- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06141122
The Colonoscopy Booklet:Effect of a Recipe Resource on Quality of Colonoscopy Bowel Preparation and Patient Experience
The Colonoscopy Booklet: the Effect of a Recipe Resource on Quality of Colonoscopy Bowel Preparation and Patient Experience
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ankara, Turkey, 06200
- Abdurrahman Yurtaslan Oncology and Training Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- All outpatients who apply for a colonoscopy appointment.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: The booklet group
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 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.
|
|
No Intervention: control
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
immediately after the procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
cecal insertion time(minutes)
Time Frame: during the procedure
|
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.
|
during the procedure
|
|
withdrawal time (minutes)
Time Frame: during the procedure
|
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.
|
during the procedure
|
|
polyp detection rate
Time Frame: during the procedure
|
It will be assessed by recording the encountered polyps during colonoscopy.
|
during the procedure
|
|
patient experience
Time Frame: immediately after the procedure
|
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).
|
immediately after the procedure
|
Collaborators and Investigators
Investigators
- Principal Investigator: selim demirci, clinical physician
Publications and helpful links
General Publications
- Spiegel 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.
- Tae 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- colonoscopybooklet
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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