GastroBot: Artificial Intelligence Applied to Bowel Preparation

NCT05836064 | Unknown DMC

• 1 other identifier: IGEA01-2023
• Study Type: interventional
• Target: 388
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Colonic Polyp; Colonic Neoplasms; Colonic Disease; Colonic Adenoma

Keywords

bowel preparation; colonoscopy quality

Outcome Measures

Primary Outcomes (2)

• Colonoscopy cleansing in terms of Boston bowel preparation score (BBPS)

  Visual assessment of colonoscopy cleansing per colonic part (left, transverse, right), based on BBPS scale.

  1 hour

• Re-scheduled colonoscopy

  If bowel preparation was enough unsatisfactory to re-scheduled colonoscopy.

  1 hour

Secondary Outcomes (4)

• Colonoscopy entrance time

  1 hour

• Adenoma and polyp detection

  1 hour

• Bowel preparation agent's tolerance

  1 hour

• GastroBot functionality

  1 hour

Study Arms (2)

GastroBot-assisted bowel preparation group (GB-group)

EXPERIMENTAL

Adult patients with no surgical high-risk comorbidities and colonoscopy indications for screening, surveillance, or diagnosis who are undergoing a colonoscopy. GastroBot assisted with the polyethylene glycol bowel preparation: patients will receive the instructions through the WhatsApp application, being guided by the software bot with multiple and personalized alternative instructions according to results.

Device: GastroBot

Conventional-assisted bowel preparation group (C-group).

EXPERIMENTAL

Adult patients with no surgical high-risk comorbidities and colonoscopy indications for screening, surveillance, or diagnosis who are undergoing a colonoscopy. The patients received bowel polyethylene glycol bowel preparation instructions in writing without prior personalized advice.

Other: Conventional explanation

Interventions

GastroBot DEVICE

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.

GastroBot-assisted bowel preparation group (GB-group)

Conventional explanation OTHER

Patients will receive in writing detailed explanation about bowel preparation with polyethylene glycol

Conventional-assisted bowel preparation group (C-group).

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Gastroenterology and Advance Endoscopy: lead

Study Sites (1)

Institute of Gastroenterology and Advanced Endoscopy (IGEA)

Bahía Blanca, Buenos Aires, 8000, Argentina

Location

Related Publications (9)

• Gubbiotti A, Spadaccini M, Badalamenti M, Hassan C, Repici A. Key factors for improving adenoma detection rate. Expert Rev Gastroenterol Hepatol. 2022 Sep;16(9):819-833. doi: 10.1080/17474124.2022.2128761. Epub 2022 Oct 14.

  PMID: 36151898 BACKGROUND

• Rex DK, Schoenfeld PS, Cohen J, Pike IM, Adler DG, Fennerty MB, Lieb JG 2nd, Park WG, Rizk MK, Sawhney MS, Shaheen NJ, Wani S, Weinberg DS. Quality indicators for colonoscopy. Gastrointest Endosc. 2015 Jan;81(1):31-53. doi: 10.1016/j.gie.2014.07.058. Epub 2014 Dec 2. No abstract available.

  PMID: 25480100 BACKGROUND

• Hassan C, Spadaccini M, Iannone A, Maselli R, Jovani M, Chandrasekar VT, Antonelli G, Yu H, Areia M, Dinis-Ribeiro M, Bhandari P, Sharma P, Rex DK, Rosch T, Wallace M, Repici A. Performance of artificial intelligence in colonoscopy for adenoma and polyp detection: a systematic review and meta-analysis. Gastrointest Endosc. 2021 Jan;93(1):77-85.e6. doi: 10.1016/j.gie.2020.06.059. Epub 2020 Jun 26.

  PMID: 32598963 BACKGROUND

• Ness RM, Manam R, Hoen H, Chalasani N. Predictors of inadequate bowel preparation for colonoscopy. Am J Gastroenterol. 2001 Jun;96(6):1797-802. doi: 10.1111/j.1572-0241.2001.03874.x.

  PMID: 11419832 BACKGROUND

• Aganiants EK. [Changes in the impulse activity of cerebral cortex neurons upon inhalation of ether in different concentrations]. Biull Eksp Biol Med. 1968 Sep;66(9):45-8. No abstract available. Russian.

  PMID: 5758907 BACKGROUND

• Jansen SV, Goedhard JG, Winkens B, van Deursen CT. Preparation before colonoscopy: a randomized controlled trial comparing different regimes. Eur J Gastroenterol Hepatol. 2011 Oct;23(10):897-902. doi: 10.1097/MEG.0b013e32834a3444.

  PMID: 21900786 BACKGROUND

• Juluri R, Eckert G, Imperiale TF. Polyethylene glycol vs. sodium phosphate for bowel preparation: a treatment arm meta-analysis of randomized controlled trials. BMC Gastroenterol. 2011 Apr 14;11:38. doi: 10.1186/1471-230X-11-38.

  PMID: 21492418 BACKGROUND

• Hassan C, East J, Radaelli F, Spada C, Benamouzig R, Bisschops R, Bretthauer M, Dekker E, Dinis-Ribeiro M, Ferlitsch M, Fuccio L, Awadie H, Gralnek I, Jover R, Kaminski MF, Pellise M, Triantafyllou K, Vanella G, Mangas-Sanjuan C, Frazzoni L, Van Hooft JE, Dumonceau JM. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2019. Endoscopy. 2019 Aug;51(8):775-794. doi: 10.1055/a-0959-0505. Epub 2019 Jul 11.

  PMID: 31295746 BACKGROUND

• Walter B, Frank R, Ludwig L, Dikopoulos N, Mayr M, Neu B, Mayer B, Hann A, Meier B, Caca K, Seufferlein T, Meining A. Smartphone Application to Reinforce Education Increases High-Quality Preparation for Colorectal Cancer Screening Colonoscopies in a Randomized Trial. Clin Gastroenterol Hepatol. 2021 Feb;19(2):331-338.e5. doi: 10.1016/j.cgh.2020.03.051. Epub 2020 Mar 30.

  PMID: 32240835 BACKGROUND

MeSH Terms

Conditions

Colonic Polyps; Colonic Neoplasms; Colonic Diseases

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases

Study Officials

• Manuel Valero, MD

  Instituto de Gastroenterología y Endoscopía de Avanzada (IGEA)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miguel Puga-Tejada, MD MSc

CONTACT

+5491165003311; miguel.puga01@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical director

Model Details: 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).

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: May 1, 2023
• Study Start: January 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: April 28, 2025
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)