Accuracy of Trans-abdominal Ultrasound in Evaluating Bowel Preparation Adequacy Before Colonoscopy

November 2, 2020 updated by: Johns Hopkins University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy adults referring for screening colonoscopy

Exclusion Criteria:

  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: Study Population (All Participants)
Patients who are referring for scheduled screening colonoscopy
Diagnostic test: Transabdominal ultrasound
Transabdominal ultrasound will be performed 30 minutes before colonoscopy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Anthony N Kalloo, MD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 5, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 12, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 4, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00222200

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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