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Trial record 1 of 1 for:    NCT03248102 | appendicitis
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Finding Evidence to Treat Or Reassure in Appendicitis (FETOR) (FETOR)

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ClinicalTrials.gov Identifier: NCT03248102
Recruitment Status : Completed
First Posted : August 14, 2017
Last Update Posted : November 5, 2019
Sponsor:
Information provided by (Responsible Party):
The Leeds Teaching Hospitals NHS Trust

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.


Condition or disease Intervention/treatment Phase
Appendicitis Diagnostic Test: Blowing into the mouthpiece Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Finding Evidence to Treat Or Reassure in Appendicitis (FETOR)
Actual Study Start Date : August 30, 2017
Actual Primary Completion Date : September 9, 2019
Actual Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Appendicitis

Arm Intervention/treatment
Experimental: Patients with suspected appendicitis
Patients with suspected appendicitis Aged 5 and up to their 16th birthday on arrival to A&E
Diagnostic Test: Blowing into the mouthpiece
Blowing into the mouthpiece of diagnostic device




Primary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03248102


Locations
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United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
Sponsors and Collaborators
The Leeds Teaching Hospitals NHS Trust

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: The Leeds Teaching Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT03248102     History of Changes
Other Study ID Numbers: PS15/261
First Posted: August 14, 2017    Key Record Dates
Last Update Posted: November 5, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Leeds Teaching Hospitals NHS Trust:
paediatric
Additional relevant MeSH terms:
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Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases