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

NCT04087265 | Withdrawn

• 1 other identifier: IRB00222200
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bowel Preparation

Keywords

transabdominal ultrasound; bowel preparation; colonoscopy

Outcome Measures

Primary Outcomes (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.

  4 months

Study Arms (1)

Study Population (All Participants)

OTHER

Patients who are referring for scheduled screening colonoscopy

Diagnostic Test: Transabdominal ultrasound

Interventions

Transabdominal ultrasound DIAGNOSTIC_TEST

Transabdominal ultrasound will be performed 30 minutes before colonoscopy

Study Population (All Participants)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy adults referring for screening colonoscopy

You may not qualify if:

• pregnancy

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Officials

• Anthony N Kalloo, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The endoscopist who performs the colonoscopy will be blinded to the ultrasound results.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 12, 2019
• Study Start: October 15, 2020
• Primary Completion: February 1, 2021
• Study Completion: March 1, 2021
• Last Updated: November 4, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share