Impact of a Colonoscopy Preparation Mobile App on Colonoscopic Cleanliness and Experience

Effects of a Smartphone Mobile Application on Quality of Bowel Preparation: A Randomized Controlled Trial

The most crucial factor determining the success and quality of a colonoscopy procedure is the patient's adherence to proper bowel preparation. When a colonoscopy is scheduled, patients are provided with a diet plan designed to improve the quality of bowel cleansing, in addition to bowel-cleansing medications, through the endoscopy secretariat. Typically, in cases of inadequate bowel cleansing, where the bowel wall is not sufficiently visible during the colonoscopy, it is found that patients have poor adherence to the diet plan and have consumed incorrect or insufficient foods. This inadequate bowel cleansing can lead to missed pathologies such as polyps, colitis, diverticulosis, angiodysplasia, and cancer, which may cause patient complaints or symptoms.

Currently, patients who come to our secretariat from various clinics and polyclinics for colonoscopy appointments receive a single-page informational sheet containing a 5-day pre-procedure diet plan. In our study, the investigators aim to increase patient adherence to the colonoscopy diet by providing a comprehensive mobile application that includes recommendations and recipes for the foods listed in the colonoscopy preparation diet plan. This randomized study will involve selecting suitable patients who have accepted our study from routine colonoscopy requests and analyzing the impact of this mobile application on the quality of colon cleansing, the time to reach the cecum, and the detection rate of colon polyps.

The quality of bowel cleansing will be assessed using the Boston Bowel Preparation Score, where a score of 6 or higher for the entire colon and scores above 2 for each individual segment indicate adequate cleaning. The time to reach the cecum will be tracked using a stopwatch on our mobile phone during the colonoscopy, and the rate of colon polyp detection will be retrospectively reviewed after the study concludes.

The goal of this study is to enhance patient adherence through a free mobile application and to reduce unnecessary administrative costs.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

A total of 104 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 the participants agreed to follow their preparation to the mobile application, 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 mobile application is an important component of bowel preparation and adhere strictly to the recipes and recommendations. 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 recipes, adapting it to align with the recommendations for a low-residue diet . 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 recipes to guarantee that the recipes followed low-residue diet guidelines. The colon preparation recommendations have been obtained from free medical information websites on the internet to facilitate adherence to bowel cleansing.

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ankara, Turkey, 06200
        • Abdurrahman Yurtaslan Oncology and Training Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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 mobile application group
The research protocol was explained during the colonoscopy appointment, and patients, when they agreed to follow their diet to the mobile application, were accepted as part of the patient intervention group.
Those who agreed to download a mobile app for colonoscopic bowel preparation on their smartphones.
No Intervention: Control
The control group consists of patients who prepared for colonoscopy with the standard low-residue diet list.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: selim demirci, clinical physician

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2024

Primary Completion (Actual)

August 1, 2024

Study Completion (Actual)

August 1, 2024

Study Registration Dates

First Submitted

August 22, 2024

First Submitted That Met QC Criteria

August 23, 2024

First Posted (Actual)

August 26, 2024

Study Record Updates

Last Update Posted (Actual)

August 26, 2024

Last Update Submitted That Met QC Criteria

August 23, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • mobilapplication

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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