ColonoscopyNCT04996888
Effect of Preoperative Automatic Reminder System on Colonoscopy
A study testing AI based preoperative automatic reminder system in people with Colonoscopy, run by Renmin Hospital of Wuhan University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Colonoscopy
- What is being tested?
- AI based preoperative automatic reminder system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 829 participants
- Where
- 1 siteChina
- Study dates
- 4 Aug 2021to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Renmin hospital of Wuhan University
Wuhan, Hubei, 430000
Honggang Yu, Doctor, +862788041911, whdxrmyy@126.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Colonoscopy
- Being tested
- AI based preoperative automatic reminder system
- Keywords
- the quality of bowel preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI based preoperative automatic reminder systemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| with AI preoperative automatic reminder system | Experimental | 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. Receives: Device: AI based preoperative automatic reminder system |
| without AI preoperative automatic reminder system | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the beginning to the end of colonoscopy
Secondary outcomes (1)
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.
Measured: A month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start4 Aug 2021 (estimated)
- Primary completion30 Dec 2021 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 829 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renmin Hospital of Wuhan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu W Honggang, Doctor, Principal investigator, Renmin Hospital of Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04996888
- Sponsor's protocol ID
- EA-21-007
- Status last verified
- Aug 2021
- First submitted
- 2 Aug 2021
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Study on the Effect of Preoperative Automatic Reminder System on Colonoscopy
- ClinicalTrials.gov ID
- NCT04996888
- Acronym / sponsor ID
- EA-21-007
- Conditions
- Colonoscopy
- Keywords
- the quality of bowel preparation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 829 participants (estimated)
- Lead sponsor
- Renmin Hospital of Wuhan UniversityUniversity, hospital or other
- Study start
- 4 Aug 2021 (estimated)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 9 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with AI preoperative automatic reminder system | Experimental | Device: AI based preoperative automatic reminder systemAfter 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 intervention | –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. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI based preoperative automatic reminder systemthe 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. | Device | with AI preoperative automatic reminder system |
Primary outcome
the rate of adequate bowel preparation
Time frame: From the beginning to the end of colonoscopy
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.
1 secondary outcome
Detection rate of adenoma
Time frame: A month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu W Honggang, Doctor principal investigator
Renmin Hospital of Wuhan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI based preoperative automatic reminder system in people with Colonoscopy, run by Renmin Hospital of Wuhan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Honggang Yu, Doctor (+862788041911, whdxrmyy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of adequate bowel preparation (time frame: From the beginning to the end of colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2021.