Impact of Telephone Call on Bowel Preparation Quality in Colonoscopies

August 31, 2021 updated by: Dr. Walid Nassreddine, Makassed General Hospital

Impact of Telephone Call for Patient Education on Bowel Preparation Quality in Outpatient Colonoscopies

Bowel preparation regimens typically incorporate dietary modifications along with oral cathartics. Inadequate bowel preparation can result in failed detection of prevalent neoplastic lesions and has been linked to an increased risk of procedural adverse events. Previous studies have suggested that patient compliance is important to ensure proper bowel cleansing. Patient counseling along with written instructions that are simple and easy to follow and in their native language should be provided to patients.

Thus, interventions that improve the quality of bowel preparation could have a great benefit regarding colonoscopy results. Little in the literature that studies the impact of enhanced patient education on bowel preparation quality.

In this study we aim to determine the impact of patient education using telephone call one day prior to outpatient colonoscopy on bowel preparation quality.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Beirut, Lebanon
        • Recruiting
        • Makassed General Hospital
        • Contact:

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients undergoing outpatient colonoscopy

Exclusion Criteria:

  • History of previous inadequate bowel preparation
  • History of colorectal surgeries
  • Patient who did not sign the consent
  • Patients with dementia
  • Patients with Swallowing difficulties

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional group
Patients will receive bowel preparation instructions in a conventional way in addition to a telephone call for education purposes one day prior to procedure
Patients undergoing outpatient colonoscopy will receive the standard bowel preparation instructions and a telephone call one day before the procedure to re-explain the instructions and the importance of bowel preparation
Patients will undergo colonoscopy
Placebo Comparator: Conventional group
Patients will receive bowel preparation instructions in a conventional way
Patients will undergo colonoscopy
Patients undergoing outpatient colonoscopy will receive the standard bowel preparation instructions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bowel preparation quality
Time Frame: Directly after colonoscopy

We will use Aronchick Scale as bowel preparation quality scale. This scale characterizes the percentage of the total colonic mucosal surface covered by fluid or stool, and is performed before washing or suctioning. This scale grades the adequacy of cleansing in the following:

  1. Excellent: Small volume of clear liquid, or greater than 95% of surface seen
  2. Good: Large volume of clear liquid covering 5-25% of the surface but greater than 90% of surface seen
  3. Fair: Presence of some semi-solid stool that could be suctioned or washed away but greater than 90% of surface seen
  4. Poor: Semi-solid stool that could not be suctioned or washed away and less than 90% of surface seen
  5. Inadequate: Repreparation needed Bowel preparation will be considered as adequate if the score is ≤ 3 and inadequate if the score of bowel preparation is ≥ 4.
Directly after colonoscopy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Colonic polyps rate
Time Frame: Directly after colonoscopy
Detect rate of colonic polyps in both groups
Directly after colonoscopy

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Walid Nassreddine, MD, Makassed General Hospital

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 (Actual)

November 25, 2020

Primary Completion (Anticipated)

August 1, 2021

Study Completion (Anticipated)

August 1, 2021

Study Registration Dates

First Submitted

November 19, 2020

First Submitted That Met QC Criteria

November 19, 2020

First Posted (Actual)

November 25, 2020

Study Record Updates

Last Update Posted (Actual)

September 1, 2021

Last Update Submitted That Met QC Criteria

August 31, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 10112020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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