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Can breath analysis predict hernia recurrence?


- candidate number24521
- NTR NumberNTR5954
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-jun-2016
- Secondary IDsMETC 16-4-142 
- Public TitleCan breath analysis predict hernia recurrence?
- Scientific TitleThe role of eNose in hernia recurrence prevention.
- ACRONYM
- hypothesisCan the eNose Aerekaprobe be used to create a prediction model based on 25 patients with ventral hernia recurrence?
- Healt Condition(s) or Problem(s) studiedHernia, Relapse
- Inclusion criteriaAny patient with a ventral hernia recurrence.
- age between 18-80 years old
- written informed concent
- Exclusion criteria- groin hernia
- parastomal hernia
- rectus diastasis without true hernia
- Ehlers Dahlos (all types)
- Other (rare) collagen disorders (i.e. Alport, hypochondrogenesis, bethlem myopathy, fuch's dystrophy, etc.)
- Diabetes Mellitus
- Alcohol consumption in past 48 hours
- Pulmonary dissease
- (former) malignancy
- non-smoker or spot smoking >3 months ago
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-aug-2016
- planned closingdate1-mrt-2017
- Target number of participants25
- InterventionsNone
- Primary outcomeBreathprint prediction model
- Secondary outcomeNone
- TimepointsNone, patients with a hernia recurrence now or in the past can both be included. Patients need to be 'tested' only once.
- Trial web siteNone
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. E. H. H. Mommers
- CONTACT for SCIENTIFIC QUERIESDrs. E. H. H. Mommers
- Sponsor/Initiator Maastricht University
- Funding
(Source(s) of Monetary or Material Support)
None
- PublicationsNone
- Brief summaryRationale
Hernia recurrence is observed in 0-52% of the ventral hernia patients, depending on the complexity of the hernia, method of repair and experience of the surgeon. Previous studies have shown that patients who develop hernia recurrences are likely to have a different ratio of collagen I and III, predispositioning then for hernia recurrence. If these patients could be identified in a reliable, low cost, non-invase manner this could effect pre-operative planning, technique for hernia repair and follow-up length.

Exhealed breath contains many volatile organic compounds (VOC) that can be measured using non-specific sensors. These sensors can build a patern or statistical model of the exhaled breath in the effected patients. Building the model will take 25 cases and an equal number of controls.

Objective:
- wheter the eNose can recognise a patern in recurrent hernia patients and descriminate then from healthy controls.

study design:
Observational study using 25 recurrent hernia patients and 25 healthy controls
- Main changes (audit trail)
- RECORD22-jun-2016 - 23-aug-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl