| Methods |
A prospective blinded randomized study |
| Participants |
Forty patients undergoing a pulmonary lobectomy. Twenty patients were randomized to the autologous fibrin sealant. Twenty patients were assigned to the control group |
| Interventions |
A) Intervention group: standard surgical lobectomy. Autologous fibrin sealant was applied. B) Control group: Standard lobectomy with no additional interventions |
| Outcomes |
Rate of air leak on the day of the operation and daily thereafter until chest drains were removed, time to chest tube removal, 24‐h and chest‐tube drainage (bleeding/exudation) volume at removal of chest tube, duration of thoracic epidural analgesia treatment and postoperative length of the hospital stay. All patients had lung tumours limited to one lobe |
| Notes |
All patients had air leaks before randomization |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
Quote: "The patients were assigned to either the control or Vivostat groups by opening a sealed envelope that contained the randomisation code (allocated by a computer general random sequence)". |
| Allocation concealment? |
Low risk |
The patients were randomized intraoperatively by opening a sealed envelope. Investigators enrolling patients could not foresee assignment. |
| Blinding?
All outcomes |
Low risk |
Quote: "The personnel recording these parameters were blinded to the intervention received". |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Quote: "No patients were withdrawn from the study". |
