Radiomic Modeling in Differentiating Uncomplicated From Complicated Acute Appendicitis

May 4, 2023 updated by: Kecheng Zhang

Development and Validation of an Individualized Nomogram to Differentiate Uncomplicated From Complicated Acute Appendicitis in Adults: a Multicenter Study

Non-operative management (NOM) with antibiotics may be a safe alternative to surgery for uncomplicated appendicitis, but preoperative differentiation between uncomplicated and complicated appendicitis is challenging. The study aimed to develop a clinical-radiomics nomogram to distinguish uncomplicated from complicated appendicitis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

250

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 Locations

  • China
      • Beijing, China
        • Recruiting
        • Chinese PLA General Hospital First Medical Center
        • Contact:
          • Kecheng Zhang

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

All adults with pathologically diagnosed as acute appendicitis after appendectomy

Description

Inclusion Criteria:

  • Pathologically diagnosed as acute appendicitis after appendectomy between January 2021 and December 2022.

Exclusion Criteria:

  • age less than 18 years (no upper age limit);
  • without CT examination within a week before surgery;
  • difficult to outline the contours of the appendix due to inflammatory exudate;
  • lack of clinical information.

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
Intervention / Treatment
Training cohort
Model construction based on training cohort
Diagnostic test: without
without
Validation cohort 1
Model validation in an independent validation cohort 1
Diagnostic test: without
without
Validation cohort 2
Model validation in an independent validation cohort 2
Diagnostic test: without
without

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of clinical-radiomic model for differentiating complicated from uncomplicated appendicitis
Time Frame: January 2021 to December 2022
ROC curve will be plotted and the area under ROC curve will be compared
January 2021 to December 2022

Collaborators and Investigators

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

Sponsor

Kecheng Zhang

Investigators

  • Principal Investigator: Kecheng Zhang, Senior Department of General Surgery, Chinese PLA General Hospital

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)

January 3, 2023

Primary Completion (Anticipated)

June 3, 2023

Study Completion (Anticipated)

December 3, 2023

Study Registration Dates

First Submitted

April 25, 2023

First Submitted That Met QC Criteria

April 25, 2023

First Posted (Estimate)

May 4, 2023

Study Record Updates

Last Update Posted (Estimate)

May 5, 2023

Last Update Submitted That Met QC Criteria

May 4, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PLAGH202304

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

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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