Clinical trial NCT05041283: Impact of Artificial Intelligence-based Patient Reinforcement on Quality of Colonoscopy
Official title: Impact of Artificial Intelligence-based Patient Reinforcement on Quality of Colonoscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bowel Preparation
Keywords: Bowel Preparation
Artificial Intelligence
Polyp Detection
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2021-09-13
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of bowel preparation
timeFrame: During colonoscopy
Secondary outcomes:
measure: Patients satisfaction with bowel preparation
timeFrame: Immediately after the intervention
measure: Comprehensiveness of bowel preparation
timeFrame: During colonoscopy
measure: Sedation dose
timeFrame: During colonoscopy
measure: Coecal intubation
timeFrame: During colonoscopy
measure: Polyp and adenoma detection rate
timeFrame: During colonoscopy
measure: Patients satisfaction with preparation support
timeFrame: Within 3 days after the intervention
measure: Anxiety referred to colonoscopy
timeFrame: Within 3 days before the intervention and 3 days after the intervention; 8 items with binary answer yes/no)
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Specialist Practice Profes. Dikopoulos/Ludwig
state: Baden-Würrtemberg
city: Ulm
country: Germany
facility: University of Ulm, Interdisciplinary Endoscopy
state: Baden-Würrtemberg
city: Berlin
country: Germany
facility: Specialist Practice
Study officials:
affiliation: University Hospital Ulm
name: Thomas Seufferlein, Prof.
role: PRINCIPAL_INVESTIGATOR
References: