NCT03248102: FETOR

Finding Evidence to Treat Or Reassure in Appendicitis (FETOR)

Completed NA Last updated 5 November 2019

What this trial tests

NA trial testing Blowing into the mouthpiece in Appendicitis in 58 participants. Completed in 30 September 2019.

Timeline

30 August 2017

Primary endpoint
9 September 2019

30 September 2019

Quick facts

Lead sponsor	The Leeds Teaching Hospitals NHS Trust
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	58
Start date	30 August 2017
Primary completion	9 September 2019
Estimated completion	30 September 2019
Sites	1 location across United Kingdom

Drugs / interventions tested

• Blowing into the mouthpiece

Conditions studied

• Appendicitis — all drugs for Appendicitis →

Sponsor

The Leeds Teaching Hospitals NHS Trust

Who can join

Adults 5 to 16, any sex, with Appendicitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Bedside breath tests in children with abdominal pain: a prospective pilot feasibility study.
   Wong DC, Relton SD, Lane V, Ismail M, et al · · 2019 · cited 2× · PMID 31720000 · DOI 10.1186/s40814-019-0502-x