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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06141122
Other study ID # colonoscopybooklet
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 15, 2023
Est. completion date November 1, 2023

Study information

Verified date November 2023
Source Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Description:

A total of 109 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.


Recruitment information / eligibility

Status Completed
Enrollment 109
Est. completion date November 1, 2023
Est. primary completion date November 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
A recipe booklet
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.

Locations

Country Name City State
Turkey Abdurrahman Yurtaslan Oncology and Training Research Hospital Ankara

Sponsors (1)

Lead Sponsor Collaborator
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. eCol — View Citation

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; — View Citation

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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 immediately after the procedure
Secondary 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. during the procedure
Secondary 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. during the procedure
Secondary polyp detection rate It will be assessed by recording the encountered polyps during colonoscopy. during the procedure
Secondary 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). immediately after the procedure
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