| Methods |
Multicenter prospective randomized control study |
| Participants |
One hundred and sixty‐one patients requiring pulmonary resections other than pneumonectomy and decortication. There were 13 patients who did not complete the trial after randomization, 8 patients in the sealant group and 5 patients in the control group. Ninety‐five patients were assigned to the sealant group and fifty‐three patients to the control group |
| Interventions |
A) Intervention group: standard surgical treatment plus polymeric biodegradable sealant. B) Control group: Standard procedures to control air leaks with no addition of sealant |
| Outcomes |
Primary: proportion of patients who remained air leak free following surgery. Secondary: proportion of intraoperative air leaks in each group that were sealed or reduced, proportion of patients in each group that was free of air leaks immediately following surgery, duration of postoperative air leak, chest tube duration and length of hospitalization |
| Notes |
Randomized patients only included those that had at least one significant air leak (≥ 2.0 mm in size) after pulmonary resection |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
Insufficient information about this domain |
| Allocation concealment? |
Unclear risk |
Insufficient information to permit judgement |
| Blinding?
All outcomes |
High risk |
Quote: "Postoperative air leaks were assessed by qualified hospital staff, including investigators..." |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Quote: "patients were followed up at 1 month and questioned about complications since discharge from the hospital". Patients in the two groups who did not complete the trial after randomization are well described. The primary reason patients randomized but excluded of the trial are well described. |
