Brief description of trial (Data source: BASEC)
In dieser Studie werden Patienten eingeschlossen, die eine Luftfistelung am Ende einer offenen Operation im Brustraum gezeigt haben. Die Patienten werden nach der Diagnose einer Luftfistelung entweder mit Tachosil® oder Neoveil®, zwei bekannte Produkte, die routinemässig in vielen Zentren verwendet werden, behandelt. Die Zuteilung geschieht zufällig.
Health conditions investigated(Data source: BASEC)
Die Behandlung von Luftfisteln, die am Ende einer Operation im Brustraum entstehen können. Von Luftfisteln spricht man, wenn Luft aus der operierten Lunge austritt.
Health conditions
(Data source: WHO)
Prolonged Air Leak;Postoperative Air Leak
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Mit dieser Studie soll untersucht werden, ob es Unterschiede bei den beiden Produkte gibt, hinsichtlich der Dauer der Thoraxdrainage.
Interventions
(Data source: WHO)
Other: TachoSil?;Other: Neoveil?
Criteria for participation in trial
(Data source: BASEC)
Patienten die nach einer offenen Operation im Brustraum eine Luftfistelung zeigen und die älter als 18 Jahren sind.
Unterschriebene Einwilligungserklärung.
Exclusion criteria
(Data source: BASEC)
Patienten, die nicht fähig sind, dem Prozess der Studie aufgrund von sprachlichen Problemen, phychische Störungen und Demenz zu folgen.
Schwangere Frauen dürfen nicht teilnehmen.
Inclusion/Exclusion Criteria
(Data source: WHO)
Gender: All
Maximum age: N/A
Minimum age: 18 Years
Inclusion Criteria:
- Patients with a pulmonary air leak following open lung surgery, regardless of whether
an anatomical or atypical resection was performed
- Patients who are able to decide for themselves whether to participate in the study or
not ( for example due to language problems, mental disorders, dementia of the
participant)
- Patients who are not family member or employee of the investigator
Exclusion Criteria:
- Inability to follow the procedures of the study, for example, due to language
problems, mental disorders, dementia of the participant
- Enrolment of the investigator, his/her family members, employees and other dependent
persons
-
Further information on trial
Recruitment status
Completed
Academic title
(Data source: WHO)
Neoveil? Versus TachoSil? for the Treatment of Pulmonary Air Leaks Following Lung Operation
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Single (Participant).
Phase
(Data source: WHO)
N/A
Primary end point
(Data source: WHO)
time required till air leak closure has occurred (hours)
Secundary end point
(Data source: WHO)
Incidence of air leak (binary outcome 0/1), i.e. air loss > 30ml;Intensity of air leak (continuous outcome, ml);Incidence of prolonged air leak (>10 days) (binary outcome 0/1)
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Link to the results in the primary register
no information available yet
Information on the availability of individual participant data
no information available yet
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Basel
Countries
(Data source: WHO)
Switzerland
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Prof Dr. Didier Lardinois
+41 61 265 71 70
didier.lardinois@usb.ch
Contact for general information
(Data source: WHO)
Didier Lardinois, Prof. MD
Department of Thoracic Surgery, University Hospital Basel
Contact for scientific information
(Data source: WHO)
Didier Lardinois, Prof. MD
Department of Thoracic Surgery, University Hospital Basel
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
Date of authorisation by the ethics committee
18.11.2019
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2019-01505
Secondary ID (Data source: WHO)
ch19Lardinois
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