TachoSil(®) sealed tubeless percutaneous nephrolithotomy to reduce urine leakage and bleeding: outcome of a randomized controlled study.

PURPOSE: We determined the efficacy and safety of TachoSil(®) in sealing the tract after percutaneous nephrolithotomy compared to nephrostomy tube placement.
MATERIALS AND METHODS: A total of 100 consecutive patients scheduled for percutaneous nephrolithotomy were randomized 1:1 to receive a 16Fr nephrostomy tube (group 1) or TachoSil in the tract (group 2). All patients received a mono-J ureteral catheter. The primary study end points were bleeding and urinary leakage rates. The secondary end points were pain as assessed by the 0 to 10-point visual analog scale, analgesic requirement and hospital stay.
RESULTS: The groups were comparable for preoperative and operative variables. In group 1, 3 patients were excluded intraoperatively because of relevant bleeding, and in group 2, 1 patient was excluded intraoperatively because of hydrothorax. Tract complications were significantly more frequent in group 1 than in group 2 (25.5% vs 2%, p <0.001). However, the difference in urinary leakage reached statistical significance (19.1% vs 2%, p = 0.007), whereas that in perirenal hematoma formation did not (6.4% vs 0%, p = 0.113). There was no difference between the groups in mean ± SD number of analgesic doses (1.17 ± 1.56 vs 1.20 ± 1.69, p = 0.791) and visual analogue scale scores (4.77 ± 2.28 vs 4.24 ± 2.32, p = 0.270). Postoperative hospital stay was significantly shorter in group 2 than in group 1 (5.15 ± 1.74 vs 2.75 ± 1.78 days, p <0.0001).
CONCLUSIONS: Although failing to reduce pain and analgesic requirement, TachoSil provided better tract control and a shorter hospital stay than nephrostomy tube placement, thus allowing the extension of indications for tubeless percutaneous nephrolithotomy to most procedures.

RCT Entities:   Population Interventions Outcomes