Methods |
Randomized controlled clinical trial |
Participants |
One hundred and twenty four patients requiring pulmonary lobectomy or bilobectomy. Four patients were withdrawn because they died. Fifty‐nine patients were assigned to the treatment group. Sixty‐one patients were controls |
Interventions |
A) Intervention group: A synthetic sealant was applied to all identified surgical sites leaking air or at risk of leaking air. B) Control group: After standard surgical treatment patients underwent no further procedures |
Outcomes |
Primary: Safety of surgical lung sealant by surveillance for unexpected adverse events during follow‐up. Secondary: percentage of alveolar air leaks effectively sealed at operation after sealant application, durability of alveolar air leaks sealing and potential effect of sealant on the in‐hospital stay |
Notes |
Randomized patients only included those judged intraoperatively to have moderate to severe alveolar air leaks |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Adequate sequence generation? |
Unclear risk |
No information reported about this domain |
Allocation concealment? |
Unclear risk |
No information reported about this domain |
Blinding?
All outcomes |
Unclear risk |
No information reported about this domain |
Incomplete outcome data addressed?
All outcomes |
Low risk |
Outcomes and patients that could not be evaluated according to the study protocol were reported |