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| Name | Class |
|---|---|
| Tofwerk AG, Thun Switzerland (equipment, data analysis) | UNKNOWN |
| Lungenliga Bern (main funding) | UNKNOWN |
| Erbe Swiss AG (equipment) | UNKNOWN |
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The investigators will define two separate groups of surgical procedures: 1.) an 'open group' in which mainly open anatomic lung resections will be included, and 2.) a 'minimally invasive' group in which mainly thoracoscopic anatomic lung resections will be included.
Both groups will then be randomized to either the performance of the surgical procedure under 'standard conditions' or to the performance of the procedure with the additional use of a smoke evacuation system.
During every procedure the hazardous smoke that is generated by the electrocautery in the surgical field will be collected through a tube at the height of the surgeons face. The smoke is then directly transferred to a mass spectrometer that is situated in the operating room (OR) and performs a real-time analysis of the chemical substances in the air. The degree of air pollution will be measured as well as the smoke evacuation systems' ability to reduce these hazardous chemical substances in the air can be evaluated.
Smoke samples will be continuously analyzed with a latest generation time of flight mass spectrometer in real time. Concerning the smoke evacuation device, the investigators will use the model IES 2 (Intelligent Evacuation System) from Erbe Swiss medical for this study.
Since this is only an observational study in which the investigators are only recording the type of surgery (i.e. open oder minimally invasive) and not recording sensitive patient data, the local ethics committee waived the need for an ethics committee approval of the study. In the end the smoke evacuation system does not have an effect on the patient or the procedure itself, but may rather influence the concentration of hazardous surgical fumes in the operating theatre.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minimally invasive surgery with smoke evacuation system (SES) | minimally invasive surgical procedures during which a smoke evacuation device is used |
| |
| Minimally invasive surgery without SES | minimally invasive surgical procedures during which no smoke evacuation device is used | ||
| Open surgery with SES | open surgical procedures during which a smoke evacuation device is used |
| |
| Open surgery without SES | open surgical procedures during which no smoke evacuation device is used |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smoke evacuation system | Device | The smoke evacuation system removes the surgical smoke directly near the electrocautery tip, where it is generated |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hazardous fumes - specifically the concentration of Furfural, Benzene and Butadiene | Analysis of surgical fume with real-time time of flight mass spectrometry | assessment of measurement will start 4 months after the project is started and will take up to 12 weeks |
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Inclusion Criteria:
- All surgical procedures with a planned duration of more than 1 hour
Exclusion Criteria:
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All surgical procedures that will be performed during the study period at the investigators' department will be randomly allocated to either the performance of surgery with or the performance of surgery without the use of a mobile smoke evacuation device. Whether the procedure will be performed open or minimally invasive will be decided by the operating surgeon and is not part of the randomization process. During the respective surgeries, a mass spectrometer will be used to measure the smoke concentrations and its composition in the operating room.
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| Name | Affiliation | Role |
|---|---|---|
| Gregor J Kocher, PD, MD | Division of Thoracic Surgery, University Hospital Bern, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Bern | Bern | 3010 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30388210 | Background | Kocher GJ, Sesia SB, Lopez-Hilfiker F, Schmid RA. Surgical smoke: still an underestimated health hazard in the operating theatre. Eur J Cardiothorac Surg. 2019 Apr 1;55(4):626-631. doi: 10.1093/ejcts/ezy356. | |
| 35322134 | Derived | Kocher GJ, Koss AR, Groessl M, Schefold JC, Luedi MM, Quapp C, Dorn P, Lutz J, Cappellin L, Hutterli M, Lopez-Hilfiker FD, Al-Hurani M, Sesia SB. Electrocautery smoke exposure and efficacy of smoke evacuation systems in minimally invasive and open surgery: a prospective randomized study. Sci Rep. 2022 Mar 23;12(1):4941. doi: 10.1038/s41598-022-08970-y. |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D055370 | Lung Injury |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D013898 | Thoracic Injuries |
| D014947 | Wounds and Injuries |