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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06192394
Other study ID # IUC-HEM-IK-01
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 2024
Est. completion date August 2025

Study information

Verified date June 2024
Source Istanbul University - Cerrahpasa (IUC)
Contact ibrahim kiyat
Phone +900 288 214 55 47
Email ibrahimkiyat@klu.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Colorectal cancers are a major global health problem, highlighting the critical importance of screening programs for early diagnosis and effective treatment. The success of colonoscopy largely depends on the quality of bowel preparation. Inadequate bowel preparation may reduce the effectiveness of colonoscopy and cause lesions to be missed. Previous research has shown the positive effects of diet, training, and polyethylene glycol use on bowel readiness. However, there is limited research on the effects of methods such as gum chewing and walking exercise. This study aims to evaluate the effects of gum chewing and walking exercise, as well as diet and medication, on the quality of bowel preparation and patient satisfaction during the bowel preparation process before colonoscopy. The study uses a randomized controlled, single-blind experimental design with three different groups: a control group, a gum chewing group, and a walking exercise group. Each group will be evaluated based on bowel preparation quality and patient satisfaction. The quality of bowel preparation will be determined using the Boston Bowel Preparation Scale, and factors such as polyp detection, workability of colonoscopy, and cecal intubation time will also be evaluated. Patient satisfaction levels will be evaluated by taking into account how satisfied the patients are with the colonoscopy procedure and their complaints before and after the procedure. The results of this study will contribute to a better understanding of the impact of chewing gum and walking exercise before colonoscopy on the quality of bowel preparation and patient satisfaction. Identifying effective methods to improve the quality of bowel preparation can contribute to a healthier society by raising the standard of nursing care. At the same time, this research may improve the comfort and effectiveness of the colonoscopy process for patients and benefit public health by increasing the effectiveness of colorectal cancer screening programs.


Description:

An ideal bowel preparation should have the capacity to evacuate the fecal load quickly, without compromising the comfort of patients or causing fluid-electrolyte imbalance. Various methods are used to improve the quality of bowel preparation, such as pre-colonoscopy education, low-fiber diet, and use of split-dose polyethylene glycol (PEG). There are many scientific studies showing that these methods increase the quality of bowel preparation. However, there have been fewer studies showing that methods such as chewing gum and walking exercises before colonoscopy increase the quality of bowel preparation. No study has been found in which these two methods were evaluated together. In order to eliminate the deficiency in this field, it is thought that this study will be useful in improving the quality of bowel preparation before colonoscopy. Chewing gum is a virtual feeding method that stimulates the cephalic-vagal reflex, promoting the secretion of gastric and intestinal hormones and increasing intestinal motility. Chewing gum has advantages such as ease of application, low cost, and no reported side effects. Therefore, the use of this method as a safe intervention is recommended. Its effectiveness in reducing postoperative ileus and hospital stay has been demonstrated in many studies. It is stated that walking exercise improves bowel cleanliness and reduces discomfort associated with nausea and abdominal pain during bowel preparation for colonoscopy. A systematic review found that low and moderate-intensity exercise lasting less than 60 minutes supports gastrointestinal motility. Inadequate bowel preparation can lead to the repetition of the colonoscopy procedure, negatively affecting patients' experiences and satisfaction. In addition to this, factors such as the difficulty of the bowel preparation process in patients undergoing colonoscopy, unsedated colonoscopy, long appointment dates, and insufficient pre-procedure information can also negatively impact patient satisfaction. Assessing the satisfaction of patients is recommended for a successful and high-quality colonoscopy procedure. This study was designed as a randomized controlled experimental study to determine the effects of gum chewing and walking exercise, as well as the use of diet and medication during the bowel preparation process before colonoscopy, on the quality of bowel preparation and patient satisfaction.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 168
Est. completion date August 2025
Est. primary completion date July 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Individuals aged between 18 and 65 years, - Capable of effective communication, - Mentally healthy, - Individuals who can comprehend and implement planned interventions before colonoscopy. Exclusion Criteria: - Individuals with a history of abdominal surgery, - Those with serious illnesses that could affect the study outcomes (e.g., severe heart failure, kidney failure), - Individuals using medications that could impact intestinal functions due to systemic diseases, - Individuals who have not complied with the recommended interventions will not be included.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Chewing Gum
Patients will be asked to chew xylitol gum for 20 minutes every 2 hours (17.00-19.00, 19.00-21.00, 21.00-23.00) after drinking the X-M Diet syrup prescribed the day before the colonoscopy procedure. After the enema is given on the day of the colonoscopy, they will be asked to chew gum for 20 minutes every 2 hours until one hour before the scheduled procedure time. Xylitol is a naturally occurring five-carbon sugar alcohol (C5H12O5) found in fruits and vegetables such as plums, strawberries, cauliflower, and pumpkin. It is similar in taste to sucrose but contains 40% fewer calories than other carbohydrates (1 gram of xylitol = 2.4 calories). Xylitol has positive effects on dental health and may also have beneficial impacts on other systems such as immunity, respiratory, and digestive systems. Since xylitol is not digested by human enzymes, it has a laxative effect. In the study, sugar-free gum with xylitol will be used.
Walking Exercise
Patients will be given a pedometer to count their steps and will be asked to walk at least 3000 steps before the colonoscopy procedure.
Control
Patients will undergo standard bowel preparation determined by the hospital.

Locations

Country Name City State
Turkey Istanbul University-Cerrahpasa Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Boston Bowel Preparation Classification (BBPS) The Boston Bowel Preparation Scale (BBPS) is a rating scale used to evaluate the adequacy of bowel preparation. Day of colonoscopy only
Secondary Patient satisfaction The patient's perception of the usefulness of the intervention as self-reported in a preprocedural survey. 2 days
See also
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