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Effect of Preoperative Automatic Reminder System on Colonoscopy

A Prospective Multicenter Study on the Effect of Preoperative Automatic Reminder System on Colonoscopy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04996888
Enrollment
829
Registered
2021-08-09
Start date
2021-08-04
Completion date
2022-01-31
Last updated
2021-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonoscopy

Keywords

the quality of bowel preparation

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.

Detailed description

Despite advances in bowel preparation methods, bowel preparation is inadequate in up to one-third of all colonoscopies in reported series. Inadequate bowel cleansing results in negative con-sequences for the examination, including incomplete visualization of the colon, missed lesions(22-48%), procedural difficulties, prolonged procedure time and reduced time interval until follow-up, and an estimated 12-22% increase in overall colonoscopy cost. The adequacy of a bowel preparation is closely linked to patient compliance with both dietary and purge instructions. Previous work has shown that 18-23.5% of the patients with poor preparation had failed to follow preparation instructions. One study performed in Asia showed that non-compliance with bowel preparation instructions, lower education level, and a long wait for the colonoscopy appointment were independent risk factors for poor bowel preparation. A survey among doctors showed that gastroenterologists with the highest number of patients with inadequate bowel preparation believed that patients are unwilling to follow preparation instructions, struggle with the prescribed diet, and are unable to tolerate the full course of purgative. It is reasonable to hypothesis that efforts to improve education and maximize patient compliance during the preparatory period will enhance the efficacy of bowel preparation. A research has shown that telephone-based re-education about the details of bowel preparation on the day before colonoscopy significantly improved the quality of bowel preparation and polys detection rate. In recent years, artificial intelligence (AI) has been successfully applied in multiple medical fields. But there has not been an artificial-intelligence-based system which can automatically remind patients of the details of bowel preparation on the day before colonoscopy. In this study, we proposed an artificial intelligence-based preoperative automatic reminder system on colonoscopy, which can improve the quality of bowel preparation and the rate of polyps and adenomas detection.

Interventions

DEVICEAI based preoperative automatic reminder system

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.

Sponsors

Renmin Hospital of Wuhan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

1. Male or female between 50-75 years old; 2. Able to read, understand and sign informed consent 3. 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 4. Outpatients requiring colonoscopy

Exclusion criteria

1. colorectal surgical history 2. Severe colonic stricture or obstructive tumor 3. Obvious gastroparesis or gastric outlet obstruction or intestinal infarction 4. Pregnant or lactating women 5. Dysphagia or impaired swallowing reflex or mental state 6. Intestinal obstruction or perforation is known 7. Severe chronic renal failure(CCR\< 30ml/min) 8. Severe congestive heart failure(NYHA ⅢorⅣ) 9. Uncontrolled hypertension( systolic pressure\>170mmHg,diastolic pressure\>100mmHg) 10. Dehydration or electrolyte disorder 11. Toxic colitis or megacolon 12. Inable to give informed consent 13. Hemodynamic instability

Design outcomes

Primary

MeasureTime frameDescription
the rate of adequate bowel preparationFrom the beginning to the end of colonoscopyThe 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.

Secondary

MeasureTime frameDescription
Detection rate of adenomaA monthThe numerator is the number of patients diagnosed with adenomas, and the denominator is the total number of patients undergoing colonoscopy.

Other

MeasureTime frameDescription
Detection rate of polypA monthThe numerator is the number of patients diagnosed with polyp, and the denominator is the total number of patients undergoing colonoscopy.
Rate of willing to repeat intestinal preparationSix monththe numerator is the number of patients who are willing to prepare for colonoscopy again after inquiry due to timely treatment in the future or insufficient intestinal preparation, and the denominator is the number of patients who receive colonoscopy
Instructions compliance analysisFrom the beginning to the end of colonoscopyFailure to comply with intestinal preparation is defined as failure to take laxatives on time, failure to comply with dietary restrictions, and acknowledgement of failure to comply with instructions, including insufficient dosage of intestinal preparation solution, insufficient duration of completion of intestinal preparation solution, and insufficient hydration
Attendance rateFrom the beginning to the end of colonoscopythe numerator is the number of patients on time, and the denominator is the number of patients undergoing enteroscopy

Countries

China

Contacts

Primary ContactHonggang Yu, Doctor
whdxrmyy@126.com+862788041911

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026