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SMARTLOOP: Development of an Artificial Intelligence Algorithm

Sponsor
Groupe Hospitalier Paris Saint Joseph (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04795388
Collaborator
(none)
589
Enrollment
1
Location
29
Anticipated Duration (Months)
20.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    589 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Development of an Artificial Intelligence Algorithm to Identify the Main Risks of Ischemia of Mechanical Intestinal Obstruction
    Actual Study Start Date :
    Aug 1, 2020
    Actual Primary Completion Date :
    Oct 30, 2021
    Anticipated Study Completion Date :
    Dec 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Develop a computer tool that can support the radiologist in identifying the serious risks associated with intestinal obstruction [Day 1]

      The comparison score (Dice) between manual classifications and locations performed by clinical experts and those automatically predicted by the tool.

    2. Develop a computer tool that can support the radiologist in identifying the serious risks associated with intestinal obstruction [Day 1]

      The number of occlusions

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Groupe Hospitalier Paris Saint-Joseph Paris Ile De France France 75014

    Sponsors and Collaborators

    • Groupe Hospitalier Paris Saint Joseph

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Groupe Hospitalier Paris Saint Joseph
    ClinicalTrials.gov Identifier:
    NCT04795388
    Other Study ID Numbers:
    • SMARTLOOP
    First Posted:
    Mar 12, 2021
    Last Update Posted:
    Mar 17, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Groupe Hospitalier Paris Saint Joseph
    ischemia
    Additional relevant MeSH terms:
    Intestinal Obstruction

    Study Results

    No Results Posted as of Mar 17, 2022