Bowel PreparationNCT04087265
Accuracy of Trans-abdominal Ultrasound in Evaluating Bowel Preparation Adequacy Before Colonoscopy
A study testing Transabdominal ultrasound in people with Bowel Preparation, run by Johns Hopkins University.
Trial summary
Adequate preparation of the large bowel is required for a successful colonoscopy. It has been reported that poor preparation exists in 25% of examinations, which may lengthen overall procedure time, lower adenoma detection rate, and lead to earlier repeated colonoscopy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bowel Preparation
- What is being tested?
- Transabdominal ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2020to Mar 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy adults referring for screening colonoscopy
Who cannot join
- pregnancy
About this study
Official title: Accuracy of Trans Abdominal Ultrasound in Evaluating Bowel Preparation Adequacy Before Performing Colonoscopy
Adequate preparation of the large bowel is required for a successful colonoscopy. It has been reported that poor preparation exists in 25% of examinations, which may lengthen overall procedure time, lower adenoma detection rate, and lead to earlier repeated colonoscopy. Evaluating the large intestine preparation by transabdominal ultrasonography can be a helpful way to predict the quality of the colonoscopy before initiating the process and therefore prevent performing the procedure in case of inadequate preparation. Estimating the colon preparation using an easy, fast and low cost way as transabdominal ultrasound before performing the colonoscopy would help the physician determine the next step. In case of poor preparation, colonoscopy can be postponed and the patient can be saved from repeated colonoscopy. The aim of this is to determine the accuracy of transabdominal ultrasonography in evaluating bowel preparation adequacy before performing colonoscopy.
Read the detailed description
Colonoscopy is the most effective method of visualizing the colon mucosa. Adequate bowel preparation, which leads to clear visualization of mucosal surface of the colon, is important for a successful colonoscopy. Studies have shown that inadequate bowel preparation increases the adenoma detection failure, decreases the accuracy, prolongs the procedure time, decreases surveillance intervals, increases costs and results in procedure related complications. Poor preparation affects as many as 25% of colonoscopies and leads to an increase cost of colonoscopies. Endoscopists have long struggled to find the most appropriate follow-up strategy when the quality of bowel preparation is suboptimal. There is evidence of surveillance overuse in low-risk patients as well as underuse in high-risk patients.
Using a non-invasive, low cost approach for evaluating the bowel preparation before initiating the colonoscopy can save the patient from additional costs and procedures. Sonography has been used as a method of evaluating bowel condition in some colorectal diseases, mostly in Crohn's disease. Advantages of using ultrasound are that it is widely available, none-invasive, does not require preparation and lacks radiation exposure.
Transabdominal bowel ultrasound has the potential to be used as a screening tool for evaluating bowel preparation adequacy before performing the colonoscopy. To the best of the investigators' knowledge this is the first study evaluating bowel preparation by means of sonography before performing colonoscopy.
Consent will be obtained from volunteer patients who agree with participating in the study. Demographic data will be collected about an hour before the procedure. Patients will undergo transabdominal ultrasound by a trained physician 30 minutes before the scheduled colonoscopy. All the ultrasounds will be performed by one person. The sonologist will perform transabdominal ultrasound evaluation of bowel preparation using the following tools and criteria:
The scale of intestinal lumen of each section will be classified into one of four types: (i) empty (no intraluminal content is observed and the lumen is contracted or emptied; small amount of gas in colon lumen can be pressed away from the region of interest by using the transducer); (ii) filled (the lumen is filled with fluid and no obvious solid content); (iii) retention (flatulence and/or content retention in the intestine, with no improvement after pressing on the abdomen or changing the position of the patient); and (iv) mixed (two or three of the conditions described above is observed at a single site, namely filled + empty, retention + empty, retention + filled or retention + filled + empty).
Evaluation criteria will be divided into two main groups: cleaning grade and cleaning range. For cleaning grade, the cleanliness of each section of the intestinal lumen is assigned to a grade according to the evaluation of the lumen, as just described: I = emptying; II = filled or filled + empty; III = I or II with some retention; and IV = complete retention. Grades I and II (clear display of the colon wall) will be termed "qualified". The qualified rate of bowel preparation will be calculated with the number of qualified sections divided by the total number of colon sections in the group. For cleaning range, patients will be divided into three classes according to the number of qualified colon sections: A = all seven colon sections are fully qualified; B = four to six sections are qualified; C = three or fewer are qualified.
The scheduled colonoscopy will be performed according to the standard of care and the bowel preparation will be assessed using the BBPS score* as a routine in all colonoscopies.
*:The Boston bowel preparation scale (BBPS) was developed to limit interobserver variability in the rating of bowel-preparation quality, while preserving the ability to distinguish various degrees of bowel cleanliness. Subjective terms, such as "excellent," "good," "fair," "poor," and "unsatisfactory," are replaced by a 4-point scoring system applied to each of the 3 broad regions of the colon: the right side of the colon (including the cecum and ascending colon), the transverse section of the colon (including the hepatic and splenic flexures), and the left side of the colon (including the descending colon, sigmoid colon, and rectum). The points are assigned as follows:
- 0, unprepared colon segment with mucosa not seen because of solid stool that cannot be cleared.
- 1, portion of mucosa of the colon segment seen, but other areas of the colon segment are not well seen because of staining, residual stool, and/or opaque liquid.
- 2, minor amount of residual staining, small fragments of stool, and/or opaque liquid, but mucosa of colon segment is seen well.
- 3, entire mucosa of colon segment seen well, with no residual staining, small fragments of stool, or opaque liquid.
- Conditions
- Bowel Preparation
- Being tested
- Transabdominal ultrasound
- Keywords
- transabdominal ultrasound, bowel preparation, colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transabdominal ultrasoundDiagnostic test
Transabdominal ultrasound will be performed 30 minutes before colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Study Population (All Participants) | Other | Patients who are referring for scheduled screening colonoscopy Receives: Diagnostic Test: Transabdominal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of transabdominal ultrasound in evaluating bowel preparation adequacy before colonoscopy as assessed by the Boston Bowel Preparation Scale (BPPS)
The BBPS was developed to limit interobserver variability in the rating of bowel-preparation quality, while preserving the ability to distinguish various degrees of bowel cleanliness. The points are assigned as follows:
- 0 - unprepared colon segment with mucosa not seen because of solid stool that cannot be cleared.
- 1 - portion of mucosa of the colon segment seen, but other areas of the colon segment are not well seen because of staining, residual stool, and/or opaque liquid.
- 2 - minor amount of residual staining, small fragments of stool, and/or opaque liquid, but mucosa of colon segment is seen well.
- 3 - entire mucosa of colon segment seen well, with no residual staining, small fragments of stool, or opaque liquid.
The correlation between ultrasound score and BBPS score will be evaluated.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start15 Oct 2020 (estimated)
- Primary completionFeb 2021 (estimated)
- Study completionMar 2021 (estimated)
Why it stopped: The PI requested to terminate due to his schedule
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel PreparationStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anthony N Kalloo, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04087265
- Sponsor's protocol ID
- IRB00222200
- Status last verified
- Jul 2020
- First submitted
- 5 Sep 2019
- Last updated
- 4 Nov 2020
- 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 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Trans Abdominal Ultrasound in Evaluating Bowel Preparation Adequacy Before Performing Colonoscopy
- ClinicalTrials.gov ID
- NCT04087265
- Acronym / sponsor ID
- IRB00222200
- Conditions
- Bowel Preparation
- Keywords
- transabdominal ultrasound, bowel preparation, colonoscopy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The PI requested to terminate due to his schedule
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 15 Oct 2020 (estimated)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 12 Sep 2019 (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.
Adequate preparation of the large bowel is required for a successful colonoscopy. It has been reported that poor preparation exists in 25% of examinations, which may lengthen overall procedure time, lower adenoma detection rate, and lead to earlier repeated colonoscopy. Evaluating the large intestine preparation by transabdominal ultrasonography can be a helpful way to predict the quality of the colonoscopy before initiating the process and therefore prevent performing the procedure in case of inadequate preparation. Estimating the colon preparation using an easy, fast and low cost way as transabdominal ultrasound before performing the colonoscopy would help the physician determine the next step. In case of poor preparation, colonoscopy can be postponed and the patient can be saved from repeated colonoscopy. The aim of this is to determine the accuracy of transabdominal ultrasonography in evaluating bowel preparation adequacy before performing colonoscopy.
Detailed description
Colonoscopy is the most effective method of visualizing the colon mucosa. Adequate bowel preparation, which leads to clear visualization of mucosal surface of the colon, is important for a successful colonoscopy. Studies have shown that inadequate bowel preparation increases the adenoma detection failure, decreases the accuracy, prolongs the procedure time, decreases surveillance intervals, increases costs and results in procedure related complications. Poor preparation affects as many as 25% of colonoscopies and leads to an increase cost of colonoscopies. Endoscopists have long struggled to find the most appropriate follow-up strategy when the quality of bowel preparation is suboptimal. There is evidence of surveillance overuse in low-risk patients as well as underuse in high-risk patients.
Using a non-invasive, low cost approach for evaluating the bowel preparation before initiating the colonoscopy can save the patient from additional costs and procedures. Sonography has been used as a method of evaluating bowel condition in some colorectal diseases, mostly in Crohn's disease. Advantages of using ultrasound are that it is widely available, none-invasive, does not require preparation and lacks radiation exposure.
Transabdominal bowel ultrasound has the potential to be used as a screening tool for evaluating bowel preparation adequacy before performing the colonoscopy. To the best of the investigators' knowledge this is the first study evaluating bowel preparation by means of sonography before performing colonoscopy.
Consent will be obtained from volunteer patients who agree with participating in the study. Demographic data will be collected about an hour before the procedure. Patients will undergo transabdominal ultrasound by a trained physician 30 minutes before the scheduled colonoscopy. All the ultrasounds will be performed by one person. The sonologist will perform transabdominal ultrasound evaluation of bowel preparation using the following tools and criteria:
The scale of intestinal lumen of each section will be classified into one of four types: (i) empty (no intraluminal content is observed and the lumen is contracted or emptied; small amount of gas in colon lumen can be pressed away from the region of interest by using the transducer); (ii) filled (the lumen is filled with fluid and no obvious solid content); (iii) retention (flatulence and/or content retention in the intestine, with no improvement after pressing on the abdomen or changing the position of the patient); and (iv) mixed (two or three of the conditions described above is observed at a single site, namely filled + empty, retention + empty, retention + filled or retention + filled + empty).
Evaluation criteria will be divided into two main groups: cleaning grade and cleaning range. For cleaning grade, the cleanliness of each section of the intestinal lumen is assigned to a grade according to the evaluation of the lumen, as just described: I = emptying; II = filled or filled + empty; III = I or II with some retention; and IV = complete retention. Grades I and II (clear display of the colon wall) will be termed "qualified". The qualified rate of bowel preparation will be calculated with the number of qualified sections divided by the total number of colon sections in the group. For cleaning range, patients will be divided into three classes according to the number of qualified colon sections: A = all seven colon sections are fully qualified; B = four to six sections are qualified; C = three or fewer are qualified.
The scheduled colonoscopy will be performed according to the standard of care and the bowel preparation will be assessed using the BBPS score* as a routine in all colonoscopies.
*:The Boston bowel preparation scale (BBPS) was developed to limit interobserver variability in the rating of bowel-preparation quality, while preserving the ability to distinguish various degrees of bowel cleanliness. Subjective terms, such as "excellent," "good," "fair," "poor," and "unsatisfactory," are replaced by a 4-point scoring system applied to each of the 3 broad regions of the colon: the right side of the colon (including the cecum and ascending colon), the transverse section of the colon (including the hepatic and splenic flexures), and the left side of the colon (including the descending colon, sigmoid colon, and rectum). The points are assigned as follows:
- 0, unprepared colon segment with mucosa not seen because of solid stool that cannot be cleared.
- 1, portion of mucosa of the colon segment seen, but other areas of the colon segment are not well seen because of staining, residual stool, and/or opaque liquid.
- 2, minor amount of residual staining, small fragments of stool, and/or opaque liquid, but mucosa of colon segment is seen well.
- 3, entire mucosa of colon segment seen well, with no residual staining, small fragments of stool, or opaque liquid.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Population (All Participants) | Other | Diagnostic Test: Transabdominal ultrasoundPatients who are referring for scheduled screening colonoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy adults referring for screening colonoscopy
Key exclusion criteria (1 listed)
- pregnancy
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 |
|---|---|---|
| Transabdominal ultrasoundTransabdominal ultrasound will be performed 30 minutes before colonoscopy | Diagnostic test | Study Population (All Participants) |
Primary outcome
Accuracy of transabdominal ultrasound in evaluating bowel preparation adequacy before colonoscopy as assessed by the Boston Bowel Preparation Scale (BPPS)
Time frame: 4 months
The BBPS was developed to limit interobserver variability in the rating of bowel-preparation quality, while preserving the ability to distinguish various degrees of bowel cleanliness. The points are assigned as follows: * 0 - unprepared colon segment with mucosa not seen because of solid stool that cannot be cleared. * 1 - portion of mucosa of the colon segment seen, but other areas of the colon segment are not well seen because of staining, residual stool, and/or opaque liquid. * 2 - minor amount of residual staining, small fragments of stool, and/or opaque liquid, but mucosa of colon segment is seen well. * 3 - entire mucosa of colon segment seen well, with no residual staining, small fragments of stool, or opaque liquid. The correlation between ultrasound score and BBPS score will be evaluated.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Individual participant dataSharing planned: No
Related trials for Bowel Preparation
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Recruiting
Visual Aids for Colonoscopy Preparation: A Prospective Study on Patient Understanding and Bowel Cleanliness in Colonoscopy Patients
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Dose-Escalated Short-Course Proton Therapy for Locally Advanced Rectal Cancer
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Social Software-Based Intelligent Management System for Bowel Preparation
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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.
Anthony N Kalloo, MD principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
A study testing Transabdominal ultrasound in people with Bowel Preparation, run by Johns Hopkins University.
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 1 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: withdrawn, as of the sponsor's last update on 4 Nov 2020. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Accuracy of transabdominal ultrasound in evaluating bowel preparation adequacy before colonoscopy as assessed by the Boston Bowel Preparation Scale (BPPS) (time frame: 4 months). 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 4 Nov 2020.