Development of an Artificial Intelligence Algorithm

Active, not recruiting

• Conditions: Mechanical Intestinal Obstruction

• Registration Number: NCT04795388
• Lead Sponsor: Fondation Hôpital Saint-Joseph

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

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 Timeline

• Study Start: 2020-08-01
• Study First Submitted: 2021-03-05
• Study First Submitted QC: 2021-03-11
• Study First Posted: 2021-03-12
• Primary Completion: 2021-10-30
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-26
• Last Update Posted: 2023-04-27
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 589

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Develop a computer tool that can support the radiologist in identifying the serious risks associated with intestinal obstruction	Day 1	The number of occlusions

Trial Locations

Locations (1)

Groupe Hospitalier Paris Saint-Joseph; 🇫🇷 Paris, Ile De France, France