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OpenTrials
Completed

NCT Number: NCT07093099

Effect of Counseling and Education on Mechanical Bowel Preparation

The goal of this clinical trial is to learn whether enhanced education and counseling can improve bowel preparation before colonoscopy in high-risk patients. The main questions it aims to answer are:

Does enhanced education lead to better bowel cleansing as measured by the Boston Bowel Preparation Scale (BBPS)?

Does it improve patient satisfaction, compliance with instructions, and procedure efficiency?

Researchers will compare an enhanced education program (including counseling, video, booklet, and mobile app) to standard written instructions typically given before colonoscopy.

Participants will:

Be randomly assigned to either the enhanced education group or the standard instruction group

Undergo routine colonoscopy after following the assigned preparation method

Complete short questionnaires about their experience, satisfaction, and willingness to repeat the process

This study is being done at two hospitals in Palestine.

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Key information

Conditions

Colonoscopy Colorectal Cancer Screening

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rafidia Surgical Hospital

Nablus, P400, Palestinian Territories

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age 18 years or older

Undergoing elective colonoscopy

Considered high-risk for inadequate bowel preparation, including at least one of the following:

Prior abdominal or pelvic surgery

Chronic constipation (fewer than 3 bowel movements per week)

Use of constipating medications (e.g., opioids, tricyclic antidepressants, calcium channel blockers)

Age >65 years

Multiple comorbidities (e.g., diabetes, neurologic disorders affecting motility)

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Exclusion criteria

Known allergy or intolerance to bowel preparation agents

Pregnancy

Severe comorbidities (e.g., decompensated liver disease, severe heart failure)

Cognitive impairment or illiteracy preventing understanding of instructions

Emergency colonoscopy or known obstructive colorectal disease

Treatment and study plan

Enhanced Education Package for Bowel Preparation

Behavioral

a multifaceted intervention was designed to improve mechanical bowel preparation (MBP) in patients undergoing colonoscopy. It included:

Structured face-to-face counseling on the importance of bowel prep, potential complications of poor prep, and how to follow instructions.

A 6-minute instructional video explaining step-by-step dietary and medication instructions.

A printed booklet with visual aids summarizing key steps.

A mobile phone app delivering interactive reminders, tracking tools, and preparation guidance.

All participants used the same polyethylene glycol-based bowel cleansing agent.

Other names: Enhanced Counseling, Video Instruction, Booklet and Mobile App Support

Standard Education Leaflet

Other

Participants in this arm received a standard hospital-issued bowel preparation instruction leaflet. The document provided written instructions on dietary modifications, timing and dosage of the bowel cleansing agent, and day-of-procedure guidance. No personalized counseling, video support, or reminder tools were provided. This reflects the routine care practice at the study hospitals.

Other names: Standard Instructions, Usual Care Preparation

Primary outcomes

  1. Boston Bowel Preparation Scale (BBPS) Total Score

    Time frame: During the procedure itself

    The BBPS is a validated scoring system to assess bowel cleanliness during colonoscopy. It ranges from 0-9, with three sub-scores (right, transverse, left colon) each scored 0-3. Higher scores indicate better bowel preparation quality. Total BBPS score will be compared between groups.

Secondary outcomes

  1. Patient Satisfaction Score

    Time frame: Within 24 hours after colonoscopy

    Measured on a 10-point Likert scale, with 1 = very dissatisfied and 10 = very satisfied. Participants were surveyed about their experience with the preparation process.

  2. Cecal Intubation Time

    Time frame: During the procedure itself

    Time (in minutes) from insertion of the colonoscope to successful intubation of the cecum, recorded by the performing endoscopist. Lower times indicate more efficient procedures.

  3. Willingness to Repeat Preparation

    Time frame: Within 24 hours after colonoscopy

    Participant-reported willingness to use the same bowel preparation method again, expressed as a binary outcome (Yes/No).

Sponsors and collaborators

Lead sponsor

Al-Ram Drug Store

Industry

Collaborators

  • An-Najah National University

Registry information

Official study title

Efficacy of Enhanced Focused Education and Counseling on Adequacy of Mechanical Bowel Preparation Among High-Risk Patients: A Randomized Clinical Trial

Acronym: EEFEC-AMBP

Important dates

Study start
2020
Primary completion
2021
Study completion
2025
First posted
Jul 30, 2025
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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