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

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ClinicalTrials.gov Identifier: NCT04087265
Recruitment Status : Not yet recruiting
First Posted : September 12, 2019
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Bowel Preparation Diagnostic Test: Transabdominal ultrasound Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: The endoscopist who performs the colonoscopy will be blinded to the ultrasound results.
Primary Purpose: Other
Official Title: Accuracy of Trans Abdominal Ultrasound in Evaluating Bowel Preparation Adequacy Before Performing Colonoscopy
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy adults referring for screening colonoscopy

Exclusion Criteria:

  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04087265


Contacts
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Contact: Anthony N Kalloo, MD 410-955-9697 akalloo@jhmi.edu

Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Anthony N Kalloo, MD Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04087265     History of Changes
Other Study ID Numbers: IRB00222200
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
transabdominal ultrasound
bowel preparation
colonoscopy