| Methods |
Patients were allocated to treatment based on a balanced, block randomisation process with a block size of 6 patients. When a patient met all criteria, a sealed envelope was opened in sequence and the patient was accordingly allocated to a group. Participants were not blinded. One patient crossed over from the control to the experimental group after group allocation was revealed. This patient was excluded from the analysis. |
| Participants |
63 patients undergoing elective percutaneous nephrolithotomy were randomly allocated to 1 of 2 groups:
(1) Fibrin sealant group (n = 32), M/F = 22/10, mean age (+/‐SD) = 45.63 (11.96) years.
(2) Control group (n = 31), M/F = 19/12, mean age (+/‐SD) = 45.55 (13.02) years. |
| Interventions |
(1) Fibrin sealant group: a Duplotip applicator was loaded with 2 ml of Tisseel fibrin sealant, which was then introduced through the working channel of the nephroscope. The entire assembly was gradually withdrawn until the applicator tip was just below the renal capsule. Intra‐irrigation was stopped at this point to prevent the entry of fibrin glue into the pelvicaliceal system. The fibrin sealant was gradually injected into the nephrostomy tract and the Amplatz sheath was simultaneously withdrawn. The skin incision was left unsutured and strapped with a pressure dressing.
(2) Control group: after complete stone clearance was confirmed fluroscopically and endoscopically a 6 Fr Double‐J stent was placed in antegrade fashion. The Amplatz sheath was removed and the wound strapped with a pressure dressing. |
| Outcomes |
Number of patients exposed to allogeneic blood transfusion (n).
Septicaemia (n).
Length of hospital stay (days).
Mild haematuria (n).
Urethral catheterisation (n).
Post‐operative fever (n).
Urinary retention (n). |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
Method of randomisation was not reported |
| Allocation concealment? |
High risk |
C ‐ Inadequate (sealed envelopes) |
| Blinding?
All outcomes |
Unclear risk |
Not reported |
