Finding Evidence to Treat Or Reassure in Appendicitis (FETOR)

NCT ID: NCT03248102

Last Updated: 2019-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-30
• Study Completion Date: 2019-09-30

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients with suspected appendicitis

Patients with suspected appendicitis Aged 5 and up to their 16th birthday on arrival to A\&E

Group Type: EXPERIMENTAL

Blowing into the mouthpiece

Intervention Type: DIAGNOSTIC_TEST

Blowing into the mouthpiece of diagnostic device

Interventions

Blowing into the mouthpiece

Blowing into the mouthpiece of diagnostic device

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Leeds Teaching Hospitals NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Leeds Teaching Hospitals NHS Trust

Leeds, , United Kingdom

Countries

United Kingdom

References

Wong DC, Relton SD, Lane V, Ismail M, Goss V, Bytheway J, West RM, Deuchars J, Sutcliffe J. Bedside breath tests in children with abdominal pain: a prospective pilot feasibility study. Pilot Feasibility Stud. 2019 Nov 5;5:121. doi: 10.1186/s40814-019-0502-x. eCollection 2019.

Reference Type: DERIVED

PMID: 31720000 (View on PubMed)

Other Identifiers

PS15/261

Identifier Type: -

Identifier Source: org_study_id