Acute AppendicitisNCT05843630
Radiomic Modeling in Differentiating Uncomplicated From Complicated Acute Appendicitis
An observational study of Acute Appendicitis, run by Kecheng Zhang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Appendicitis
- What is being tested?
- without
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 3 Jan 2023to 3 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: All adults with pathologically diagnosed as acute appendicitis after appendectomy
Who may be able to join
- Pathologically diagnosed as acute appendicitis after appendectomy between January 2021 and December 2022.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital First Medical Center
Beijing
Kecheng Zhang
About this study
Official title: 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.
- Conditions
- Acute Appendicitis
- Being tested
- without
- Keywords
- acute appendicitis, diagnosis, nomogram
- Medical subject headings
- Appendicitis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
withoutDiagnostic test
without
| Study group | Role | What they receive |
|---|---|---|
| Training cohort | Model construction based on training cohort Receives: Diagnostic Test: without | |
| Validation cohort 1 | Model validation in an independent validation cohort 1 Receives: Diagnostic Test: without | |
| Validation cohort 2 | Model validation in an independent validation cohort 2 Receives: Diagnostic Test: without |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: January 2021 to December 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start3 Jan 2023
- Primary completion3 Jun 2023 (estimated)
- Study completion3 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kecheng Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kecheng Zhang, Chinese PLA General Hospital
- Investigators
- Kecheng Zhang, Principal investigator, Senior Department of General Surgery, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05843630
- Sponsor's protocol ID
- PLAGH202304
- Status last verified
- May 2023
- First submitted
- 25 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of an Individualized Nomogram to Differentiate Uncomplicated From Complicated Acute Appendicitis in Adults: a Multicenter Study
- ClinicalTrials.gov ID
- NCT05843630
- Acronym / sponsor ID
- PLAGH202304
- Conditions
- Acute Appendicitis
- Keywords
- acute appendicitis, diagnosis, nomogram
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Kecheng ZhangUniversity, hospital or other
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 3 Jun 2023 (estimated)
- Study completion
- 3 Dec 2023 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Training cohort | – | Diagnostic Test: withoutModel construction based on training cohort |
| Validation cohort 1 | – | Diagnostic Test: withoutModel validation in an independent validation cohort 1 |
| Validation cohort 2 | – | Diagnostic Test: withoutModel validation in an independent validation cohort 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All adults with pathologically diagnosed as acute appendicitis after appendectomy
Key inclusion criteria (1 listed)
- Pathologically diagnosed as acute appendicitis after appendectomy between January 2021 and December 2022.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| withoutwithout | Diagnostic test | Training cohort, Validation cohort 1, Validation cohort 2 |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: Undecided
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Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
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Piperacillin/Tazobactam Versus Ceftriaxone and Metronidazole for Children With Perforated Appendicitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kecheng Zhang principal investigator
Senior Department of General Surgery, Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Appendicitis, run by Kecheng Zhang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact LI LI (13210613213, 1192225348@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of clinical-radiomic model for differentiating complicated from uncomplicated appendicitis (time frame: January 2021 to December 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.