Effect of Preoperative Automatic Reminder System on Colonoscopy

NCT ID: NCT04996888

Last Updated: 2021-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

829 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-04

Study Completion Date

2022-01-31

Brief Summary

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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

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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.

Conditions

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Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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with AI preoperative automatic reminder system

After 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.

Group Type EXPERIMENTAL

AI based preoperative automatic reminder system

Intervention Type DEVICE

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.

without AI preoperative automatic reminder system

The 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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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AI 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Renmin Hospital of Wuhan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yu W Honggang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Renmin Hospital of Wuhan University

Locations

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Renmin hospital of Wuhan University

Wuhan, Hubei, China

Site Status

Countries

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China

Central Contacts

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Honggang Yu, Doctor

Role: CONTACT

+862788041911

Facility Contacts

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Honggang Yu, Doctor

Role: primary

+862788041911

Other Identifiers

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EA-21-007

Identifier Type: -

Identifier Source: org_study_id

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