In order to improve bowel preparation for colonoscopy and consequently enhance detection rate of malignant and premalignant findings, a prospective, randomized and controlled three-arm study was developed. Patients who undergo ambulatory colonoscopy are randomly assigned into a control group with standard preparation, a phone call supported preparation group or a group supported by an artificial intelligence based chatbot. Primary endpoint is defined as quality of bowel preparation (Boston Bowel Preparation Score), secondary endpoints are patients satisfaction, comprehensiveness of bowel preparation, sedation dose, rate of coecal intubation and the rate of adenoma and polyp detection, anxiety referred to colonoscopy and patients satisfaction with preparation support.
Adequate bowel preparation is crucial for detection of adenoma and polyps of the colon, which can transform into malignant and premalignant lesions. In particular ambulatory performed colonoscopy is often insufficient due to inadequate preparation by patients at home. To focus this issue, a artificial intelligence based chatbot was developed to help patients who undergo bowel preparation by answering questions concerning bowel preparation. To compare the effect of this program, a three-arm randomized, controled multicentric clinical trial was developed. All patients who undergo ambulatory colonoscopy and meet the inclusion criteria (18 y.o., informed consent, WhatsApp access) were randomized in a standard preparation group (medical briefing and preparation brochure), a group receiving phone calls with instructions for bowel preparation and a third group with access to the chat bot answering questions concerning bowel preparation and examination conduct. As the primary end point, the quality of bowel preparation measured as Boston Bowel Preparation Scale was defined. As secondary endpoints patients satisfaction, comprehensiveness of bowel preparation, sedation dose, rate of coecal intubation, the rate of adenoma and polyp detection, anxiety referred to colonoscopy and patients satisfaction with preparation support were measured.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
258
A artificial-intelligence based chatbot is provided 3 days before colonoscopy to answer questions concerning bowel preparation and colonoscopy conduct.
A phone call is performed every day starting at 3 days before colonoscopy to support bowel preparation.
Specialist Practice Profes. Dikopoulos/Ludwig
Ulm, Baden-Würrtemberg, Germany
RECRUITINGUniversity of Ulm, Interdisciplinary Endoscopy
Ulm, Baden-Würrtemberg, Germany
RECRUITINGSpecialist Practice
Berlin, Germany
RECRUITINGQuality of bowel preparation
evaluated with the Boston Bowel Preparation Scale (0-9, 1=worst preparation, 9= best preparation)
Time frame: During colonoscopy
Patients satisfaction with bowel preparation
Via questionnaire; 8 items, ordinal scale with 4 grades (completely satisfied/mainly satisfied/mainly dissatisfied/completely dissatisfied)
Time frame: Immediately after the intervention
Comprehensiveness of bowel preparation
Rate of successfully completed colonoscopy without premature termination due to remaining feces(from anus to terminal ileum)
Time frame: During colonoscopy
Sedation dose
Total amount of administered sedation per examination
Time frame: During colonoscopy
Coecal intubation
Successful coecal intubation during colonoscopy
Time frame: During colonoscopy
Polyp and adenoma detection rate
Rate of detected polyps and adenomas
Time frame: During colonoscopy
Patients satisfaction with preparation support
Via questionnaire; 8 items, ordinal scale with 4 grades (completely satisfied/mainly satisfied/mainly dissatisfied/completely dissatisfied)
Time frame: Within 3 days after the intervention
Anxiety referred to colonoscopy
German ABI-MS questionnaire (questionnaire on overcoming fear considering medical therapy;
Time frame: Within 3 days before the intervention and 3 days after the intervention; 8 items with binary answer yes/no)
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