Finding Evidence to Treat Or Reassure in Appendicitis (FETOR)

Appendicitis Clinical Trial

— FETOR  

Official title:

Finding Evidence to Treat Or Reassure in Appendicitis (FETOR)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03248102
• Other study ID #: PS15/261
• Status: Completed
• Phase: N/A
• Start date: August 30, 2017
• Est. completion date: September 30, 2019

Study information

• Verified date: November 2019
• Source: The Leeds Teaching Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: September 30, 2019
• Est. primary completion date: September 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 16 Years

Eligibility

Inclusion Criteria:

• Patients with suspected appendicitis

• Aged 5 and up to their 16th birthday on arrival to A&E

• Patients referred to the Paediatric surgical team that have presented to the Leeds General Infirmary through A&E, the Children's Assessment Unit, or via direct referral from another team or hospital.

• Consecutive presentations who can have some or all of VOC sampling during working week.

Exclusion Criteria:

• Patients with known alternative cause of abdominal pain (e.g. known Inflammatory Bowel Disease)

• Patients who are both admitted and discharged when no researcher is available

Related Conditions & MeSH terms

• Appendicitis

Intervention

Diagnostic Test:
• Blowing into the mouthpiece
Blowing into the mouthpiece of diagnostic device

Locations

Country	Name	City	State
United Kingdom	Leeds Teaching Hospitals NHS Trust	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
The Leeds Teaching Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breath collection for analysis	Collect breath from children with abdominal pain meeting inclusion criteria assess ment to changes in Volatile Organic Compounds (VOC)	3 minutes