Trial Title:
GastroBot: Artificial Intelligence Applied to Bowel Preparation
NCT ID:
NCT05836064
Condition:
Colonic Polyp
Colonic Neoplasms
Colonic Disease
Colonic Adenoma
Conditions: Official terms:
Adenoma
Colonic Neoplasms
Colonic Diseases
Colonic Polyps
Conditions: Keywords:
bowel preparation
colonoscopy quality
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
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. 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).
Primary purpose:
Diagnostic
Masking:
Double (Investigator, Outcomes Assessor)
Masking description:
A clinical coordinator will be responsible for patients' randomization. The endoscopist
will perform the endoscopy by assessing primary and secondary endpoints, blinded to the
patient's study group.
Intervention:
Intervention type:
Device
Intervention name:
GastroBot
Description:
An artificial intelligence-developed and WhatsApp-based software bot. It will send the
instructions to the patient through the WhatsApp application, guided by the software bot
with multiple and personalized alternative instructions according to results.
Arm group label:
GastroBot-assisted bowel preparation group (GB-group)
Intervention type:
Other
Intervention name:
Conventional explanation
Description:
Patients will receive in writing detailed explanation about bowel preparation with
polyethylene glycol
Arm group label:
Conventional-assisted bowel preparation group (C-group).
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 patient's 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 adenoma/polyp 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. (3,4)
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. (7,8)
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 patient's
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 patient's study group.
Sample size Considering the proportion of insufficient BBPS (<6) among the App-group
(7.7%) vs. controls (16.9%) 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 Student's t-test for continuous variables. A P value of less than 0.05 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age under 18 and over 80 years old.
- Who agrees to participate in the study and can understand and provide written
informed consent.
- Any colonoscopy indication: colorectal neoplasia screening, surveillance of colon
pre-existing diseases, or diagnostic approach in symptomatic patients.
- Smartphone owners (any device) and WhatsApp users, independence of local or
international mobile phone provider.
Exclusion Criteria:
- Scheduled colonoscopies with any therapeutic approach will be categorically excluded
if it does not have a cecal intubation indication.
- Patients with difficulty understanding instructions for bowel preparation or not
being able to use WhatsApp.
- History of diabetes mellitus with insulin therapy, heart disease, kidney, liver, or
severe metabolic disorder.
- Phenprocoumon therapy or severe uncontrolled coagulopathy
- Pregnancy and lactation
- Prior history of colon resection, ileostomy, or colostomy
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Institute of Gastroenterology and Advanced Endoscopy (IGEA)
Address:
City:
Bahía Blanca
Zip:
8000
Country:
Argentina
Start date:
January 1, 2024
Completion date:
April 28, 2025
Lead sponsor:
Agency:
Institute of Gastroenterology and Advance Endoscopy
Agency class:
Other
Source:
Institute of Gastroenterology and Advance Endoscopy
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05836064
