Finding Evidence to Treat Or Reassure in Appendicitis (FETOR) (FETOR)
Primary Purpose
Appendicitis
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Blowing into the mouthpiece
Sponsored by
About this trial
This is an interventional diagnostic trial for Appendicitis focused on measuring paediatric
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
Sites / Locations
- Leeds Teaching Hospitals NHS Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with suspected appendicitis
Arm Description
Patients with suspected appendicitis Aged 5 and up to their 16th birthday on arrival to A&E
Outcomes
Primary Outcome Measures
Breath collection for analysis
Collect breath from children with abdominal pain meeting inclusion criteria assess ment to changes in Volatile Organic Compounds (VOC)
Secondary Outcome Measures
Full Information
NCT ID
NCT03248102
First Posted
July 4, 2017
Last Updated
November 4, 2019
Sponsor
The Leeds Teaching Hospitals NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT03248102
Brief Title
Finding Evidence to Treat Or Reassure in Appendicitis (FETOR)
Acronym
FETOR
Official Title
Finding Evidence to Treat Or Reassure in Appendicitis (FETOR)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
August 30, 2017 (Actual)
Primary Completion Date
September 9, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Leeds Teaching Hospitals NHS Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis
Keywords
paediatric
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with suspected appendicitis
Arm Type
Experimental
Arm Description
Patients with suspected appendicitis Aged 5 and up to their 16th birthday on arrival to A&E
Intervention Type
Diagnostic Test
Intervention Name(s)
Blowing into the mouthpiece
Intervention Description
Blowing into the mouthpiece of diagnostic device
Primary Outcome Measure Information:
Title
Breath collection for analysis
Description
Collect breath from children with abdominal pain meeting inclusion criteria assess ment to changes in Volatile Organic Compounds (VOC)
Time Frame
3 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Leeds Teaching Hospitals NHS Trust
City
Leeds
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
31720000
Citation
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.
Results Reference
derived
Learn more about this trial
Finding Evidence to Treat Or Reassure in Appendicitis (FETOR)
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