Day care PNL using 'Santosh-PGI hemostatic seal' versus standard PNL: A randomized controlled study

Abstract

IntroductionTo compare the outcomes of tubeless day care PNL using hemostatic seal in the access tract versus standard PNL.Material and methodsIt was a prospective randomized controlled study. Cases were randomized to either the day care group with hemostatic seal (DCS) or the control group where patients were admitted and a nephrostomy tube was placed at the conclusion of surgery.ResultsA total of 180 cases were screened and out of these, 113 were included in the final analysis. The stone clearance rates were comparable in both the groups. The mean drop in hemoglobin was significantly lower in DCS group than the control group (1.05 ±0.68 vs. 1.30 ±0.58 gm/dl, p = 0.038).Mean postoperative pain score, analgesic requirement (paracetamol) and duration of hospital stay were also significantly lower in the DCS group (3.79 ±1.23 vs. 6.12 ±0.96, 1.48 ±0.50 vs. 4.09 ±1.11 grams and 0.48 ±0.26 vs. 4.74 ±1.53 days respectively; p <0.05). The incidence of urine leakage through the access tract site was significantly lower in the DCS subgroup when compared to the controls (3.6% vs. 21.1%, p <0.05). Cases in the DCS group resumed their normal activities in a significantly shorter time (8.05 ±3.05 vs.18.42 ±4.42 days; p <0.05). Higher proportion of cases in the DCS group got re-admitted, although it was not a statistically significant number (7.1% vs. 1.8%; p = 0.21).ConclusionsTubeless day care PNL with composite hemostatic tract seal is considered safe. It resulted in a significant reduction of blood loss and analgesic requirement with significantly reduced hospital stay, nephrostomy tube site morbidity and time required to resume normal activity when compared to the standard PNL. However, patients must be compliant with the given instructions and should have access to a health care facility, as few of them may need re-admission.

Tubeless versus standard percutaneous nephrolithotomy: an update meta-analysis

“…Based on the inclusion and exclusion criteria, 14 RCTs [ 11 – 24 ] were finally included in our meta-analysis, and consisted of 576 patients who underwent tubeless PCNL and 572 patients who underwent standard PCNL. The process used for literature search and study selection is shown in Fig.…”

“…1 . The studies included five RCTs [ 16 – 19 , 24 ] which compared total tubeless PCNL with standard PCNL and nine RCTs [ 11 – 15 , 20 – 23 ] which discussed partial tubeless PCNL. Table 1 shows the basic characteristics of the studies.…”

“…The sex ratio was not reported in one study [ 11 ] and three studies [ 13 , 18 , 22 ] did not mention the size of the drainage tube. Other baseline characteristics which may have affected the outcome measures, such as body mass Index (BMI) [ 11 , 13 , 18 , 19 , 23 ], stone side [ 16 , 19 , 23 , 24 ], number of punctures [ 10 , 12 , 22 , 23 ], subcostal and supracostal punctures [ 13 , 14 , 17 ], and auxiliary procedures [ 13 , 14 , 18 , 19 , 21 , 22 , 24 ] were also reported in some studies. All data was also comparable between the two groups for each study.…”

“…Eleven studies [ 11 – 14 , 17 – 20 , 22 – 24 ] assessed the operative time. Due to the lack of SD reported, two studies [ 13 , 22 ] were excluded from the data combination.…”

“…Furthermore, tubeless PCNL has not been generally accepted in clinical medicine, probably due to concerns of urine leakage, obstruction by residual stone fragments, or requirement for repeat access [ 10 ]. Since 1997, several RCTs [ 11 – 24 ] have been performed to compare the safety and effectiveness of tubeless and standard PCNL, including five high-quality RCTs published after 2012 [ 20 – 24 ]. These latest publications need to be included in an updated review to explore the most recent evidence on the use of tubeless PCNL.…”