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Radiomic Modeling in Differentiating Uncomplicated From Complicated Acute Appendicitis

Sponsor
Kecheng Zhang (Other)
Overall Status
Recruiting
CT.gov ID
NCT05843630
Collaborator
(none)
250
Enrollment
1
Location
11
Anticipated Duration (Months)
22.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: without

Study Design

Study Type:
Observational
Anticipated Enrollment :
250 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Development and Validation of an Individualized Nomogram to Differentiate Uncomplicated From Complicated Acute Appendicitis in Adults: a Multicenter Study
Actual Study Start Date :
Jan 3, 2023
Anticipated Primary Completion Date :
Jun 3, 2023
Anticipated Study Completion Date :
Dec 3, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Accuracy of clinical-radiomic model for differentiating complicated from uncomplicated appendicitis [January 2021 to December 2022]

    ROC curve will be plotted and the area under ROC curve will be compared

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chinese PLA General Hospital First Medical Center Beijing China

Sponsors and Collaborators

  • Kecheng Zhang

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kecheng Zhang, Department of General Surgery, Chinese PLA General Hospital First Medical Center, Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT05843630
Other Study ID Numbers:
  • PLAGH202304
First Posted:
May 6, 2023
Last Update Posted:
May 6, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kecheng Zhang, Department of General Surgery, Chinese PLA General Hospital First Medical Center, Chinese PLA General Hospital
acute appendicitis
diagnosis
nomogram
Additional relevant MeSH terms:
Appendicitis
Acute Disease

Study Results

No Results Posted as of May 6, 2023