Development of an Artificial Intelligence Algorithm (SMARTLOOP)

April 26, 2023 updated by: Groupe Hospitalier Paris Saint Joseph

Development of an Artificial Intelligence Algorithm to Identify the Main Risks of Ischemia of Mechanical Intestinal Obstruction

Mechanical obstruction of the small intestine is an interruption of intestinal transit due to an organic obstacle in the digestive tract that results in a shutdown of materials and gas. Without medical care, it can lead to perforation of the intestinal wall and acute peritonitis. It accounts for 4% of emergency department admissions and 20% of emergency surgeries

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

The abdominopelvic tomodensitometric examination is the gold standard for making a diagnosis and identifying the cause, the level of the lesion and looking for signs of severity related to the risk of ischemia of the intestinal tissue. Well characterized, these signs remain difficult to identify for a non-expert radiologist. The evaluation of the detection performance of these signs shows a sensitivity between 63 and 100% and a specificity between 61 and 96% with a great variation according to the signs studied.

Our research project aims to develop a tool for the detection of the three main signs of severity of mechanical intestinal obstruction to raise and standardize the level of detection of the risk of ischemia on abdominal CT images.

Study Type

Observational

Enrollment (Actual)

589

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile De France
      • Paris, Ile De France, France, 75014
        • Groupe Hospitalier Paris Saint-Joseph

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with an abdominal scan performed at Saint-Joseph Hospital and diagnosed with mechanical obstruction of the small intestine on a flange or adhesion

Description

Inclusion Criteria:

  • Patient whose age is ≥ 18 years
  • Patients with an abdominal scan performed at Saint-Joseph Hospital
  • Patients diagnosed with mechanical obstruction of the small intestine on a flange or adhesion
  • Patients having abdominal surgery within 48 hours of diagnosis or medical follow-up at Saint Joseph Hospital
  • French-speaking patient

Exclusion Criteria:

  • Patients with a history of abdominal surgery one month before diagnosis
  • Patients objecting to the use of their data for this research
  • Patient under guardianship or curatorship
  • Patient under legal protection
  • Patient deprived of liberty

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Develop a computer tool that can support the radiologist in identifying the serious risks associated with intestinal obstruction
Time Frame: Day 1
The comparison score (Dice) between manual classifications and locations performed by clinical experts and those automatically predicted by the tool.
Day 1
Develop a computer tool that can support the radiologist in identifying the serious risks associated with intestinal obstruction
Time Frame: Day 1
The number of occlusions
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Paris Saint Joseph

Investigators

  • Principal Investigator: Marc ZINS, Groupe Hospitalier Paris Saint Joseph

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2020

Primary Completion (Actual)

October 30, 2021

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

March 5, 2021

First Submitted That Met QC Criteria

March 11, 2021

First Posted (Actual)

March 12, 2021

Study Record Updates

Last Update Posted (Actual)

April 27, 2023

Last Update Submitted That Met QC Criteria

April 26, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMARTLOOP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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