Development of an Artificial Intelligence Algorithm

Mechanical Intestinal Obstruction Clinical Trial

— SMARTLOOP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04795388
• Other study ID #: SMARTLOOP
• Status: Active, not recruiting
• Start date: August 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 589
• Est. completion date: December 31, 2023
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intestinal Obstruction
• Mechanical Intestinal Obstruction

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint-Joseph	Paris	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

Outcome

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