Skip to content

To determine whether the powered endopath stapler device reduces the incidence of prolonged air leak and duration of chest tube drainage after lung volume reduction surgery

Powered endopath stapler device reduces the incidence of prolonged air leak and duration of chest tube drainage after lung volume reduction surgery: A prospective randomized blinded study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13216935
Enrollment
25
Registered
2014-12-04
Start date
2014-07-02
Completion date
Unknown
Last updated
2020-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung emphysema, chronic obstructive pulmonary disease Respiratory Emphysema, unspecified

Interventions

Bilateral lung-volume-reduction-surgery (LVRS) by video-assisted thoracic surgery (VATS) with use of powered versus non-powered Endopath stapler from Echelon for left or right side of the lung. Before

Sponsors

University Hospital Basel
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Adult patients with non-bullous pulmonary emphysema were included when they were severely symptomatic despite optimal medical therapy 2. Had severe air flow obstruction (forced expiratory volume in 1 second (FEV1) of 40% of predicted value) 3. Had pulmonary hyperinflation (residual volume (RV) of 200% of predicted value, RV/total lung capacity of 0.60) 4. Minimum age of 18 years 5. Able to consent and indication for bilateral LVRS with a signed informant consent

Exclusion criteria

Exclusion criteria: 1. Patients with bullous pulmonary emphysema 2. Severely impaired carbon dioxide diffusing capacity (20% of predicted value) 3. Significant coronary artery disease 4. Under age of 18 years 5. Persons unable to consent and without a signed informant consent

Design outcomes

Primary

MeasureTime frame
1. Incidence and volume of air leaks 2. Duration of chest tube drainage of the each side

Secondary

MeasureTime frame
1. Duration and volume of air leak postoperative as well as twice a day, each morning and each afternoon until removal of the chest tubes 2. Operative time, and postoperative complications grade e.g. necessity of reoperation, hospitalisations time

Countries

Switzerland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026