NCT05843630

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2023

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

5 months

First QC Date

April 25, 2023

Last Update Submit

May 4, 2023

Conditions

Keywords

acute appendicitisdiagnosisnomogram

Outcome Measures

Primary Outcomes (1)

  • Accuracy of clinical-radiomic model for differentiating complicated from uncomplicated appendicitis

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

    January 2021 to December 2022

Study Arms (3)

Training cohort

Model construction based on training cohort

Diagnostic Test: without

Validation cohort 1

Model validation in an independent validation cohort 1

Diagnostic Test: without

Validation cohort 2

Model validation in an independent validation cohort 2

Diagnostic Test: without

Interventions

withoutDIAGNOSTIC_TEST

without

Training cohortValidation cohort 1Validation cohort 2

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adults with pathologically diagnosed as acute appendicitis after appendectomy

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital First Medical Center

Beijing, China

RECRUITING

MeSH Terms

Conditions

AppendicitisDisease

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kecheng Zhang

    Senior Department of General Surgery, Chinese PLA General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Department of General Surgery, Chinese PLA General Hospital First Medical Center

Study Record Dates

First Submitted

April 25, 2023

First Posted

May 6, 2023

Study Start

January 3, 2023

Primary Completion

June 3, 2023

Study Completion

December 3, 2023

Last Updated

May 6, 2023

Record last verified: 2023-05

Locations