Prospective randomized trial of three different methods of nephrostomy tract closure after percutaneous nephrolithotripsy.

OBJECTIVE: • To evaluate the safety and efficacy of 'tubeless' nephrostomy tract closure in reducing postoperative morbidity after percutaneous nephrolithotomy (PCNL).
MATERIALS AND METHODS: • In all, 31 patients undergoing PCNL were randomized into three groups, each with a different method of nephrostomy tract closure: using either a gelatin matrix haemostatic sealant (FloSeal), fascial stitch or Cope loop nephrostomy tube. • We compared operative time, estimated blood loss (EBL), postoperative stay, analgaesics use, changes in creatinine and haemoglobin levels, and stone clearance rate, as well as postoperative short-form (SF)-36 quality-of-life and pain analogue scores at five different time points after surgery. • All data were analysed using a one-way anova test. • A repeated measures anova test was used selectively to assess the progression of SF-36 and pain analogue scores.
RESULTS: • The preoperative variables operative time, EBL, postoperative stay (P = 0.45), analgaesia use (P = 0.79), changes in creatinine (P = 0.28) and haemoglobin (P = 0.09) levels, and postoperative SF-36 scores were not significantly different. • In contrast, the differences in analogue pain scales at 1 week after surgery (P = 0.02) and the trends of analogue pain score progression (P = 0.03) were statistically significant. • Three patients underwent second-look procedures for residual stones and there was one case of postoperative pyelonephritis in a multiple sclerosis patient.
CONCLUSIONS: • The Cope loop closure patients recovered fastest, while FloSeal closure patients experienced initial increase in pain followed by resolution at 1 month. • As a result of the small study group sizes, it is difficult to show any significant difference in postoperative pain, especially in long-term follow-up; further clinical evaluation is necessary.

RCT Entities:   Population Interventions Outcomes