2015 Jul;149(1):79-88. doi: 10.1053/j.gastro.2015.04.004. Epub 2015 Apr 8.
- Background: PubMed 27377521Horton N, Garber A, Hasson H, Lopez R, Burke CA. Impact of Single- vs. Split-Dose Low-Volume Bowel Preparations on Bowel Movement Kinetics, Patient Inconvenience, and Polyp Detection: A Prospective Trial. Am J Gastroenterol. 2016 Sep;111(9):1330-7. doi: 10.1038/ajg.2016.273. Epub 2016 Jul 5.
- Background: PubMed 26657900Radaelli F, Paggi S, Hassan C, Senore C, Fasoli R, Anderloni A, Buffoli F, Savarese MF, Spinzi G, Rex DK, Repici A. Split-dose preparation for colonoscopy increases adenoma detection rate: a randomised controlled trial in an organised screening programme. Gut. 2017 Feb;66(2):270-277. doi: 10.1136/gutjnl-2015-310685. Epub 2015 Dec 9.
- Background: PubMed 25053529Bucci C, Rotondano G, Hassan C, Rea M, Bianco MA, Cipolletta L, Ciacci C, Marmo R. Optimal bowel cleansing for colonoscopy: split the dose! A series of meta-analyses of controlled studies. Gastrointest Endosc. 2014 Oct;80(4):566-576.e2. doi: 10.1016/j.gie.2014.05.320. Epub 2014 Jul 19.
- Background: PubMed 19251013Siddiqui AA, Yang K, Spechler SJ, Cryer B, Davila R, Cipher D, Harford WV. Duration of the interval between the completion of bowel preparation and the start of colonoscopy predicts bowel-preparation quality. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):700-6. doi: 10.1016/j.gie.2008.09.047.
- Background: PubMed 25239068Johnson DA, Barkun AN, Cohen LB, Dominitz JA, Kaltenbach T, Martel M, Robertson DJ, Boland CR, Giardello FM, Lieberman DA, Levin TR, Rex DK; US Multi-Society Task Force on Colorectal Cancer. Optimizing adequacy of bowel cleansing for colonoscopy: recommendations from the US multi-society task force on colorectal cancer. Gastroenterology. 2014 Oct;147(4):903-24. doi: 10.1053/j.gastro.2014.07.002. No abstract available.
- Background: PubMed 23335011Hassan C, Bretthauer M, Kaminski MF, Polkowski M, Rembacken B, Saunders B, Benamouzig R, Holme O, Green S, Kuiper T, Marmo R, Omar M, Petruzziello L, Spada C, Zullo A, Dumonceau JM; European Society of Gastrointestinal Endoscopy. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy. 2013;45(2):142-50. doi: 10.1055/s-0032-1326186. Epub 2013 Jan 18.
- Background: PubMed 24985353Ton L, Lee H, Taunk P, Calderwood AH, Jacobson BC. Nationwide variability of colonoscopy preparation instructions. Dig Dis Sci. 2014 Aug;59(8):1726-32. doi: 10.1007/s10620-014-3262-8. Epub 2014 Jul 2.
- Background: PubMed 26439436Clark BT, Protiva P, Nagar A, Imaeda A, Ciarleglio MM, Deng Y, Laine L. Quantification of Adequate Bowel Preparation for Screening or Surveillance Colonoscopy in Men. Gastroenterology. 2016 Feb;150(2):396-405; quiz e14-5. doi: 10.1053/j.gastro.2015.09.041. Epub 2015 Oct 9.
- Background: PubMed 24629422Calderwood AH, Schroy PC 3rd, Lieberman DA, Logan JR, Zurfluh M, Jacobson BC. Boston Bowel Preparation Scale scores provide a standardized definition of adequate for describing bowel cleanliness. Gastrointest Endosc. 2014 Aug;80(2):269-76. doi: 10.1016/j.gie.2014.01.031. Epub 2014 Mar 12.
- Background: PubMed 26782820Parmar R, Martel M, Rostom A, Barkun AN. Validated Scales for Colon Cleansing: A Systematic Review. Am J Gastroenterol. 2016 Feb;111(2):197-204; quiz 205. doi: 10.1038/ajg.2015.417. Epub 2016 Jan 19.
- 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.
Harminder Singh, MD, MPH principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonoscopy and Patient Compliance, run by Harminder Singh at 1 site 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 3 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 9 Jan 2024. 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 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.
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 bowel cleanliness as measured by Boston Bowel Preparation Scale Score (0-2) in all segments (time frame: At the scheduled colonoscopy procedure performed with the instructions provided, expected average within 3 months). 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 NCT03650725, which also lists 23 linked publications.
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 9 Jan 2024.