A prospective, Randomized Trial evaluating the efficacy of two different Hemostatic sealant in Tubeless Percutaneous Nephrolithotomy
Sources of Funding: none
Introduction
We performed a prospective, randomized trial to assess the safety and efficacy of Tisseel®, Tachosil® in tubeless percutaneous nephrolithotomy.
Methods
A total of 75 patients undergoing tubeless percutaneous nephrolithotomy(PCNL) were randomized to receive Tisseel®, Tachosil® and control at the end of the procedure. _x000D_ The three groups were comparable in age, sex, height, weight, body mass index, stone size and in metabolic and anatomic features. (Table 1) After stone clearance, at the end of the procedure, the nephrostomy tract was closed with a deep #1-0 silk stitch in group 1 patients. Tisseel sealant was loaded and introduced into nephrostomy tract in group 2 patients. In group 3 patients, Tachosil was dipped in contrast medium, rolled like a cigarette and inserted through the nephrostomy tract. The primary end of this study was to evaluate the efficacy of sealants in PCNL. And, the secondary end was compliance of sealants by pain and hospital stay._x000D_
Results
There were no differences in the hemoglobin decrease and blood transfusion requirement among the groups during the operation. (Table 2) Serial changes in hemoglobin were comparable among the groups during the hospital stay. (Table 3) There was no significant difference in the extent of postoperative perirenal hematoma formation. (p=0.694) (Table 4) The average visual analog scale pain score on postoperative 1 day were 1.92±2.47, 1.72±1.67 and 1.48±1.73 respectively in each group. (p=0.378) The hospital stay were 2.28±0.93, 2.00±0.96, and 2.04±0.99 (p=0.579) in each group. No long-term sequelae were observed in the median follow up period of 24 months in any patient.
Conclusions
This study indicates that the hemostatic agents in standard tubeless PCNL were not expected to be effective or mandatory. Additional wide, prospective, randomized studies are required to get more fine clinical evidence for the hemostatic agent usage in tubeless PCNL.
Funding
none
Kyu Won Lee
Woong Jin Bae
Sung-Dae Kim
Sung-Hoo Hong
Ji Youl Lee
Sae Woong Kim
Hyuk Jin Cho