Impact of Telephone Call on Bowel Preparation Quality in Colonoscopies

NCT04644939 | Unknown

• 1 other identifier: 10112020
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colonoscopy

Outcome Measures

Primary Outcomes (1)

• Bowel preparation quality

  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 Outcomes (1)

• Colonic polyps rate

  Directly after colonoscopy

Study Arms (2)

Interventional group

EXPERIMENTAL

Patients will receive bowel preparation instructions in a conventional way in addition to a telephone call for education purposes one day prior to procedure

Other: Phone calls; Other: Colonoscopy

Conventional group

PLACEBO COMPARATOR

Patients will receive bowel preparation instructions in a conventional way

Other: Standard bowel preparation; Other: Colonoscopy

Interventions

Phone calls OTHER

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

Interventional group

Standard bowel preparation OTHER

Patients undergoing outpatient colonoscopy will receive the standard bowel preparation instructions

Conventional group

Colonoscopy OTHER

Patients will undergo colonoscopy

Conventional group; Interventional group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing outpatient colonoscopy

You may not qualify if:

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

Sponsors & Collaborators

• Makassed General Hospital: lead

Study Sites (1)

Makassed General Hospital

Beirut, Lebanon

RECRUITING

MeSH Terms

Interventions

Colonoscopy

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Walid Nassreddine, MD

  Makassed General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Walid Nassreddine, MD

CONTACT

+9611636000; walidan@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Gastroenterology division

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: November 25, 2020
• Study Start: November 25, 2020
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: September 1, 2021

Record last verified: 2021-08

Locations

LE (1)