An interventional study of Non-powered AeonTM Endostapler (according to manufacturer medical device classification IIb) and Echelon FLEX™ Powered plus Stapler (according to manufacturer medical device classification IIb) in Postoperative Air Leak and Lung Resection, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-21.
Sponsored by University Hospital, Basel, Switzerland · Not applicable, Interventional, and Treatment
Prolonged air leak is reported in up to 60 to 75% of patients after lung operation in the presence of severe lung emphysema. The effect of the non-powered AEONTM Endostapler as compared to the Echelon FlexTM Powered plus stapler on the volume and duration of air leak and on the time to chest drain removal after lung operation in the presence of severe lung emphysema will be investigated in a randomized, prospective, single-blinded clinical trial.
Patients with severe lung emphysema Grad III or IV scheduled for an operation by video-assisted thoracic surgery (VATS) or open method at the Department of Thoracic Surgery at the University Hospital Basel will be pre-screened in terms of inclusion and exclusion criteria. Before the operation, a randomization envelope is opened in the operation room, in which it is specified on which side and with which method the lung tissue will be closed. If bilateral surgery is planned, the other side is automatically closured using the other method. If for example the non-powered AEONTM Endostapler is randomly allocated to the left side, the right side is automatically operated with the Echelon FLEXTM Powered plus Stapler and vice versa. In cases of a unilateral surgery a random stapler as stated in the envelop would be allocated for that side in question. On the day of the operation, postoperative air leak will be measured quantitatively in ml per minute immediately, 2h, 4h, 8h, and 12h after skin closure. Starting on the first postoperative day, this is done twice a day at 8 am and 5 pm until the air leak stops or another surgery must be performed. Cessation of air leak is the case when a value of 0ml/min or two consecutive values under 30 ml/min by use of thoracic drainage Medela- Topaz™ system are read by the investigator.
339 studies on the registry are indexed under Emphysema; 59 are open to participants now.
This study's enrollment of 19 is below the median of 48 across 208 interventional studies indexed under Emphysema.
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Exclusion Criteria:
Bilateral or unilateral lung-volume-reduction-surgery (LVRS) by video-assisted thoracic surgery (VATS) or open method with use of the non-powered AEON™ Endostapler for left and/or right side of the lung. By randomization it is specified on which side and with which method the lung tissue will be closed. If bilateral surgery is planned, the other side is automatically closured using the other method. In cases of a unilateral surgery a random stapler as stated in the envelop would be allocated for that side in question.
Procedure: Non-powered AeonTM Endostapler (according to manufacturer medical device classification IIb)
Bilateral or unilateral lung-volume-reduction-surgery (LVRS) by video-assisted thoracic surgery (VATS) or open method with use of the Echelon FLEX™ Powered plus Stapler for left and/or right side of the lung. By randomization it is specified on which side and with which method the lung tissue will be closed. If bilateral surgery is planned, the other side is automatically closured using the other method. In cases of a unilateral surgery a random stapler as stated in the envelop would be allocated for that side in question.
Procedure: Echelon FLEX™ Powered plus Stapler (according to manufacturer medical device classification IIb)
Closure of the left and/or right side of the lung after bilateral or unilateral lung-volume-reduction- surgery is performed with the non-powered Aeon™ Endostapler (Lexington medical) 60-mm and 45-mm. At the end of the operation, two 24F apical chest tubes are placed on each side and are systematically set at -10 cm H2O suction via the Medela- Topaz™ system. Air leak will be measured quantitatively in ml per minute by use of a Medela-Topaz™ system. Cessation of air leak is the case when a value of 0ml/min or two consecutive values under 30 ml/min by use of thoracic drainage Medela- Topaz™ system are read.
Closure of the left and/or right side of the lung after bilateral or unilateral lung-volume-reduction- surgery is performed with the Echelon FLEX™ Powered plus Stapler (Ethicon) 60-mm and 45-mm. At the end of the operation, two 24F apical chest tubes are placed on each side and are systematically set at -10 cm H2O suction via the Medela- Topaz™ system. Air leak will be measured quantitatively in ml per minute by use of a Medela-Topaz™ system. Cessation of air leak is the case when a value of 0ml/min or two consecutive values under 30 ml/min by use of thoracic drainage Medela- Topaz™ system are read.
Time interval between the end of operation (skin closure) and air leak closure (when the volume is < 30 ml/min measured twice on Medela- Topaz™ drainage system) between the two staplers.
Comparison of the time interval between the end of operation (skin closure) and air leak closure (when the volume is \< 30 ml/min measured twice on drainage system) between the two staplers.
Time frame: End of the operation (0 hours) until timepoint of air leak closure (approx. 3 days to a maximum of 7 days)
Change in Volume of air leak
Volume of air leak measured following connection of chest tube drainages until removal of the chest tubes
Time frame: End of the operation (0 hours), at 2 hours, 4 hours, 8 hours and 12 hours thereafter and from the first postoperative day, at 8 am and 5 pm daily until removal of the chest tubes (approx. 3 days to a maximum of 7 days)
Number of postoperative air leaks
Number of postoperative air leaks
Time frame: End of the operation (0 hours) until timepoint of air leak closure (approx. 3 days to a maximum of 7 days)
Duration of postoperative air leaks until removal of the chest tubes in days
Duration of postoperative air leaks until removal of the chest tubes in days
Time frame: End of the operation (0 hours) until timepoint of air leak closure (approx. 3 days to a maximum of 7 days)
Postoperative complications graded using the Clavien -Dindo Classification
The Clavien Classification system differentiates in five degrees of severity upon the intention to treat (Grade-I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions up to Grade-V: Death of a patient).
Time frame: End of the operation (0 hours) until timepoint of air leak closure (approx. 3 days to a maximum of 7 days)
Number of resurgeries due to prolonged or profuse air leak
Number of resurgeries due to prolonged or profuse air leak
Time frame: From the day of admittance to hospital to the day of discharge (approx. 7 days)
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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University Hospital, Basel, Switzerland →