Methods |
Multicenter randomized and prospective study |
Participants |
One hundred and eighty‐nine patients undergoing lobectomy or bilobectomy for lung cancer were enrolled in this trial. Ninety‐six patients were assigned to treatment group and 93 to control group |
Interventions |
A) Treatment group: standard surgical resection plus absorbable patch consisting of an equine‐collagen fleece coated with human fibrinogen and human thrombin. B) Control Group: Surgical standard procedures with no additional treatments |
Outcomes |
Primary: incidence of air leakage 48 h after lobectomy. Secondary: reduction of intraoperative air leakage intensity after the first test treatment, intensity and duration of postoperative air leakage up to postoperative day 9, postoperative mortality and morbidity |
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Adequate sequence generation? |
Unclear risk |
Insufficient information about the sequence generation |
Allocation concealment? |
Unclear risk |
There is not sufficient 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 |
Patients included and excluded are well reported, outcomes were recorded in all patients until a final follow‐up control 1 month postoperatively |