ColonoscopyNCT04644939
Impact of Telephone Call on Bowel Preparation Quality in Colonoscopies
A study testing Phone calls, Standard bowel preparation and Colonoscopy in people with Colonoscopy, run by Makassed General Hospital at 1 site in Lebanon.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonoscopy
- What is being tested?
- Phone calls, Standard bowel preparation and Colonoscopy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteLebanon
- Study dates
- 25 Nov 2020to Aug 2021
- 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
- patients undergoing outpatient colonoscopy
Who cannot join
- History of previous inadequate bowel preparation
- History of colorectal surgeries
- Patient who did not sign the consent
- Patients with dementia
- Patients with Swallowing difficulties
Trial locations and contacts
1 site in 1 country.
Lebanon1 site, 1 recruiting
- Recruiting
Makassed General Hospital
Beirut
Walid Nasreddine, MD, +9611636000 ext. 6913, walidan@hotmail.com
About this study
Official title: 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.
- Conditions
- Colonoscopy
- Being tested
- Phone calls, Standard bowel preparation, Colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone callsOther
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
Standard bowel preparationOther
Patients undergoing outpatient colonoscopy will receive the standard bowel preparation instructions
ColonoscopyOther
Patients will undergo colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Phone calls; Other: Colonoscopy |
| Conventional group | Placebo comparator | Patients will receive bowel preparation instructions in a conventional way Receives: Other: Standard bowel preparation; Other: Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Excellent: Small volume of clear liquid, or greater than 95% of surface seen
- Good: Large volume of clear liquid covering 5-25% of the surface but greater than 90% of surface seen
- Fair: Presence of some semi-solid stool that could be suctioned or washed away but greater than 90% of surface seen
- Poor: Semi-solid stool that could not be suctioned or washed away and less than 90% of surface seen
- 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.
Measured: Directly after colonoscopy
Secondary outcomes (1)
Colonic polyps rate
Detect rate of colonic polyps in both groups
Measured: Directly after colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start25 Nov 2020
- Primary completionAug 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Makassed General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Walid Nassreddine, Makassed General Hospital
- Investigators
- Walid Nassreddine, MD, Principal investigator, Makassed General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04644939
- Sponsor's protocol ID
- 10112020
- Status last verified
- Aug 2021
- First submitted
- 19 Nov 2020
- Last updated
- 1 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Telephone Call for Patient Education on Bowel Preparation Quality in Outpatient Colonoscopies
- ClinicalTrials.gov ID
- NCT04644939
- Acronym / sponsor ID
- 10112020
- Conditions
- Colonoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Makassed General HospitalUniversity, hospital or other
- Study start
- 25 Nov 2020 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 25 Nov 2020 (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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Other: Phone calls, Other: ColonoscopyPatients will receive bowel preparation instructions in a conventional way in addition to a telephone call for education purposes one day prior to procedure |
| Conventional group | Placebo comparator | Other: Standard bowel preparation, Other: ColonoscopyPatients will receive bowel preparation instructions in a conventional way |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing outpatient colonoscopy
Key exclusion criteria (5 listed)
- History of previous inadequate bowel preparation
- History of colorectal surgeries
- Patient who did not sign the consent
- Patients with dementia
- Patients with Swallowing difficulties
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 |
|---|---|---|
| Phone callsPatients 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 | Other | Interventional group |
| Standard bowel preparationPatients undergoing outpatient colonoscopy will receive the standard bowel preparation instructions | Other | Conventional group |
| ColonoscopyPatients will undergo colonoscopy | Other | Conventional group, Interventional group |
Primary outcome
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.
1 secondary outcome
Colonic polyps rate
Time frame: Directly after colonoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
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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.
Walid Nassreddine, MD principal investigator
Makassed General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phone calls, Standard bowel preparation and Colonoscopy in people with Colonoscopy, run by Makassed General Hospital at 1 site in Lebanon.
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 1 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: status not confirmed, as of the sponsor's last update on 1 Sep 2021. 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 Lebanon. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Walid Nassreddine, MD (+9611636000 ext. 913, walidan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bowel preparation quality (time frame: Directly after colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2021.