Predicting NOM Failure in Bowel Obstruction

April 9, 2025 updated by: Centre Hospitalier Universitaire de Nice

Predicting Failure of Non-operative Management of Adhesive Small Bowel Obstruction Through Deep Learning.

"This study aims to collect data on patients with small bowel obstruction (SBO) admitted to hospitals in France and Italy from May 2022 to October 2024 to develop a deep convolutional neural network (DCNN) model. This model will analyze anonymized CT scans to assess the effectiveness of non-operative management (NOM) for SBO, supporting decisions on surgical intervention. Eligible patients are those diagnosed with SBO due to abdominal adhesions who initially received NOM for at least 24 hours. Patients with other SBO causes, early surgery within 24 hours, or those without a CT scan diagnosis are excluded.

Data collection spans hospitals in Antibes, Nice, Milan, and Vimercate, targeting consecutive SBO cases with adhesive etiology. To perform an external validation of the DCNN, data will also be retrospectively collected from patients admitted to the Antibes hospital between May 2021 and April 2022 with adhesive SBO. This validation set includes patients who underwent NOM successfully and those who needed surgery after NOM failure. The DCNN model will be applied to anonymized, non-contrast and contrast-enhanced portal-phase CT scans of these patients, with researchers blinded to each patient's NOM outcome to prevent bias. The model's performance will then be evaluated using accuracy metrics consistent with those used in initial model testing, ensuring the reliability of results when applied to external cases.

NOM, after adhesive SBO diagnosis via clinical exams, blood tests, and CT scans, includes fasting, analgesics, antiemetics, and fluids as per current guidelines, without necessarily using nasogastric tubes or contrast agents. Patients are re-evaluated after 24 hours to determine whether NOM should continue or if surgery is necessary. NOM is deemed effective if patients experience symptom resolution, stool passage, and no recurrence within 90 days. NOM failure is defined by the need for laparoscopic or laparotomic surgery, based on symptoms' persistence, worsening, or radiological indicators of blockage despite adequate NOM.

Data collection, registered with the French National Committee for Data Protection, includes variables like age, sex, medical history, symptoms, blood tests, CT-scan findings, NOM details, and surgical information. Radiological data, including Digital Imaging and Communication in Medicine (DICOM) files of CT scans, will be anonymized and converted to the Neuroimaging Informatics Technology Initiative (NIfTI) format for secure storage and analysis.

The NIfTI data files will be randomly split into training and test datasets in an 80%-20% ratio, processed separately for non-contrast and contrast-enhanced CT scans. Data augmentation, including random rotation, flipping, zooming, translation, and noise addition, will be applied to improve model accuracy and reduce overfitting. Different DCNN models will be trained and tested and furtherly undergo external validation to produce a tool capable of predicting NOM failure and need for surgery in patients with adhesive SBO."

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
370

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Nice, France, 06000
        • Andrea CHIERICI

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The team will collect data from consecutive patients admitted to the Digestive Surgery Department of the Hospital of Antibes (Centre Hospitalier d'Antibes Juan-les-Pins, France) from May the 1st 2022 to October the 31st 2024, to the Digestive and Emergency Surgery Department (Nice University Hospital , France) from the 1st of May 2022 to the 31st of October 2024 , to the General Surgery and Trauma Center of the University Hospital Niguarda in Milan (Grande Ospedale Metropolitano Niguarda, Italy) from the 1st of May 2023 and the 31st of October 2024, and to the General Surgery Department of the Vimercate Hospital (Ospedale di Vimercate, Italy) from the 1st of May 2023 and the 31st of October 2024 with the diagnosis of SBO. Moreover, to perform external validation of the DCNN model, the team will collect data of patients admitted to the Digestive Surgery Department of the Antibes Juan-les-Pins hospital from the 1st of May 2021 to the 30th of April 20

Description

Inclusion Criteria:

  • SBO diagnosed through clinical evaluation, blood tests, and an abdominal CT-scan performed at the admission in the Emergency Department.
  • SBO secondary to single or multiple abdominal adhesions.
  • Initial treatment of SBO by NOM for at least 24 hours.
  • Non-opposition to the anonymous data processing by the included patients."

Exclusion Criteria:

  • admission for SBO other than of adhesive etiology (hernias, bowel or other abdominal neoplasms, foreign bodies, functional obstruction, etc.).
  • surgical treatment of SBO within 24 hours from admission or rather NOM duration < 24 hours.
  • SBO diagnosis performed without CT-scan."

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
SBO patients

"After adhesive SBO diagnosis is performed through clinical examination, blood tests, and abdominal CT-scan, and need for urgent surgical exploration excluded, patients are admitted to the General/Digestive Surgery Department for NOM. NOM consists in fasting, analgesics, antiemetics, and fluids administration, with or without electrolytes correction. Nasogastric tube positioning and/or hyperosmolar water-soluble contrast administration is not deemed necessary for the patient to be included in this study, thus allowing us to evaluate different management strategies for adhesive SBO.

After at least 24 hours of NOM, patients are re-evaluated for NOM prosecution or surgical treatment.

NOM is considered effective when patients achieved symptoms remission, flatus and stools evacuation, and realimentation without symptoms recurrence for at least 90 days.

NOM failure is defined as need for surgery, both laparoscopic or laparotomic, to treat adhesive SBO. Surgical management depends on single

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Performance of Deep Learning model in predicting NOM failure
Time Frame: 90 days from patients hospital discharge.
To measure the degree of agreement between the prediction made by the Deep Learning model and the actual success or failure of non-operative management for small bowel obstruction in the real situation. This will be measured through Area Under the Receiver Operator Characteristic curve (AUROC) assesment. AUROC varies between 0.5 and 1, corresponding to no class separation capacity and full class separation capacity, respectively.
90 days from patients hospital discharge.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Performance evaluation: accuracy
Time Frame: 90 days from patients hospital discharge.
The number of true positives and true negatives among all predictions. It varies between 0 (no correct prediction) to 1 (full correct predictions).
90 days from patients hospital discharge.
Performance evaluation: precision
Time Frame: 90 days from patients hospital discharge.
The number of true positives divided by all the positive predictions (true positives and false positives). It varies between 0 (no correct prediction) to 1 (full correct predictions)
90 days from patients hospital discharge.
Performance evaluation: recall
Time Frame: 90 days from patients hospital discharge.
The number of true positives divided by the actual positive instances in the dataset (true positives and false negatives). It varies between 0 (no correct prediction) to 1 (full correct predictions).
90 days from patients hospital discharge.
Performance evaluation : balanced accuracy
Time Frame: 90 days from patients hospital discharge.
the aritmethic mean of sensitivity and specificity. It varies between 0 (no correct prediction) to 1 (full correct predictions).
90 days from patients hospital discharge.
Performance evaluation:F1-score
Time Frame: 90 days from patients hospital discharge.
It combines precision and recall. It ranges from 0-100%, and a higher F1 score denotes a better quality classifier.
90 days from patients hospital discharge.
Performance evaluation: Confusion matrix
Time Frame: 90 days from patients hospital discharge.
A visual representation of true positives, false positives, true negatives, and false negatives. It is depicted through a table.
90 days from patients hospital discharge.
Performance evaluation :Log-loss
Time Frame: 90 days from patients hospital discharge.
It indicates how close the prediction probability is to the corresponding actual/true value (0 or 1 in case of binary classification). The more the predicted probability diverges from the actual value, the higher is the log-loss value.
90 days from patients hospital discharge.
Performance evaluation: Cohen's Kappa
Time Frame: 90 days from patients hospital discharge.
A metric used to measure the level of agreement between two raters which can be a useful tool to gauge the performance of a classification model. It accounts for the fact that the raters may happen to agree on some items purely by chance. It varies between 0 (no correct prediction) to 1 (full correct predictions).
90 days from patients hospital discharge.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nice

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 2, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 24Chirdig01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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