J90 C78 D48 I31
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Age at least 18 years Indication for VATS 1. VATS with partial pleurectomy 2. VATS with talcum pleurodesis (with or without partial pleurectomy) 3. VATS with permanent chest tube (with or without partial pleurectomy) 4. VATS with local lymphnodectomy of hilus or mediastinum 5. VATS with peripheral wedge resection 6. VATS with pericardial window Patient suitable for local as well as general anaesthesia Informed consent
Exclusion criteria
Exclusion criteria: - Systematic lymphadenectomy - Extensive lung resection - Expected difficult airway - Emergent surgery - Severe coagulation disorders (INR > 1.5, PTT > 40sec) - Previous ipsilateral radiation or surgery - suggested need for thoracotomy in the preoperative planning - COPD with severe impairment of lung function (FEV1 < 30%, DLCO / VC < 30%) - Pregnancy and lactation - simultaneous or recent (< 30 days) participation in another interventional Trial - Persons who are in dependence or employment relationship with the sponsor or the investigators - Incapable patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patients' satisfaction, receiving VATS (Video Assisted Thoracoscopic Surgery), depending on the anaesthesia (local versus general), measured by means of the psychometrically validated questionnaire "ANP" ("Anästhesiologischer Nachbefragungsbogen für Patienten", Hüppe et al. 2003) | — |
Secondary
| Measure | Time frame |
|---|---|
| - patients' satisfaction corrected by their expectations by means of the ANP at the first day after operation - postoperative pain scales at discharge and follow-up measured as numeric rating scale from 0 to 10 - postoperative complication rates including postoperative cognitive disorders (POD), at the time of discharge, by means of a checklist - C-reactive protein levels postoperatively during the hospital stay, measured in mg/l - comparison of intraoperative capnography (continous measurement of endtidal carbon dioxide in mmHg) and correlation with the preoperative lung function (forced expiratory volume in one second) - the surgeon's and the anaesthetist's satisfaction with the feasibility of the operation in local anaesthesia as numeric rating scale from 0 to 10 - comparison of standard data: Operation time (minutes), blood loss (ml), blood gas analysis (paCO2 in mmHg), duration of chest tube drainage (days), hospital length of stay (days) - comparison of costs by measuring both, staff and material, during the postoperative hospital length of stay | — |
Countries
Germany
Contacts
Lungenklinik Kliniken der Stadt Köln gGmbH, Standort Merheim