Bowel Preparation
Conditions
Keywords
Bowel Preparation, Artificial Intelligence, Polyp Detection
Brief summary
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.
Detailed description
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.
Interventions
OTHERChatbot
A artificial-intelligence based chatbot is provided 3 days before colonoscopy to answer questions concerning bowel preparation and colonoscopy conduct.
OTHERPhone call
A phone call is performed every day starting at 3 days before colonoscopy to support bowel preparation.
Sponsors
University of Ulm
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* informed consent * smartphone with access to WhatsApp * indication for ambulatory colonoscopy * ASA I or II
Exclusion criteria
* no informed consent given or possible * no access to a smartphone with WhatsApp * \<18 years old * Pregnancy/Lactation * Allergy to Moviprep© * ASA (American Society of Anesthesiologists) state \>II * extended abdominal surgery in past history * no indication for ambulatory colonoscopy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of bowel preparation | During colonoscopy | evaluated with the Boston Bowel Preparation Scale (0-9, 1=worst preparation, 9= best preparation) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Polyp and adenoma detection rate | During colonoscopy | Rate of detected polyps and adenomas |
| Patients satisfaction with preparation support | Within 3 days after the intervention | Via questionnaire; 8 items, ordinal scale with 4 grades (completely satisfied/mainly satisfied/mainly dissatisfied/completely dissatisfied) |
| Comprehensiveness of bowel preparation | During colonoscopy | Rate of successfully completed colonoscopy without premature termination due to remaining feces(from anus to terminal ileum) |
| Coecal intubation | During colonoscopy | Successful coecal intubation during colonoscopy |
| Sedation dose | During colonoscopy | Total amount of administered sedation per examination |
| Anxiety referred to colonoscopy | Within 3 days before the intervention and 3 days after the intervention; 8 items with binary answer yes/no) | German ABI-MS questionnaire (questionnaire on overcoming fear considering medical therapy; |
| Patients satisfaction with bowel preparation | Immediately after the intervention | Via questionnaire; 8 items, ordinal scale with 4 grades (completely satisfied/mainly satisfied/mainly dissatisfied/completely dissatisfied) |
Countries
Germany
Contacts
Primary ContactBenjamin Walter, MD
Backup ContactNiklas Sturm, MD
Outcome results
None listed