| Methods |
Randomized, prospective, controlled parallel‐group trial |
| Participants |
Forty patients were randomized. Twenty were assigned to the treatment group. Twenty were assigned to standard treatment group. |
| Interventions |
Interventions A) Intervention group: electrocautery surgical dissection of interlobar fissures plus a collagen patch with human fibrinogen and human thrombin. B) Control group: routine surgical procedure with staplers with no additional treatments |
| Outcomes |
Primary: Percentage of demonstrated intraoperative alveolar air leak effectively sealed after application of the sealant and to compare the proportion of patients in the sealant and control groups who were free of air leaks throughout hospitalization. Secondary: Postoperative air leaks, the moment of chest tube removal, length of hospitalization. Costs of the procedure and hospitalization, safety of the sealant treatment by surveillance of the incidence and severity of complications |
| Notes |
All the randomized patients had early‐stage non‐small cell lung cancer. This was a pilot study, and no attempts were made to calculate a sample size to provide statistical power sufficient for confident evaluation of the results. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
Quote: "Randomization was performed intraoperatively using closed envelopes containing notes reading either ‘‘ES’’ for electrocautery and sealant or ‘‘ST’’ for conventional treatment with staplers". |
| Allocation concealment? |
Low risk |
Randomization was performed using closed envelopes |
| Blinding?
All outcomes |
Unclear risk |
The study did not address this outcome |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
No missing outcome data. Quote: "One and 3 months after surgery the treated patients underwent a clinical examination and chest radiography" |
