Methods |
Open, randomized, prospective, multicenter, parallel‐group trial |
Participants |
Three hundred and one patients requiring pulmonary lobectomy. One hundred and forty‐nine were assigned to the treatment group. One hundred and fifty were assigned to standard treatment group |
Interventions |
A) Intervention group: standard surgical resection plus absorbable patch consisting of human fibrinogen and human thrombin. B) Control group: surgical standard procedures with no additional treatments |
Outcomes |
Primary: Duration of postoperative air leak. Secondary: reduction of intraoperative air leakage intensity after treatment, number of days after removal of last chest tubes, adverse effects |
Notes |
All patients randomized had lung cancer. Only patients with grade one or two air leakage evaluated by water submersion test were randomized |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Adequate sequence generation? |
Low risk |
Quote: "patients were randomized by means of an interactive voice response system" |
Allocation concealment? |
Unclear risk |
Insufficient information about the allocation concealment |
Blinding?
All outcomes |
Unclear risk |
The study did not address this outcome |
Incomplete outcome data addressed?
All outcomes |
Low risk |
No missing outcome data is reported |