NCT05973266

Brief Summary

Colonoscopy is the examination of the large intestine with an instrument called a colonoscope. To make an accurate evaluation during a colonoscopy performed for diagnosis and treatment, adequate preparation of the large intestine must be made. Information given to patients is very important for adequate bowel preparation and adherence to treatment. Therefore, this study was planned as a prospective, single-blind randomized controlled study to determine the effect of mobile application-based bowel preparation training on patients' bowel preparation compliance, quality and anxiety level in patients scheduled for colonoscopy. The study will be carried out with 160 patients (experimental: 80, control: 80) who will apply to the Istanbul University Istanbul Medical Faculty Hospital General Surgery Department Endoscopy Unit, who will undergo colonoscopy as an outpatient. Both groups will receive oral and written instructions for bowel preparation. In addition, the smart phone app group will received instructions through a medical smart phone app. The primary outcome was the rate of adequate bowel preparation according to the Boston bowel preparation scale score. The secondary outcomes included patient compliance.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 3, 2021

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 2, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2023

Completed
Last Updated

August 3, 2023

Status Verified

August 1, 2023

Enrollment Period

2.4 years

First QC Date

July 26, 2023

Last Update Submit

August 2, 2023

Conditions

Keywords

colonoscopybowel preparationmobile application

Outcome Measures

Primary Outcomes (1)

  • quality of bowel preparation

    The Boston bowel preparation scale is a four-point (0-3) assessment tool for bowel cleansing administered separately for each of the three sections of the colon during colonoscopy.Each region of the colon receives a "segment score" from 0 to 3 and these segment scores are summed for a total Boston bowel preparation scale score ranging from 0 to 9. Therefore, the maximum Boston bowel preparation scale score for a perfectly clean colon without any residual liquid is 9 and the minimum Boston bowel preparation scale score for an unprepared colon is 0.

    filled in by the endoscopist during the colonoscopy procedure after training

Secondary Outcomes (1)

  • Anxiety

    will be administered to patients before colonoscopy

Study Arms (2)

Experimental Group

EXPERIMENTAL

Patients using mobile application as well as verbal and written information in bowel preparation training in patients who will undergo colonoscopy will constitute the experimental group.

Behavioral: Mobile Application-Based Bowel Preparation Training

Control Group

NO INTERVENTION

Patients who will be given oral and written information in bowel preparation training in patients who will undergo colonoscopy will form the control group.

Interventions

The contents of the training in the mobile application where the patients receive bowel preparation training before the procedure are; short videos, images and slides about colonoscopy, bowel preparation drugs, liquid-clear diet and foods recommendations.A mobile application-based training will be provided to guide patients, where user (patient) usage activities are monitored by the researcher, sending notifications or reminders to the patient in accordance with the colonoscopy procedure date.

Experimental Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Years to 65 Years, Internet-enabled smart phone Outpatient admission to endoscopy Patient undergoing colonoscopy for the first time Patients who agreed to participate in the study

You may not qualify if:

  • Have undergone colon and abdominal surgery Active lower gastrointestinal bleeding Known dementia etc. patients with cognitive disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University - Cerrahpasa (IUC)

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Sengor K, Keskin M, Akyuz N. Mobile app-based bowel preparation training: effects on compliance, quality, and anxiety in colonoscopy patients-a randomized controlled trial. Surg Endosc. 2025 Nov;39(11):7312-7323. doi: 10.1007/s00464-025-12074-9. Epub 2025 Aug 27.

MeSH Terms

Conditions

Colonic DiseasesColonic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasms

Study Officials

  • Kübra Şengör, Msc

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kübra Şengör, Msc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
endoscopist blinded
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Randomized controlled experimental design
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

July 26, 2023

First Posted

August 2, 2023

Study Start

June 3, 2021

Primary Completion

October 27, 2023

Study Completion

December 29, 2023

Last Updated

August 3, 2023

Record last verified: 2023-08

Locations