Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05973266
Other study ID # IstanbulUC-FNHF-KS-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 3, 2021
Est. completion date December 29, 2023

Study information

Verified date August 2023
Source Istanbul University - Cerrahpasa (IUC)
Contact Kübra Sengör, Msc
Phone 05422713460
Email kubra.sengor@iuc.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Colorectal cancers (CRC) are the third most common cancers worldwide, regardless of age and gender, and the second among cancer deaths. In terms of the incidence of colorectal cancers in Turkey, regardless of gender, it ranks third in all age groups (9.8% in men, 8.1% in women) (Turkey Unified Database, 2017). According to the Global Cancer 2020 data published by the International Agency for Research on Cancer (IARC), it is predicted that approximately 21,000 individuals will be diagnosed with colorectal cancer in 2020 and the estimated age-standardized death rate will be 10.1 per 100,000 individuals. Colonoscopy, which is the gold standard for early diagnosis of colorectal cancers, reduces cancer-related morbidity and mortality rates (World Health Organization, 2022). Colonoscopy is a lower gastrointestinal system endoscopy method that enables imaging of the large intestine (colon) for the purposes of screening, diagnosis, treatment and monitoring of colorectal and anal canal pathologies. In the colonoscopy procedure, adequate intestinal preparation is necessary for a good visualization of the entire mucosa and for an accurate evaluation. American Society for Gastrointestinal Endoscopy (ASGE), ideal bowel preparation (BH); defined as the rapid clearance of all macroscopic and microscopic fecal load in the colon without disturbing the patient's comfort and fluid-electrolyte balance. Inadequate bowel cleansing rates ranging from 10% to 75% have been reported in studies. It is stated that when the bowel preparation of the patients is insufficient, 45% less polyps are detected, and the rate of incomplete and canceled procedures is 5%. In addition, gas compression and explosion, which can be seen rarely as a result of gas insufflation during colonoscopy due to insufficient bowel preparation, can cause perforation of the intestines and undesirable events such as bleeding. As a result, inadequate bowel cleansing can cause repetition or prolongation of the procedure, loss of labor, time and cost for patients and healthcare personnel. Before colonoscopy, nurses provide patients with written and oral bowel preparation standard training set by the institution. However, many studies suggest that this training should be supported by visual and auditory tools to increase its effectiveness. In interventional studies aimed at increasing the effectiveness of colonoscopy bowel preparation, the use of educational booklets, patient education with poster images, patient education with both visual use and educational videos, telephone/short message, interactive social media and patient education with the use of telephone applications methods were used. As a result of the literature review, Mobile Application Based Bowel Preparation Training, which is an innovative method, was planned in order to improve the quality of colonoscopy bowel preparation. In this study, it was determined that the quality of bowel preparation and compliance with the procedure will increase by applying Mobile Application-Based Bowel Preparation Training together with the standard education method in patient education before colonoscopy; anxiety is predicted to decrease. Aim 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. With the increase in the quality of bowel preparation, effective and accurate evaluation of colon pathologies during colonoscopy and, as a result, early diagnosis of colon cancer will be provided. With adequate bowel preparation, the risk of complications (perforation, hemorrhage, etc.) that may occur during colonoscopy will be reduced, and labor, time and cost loss due to repeated or prolonged colonoscopy will be prevented. Material Method In this study, in order to determine the effect of mobile application-based bowel preparation training on the quality of bowel preparation, compliance and anxiety level of patients who are planned for colonoscopy; The calculation (d-value) method developed by Cohen was used to calculate the effect size. To determine the effect size index d. The findings of the study, which investigated the effect of mobile application on patient bowel cleansing before colonoscopy, were used. In the calculation made using the findings of this study, the effect size of the bowel cleansing efficiency between the two groups (Experiment=7.70±1.1; Control=7.70±0.8; p=0.007) was determined to be d=0.48. In this context, a sample group of 140 people, 70 people in each group, was determined with the help of the G-power (version 3.1) package program, accompanied by the specified criteria, with d=0.48, α=0.05 (error margin), 1-β=0.80 (power). Due to the loss of patients who left the study during data collection, 10 individuals will be added to the experimental and control groups, and the data collection process will be completed. The sample will consist of patients who meet the inclusion criteria and agree to participate in the study, whose colonoscopy procedure is planned.


Recruitment information / eligibility

Status Recruiting
Enrollment 160
Est. completion date December 29, 2023
Est. primary completion date October 27, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - 18 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 Exclusion Criteria: - Have undergone colon and abdominal surgery Active lower gastrointestinal bleeding Known dementia etc. patients with cognitive disorders

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Mobile Application-Based Bowel Preparation Training
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.

Locations

Country Name City State
Turkey Istanbul University - Cerrahpasa (IUC) Istanbul

Sponsors (2)

Lead Sponsor Collaborator
Kubra Sengor The Scientific and Technological Research Council of Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Anxiety State-Trait Anxiety Inventory (STAI); STAI-I was developed by Spielberger in 1970. The scale consists of 20 items. The answers range from 1-4. The total point value obtained from the scale is between 20-80. A high score indicates a high level of anxiety. STAI 2 Trait Anxiety Scale; It aims to measure how the individual feels, that is, his trait anxiety, regardless of the situation and conditions he is in. These individuals also experience state anxiety more frequently and intensely than others. In answering the state anxiety scale; choosing one of the options "Not at all", "A little", "A lot", "Totally" according to the level of severity of the feelings, behaviors or thoughts expressed by the items; In answering the trait anxiety scale, it is required to select and mark one of the options "Almost Never", "Sometimes", "Very Often" and "Almost Always" according to the frequency level of the feelings, behaviors or thoughts expressed by the items. will be administered to patients before colonoscopy
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05551052 - CRC Detection Reliable Assessment With Blood
Completed NCT03457454 - Reducing Rural Colon Cancer Disparities
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT04088955 - A Digimed Oncology PharmacoTherapy Registry
Recruiting NCT06010862 - Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors Phase 1
Terminated NCT01347645 - Irinotecan Plus E7820 Versus FOLFIRI in Second-Line Therapy in Patients With Locally Advanced or Metastatic Colon or Rectal Cancer Phase 1/Phase 2
Completed NCT03390907 - Hybrid APC Assisted EMR for Large Colon Polyps N/A
Recruiting NCT03175224 - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors Phase 2
Completed NCT04079478 - The AID Study: Artificial Intelligence for Colorectal Adenoma Detection
Active, not recruiting NCT04057274 - Acute Effect of modeRate-intensity aerOBIc Exercise on Colon Cancer Cell Growth N/A
Recruiting NCT03190941 - Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients Phase 1/Phase 2
Not yet recruiting NCT05147545 - Impact of Exercise and Hyperlipidic Meal on Free Circulating DNA in Patients With Metastatic Colonic Cancer and Healthy Subjects N/A
Recruiting NCT05026268 - The Laparoscopic Right Colectomy With Intracoroporeal Anastomosis N/A
Not yet recruiting NCT03277235 - Effect of a Resilience Model-Based Care Plan in Newly Diagnosed Colorectal Cancer Patients N/A
Active, not recruiting NCT02959541 - PK/PD Investigation of Calciumfolinat in Blood, Tumor and Adjacent Mucosa in Patient With Colon Cancer N/A
Active, not recruiting NCT02730702 - Colon Cancer Risk-stratification Via Optical Analysis of Rectal Ultrastructure
Completed NCT02810652 - Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection N/A
Recruiting NCT02577627 - Multi-Indication, Retrospective Oncological Study to Validate the Accuracy in Predicting TTP by PrediCare in Patients Under SOC N/A
Terminated NCT02628535 - Safety Study of MGD009 in B7-H3-expressing Tumors Phase 1
Recruiting NCT02526836 - Complete Mesocolic Excision With Central Vessel Ligation Compared With Conventional Surgery for Colon Cancer Phase 2/Phase 3