Finding Evidence to Treat Or Reassure in Appendicitis (FETOR) (FETOR)
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|ClinicalTrials.gov Identifier: NCT03248102|
Recruitment Status : Completed
First Posted : August 14, 2017
Last Update Posted : November 5, 2019
Acute appendicitis is the most common surgical emergency in childhood. Despite access to current diagnostic modalities, diagnosis may be challenging since the child may have difficulty in articulating symptoms. Additionally there is a high frequency of atypical presentation and rapid progression. Delayed diagnosis in children is reported as being up to 60%. Delayed diagnosis >48hr increases the perforation rate from 21% to 71%. Around 20% of children presenting with appendicitis have perforated by the time they come to surgery.
Appendix perforation is associated with a prolonged hospital stay and increased cost. Once perforated, major complication rates increase from 1.2% to 6.4%, median bed stay increases from 2 to 6 days and hospitalisation costs are estimated at US $33,348.
Conversely, a false positive diagnosis leads to unnecessary surgery in 12%. It has been suggested that only 35% of surgical referrals with possible appendicitis actually need surgery thus impacting on resource use.
A reliable test, especially if painless, would be very useful. If positive the child could undergo early appendicectomy in expectation of a reduction in the perforation rate (and, therefore, reduction in hospital stay). If negative the child could be discharged home safely. No adequate biomarker has been identified.
Technology already exists to detect changes in Volatile Organic Compounds (VOC) in gases. VOC analysis is already used commercially to identify disease processes in animals and crops. Although VOC has been previously used to detect human diseases, it has never been used to look for changes in the composition of breath in appendicitis.
The investigators hypothesise that the composition of VOC's in children with appendicitis will differ from those without. The investigators anticipate these differences will be of diagnostic and prognostic value in clinical practice. The feasibility of collecting breath samples from children with possible appendicitis to allow VOC testing has not been examined.
|Condition or disease||Intervention/treatment||Phase|
|Appendicitis||Diagnostic Test: Blowing into the mouthpiece||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Finding Evidence to Treat Or Reassure in Appendicitis (FETOR)|
|Actual Study Start Date :||August 30, 2017|
|Actual Primary Completion Date :||September 9, 2019|
|Actual Study Completion Date :||September 30, 2019|
Experimental: Patients with suspected appendicitis
Patients with suspected appendicitis Aged 5 and up to their 16th birthday on arrival to A&E
Diagnostic Test: Blowing into the mouthpiece
Blowing into the mouthpiece of diagnostic device
- Breath collection for analysis [ Time Frame: 3 minutes ]Collect breath from children with abdominal pain meeting inclusion criteria assess ment to changes in Volatile Organic Compounds (VOC)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03248102
|Leeds Teaching Hospitals NHS Trust|
|Leeds, United Kingdom|