AppendicitisFETORNCT03248102
Finding Evidence to Treat Or Reassure in Appendicitis (FETOR)
A study testing Blowing into the mouthpiece in people with Appendicitis, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Appendicitis
- What is being tested?
- Blowing into the mouthpiece
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Aug 2017to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Blowing into the mouthpiece
- Keywords
- paediatric
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blowing into the mouthpieceDiagnostic test
Blowing into the mouthpiece of diagnostic device
| Study group | Role | What they receive |
|---|---|---|
| Patients with suspected appendicitis | Experimental | Patients with suspected appendicitis Aged 5 and up to their 16th birthday on arrival to A\&E Receives: Diagnostic Test: Blowing into the mouthpiece |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breath collection for analysis
Collect breath from children with abdominal pain meeting inclusion criteria assess ment to changes in Volatile Organic Compounds (VOC)
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study start30 Aug 2017
- Primary completion9 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03248102
- Sponsor's protocol ID
- PS15/261
- Acronym
- FETOR
- Status last verified
- Nov 2019
- First submitted
- 4 Jul 2017
- Last updated
- 5 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31720000
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Finding Evidence to Treat Or Reassure in Appendicitis (FETOR)
- ClinicalTrials.gov ID
- NCT03248102
- Acronym / sponsor ID
- FETOR / PS15/261
- Conditions
- Appendicitis
- Keywords
- paediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Study start
- 30 Aug 2017 (actual)
- Primary completion
- 9 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 14 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected appendicitis | Experimental | Diagnostic Test: Blowing into the mouthpiecePatients with suspected appendicitis Aged 5 and up to their 16th birthday on arrival to A\&E |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blowing into the mouthpieceBlowing into the mouthpiece of diagnostic device | Diagnostic test | Patients with suspected appendicitis |
Primary outcome
Breath collection for analysis
Time frame: 3 minutes
Collect breath from children with abdominal pain meeting inclusion criteria assess ment to changes in Volatile Organic Compounds (VOC)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2019.
- Derived from this study: PubMed 31720000Wong 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blowing into the mouthpiece in people with Appendicitis, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breath collection for analysis (time frame: 3 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03248102, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2019.