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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.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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.
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 groups in NCT04087265
Study groupRoleWhat they receive
Study Population (All Participants)OtherPatients 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.

  1. 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.

  1. First posted12 Sep 2019
  2. Study start15 Oct 2020 (estimated)
  3. Primary completionFeb 2021 (estimated)
  4. Study completionMar 2021 (estimated)

Why it stopped: The PI requested to terminate due to his schedule

Resources

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)
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

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.

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