1891 PRELIMINARY RESULTS OF A PROSPECTIVE RANDOMIZED TRIAL OF TUBELESS FLOSEAL VS TUBELESS FASCIAL STITCH VS COPE LOOP NEPHROSTOMY PERCUTANEOUS NEPHROLITHOTOMY (PCNL)

Vol. 183, No. 4, Supplement, Wednesday, June 2, 2010

the quality of the chosen access prior to dilating the operating tract to standard nephroscope sizes of 24-28F. We used micro-optics of 0.9mm (angle of view: 120°) and 0.6 mm (angle of view: 70°) diameter, with resolutions of up to 10k Pixels suitable for exploration of renal calyces and pelvis. The micro-optics with integrated light lead are inserted in the working sheath of the puncture needle. The special needle has an outer diameter of 1.6mm (4.85F), slightly larger than the diameter of a standard needle of 1.3mm. The needle comprises a Y-piece for connection of irrigation. The optics are length adjusted so that the distal end is flush with the tip of the needle. The optics are connected via a zoom ocular and light adapters to standard endoscopic camera systems and to Xenon light sources of at least 100W power. RESULTS: The optical puncture needle was used in 15 patients during PCNL procedures. In all cases, we were able to visualize the punctured kidney calyces and to confirm presence of calculi prior to dilating up the tract for insertion of the operating nephroscope. The 0.9mm optic was found to be superior in terms of field of view, brightness and sharpness. Sufficient irrigation was confirmed for both optical systems. The puncture with the 1.6mm needle was smooth and no differences compared to standard 1.3mm needles were perceived. CONCLUSIONS: The optical puncture needle for PCNL appears to be extremely helpful for confirming the percutaneous access to the kidney prior to dilation of the operating tract, thus making PCNL, a surgery where access is the key, inherently safer. In our opinion, this system can substantially assist the learning curve for puncturing of the kidney. The space inside the working sheath of the needle is even sufficient to introduce a laser fiber (365 micrometer with the 0.9mm optics, up to 600 micrometer with the 0.6mm optics) for lithotripsy of small fragments into spontaneously passable fragments. This therapeutic extension will be investigated in future treatment series.

THE JOURNAL OF UROLOGY姞

e735

CONCLUSIONS: Nephrostomy tract closure with Floseal, deep fascial stitch and 10F Cope loop nephrostomy tube following PCNL result in similar peri-op bleeding, changes in serum creatinine and post-op discomfort. Patients had similar post-op hospital stays and analgesic use with no statistical difference in SF-36 and analog pain scale scores on the first post-op day, 1 month post-op, and 3 months post-op. In this preliminary study, the post PCNL placement of a fascial suture appears to be a reasonable way of managing PCNL patients, especially if a nephrostomy free approach is reasonable. Table 1

Hospital stay (days)

Floseal Fascial stitch 1.7 ⫾ 1.16 1.5 ⫾ 0.71

Test of Cope loop significance 2 ⫾ 0.77 P ⫽ 0.4

Parenteral analgesics (Morphine equivalents)

28.42 ⫾ 41.3

19.5 ⫾ 15.2

24.3 ⫾ 26.9

P ⫽ 0.8

Change in serum Cr

0.08 ⫾ 1.16

0.19 ⫾ 0.21

0.08 ⫾ 0.17

P ⫽ 0.3

Change in hemoglobin -2.56 ⫾ 1.06 -2.49 ⫾ 1.16 -2.88 ⫾ 1.25

P ⫽ 0.7

SF-36 total scores Pre-op

69.2 ⫾ 20.6

55.3 ⫾ 24.7

56 ⫾ 17.6

Post-op day #1

58.7 ⫾ 22.9

45.4 ⫾ 22.5

55 ⫾ 15.0

P ⫽ 0.5

55 ⫾ 14.7

52.3 ⫾ 22.2

51.2 ⫾ 12.0

P ⫽ 0.9

1 month

68.8 ⫾ 23.5

70.3 ⫾ 29.8

69.5 ⫾ 18.7

P ⫽ 1.0

3 months

72.2 ⫾ 18.2

65 ⫾ 31.3

67 ⫾ 16.7

P ⫽ 0.8

1 week

P ⫽ 0.4

Analog pain scale 8 ⫾ 12.6

14.4 ⫾ 19.0

16.1 ⫾ 14.5

P ⫽ 0.7

Post-op day #1

16.2 ⫾ 14.9

23.8 ⫾ 17.0

25.1 ⫾ 14.9

P ⫽ 0.6

1 week

22.6 ⫾ 11.3

15.6 ⫾ 13.3

4.6 ⫾ 4.5

P ⬍ 0.05

1 month

15.8 ⫾ 11.3

16.7 ⫾ 23.0

9.4 ⫾ 11.6

P ⫽ 0.7

3 months

9.8 ⫾ 11.4

12 ⫾ 19.1

8.6 ⫾ 12.0

P ⫽ 0.9

Pre-op

Source of Funding: None

Source of Funding: None

1891

1892

PRELIMINARY RESULTS OF A PROSPECTIVE RANDOMIZED TRIAL OF TUBELESS FLOSEAL VS TUBELESS FASCIAL STITCH VS COPE LOOP NEPHROSTOMY PERCUTANEOUS NEPHROLITHOTOMY (PCNL)

UPDATED RESULTS ON LOWER POLE STONE MANAGEMENT: URETERORENOSCOPY VS TUBELESS PCNL VS. SHOCKWAVE LITHOTRIPSY FOR 0.5MM TO 1.5CM STONES

Roger Li, Jason Lee*, Hak J Lee, Donald Pick, Michael Louie, Rosanne T Santos, Denise Wong, Elspeth M McDougall, Orange, CA INTRODUCTION AND OBJECTIVES: We present the preliminary results of a prospective randomized trial evaluating the safety and efficacy of various “tubeless” PCNL techniques in reducing post-operative (post-op) morbidity. We compared post-op hospital stay, analgesics use, changes in serum creatinine, changes in hemoglobin, SF-36 scores, as well as post-op pain analog scores among patients randomized to undergo nephrostomy tract closure with Floseal (hemostatic gelatin matrix), a deep fascial stitch, or a 10F Cope loop nephrostomy tube. METHODS: A total of 31 patients undergoing PCNL met the inclusion criteria for the study and were randomized into one of the 3 aforementioned groups; 10 Floseal, 10 fascial stitch, 11 Cope loop. All patients underwent an uncomplicated endoscopic-guided PCNL, standard technique at our institution. A study questionnaire consisting of a SF-36 questionnaire and analog pain scales were given pre-operatively, on post-op day #1, and at 1 week, 1 month and 3 months after the procedure. Statistical analysis was performed using the ANOVA test. RESULTS: The mean age, BMI, stone burden, pre-op labs, and complication rates were not significantly different among the three groups. The post-op hospital stay (p ⫽ 0.45), amount of opioid analgesia used in morphine equivalents (p ⫽ 0.79), changes in serum creatinine (p ⫽ 0.28) and hemoglobin (p ⫽ 0.09) were also not significantly different among the groups. The SF-36 total scores and pain analog scores were all comparable at each time-point, except at 1 week post-op, when there was a significantly higher pain analog score in the Floseal group compared to the Cope loop group (p ⫽ 0.02).

Michael Lasser*, Sutchin Patel, George Haleblian, Gyan Pareek, Providence, RI INTRODUCTION AND OBJECTIVES: Lower pole stone data suggest that tubeless percutaneous nephrolithotomy (PNL), ureterorenoscopy (URS) and shockwave lithotripsy (SWL) are available treatment modalities for stones ⬍1.5 cm. Previously, we reported that tubeless PNL may be more efficacious than the other modalities. As more experience has been gained, an updated analysis was performed to evaluate the efficacy of front line URS, SWL, or tubeless PNL for treatment of lower pole stones. METHODS: 60 patients from the Stone Therapy Center of New England (STONE) undergoing treatment of 0.5 to 1.5 cm lower pole calculi were reviewed (2007-2009). Of these, 15 underwent tubeless PNL, 25 URS and 20 SWL. Demographic data, stone size, Hounsfield units (HU), and skin to stone distance (SSD) were measured in each cohort. The stone free status (no residual calculi) of patients was determined by post-treatment imaging (CT scan or KUB) at 6 weeks. In addition the number of auxiliary procedures to clear calculi and the number of complications in each group were tabulated. Statistical analysis was performed to evaluate for significant difference in SF rates and the number of auxiliary procedures. RESULTS: Between the three cohorts, there was no statistically significant difference in demographics, HU and SSD. The mean stone size was 0.9 cm, 0.9 cm, 1.2 cm for the SWL, URS and tubeless PNL groups respectively (p⬎0.05). There was a significant difference between the stone free rates in the tubeless PNL group (100%) and SWL Group (33%) (p⬍0.05). There was no significant difference in stone free rates between the tubeless PNL group and URS group. The number of auxiliary procedures in the SWL cohort (n ⫽ 9) was significantly greater than in the URS (n ⫽ 2) and tubeless PNL (n ⫽ 0) groups. Mean hospital stay for tubeless PNL patients was 1.2 days