Trials / Completed

CompletedNCT05628415

Comparison Between the Non-powered AEON™ Endostapler and Echelon FLEX™ Powered Plus Stapler With Regards to the Closure of Lung Tissue After Lung Resection in the Presence of Severe Lung Emphysema

Status: Completed
Phase: N/A
Study type: Interventional
Enrollment: 19 (actual)

Sponsor: University Hospital, Basel, Switzerland · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

Type	Name	Description
PROCEDURE	Non-powered AeonTM Endostapler (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.
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 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.

Timeline

Start date: 2022-11-15
Primary completion: 2025-02-20
Completion: 2025-02-20
First posted: 2022-11-28
Last updated: 2025-02-21

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT05628415. Inclusion in this directory is not an endorsement.