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Finding Evidence to Treat Or Reassure in Appendicitis (FETOR)

NCT03248102 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2019-11-05

No results posted yet for this study

Summary

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.

Conditions

  • Appendicitis

Interventions

DIAGNOSTIC_TEST

Blowing into the mouthpiece

Blowing into the mouthpiece of diagnostic device

Sponsors & Collaborators

  • The Leeds Teaching Hospitals NHS Trust

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-30
Primary Completion
2019-09-09
Completion
2019-09-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03248102 on ClinicalTrials.gov