| Methods |
Randomized, prospective, open‐label, parallel group study carried out at a single center |
| Participants |
One hundred and fifty‐two patients were randomized. Seventy‐seven were assigned to the treatment group. Seventy‐five were assigned to standard treatment group |
| Interventions |
Inteventions A) Intervention group: parenchymal suturing, stapling or electrocautery plus a collagen patch with human fibrinogen and human thrombin. B) Control group: standard surgical procedure with parenchymal suturing, staplers, and electrocautery with no additional treatments |
| Outcomes |
Primary: Quantitative measure of postoperative air leaks at days one and two. Secondary: Mean time to chest drain removal, mean time to hospital discharge |
| Notes |
All the randomized patients had a non‐small cell lung cancer. One hundred and forty‐eight patients undergoing lobectomy; twenty five undergoing a segmentectomy |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
Quote: "Randomisation, on the basis of the use of close envelopes containing notes reading either ‘A’ for Tachosil® or ‘B’ for conventional treatment, was performed intraoperatively...". |
| Allocation concealment? |
Low risk |
Quote: "Randomisation, on the basis of the use of close envelopes..." |
| Blinding?
All outcomes |
High risk |
Postoperative air leakage volume measurements were made by the investigators. |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Early and late outcomes were controlled in all patients. |
