Ignite Creation Date:
2024-05-06 @ 6:55 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05836064
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-24
First Post:
2023-04-18
Brief Title:
GastroBot Artificial Intelligence Applied to Bowel Preparation
Sponsor:
Institute of Gastroenterology and Advance Endoscopy
Organization:
Institute of Gastroenterology and Advance Endoscopy
Study Overview
Official Title:
GastroBot a New Artificial Intelligence-developed Software Bot to Improve Bowel Preparation and Colonoscopy Quality
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
It is estimated that about 20 of colonoscopies have inadequate preparation 5 This is associated with lengthy procedures and less detection of adenomas reduces the screening intervals and increases the costs and risks of complications Several strategies have been proposed to improve the quality of bowel preparation Mobile healthcare Apps have been developed to increase adherence to bowel preparation agents improving the quality of bowel preparation However adherence to mobile healthcare Apps is also a quality criterion and a pending problem to solve with this new technology
GastroBot is a new technology based on artificial intelligence that allows through a software bot to carry out a personalized follow-up of the patients bowel cleansing advising the patient to overcome contingencies that arise with the preparation which in other circumstances could lead to the failure of it The primary aim of this study is to determine the improvement in bowel preparation after GastroBot assistance compared with the traditional explanation As a secondary aim this study also pursues to determine adenoma and polyp detection rates ADR and PDR respectively bowel preparation agents tolerance and GastroBot functionality
GastroBot is a new technology based on artificial intelligence that allows through a software bot to carry out a personalized follow-up of the patients bowel cleansing advising the patient to overcome contingencies that arise with the preparation which in other circumstances could lead to the failure of it The primary aim of this study is to determine the improvement in bowel preparation after GastroBot assistance compared with the traditional explanation As a secondary aim this study also pursues to determine adenoma and polyp detection rates ADR and PDR respectively bowel preparation agents tolerance and GastroBot functionality
Detailed Description:
Background Colorectal cancer CRC is the third most frequent tumor the most frequent gastrointestinal tumor and the second cause of cancer-related death 1 In more than 80-90 of cases CRC has a precursor lesion an adenomatous polyp or adenoma slowly progressing towards CRC Colonoscopy is considered the gold standard in its prevention since it allows the detection and treatment of its initial form 2 Considering this several colonoscopy quality indicators have been described such as cecal intubation rate withdrawal time and adenomapolyp detection rate ADR the last is the most important indicator correlating with CRC risk 3
Therefore focusing on improving the ADR is mandatory to reduce the incidence of CRC Many techniques have been described for this purpose like improving endoscopists education and training split-dosing bowel preparations withdrawal time 9 minutes and right colon second view high-definition white light endoscopy Endocuff vision G-EYE scope or Artificial Intelligence 2 4 However all these techniques have in common the need for optimal visualization of the intestinal mucosa which depends on bowel cleansing 34
Problem It is estimated that about 20 of colonoscopies have inadequate preparation 5 This is associated with lengthy procedures and less detection of adenomas reduces the screening intervals and increases the costs and risks of complications This causes frustration for the patient and physician with medico-legal conflicts 6 The ideal cleansing method must be safe well-tolerated and effective However none of the current options fulfills these characteristics The main cause of inappropriate cleansing 80 of cases is a failure to adequately follow preparation instructions and mostly because of intolerance to the oral solution 78
Several strategies have been proposed to improve the quality of bowel preparation As in other fields mobile healthcare Apps have been developed to increase adherence to bowel preparation agents improving quality bowel preparation However adherence to mobile healthcare Apps is also a quality criterion and a pending problem to solve with this new technology Also as with any mobile App mobile healthcare Apps must be compatible with specific devices GastroBot is a new technology based on artificial intelligence that allows through a software bot to carry out a personalized follow-up of the patients bowel cleansing advising the patient to overcome contingencies that arise with the preparation which in other circumstances could lead to the failure of it
Aim The primary aim of this study is to determine the improvement in bowel preparation after GastroBot assistance compared with the traditional explanation As a secondary aim this study also pursues to determine adenoma and polyp detection rates ADR and PDR respectively bowel preparation agents tolerance and GastroBot functionality
MATERIALS AND METHODS
Study design Study type The following is a cross-section simple-blind and single-center controlled randomized trial Two groups will be established the GastroBot-assisted bowel preparation GB-group and the conventional-assisted bowel preparation C-group group
Setting It will be performed in consecutive patients with bowel preparation agents indication before undergoing a colonoscopy with cecal intubation at the Instituto de Gastroenterología y Endoscopía de Avanzada IGEA Hospital de la Asociación Médica HAM Dr Felipe Glasman Bahía Blanca Buenos Aires province Argentina The study protocol and consent form have been approved by the Institutional Review Board IRB and will be conducted according to the declaration of Helsinki Patients will sign an informed consent
Intervention A clinical coordinator will be responsible for patients randomization Patients from both study groups will receive the same type of preparation with polyethylene glycol in split dose establishing the intake time according to three-time segments 8-11 am 11-2 pm 2-4 pm The C-group will receive the instructions in writing without prior personalized advice The GB group will receive the instructions through the WhatsApp application guided by the software bot with multiple and personalized alternative instructions according to results The endoscopist will perform the endoscopy by assessing primary and secondary endpoints blinded to the patients study group
Sample size Considering the proportion of insufficient BBPS 6 among the App-group 77 vs controls 169 described by Walter B et al 2021 a sample size of 194 cases per study group was estimated to determine a two-sided difference on BBPS between GB-group vs C-group with an 80 statistical power
Statistical analysis Baseline characteristics will be compared between the case and control group using Chi-square o Fisher test for categorical variables and Mann-Whitney U or Students t-test for continuous variables A P value of less than 005 will be considered statistically significant All the statistical analysis will be performed using the latest version of the statistical program R R Foundation for Statistical Computing Vienna Austria
Limitations The protocol will be performed in only one center and by six endoscopists It is a simple blind study The patients will know they are using or not a novel instrument to increase bowel preparation quality
Therefore focusing on improving the ADR is mandatory to reduce the incidence of CRC Many techniques have been described for this purpose like improving endoscopists education and training split-dosing bowel preparations withdrawal time 9 minutes and right colon second view high-definition white light endoscopy Endocuff vision G-EYE scope or Artificial Intelligence 2 4 However all these techniques have in common the need for optimal visualization of the intestinal mucosa which depends on bowel cleansing 34
Problem It is estimated that about 20 of colonoscopies have inadequate preparation 5 This is associated with lengthy procedures and less detection of adenomas reduces the screening intervals and increases the costs and risks of complications This causes frustration for the patient and physician with medico-legal conflicts 6 The ideal cleansing method must be safe well-tolerated and effective However none of the current options fulfills these characteristics The main cause of inappropriate cleansing 80 of cases is a failure to adequately follow preparation instructions and mostly because of intolerance to the oral solution 78
Several strategies have been proposed to improve the quality of bowel preparation As in other fields mobile healthcare Apps have been developed to increase adherence to bowel preparation agents improving quality bowel preparation However adherence to mobile healthcare Apps is also a quality criterion and a pending problem to solve with this new technology Also as with any mobile App mobile healthcare Apps must be compatible with specific devices GastroBot is a new technology based on artificial intelligence that allows through a software bot to carry out a personalized follow-up of the patients bowel cleansing advising the patient to overcome contingencies that arise with the preparation which in other circumstances could lead to the failure of it
Aim The primary aim of this study is to determine the improvement in bowel preparation after GastroBot assistance compared with the traditional explanation As a secondary aim this study also pursues to determine adenoma and polyp detection rates ADR and PDR respectively bowel preparation agents tolerance and GastroBot functionality
MATERIALS AND METHODS
Study design Study type The following is a cross-section simple-blind and single-center controlled randomized trial Two groups will be established the GastroBot-assisted bowel preparation GB-group and the conventional-assisted bowel preparation C-group group
Setting It will be performed in consecutive patients with bowel preparation agents indication before undergoing a colonoscopy with cecal intubation at the Instituto de Gastroenterología y Endoscopía de Avanzada IGEA Hospital de la Asociación Médica HAM Dr Felipe Glasman Bahía Blanca Buenos Aires province Argentina The study protocol and consent form have been approved by the Institutional Review Board IRB and will be conducted according to the declaration of Helsinki Patients will sign an informed consent
Intervention A clinical coordinator will be responsible for patients randomization Patients from both study groups will receive the same type of preparation with polyethylene glycol in split dose establishing the intake time according to three-time segments 8-11 am 11-2 pm 2-4 pm The C-group will receive the instructions in writing without prior personalized advice The GB group will receive the instructions through the WhatsApp application guided by the software bot with multiple and personalized alternative instructions according to results The endoscopist will perform the endoscopy by assessing primary and secondary endpoints blinded to the patients study group
Sample size Considering the proportion of insufficient BBPS 6 among the App-group 77 vs controls 169 described by Walter B et al 2021 a sample size of 194 cases per study group was estimated to determine a two-sided difference on BBPS between GB-group vs C-group with an 80 statistical power
Statistical analysis Baseline characteristics will be compared between the case and control group using Chi-square o Fisher test for categorical variables and Mann-Whitney U or Students t-test for continuous variables A P value of less than 005 will be considered statistically significant All the statistical analysis will be performed using the latest version of the statistical program R R Foundation for Statistical Computing Vienna Austria
Limitations The protocol will be performed in only one center and by six endoscopists It is a simple blind study The patients will know they are using or not a novel instrument to increase bowel preparation quality
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None