Methods |
Randomized controlled trial |
Participants |
Thirty patients requiring pulmonary resection other than pneumonectomy. Four were ineligible because they eventually required pneumonectomy. Two were pilot patients. Thirteen (9 male and 4 female of 61 years mean age) were assigned to the treatment group. Eleven (9 male and 2 female of 59 years mean age) were controls |
Interventions |
A) Intervention group: standard bronchial closure and suture; a synthetic sealant was applied to all identified surgical sites (staple lines, suture lines, areas of dissection or adhesiolysis), excluding bronchial stump, regardless of the presence of air leaks. Additional sealant was applied if leaks persisted or new leaks were identified. B) Control group: standard bronchial closure and suture, with no addition of sealant |
Outcomes |
Primary: persistence of air leaks during operation and duration of chest tube air leaks. Secondary: time from operation to chest tube removal and hospital discharge, hospitalization time and costs |
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Adequate sequence generation? |
Unclear risk |
Quote: "the randomization for each patient was maintained in a sealed envelope" |
Allocation concealment? |
Low risk |
Quote: "The envelopes were sequentially opened" |
Blinding?
All outcomes |
Unclear risk |
The study did not address this outcome |
Incomplete outcome data addressed?
All outcomes |
Low risk |
No missing outcome data in the study |