1667

EXPLORING THE LEARNING CURVE FOR NERVE SPARING LAPAROSCOPIC RADICAL PROSTATECTOMY USING A VARIETY OF OUTCOME MEASURES.

Richard E Link*, Christian P Pavlovich, Wendy Sullivan, Bruce J Trock, Li-Ming Su, Baltimore, MD

INTRODUCTION AND OBJECTIVE: Nerve sparing laparoscopic radical prostatectomy (LRP) is a technically challenging procedure requiring an advanced laparoscopic skill set. In this study, we assess the learning curve for LRP by reviewing outcome trends for our first 359 cases.

METHODS: LRP was performed using the transperitoneal Montsouris technique and nerve sparing was accomplished in 96% of preoperatively potent men. Quality of life outcomes were assessed prospectively using a validated questionnaire (EPIC) at 0, 3, 6 and 12 months. Five surrogate markers were used to assess the learning curve: operative time, % bilateral nerve sparing, positive margin rate, 6-month continence and 12-month potency. Continence and potency were assessed using the EPIC urinary incontinence and sexual function subdomains, respectively. Data from two fellowship-trained surgeons were combined to search for common experiences in learning LRP.

RESULTS: 98.9% of cases were completed laparoscopically with an overall positive margin rate of 10.6% (7.9% for pT2). Joinpoint regression analysis identified three phases to the learning curve for operative time. After a brief period of rapid progress (to ~ 10 cases), gradual improvement in operative time was observed out to 129 cases before reaching a plateau. In contrast, 6-month continence reached a steady state after only 25 cases. For good nerve sparing candidates (cT1, preoperatively potent), a greater proportion of men underwent successful bilateral nerve sparing after the first 25 cases. Analysis of 12-month potency and positive margin rates did not yield a recognizable learning curve for LRP, likely reflecting the diverse patient and disease factors which impact on these measures.

CONCLUSIONS: The learning curve for nerve-sparing LRP can be assessed objectively using a variety of outcome measures. For continence and completion of bilateral nerve sparing, surgeons may expect to reach a steady state after a relatively short learning curve of ~ 25 cases. The operative time learning curve for LRP, however, may be significantly longer than previously proposed (> 125 cases).

1680

EFFICACY OF EXPULSIVE MEDICAL THERAPY USING NIFEDIPINE OR TAMSULOSIN AFTER SHOCK WAVE LITHOTRIPSY OF URETERAL STONES.

Salvatore Micali*, Antonio Celia, Sighinolfi Maria Chiara, Marco Grande, Matteo Bisi, Stefano De Stefani, Giampaolo Bianchi, Modena, Italy

INTRODUCTION AND OBJECTIVE: Extracorporeal shock wave lithotripsy (ESWL) is currently considered one of the best treatments for ureteral stones. Some studies reported the effectiveness of pharmacologic therapies (calcium antagonists or alpha-blockers and FANS) in facilitating ureteral stone expulsion. We prospectively evaluated the efficacy of nifedipine on upper-middle ureteral and tamsulosin on lower ureteral stones after ESWL.

METHODS: From Genuary 2003 to May 2004 we prospectively evaluated 81 patients affected by calcium-oxalate ureteral stones. Average stone size was 9,91 mm (range: 5-20 mm). 26 stones were upper located, 18 involved the middle ureter, 37 were lower. All the patients received a SWL single-session (3500 pulses) by means of a Dornier Lithotripter S ( mean energy power for each treatment: 84%). Both ultrasound and x-ray were used for stone scanning. After the treatment, 49/81 patients received a pain-relieving therapy (Group A); 32/81 patients (Group B) were submitted to expulsive medical therapy for 2 weeks (nifedipine 30 mg/day for upper and middle ureteral stones, tamsulosin 0,4 mg/day for lower ureteral stones). No significant difference in stone size among the two Groups before treatment was found. Stone clearance was assessed 30 and 90 days after ESWL by means of KUB and ultrasound scan. Stone-free condition was defined as the complete stone clearance or the presence of residual fragments less than 3 mm.

RESULTS: Stone free rate in Group A was 26,5% and 55% at 1 and 3 months respectively; otherwise stone free rate in Group B was 50% and 81% (p = 0.04; p =0.00 respectively). Re-treatment necessity for Group A was 50% and 31% in Group B (p=0.00). Stone free condition was 82,9 (range: 5-180) days in Group A and 49,9 (range: 5-150) days in Group B (p = 0.048).

CONCLUSIONS: Expulsive medical therapy self administration results in an increased 1 to 3 months stone free rate, in a lower percentage of re-treatment and in a faster clearance of stone fragments. The efficacy of expulsive medical therapy make this therapy suitable to improve overall outcomes of ureteral stones shock wave lithotripsy..

1683

A PROSPECTIVE RANDOMIZED CLINICAL TRIAL COMPARING LEVELS OF SYMPTOMS AND DISCOMFORT ASSOCIATED WITH TWO INVESTIGATIONAL AND TWO CURRENTLY MARKETED URETERAL STENTS

Glenn M Preminger*, Durham, NC; James E Lingeman, Indianapolis, IN; Evan Goldfischer, Pleasant Valley, NY; Manoj Monga, Edina, MN; Brian K Auge, El Cajon, CA; Paul K Pietrow, Kansas CIty, KS; Dean G Assimos, Winston-Salem, NC; Richard Norman, Nova Scotia, NB, Canada; John Dushinski, Calgary, AB, Canada; Joseph N Macaluso, Jr, Gretna, LA; David M Hoenig, Bronx, NY; Richard J Kahnoski, Grand Rapids, MI; Jaime Landman, St. Louis, MO

INTRODUCTION AND OBJECTIVE: The intramural and/or intravesical portions of stents may contribute to irritative symptoms associated with temporary ureteral stenting. The proximal portions of 2 test stents (long loop tail [LLT] or short loop tail [SLT]) are basically identical to that of 2 marketed (control) stents (Polaris [P] or Percuflex Plus [PP]); only the distal portion differs in configuration. Our hypothesis stated that reducing the mass of stent material in the intramural (LLT) or the bladder (SLT) would reduce patient discomfort associated with ureteral stenting. The purpose of this study was to determine differences in patient comfort between 2 test and 2 control stents using a validated Ureteral Stent Symptom Questionnaire (USSQ).

METHODS: Two hundred thirty-six patients were randomized in blinded fashion to receive 1 of 4 stents after a ureteroscopic procedure: P; PP; LLT; or SLT. Patient data were collected prospectively before and after stent placement and removal, 4 days after stent placement, and 30 days after stent removal. The primary endpoint was assessment of comfort as measured by location/extent of body pain and urinary tract symptoms.

RESULTS: The 4 stent groups were demographically similar, and most patients (96%) had their stent removed on or after Day 4 (mean device indwell time was 4.1 days). Results of patient assessments (mean score ± standard deviation) on Day 4 and the change in score from Day 4 to Day 30 Post-Removal are summarized below. There was no statistically significant difference between any 2 stent groups. The adverse event profile was similar for test and control stents. Only 3 patients (1 PP; 2 LLT) withdrew early from the study because of adverse events.

CONCLUSIONS: We present the largest well-controlled clinical trial to employ the USSQ. Statistically significant improvement in comfort with the newly designed loop tail stents was not demonstrated. Two possible explanations are: 1) the hypothesis was incorrect; or 2) the tool used to assess comfort (USSQ) was not sensitive enough to discern differences between test and control stents. Further study is warranted.

1690

EXTRACORPORAL SHOCK WAVE LITHOTRIPSY VERSUS URETEROSCOPY FOR PROXIMAL URETERAL CALCULI: A PROSPECTIVE RANDOMIZED STUDY.

Richard Neururer*, Kadir Tosun, Reinhard Peschel, Georg C Bartsch, Innsbruck, Austria

INTRODUCTION AND OBJECTIVE: ESWL and ureteroscopy are currently accepted treatment modalities for proximal ureteral stones. We performed a prospective randomized study to determine appropriate first line treatment for proximal ureteral stones.

METHODS: Between November 2002 and July 2004, 40 patients with proximal ureteral stones were randomized and treated with extracorporal shock wave lithotripsy (Philips Litho Diagnost M) or ureteroscopy with a 6.5F semirigid ureteroscope. A double pigtail catheter was routinely placed in the ureteroscopy group. Patients with an average age of 47 (range 20- 78) presented with radiodense ureteral stones (size between 4 - 16 mm) proximal to the bony pelvis were included.

RESULTS: Ureteroscopy was significantly better in terms of time to achieve a stone-free state (mean 5 days vs. 14 days in the ESWL group). After 3 weeks a stone-free state was achieved in 90 % in the ureteroscopy group and in 60% in the ESWL group. Average treatment time was 38 minutes (range 21- 69) in the ureteroscopy group and 52 minutes (range 40-63) in the ESWL group.

CONCLUSIONS: For proximal ureteral stones we recommend ureteroscopy as first line treatment.

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