Effect of Preoperative Automatic Reminder System on Colonoscopy

Colonoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04996888
• Other study ID #: EA-21-007
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 4, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: August 2021
• Source: Renmin Hospital of Wuhan University
• Contact: Honggang Yu, Doctor
• Phone: +862788041911
• Email: whdxrmyy[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 829
• Est. completion date: January 31, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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 ?or?)

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

Related Conditions & MeSH terms

• Colonoscopy

Intervention

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.

Locations

Country	Name	City	State
China	Renmin hospital of Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Renmin Hospital of Wuhan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	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	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