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Bowel PreparationNCT06569277

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

A study testing A mobile application 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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
A mobile application
Could I receive a placebo?
No, everyone receives an active treatment
How many people
104 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Jun 2024to 1 Aug 2024
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

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read more

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.

Read the 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.

Being tested
A mobile application
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 mobile applicationOther

    Those who agreed to download a mobile app for colonoscopic bowel preparation on their smartphones.

Study groups in NCT06569277
Study groupRoleWhat they receive
The mobile application groupExperimentalThe 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.
Receives: Other: A mobile application
ControlNo interventionThe control group consists of patients who prepared for colonoscopy with the standard low-residue diet list.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. 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

  2. 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

  3. polyp detection rate

    It will be assessed by recording the encountered polyps during colonoscopy.

    Measured: during the procedure

  4. 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.

  1. First posted26 Aug 2024
  2. Study start15 Jun 2024
  3. Primary completion1 Aug 2024
  4. Study completion1 Aug 2024

Resources

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
104 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06569277
Sponsor's protocol ID
mobilapplication
Status last verified
Aug 2024
First submitted
22 Aug 2024
Last updated
26 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhao K, Dong R, Xia S, Feng L, Zhou W, Zhang M, Zhang Y, Tian D, Liu M, Liao J. Improving the quality of bowel preparation by smartphone education platform prior to colonoscopy: a randomized trail. Ann Med. 2022 Dec;54(1):2777-2784. doi: 10.1080/07853890.2022.2130972.

    PubMed 36254495
  • Dao HV, Dao QV, Lam HN, Hoang LB, Nguyen VT, Nguyen TT, Vu DQ, Pokorny CS, Nguyen HL, Allison J, Goldberg RJ, Dao ATM, Do TTT, Dao LV. Effectiveness of using a patient education mobile application to improve the quality of bowel preparation: a randomised controlled trial. BMJ Open Gastroenterol. 2023 Jun;10(1):e001107. doi: 10.1136/bmjgast-2023-001107.

    PubMed 37277203
  • van der Zander QEW, Reumkens A, van de Valk B, Winkens B, Masclee AAM, de Ridder RJJ. Effects of a Personalized Smartphone App on Bowel Preparation Quality: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Aug 19;9(8):e26703. doi: 10.2196/26703.

    PubMed 34420924
  • Demirci S, Sezer S. Effects of a smartphone mobile application on quality of bowel preparation: A randomized controlled trial. Pak J Med Sci. 2025 Jul;41(7):1905-1912. doi: 10.12669/pjms.41.7.11852.

    PubMed 40735592

Questions about this trial

What is this clinical trial studying?

A study testing A mobile application 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 26 Aug 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 NCT06569277, which also lists 4 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 26 Aug 2024.

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