ColonoscopyEEFEC-AMBPNCT07093099
Effect of Counseling and Education on Mechanical Bowel Preparation
A study testing Enhanced Education Package for Bowel Preparation and Standard Education Leaflet in people with Colonoscopy and Colorectal Cancer Screening, run by Al-Ram Drug Store at 1 site in Palestinian Territories.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonoscopy, Colorectal Cancer Screening
- What is being tested?
- Enhanced Education Package for Bowel Preparation and Standard Education Leaflet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- 1 Dec 2020to 20 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- Age >65 years
- Multiple comorbidities (e.g., diabetes, neurologic disorders affecting motility)
- ----------------------------------------------------
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Palestinian Territories1 site
Rafidia Surgical Hospital
Nablus, P400
About this study
Official title: Efficacy of Enhanced Focused Education and Counseling on Adequacy of Mechanical Bowel Preparation Among High-Risk Patients: A Randomized Clinical Trial
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)?
Read more
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.
- Conditions
- Colonoscopy, Colorectal Cancer Screening
- Being tested
- Enhanced Education Package for Bowel Preparation, Standard Education Leaflet
- Keywords
- Bowel prep, Colonoscopy preparation, BBPS (Boston Bowel Preparation Scale), Enhanced education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Education Package for Bowel PreparationBehavioural
Also called Enhanced Counseling, Video Instruction, Booklet and Mobile App Support
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.
Standard Education LeafletOther
Also called Standard Instructions, Usual Care Preparation
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.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Education Group | Experimental | Participants in this group received enhanced bowel preparation education. The intervention included:
Face-to-face counseling by trained staff about the importance of bowel prep and how to follow instructions; A 6-minute instructional video explaining dietary restrictions, purgative usage, and procedure timeline; A printed booklet with illustrated step-by-step instructions; and Access to a smartphone app with automated reminders, preparation tracking, and guidance.
All participants used the same bowel cleansing agent (polyethylene glycol-based preparation). Receives: Behavioral: Enhanced Education Package for Bowel Preparation; Other: Standard Education Leaflet |
| Standard Education Group | Active comparator | Participants in this group received standard bowel preparation instructions in the form of a hospital-issued informational leaflet. This leaflet included basic written instructions about dietary restrictions, timing and method of laxative use, and preparation day logistics.
No counseling, video, or app-based support was provided. The same bowel cleansing agent was used in both arms. Receives: Other: Standard Education Leaflet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boston Bowel Preparation Scale (BBPS) Total Score
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.
Measured: During the procedure itself
Secondary outcomes (3)
Patient Satisfaction Score
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.
Measured: Within 24 hours after colonoscopy
Cecal Intubation Time
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.
Measured: During the procedure itself
Willingness to Repeat Preparation
Participant-reported willingness to use the same bowel preparation method again, expressed as a binary outcome (Yes/No).
Measured: Within 24 hours after colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start1 Dec 2020
- Primary completion30 Jun 2021
- Study completion20 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Ram Drug Store
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- An-Najah National University
- Responsible party
- Principal investigator, Mohammed M. H. Hajhamad, An-Najah National University
- Investigators
- Mohammed M Hajhamad, MD, Principal investigator, An-Najah National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093099
- Sponsor's protocol ID
- 2021/134/162
- Other IDs
- 2021/134/162
- Acronym
- EEFEC-AMBP
- Status last verified
- Jul 2025
- First submitted
- 21 Jul 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hattab M, Shakhshir M, Khalil C, Mletat R, Rabi R, Yassin R, Hejaz M, Hajhamad MM. Multimodal patient education improves bowel preparation for colonoscopy: a randomized controlled trial. BMC Gastroenterol. 2025 Dec 18;26(1):54. doi: 10.1186/s12876-025-04569-5.
PubMed 41413490
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Enhanced Focused Education and Counseling on Adequacy of Mechanical Bowel Preparation Among High-Risk Patients: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07093099
- Acronym / sponsor ID
- EEFEC-AMBP / 2021/134/162
- Conditions
- Colonoscopy, Colorectal Cancer Screening
- Keywords
- Bowel prep, Colonoscopy preparation, BBPS (Boston Bowel Preparation Scale), Enhanced education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Al-Ram Drug StoreIndustry (pharma, biotech, devices)
- Collaborators
- An-Najah National University
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Education Group | Experimental | Behavioral: Enhanced Education Package for Bowel Preparation, Other: Standard Education LeafletParticipants in this group received enhanced bowel preparation education. The intervention included: Face-to-face counseling by trained staff about the importance of bowel prep and how to follow instructions; A 6-minute instructional video explaining dietary restrictions, purgative usage, and procedure timeline; A printed booklet with illustrated step-by-step instructions; and Access to a smartphone app with automated reminders, preparation tracking, and guidance. All participants used the same bowel cleansing agent (polyethylene glycol-based preparation). |
| Standard Education Group | Active comparator | Other: Standard Education LeafletParticipants in this group received standard bowel preparation instructions in the form of a hospital-issued informational leaflet. This leaflet included basic written instructions about dietary restrictions, timing and method of laxative use, and preparation day logistics. No counseling, video, or app-based support was provided. The same bowel cleansing agent was used in both arms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Education Package for Bowel PreparationAlso: Enhanced Counseling, Video Instruction, Booklet and Mobile App Supporta 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. | Behavioural | Enhanced Education Group |
| Standard Education LeafletAlso: Standard Instructions, Usual Care PreparationParticipants 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 | Enhanced Education Group, Standard Education Group |
Primary outcome
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.
3 secondary outcomes
Patient Satisfaction Score
Time frame: Within 24 hours after colonoscopy
Cecal Intubation Time
Time frame: During the procedure itself
Willingness to Repeat Preparation
Time frame: Within 24 hours after colonoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Derived from this study: PubMed 41413490Hattab M, Shakhshir M, Khalil C, Mletat R, Rabi R, Yassin R, Hejaz M, Hajhamad MM. Multimodal patient education improves bowel preparation for colonoscopy: a randomized controlled trial. BMC Gastroenterol. 2025 Dec 18;26(1):54. doi: 10.1186/s12876-025-04569-5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammed M Hajhamad, MD principal investigator
An-Najah National University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Education Package for Bowel Preparation and Standard Education Leaflet in people with Colonoscopy and Colorectal Cancer Screening, run by Al-Ram Drug Store at 1 site in Palestinian Territories.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Palestinian Territories. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Boston Bowel Preparation Scale (BBPS) Total Score (time frame: During the procedure itself). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07093099, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.