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NCT04519086: OPTICAP>30
The Optimization of a Low-dose CT Protocol in Patients With Suspected Uncomplicated Acute Appendicitis and BMI >30
NA trial testing Low-dose CT in Appendicitis in 30 participants. Suspended.
17 November 2021
Quick facts
| Lead sponsor | Turku University Hospital |
|---|---|
| Phase | NA |
| Status | Suspended |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 30 |
| Start date | 4 November 2020 |
| Primary completion | 17 November 2021 |
| Estimated completion | 17 November 2023 |
| Sites | 1 location across Finland |
Drugs / interventions tested
- Low-dose CT
- Laparoscopic appendectomy
Conditions studied
- Appendicitis — all drugs for Appendicitis →
- Other and Unspecified Acute Appendicitis — all drugs for Other and Unspecified Acute Appendicitis →
- Acute Disease — all drugs for Acute Disease →
- Gastrointestinal Disease — all drugs for Gastrointestinal Disease →
Sponsor
Turku University Hospital
Who can join
Adults 18 to 60, any sex, with Appendicitis or Other and Unspecified Acute Appendicitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study focuses on the use of contrast enhanced low-dose CT imaging as a modality to differentiate between uncomplicated and complicated acute appendicitis. Accurate differential diagnosis allows the assessment of all available treatment options. Complicated acute appendicitis requires emergency appendectomy, while uncomplicated acute appendicitis can be safely and efficiently treated with antibiotics in the majority of patients. Our study group already published the results of the initial OPTICAP trial enrolling patients with BMI under 30 showing similar accuracy between the low-dose and the stadard dose CT, but a significant dose reduction associated with the low-dose CT. All patients will undergo both imaging protocols as the standard CT is also optimized for a low as possible radiation dosage and imaging sequence per patient is randomized due to the optimization of contrast media injection timing. All patients participating in this study will be treated operatively with a laparoscopic appendectomy to obtain histological confirmation for the diagnosis to evaluate the accuracy of the CT imaging. The aim of this study is to optimize a well-performing low-dose CT imaging protocol to use in the diagnosis of uncomplicated acute appendicitis in patients with body mass index over 30 kg/m2.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04519086
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Other Turku University Hospital trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04519086 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Turku University Hospital
- Last refreshed: 25 February 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04519086.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing