Effect of Preoperative Automatic Reminder System on Colonoscopy

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colonoscopy
• Intervention / Treatment: Device: AI based preoperative automatic reminder system

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.

• Study Type: Interventional
• Enrollment (Anticipated): 829
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Honggang Yu, Doctor; Phone Number: +862788041911; Email: whdxrmyy@126.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Renmin Hospital of Wuhan University
      • Contact: Honggang Yu, Doctor; Phone Number: +862788041911; Email: whdxrmyy@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection rate of adenoma	The numerator is the number of patients diagnosed with adenomas, and the denominator is the total number of patients undergoing colonoscopy.	A month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection rate of polyp	The numerator is the number of patients diagnosed with polyp, and the denominator is the total number of patients undergoing colonoscopy.	A month
Rate of willing to repeat intestinal preparation	the 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	Six month
Instructions compliance analysis	Failure 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	From the beginning to the end of colonoscopy
Attendance rate	the numerator is the number of patients on time, and the denominator is the number of patients undergoing enteroscopy	From the beginning to the end of colonoscopy

Collaborators and Investigators

• Sponsor: Renmin Hospital of Wuhan University
• Investigators: Principal Investigator: Yu w Honggang, Doctor, Renmin Hospital of Wuhan University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 4, 2021
• Primary Completion (Anticipated): December 30, 2021
• Study Completion (Anticipated): January 31, 2022

Study Registration Dates

• First Submitted: August 2, 2021
• First Submitted That Met QC Criteria: August 2, 2021
• First Posted (Actual): August 9, 2021

Study Record Updates

• Last Update Posted (Actual): August 9, 2021
• Last Update Submitted That Met QC Criteria: August 2, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: the quality of bowel preparation
• Other Study ID Numbers: EA-21-007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No