Bowel PreparationNCT06141122
The Colonoscopy Booklet:Effect of a Recipe Resource on Quality of Colonoscopy Bowel Preparation and Patient Experience
A study testing A recipe booklet in people with Bowel Preparation and Patient Experience, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to provide a recipe resource with visuals in line with the low-residue diet recommendations given to patients before colonoscopy, including cooking instructions for the meals in the diet list. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bowel Preparation, Patient Experience, Patient Satisfaction
- What is being tested?
- A recipe booklet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2023to 1 Nov 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All outpatients who apply for a colonoscopy appointment.
Who cannot join
- Patients with a history of prior colonoscopic procedures
- Using anticholinergic or gastrointestinal motility-reducing drugs
- Severe chronic kidney failure (GFR<30 ml/min)
- Advanced heart failure (NYHA III-IV)
- History of abdominal surgery were not included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Abdurrahman Yurtaslan Oncology and Training Research Hospital
Ankara, 06200
About this study
Official title: The Colonoscopy Booklet: The Effect of a Recipe Resource on Quality of Colonoscopy Bowel Preparation and Patient Experience
This study aimed to provide a recipe resource with visuals in line with the low-residue diet recommendations given to patients before colonoscopy, including cooking instructions for the meals in the diet list. In this way, we aimed to minimize confusion regarding dietary restrictions during colonoscopy preparation and ensure full compliance with the diet list. Our hypothesis is that this approach may enhance compliance with current recommendations and improve the quality of bowel preparation.
Read the detailed description
A total of 153 patients were included in this study. At the time of scheduling an outpatient colonoscopy, intervention group and control group were randomly assigned using a random-number generator for treatment allocation. The research protocol was explained during the colonoscopy appointment, and patients, when they agreed to follow their diet according to the recipe booklet, were accepted as part of the patient intervention group. A consent form was signed and collected. The nurse responsible for patient education in the endoscopy secretariat informed the patient that this booklet is an important component of bowel preparation and adhere strictly to the recipes in the booklet. The group who received the standard diet list and applied for their colonoscopy appointments were randomly designated as the control group. Bowel preparation was evaluated during the colonoscopy using the Boston Bowel Preparation Scale (BBPS). Cecal insertion and withdrawal times, polyp detection rate, utilization of the recipe resource, and patients' experiences related to colonoscopy were recorded.
The research team utilized freely available resources from general cookery recipe websites to create the recipe resource, adapting it to align with the recommendations for a low-residue diet (figure). Recipes were selected based on criteria such as being visually appealing, easy to prepare, and easily modifiable to comply with the low-residue diet. A dietitian examined the recipe resource to guarantee that the recipes followed low-residue diet guidelines.
- Conditions
- Bowel Preparation, Patient Experience, Patient Satisfaction
- Being tested
- A recipe booklet
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A recipe bookletOther
A recipe resource with visuals in line with the low-residue diet recommendations given to patients before colonoscopy, including cooking instructions for the meals in the diet list.
| Study group | Role | What they receive |
|---|---|---|
| The booklet group | Experimental | The research protocol was explained during the colonoscopy appointment, and patients, when they agreed to follow their diet according to the recipe booklet, were accepted as part of the patient intervention group. Receives: Other: A recipe booklet |
| control | No intervention | The control group consists of patients who prepared for colonoscopy with the standard low-residue diet list without being given a recipe booklet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boston Bowel Preparation Scale (BBPS)
The BBPS is used to evaluate the quality of bowel preparation, with a scale from 0 to 9 (0 = very poor, 9 = excellent). Total BBPS score ≥ 6 and three segments of the colon (right, transverse, and the left side of the colon) ≥ 2 accepted as good bowel preparation
Measured: immediately after the procedure
Secondary outcomes (4)
cecal insertion time(minutes)
Insertion time, as defined, refers to the duration between the initiation of the colonoscopy procedure and the moment when the endoscope reaches the cecum, with identification of the appendiceal orifice.
Measured: during the procedure
withdrawal time (minutes)
Withdrawal time, as defined, refers to the period between the commencement of withdrawing the colonoscope from the cecum and the complete removal of the colonoscope from the patient.
Measured: during the procedure
polyp detection rate
It will be assessed by recording the encountered polyps during colonoscopy.
Measured: during the procedure
patient experience
The patient experience of the study group was evaluated using a 3-point scale (1-worse than expected, 2-as expected, 3-better than expected).
Measured: immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start15 Sep 2023
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bowel PreparationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, selim demirci, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Investigators
- selim demirci, Principal investigator, clinical physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06141122
- Sponsor's protocol ID
- colonoscopybooklet
- Status last verified
- Nov 2023
- First submitted
- 15 Nov 2023
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bennett L, Knox R, Luscombe G, Egan J, Wallace L. The Colonoscopy Cookbook: Analysis of effect of a recipe resource on quality and experience of bowel preparation in colonoscopy. Endosc Int Open. 2023 May 26;11(5):E561-E565. doi: 10.1055/a-2057-4374. eCollection 2023 May.
PubMed 37251792Spiegel BM, Talley J, Shekelle P, Agarwal N, Snyder B, Bolus R, Kurzbard N, Chan M, Ho A, Kaneshiro M, Cordasco K, Cohen H. Development and validation of a novel patient educational booklet to enhance colonoscopy preparation. Am J Gastroenterol. 2011 May;106(5):875-83. doi: 10.1038/ajg.2011.75. Epub 2011 Apr 12.
PubMed 21483463Tae JW, Lee JC, Hong SJ, Han JP, Lee YH, Chung JH, Yoon HG, Ko BM, Cho JY, Lee JS, Lee MS. Impact of patient education with cartoon visual aids on the quality of bowel preparation for colonoscopy. Gastrointest Endosc. 2012 Oct;76(4):804-11. doi: 10.1016/j.gie.2012.05.026. Epub 2012 Jul 27.
PubMed 22840295
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Colonoscopy Booklet: The Effect of a Recipe Resource on Quality of Colonoscopy Bowel Preparation and Patient Experience
- ClinicalTrials.gov ID
- NCT06141122
- Acronym / sponsor ID
- colonoscopybooklet
- Conditions
- Bowel Preparation, Patient Experience, Patient Satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 21 Nov 2023 (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.
This study aimed to provide a recipe resource with visuals in line with the low-residue diet recommendations given to patients before colonoscopy, including cooking instructions for the meals in the diet list. In this way, we aimed to minimize confusion regarding dietary restrictions during colonoscopy preparation and ensure full compliance with the diet list. Our hypothesis is that this approach may enhance compliance with current recommendations and improve the quality of bowel preparation.
Detailed description
A total of 153 patients were included in this study. At the time of scheduling an outpatient colonoscopy, intervention group and control group were randomly assigned using a random-number generator for treatment allocation. The research protocol was explained during the colonoscopy appointment, and patients, when they agreed to follow their diet according to the recipe booklet, were accepted as part of the patient intervention group. A consent form was signed and collected. The nurse responsible for patient education in the endoscopy secretariat informed the patient that this booklet is an important component of bowel preparation and adhere strictly to the recipes in the booklet. The group who received the standard diet list and applied for their colonoscopy appointments were randomly designated as the control group. Bowel preparation was evaluated during the colonoscopy using the Boston Bowel Preparation Scale (BBPS). Cecal insertion and withdrawal times, polyp detection rate, utilization of the recipe resource, and patients' experiences related to colonoscopy were recorded.
The research team utilized freely available resources from general cookery recipe websites to create the recipe resource, adapting it to align with the recommendations for a low-residue diet (figure). Recipes were selected based on criteria such as being visually appealing, easy to prepare, and easily modifiable to comply with the low-residue diet. A dietitian examined the recipe resource to guarantee that the recipes followed low-residue diet guidelines.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The booklet group | Experimental | Other: A recipe bookletThe research protocol was explained during the colonoscopy appointment, and patients, when they agreed to follow their diet according to the recipe booklet, were accepted as part of the patient intervention group. |
| control | No intervention | –The control group consists of patients who prepared for colonoscopy with the standard low-residue diet list without being given a recipe booklet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All outpatients who apply for a colonoscopy appointment.
Key exclusion criteria (5 listed)
- Patients with a history of prior colonoscopic procedures
- Using anticholinergic or gastrointestinal motility-reducing drugs
- Severe chronic kidney failure (GFR<30 ml/min)
- Advanced heart failure (NYHA III-IV)
- History of abdominal surgery were not included in the study.
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 |
|---|---|---|
| A recipe bookletA recipe resource with visuals in line with the low-residue diet recommendations given to patients before colonoscopy, including cooking instructions for the meals in the diet list. | Other | The booklet group |
Primary outcome
Boston Bowel Preparation Scale (BBPS)
Time frame: immediately after the procedure
The BBPS is used to evaluate the quality of bowel preparation, with a scale from 0 to 9 (0 = very poor, 9 = excellent). Total BBPS score ≥ 6 and three segments of the colon (right, transverse, and the left side of the colon) ≥ 2 accepted as good bowel preparation
4 secondary outcomes
cecal insertion time(minutes)
Time frame: during the procedure
withdrawal time (minutes)
Time frame: during the procedure
polyp detection rate
Time frame: during the procedure
patient experience
Time frame: immediately after the procedure
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 12 Nov 2024.
- Results publication: PubMed 37251792Bennett L, Knox R, Luscombe G, Egan J, Wallace L. The Colonoscopy Cookbook: Analysis of effect of a recipe resource on quality and experience of bowel preparation in colonoscopy. Endosc Int Open. 2023 May 26;11(5):E561-E565. doi: 10.1055/a-2057-4374. eCollection 2023 May.
- Results publication: PubMed 21483463Spiegel BM, Talley J, Shekelle P, Agarwal N, Snyder B, Bolus R, Kurzbard N, Chan M, Ho A, Kaneshiro M, Cordasco K, Cohen H. Development and validation of a novel patient educational booklet to enhance colonoscopy preparation. Am J Gastroenterol. 2011 May;106(5):875-83. doi: 10.1038/ajg.2011.75. Epub 2011 Apr 12.
- Results publication: PubMed 22840295Tae JW, Lee JC, Hong SJ, Han JP, Lee YH, Chung JH, Yoon HG, Ko BM, Cho JY, Lee JS, Lee MS. Impact of patient education with cartoon visual aids on the quality of bowel preparation for colonoscopy. Gastrointest Endosc. 2012 Oct;76(4):804-11. doi: 10.1016/j.gie.2012.05.026. Epub 2012 Jul 27.
- 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.
selim demirci principal investigator
clinical physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A recipe booklet in people with Bowel Preparation and Patient Experience, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 12 Nov 2024. 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 Turkey (Türkiye). 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) (time frame: immediately after the procedure). 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 NCT06141122, which also lists 3 linked publications.
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 12 Nov 2024.