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Effect of Counseling and Education on Mechanical Bowel Preparation

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07093099
Acronym
EEFEC-AMBP
Enrollment
150
Registered
2025-07-30
Start date
2020-12-01
Completion date
2025-05-20
Last updated
2025-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonoscopy, Colorectal Cancer Screening

Keywords

Bowel prep, Colonoscopy preparation, BBPS (Boston Bowel Preparation Scale), Enhanced education

Brief summary

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.

Interventions

BEHAVIORALEnhanced Education Package for Bowel Preparation

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.

OTHERStandard Education Leaflet

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.

Sponsors

An-Najah National University
CollaboratorOTHER
Al-Ram Drug Store
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Endoscopists scoring bowel preparation using the Boston Bowel Preparation Scale (BBPS) were blinded to the participant's group assignment. Participants and care providers were not masked due to the nature of the intervention.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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) \----------------------------------------------------

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

Design outcomes

Primary

MeasureTime frameDescription
Boston Bowel Preparation Scale (BBPS) Total ScoreDuring the procedure itselfThe 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

MeasureTime frameDescription
Patient Satisfaction ScoreWithin 24 hours after colonoscopyMeasured on a 10-point Likert scale, with 1 = very dissatisfied and 10 = very satisfied. Participants were surveyed about their experience with the preparation process.
Cecal Intubation TimeDuring the procedure itselfTime (in minutes) from insertion of the colonoscope to successful intubation of the cecum, recorded by the performing endoscopist. Lower times indicate more efficient procedures.
Willingness to Repeat PreparationWithin 24 hours after colonoscopyParticipant-reported willingness to use the same bowel preparation method again, expressed as a binary outcome (Yes/No).

Countries

Palestinian Territories

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026