Effect of Preoperative Automatic Reminder System on Colonoscopy
A Prospective Multicenter Study on the Effect of Preoperative Automatic Reminder System on Colonoscopy
1 other identifier
interventional
829
1 country
1
Brief Summary
In this study, the investigators proposed an artificial intelligence-based preoperative automatic reminder system on colonocopy, which can improve the quality of bowel preparation and the rate of polyps and adenomas detection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 2, 2021
CompletedStudy Start
First participant enrolled
August 4, 2021
CompletedFirst Posted
Study publicly available on registry
August 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2022
CompletedAugust 9, 2021
August 1, 2021
5 months
August 2, 2021
August 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the rate of adequate bowel preparation
The numerator is the number of patients qualified for intestinal preparation, and the denominator is the number of all patients undergoing colonoscopy. The definition of intestinal preparation qualification is: e-bbps qualification is defined as colonoscopy with e-bbps ≥ 6; BBPS is defined as enteroscopy with scores ≥2 for ascending colon, transverse colon and descending colon. At the same time, if one or more of the following conditions are met, intestinal preparation is considered insufficient: (1) colonoscopy with e-bbps \<6 is insufficient（ 2) Cancel colonoscopy due to poor intestinal preparation or personal reasons（ 3) Incomplete colonoscopy.
From the beginning to the end of colonoscopy
Secondary Outcomes (1)
Detection rate of adenoma
A month
Other Outcomes (4)
Detection rate of polyp
A month
Rate of willing to repeat intestinal preparation
Six month
Instructions compliance analysis
From the beginning to the end of colonoscopy
- +1 more other outcomes
Study Arms (2)
with AI preoperative automatic reminder system
EXPERIMENTALAfter receiving regular instructions at the time of their appointment to discuss colonoscopy and education about colonoscopy provided by one nurse, including the importance of bowel preparation, the side effects of the agents used, and the exact preparation instructions, the patients in the experimental group will be sent a message and a phone call by AI system on the day before colonoscopy, which will emphasize the importance of bowel preparation, the directions for use and side effects of purgatives, the proper food type, and the start time.
without AI preoperative automatic reminder system
NO INTERVENTIONThe patients in the control group accept colonoscopy routinely without AI based preoperative automatic reminder system. All patients will receive regular instructions at the time of their appointment to discuss colonoscopy and education about colonoscopy provided by one nurse, including the importance of bowel preparation, the side effects of the agents used, and the exact preparation instructions.
Interventions
the patients in the experimental group will be sent a message and a phone call by AI system on the day before colonoscopy, which will emphasize the importance of bowel preparation, the directions for use and side effects of purgatives, the proper food type, and the start time. The system is an non-invasive AI system.
Eligibility Criteria
You may qualify if:
- Male or female between 50-75 years old;
- Able to read, understand and sign informed consent
- The investigator believes that the subjects can understand the process of the clinical study, are willing and able to complete all study procedures and follow-up visits, and cooperate with the study procedures
- Outpatients requiring colonoscopy
You may not qualify if:
- colorectal surgical history
- Severe colonic stricture or obstructive tumor
- Obvious gastroparesis or gastric outlet obstruction or intestinal infarction
- Pregnant or lactating women
- Dysphagia or impaired swallowing reflex or mental state
- Intestinal obstruction or perforation is known
- Severe chronic renal failure（CCR\< 30ml/min）
- Severe congestive heart failure（NYHA ⅢorⅣ）
- Uncontrolled hypertension( systolic pressure\>170mmHg，diastolic pressure\>100mmHg)
- Dehydration or electrolyte disorder
- Toxic colitis or megacolon
- Inable to give informed consent
- Hemodynamic instability
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Renmin hospital of Wuhan University
Wuhan, Hubei, 430000, China
Study Officials
- PRINCIPAL INVESTIGATOR
Yu W Honggang, Doctor
Renmin Hospital of Wuhan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2021
First Posted
August 9, 2021
Study Start
August 4, 2021
Primary Completion
December 30, 2021
Study Completion
January 31, 2022
Last Updated
August 9, 2021
Record last verified: 2021-08