Jeff Nix

Prospective Randomized Controlled Trial of Robotic versus Open Radical Cystectomy for Bladder Cancer: Perioperative and Pathologic Results

BACKGROUNDnIn recent years, surgeons have begun to report case series of minimally invasive approaches to radical cystectomy, including robotic-assisted techniques demonstrating the surgical feasibility of this procedure with the potential of lower blood loss and more rapid return of bowel function and hospital discharge. Despite these experiences and observations, at this point high levels of clinical evidence with regard to the benefits of robotic cystectomy are absent, and the current experiences represent case series with limited comparisons to historical controls at best.nnnOBJECTIVEnWe report our results on a prospective randomized trial of open versus robotic-assisted laparoscopic radical cystectomy with regard to perioperative outcomes, complications, and short-term narcotic usage.nnnDESIGN, SETTING, AND PARTICIPANTSnA prospective randomized single-center noninferiority study comparing open versus robotic approaches to cystectomy in patients who are candidates for radical cystectomy for urothelial carcinoma of the bladder. Of the 41 patients who underwent surgery, 21 were randomized to the robotic approach and 20 to the open technique.nnnINTERVENTIONnRadical cystectomy, bilateral pelvic lymphadenectomy, and urinary diversion by either an open approach or by a robotic-assisted laparoscopic technique.nnnMEASUREMENTSnThe primary end point was lymph node (LN) yield with a noninferiority margin of four LNs. Secondary end points included demographic characteristics, perioperative outcomes, pathologic results, and short-term narcotic use.nnnRESULTS AND LIMITATIONSnOn univariate analysis, no significant differences were found between the two groups with regard to age, sex, body mass index, American Society of Anesthesiologists classification, anticoagulation regimen of aspirin, clinical stage, or diversion type. Significant differences were noted in operating room time, estimated blood loss, time to flatus, time to bowel movement, and use of inpatient morphine sulfate equivalents. There was no significant difference in regard to overall complication rate or hospital stay. On surgical pathology, in the robotic group 14 patients had pT2 disease or higher; 3 patients had pT3/T4 disease; and 4 patients had node-positive disease. In the open group, eight patients had pT2 disease or higher; five patients had pT3/T4 disease; and seven patients had node-positive disease. The mean number of LNs removed was 19 in the robotic group versus18 in the open group. Potential study limitations include the limited clinical and oncologic follow-up and the relatively small and single-institution nature of the study.nnnCONCLUSIONSnWe present the results of a prospective randomized controlled noninferiority study with a primary end point of LN yield, demonstrating the robotic approach to be noninferior to the open approach. The robotic approach also compares favorably with the open approach in several perioperative parameters.

Robotic Radical Cystectomy for Bladder Cancer: Surgical and Pathological Outcomes in 100 Consecutive Cases

PURPOSEnRadical cystectomy remains the most effective treatment for patients with localized, invasive bladder cancer and recurrent noninvasive disease. Recently some surgeons have begun to describe outcomes associated with less invasive surgical approaches to this disease such as laparoscopic or robotic assisted techniques. We report our maturing experience with 100 consecutive cases of robotic assisted laparoscopic radical cystectomy with regard to perioperative results, pathological outcomes and surgical complications.nnnMATERIALS AND METHODSnA total of 100 consecutive patients (73 male and 27 female) underwent robotic radical cystectomy and urinary diversion at our institution from January 2006 to January 2009 for clinically localized bladder cancer. Outcome measures evaluated included operative variables, hospital recovery, pathological outcomes and complication rate.nnnRESULTSnMean age of this cohort was 65.5 years (range 33 to 86). Of the patients 61 underwent ileal conduit diversion, 38 received a neobladder and 1 had no urinary diversion (renal failure). Mean operating room time for all patients was 4.6 hours (median 4.3) and mean surgical blood loss was 271 ml (median 250). On surgical pathology 40% of the cases were pT1 or less disease, 27% were pT2, 13% were pT3/T4 disease and 20% were node positive. Mean number of lymph nodes removed was 19 (range 8 to 40). In no case was there a positive surgical margin. Mean days to flatus were 2.1, bowel movement 2.8 and discharge home 4.9. There were 41 postoperative complications in 36 patients with 8% having a major complication (Clavien grade 3 or higher) and 11% being readmitted within 30 days of surgery. At a mean followup of 21 months 15 patients had disease recurrence and 6 died of disease.nnnCONCLUSIONSnWe report a relatively large and maturing experience with robotic radical cystectomy for the treatment of bladder cancer providing acceptable surgical and pathological outcomes. These results support continued efforts to refine the surgical management of high risk bladder cancer.

Fast Track Program in Patients Undergoing Radical Cystectomy: Results in 362 Consecutive Patients

BACKGROUNDnThis article outlines our current perioperative management of patients undergoing cystectomy and urinary diversion using advancements in perioperative care to allow for early institution of an oral diet and early hospital discharge.nnnSTUDY DESIGNnThree hundred sixty-two consecutive patients underwent radical cystectomy and urinary diversion with curative intent (2001 through 2008). Each underwent a perioperative care plan (fast track program). Throughout our experience, evidence-based modifications to this program were instituted. We analyzed the impact of these modifications and report the outcomes with the most recent 100 patients in whom no additional modification has been used.nnnRESULTSnMean age of patients is 66.3 years, with 44% of the patients older than age 70 years and 12% older than age 80 years. We found no detrimental effects to immediate removal of the orogastric tube at the end of the procedure, but found a beneficial effect of empiric metoclopramide use, with lower rates of nausea and vomiting. Perioperative antibiotic coverage has been reduced to 24 hours as per American Urological Association guidelines. Gum-chewing has also been shown to be of benefit with regard to a more rapid recovery of bowel function. Use of nonnarcotic analgesics (eg, ketrolac) has also been central in the pathway. Finally, early institution of an oral diet has been an original and central component to our fast track program.nnnCONCLUSIONSnSuccessful application of a fast track program has been applied to our patients undergoing radical cystectomy and urinary diversion, with the potential to use evidence-based modifications to reduce morbidity and improve recovery.

Robotic-Assisted Laparoscopic Intracorporeal Urinary Diversion

BACKGROUNDnRecent small case series have now been reported for robotic-assisted laparoscopic radical cystectomy (RALRC). In most of these series, the urinary diversion has been performed in an extracorporeal fashion. There have been few case reports of an intracorporeal diversion and little description of the technique of such a procedure.nnnOBJECTIVEnIn this paper, we report our initial experience with robotic-assisted laparoscopic intracorporeal urinary diversion, describing stepwise the surgical procedure itself and evaluating perioperative and pathologic outcomes of this novel procedure.nnnDESIGN, SETTING, AND PARTICIPANTSnWe studied a single-institution case series of patients undergoing robotic-assisted cystectomy and intracorporeal urinary diversion for clinically localized urothelial carcinoma of the bladder (n=10) or for a noncompliant dysfunctional bladder refractory to more conservative management (n=2). Historical comparisons are also made to a consecutive case series of 20 patients undergoing robotic radical cystectomy and extracorporeal urinary diversion.nnnSURGICAL PROCEDUREnRALRC and intracorporeal urinary diversion, including ileal conduit (n=9) and orthotopic ileal neobladder (n=3).nnnMEASUREMENTSnThe stepwise operative procedure is described in detail. Outcome measures evaluated in this series included operative variables, hospital recovery, and complication rate. Comparisons were made to a contemporaneous series of 20 patients who underwent a robotic cystectomy with extracorporeal diversion during this time period (from an experience of >100 robotic cystectomy patients since 2005).nnnRESULTS AND LIMITATIONSnTwelve patients (mean age: 60.9 yr) underwent an intracorporeal diversion. Mean operating-room time of all patients was 5.3h, and mean surgical blood loss was 221ml. Mean time to flatus, bowel movement, and hospital discharge was 2.2 d, 3.2 d, and 4.5 d, respectively. Eleven of the 12 patients were discharged on or before postoperative day 5. There were six postoperative complications in five patients (42%), with one complication being Clavien grade 3 or higher. The major limitations of the study are the small sample size and the nonrandomized nature of the compared treatment groups (intracorporeal vs extracorporeal), which limits the ability to directly compare the techniques at a high level of scientific confidence.nnnCONCLUSIONSnOur initial experience with robotic-assisted laparoscopic intracorporeal diversion appears to be favorable with acceptable operative and short-term clinical outcomes.

OUTCOMES AND IMPLICATIONS OF FOLLOW-UP BIOPSIES OF MEN ON ACTIVE SURVEILLANCE FOR LOW-RISK PROSTATE CANCER

INTRODUCTION AND OBJECTIVES: Active surveillance (AS) is an important strategy for many men with low-risk prostate cancer. As part of the AS program, many chave advocated the use of follow-up biopsies (bx) to help monitor the disease. We evaluated the outcomes and implications of follow-up prostate bx in men in an AS program. METHODS: The AS program at our institution includes followup PSA, DRE, and a 12-core prostate needle bx at 6-12 months after diagnosis and every 1-2 years thereafter. The selected interval chosen was dependent on a variety of factors including patient age, health status, PSA level and dynamic, DRE, and qualitative elements of patient or physician concern. Demographic and clinical characteristics, biopsy outcomes, and clinical follow-up of these men are described. Biochemical, pathological, and clinical follow-up are described in this cohort. RESULTS: 71 men underwent initial bx and at least 1 follow-up bx as part of their AS program. Entry characteristics were as follows: mean age 63.5 years (53-82 yrs), mean PSA = 6.1 (1.3 23). 65/71 (92%) had Gleason 3+3 disease, 4 (6%) men had 3+4, 2 (3%) men had 4+3. 67 men were cT1c and 4 were cT2. On repeat (2nd) bx, negative bx rate was 41% (29/71) and the positive bx rate was 59% (42/71). No differences were observed with regard to pre-treatment PSA, original grade, stage, age, or race between those with negative vs. positive 2nd bx. Cancer core length appears to be associated with a positive 2nd bx: Of patients with negative 2nd bx, 27/29 (93%) had 1 mm and 2/29 (7%) had 2mm with no pt with 3mm or more on their original bx. Of those with positive 2nd bx, 12/42 (29%) had 1mm, 15/42 (36%) had 2 mm, and 15 (36%) had >=3mm on cores on original biopsies. Of those with a positive 2nd bx, 28 had no upgrading and 14 were upgraded. Of the 14 who had upgrading at 2nd bx, 10 had definitive treatment (6 RP, 4 XRT) and 4 were lost to FU. Of the 29 who had negative 2nd bx, none have undergone treatment. Of the 28 who had positive repeat (but no upgrading), 2 underwent treatment (1 RP and 1 brachy). Four patients with 2nd negative bx had a 3rd bx, and all were negative. 10 patients with positive 2nd bx had 3rd bx and all were positive. The PSAV trended higher in patients with negative vs. positive (no upgrade) vs. positive (upgrade) (-0.753 vs. 0.011 vs. 0.555 ng/ml/yr) CONCLUSIONS: The study helps characterize the outcomes and implications of repeat prostate bx in patients on AS. These results suggest that repeat biopsies are important in characterizing the volume, grade, and eventually decisions for treatment in men on active surveillance.

ANALGESIC USE IN MEN UNDERGOING ROBOTIC-ASSISTED LAPAROSCOPIC RADICAL PROSTATECTOMY: A DETAILED ANALYSIS OF DEMOGRAPHIC, CLINICAL, AND OPERATIVE, INFLUENCES

INTRODUCTION AND OBJECTIVES: A variety of factors may potentially influence post-operative pain and narcotic use after surgery including patient factors (e.g. cultural influences, age, obesity), clinical factors (PSA, stage), and operative outcomes (EBL, OR time). We analyzed the potential influence of demographic, clinical, and operative factors on the use of post-operative analgesics in patients undergoing robotic-assisted radical prostatectomy. METHODS: 200 consecutive men undergoing robotic-assisted radical prostatectomy were evaluated as to their inpatient analgesic use. This included both narcotic and non-narcotic (e.g. ketorolac) usage. Narcotic use was converted to morphine(MSO4-) equivalents, and ketorolac use reported as mg delivered and also converted to MSO4equivalents by a 3:1 (keteroloac:MSO4) conversion an often used conversion rate in the anesthesia literature. Analysis and comparisons were made to several demographic (race, age, BMI), clinical (PSA, stage), and operative factors (OR time, EBL) to evaluate the potential influences of these factors on post-operative analgesic usage. RESULTS: Characteristics of this cohort were as follows: mean age = 59.2 years; mean BMI = 29.2; mean PSA 6.4 ng/ml. Mean analgesic usage (MSO4 equiv) was significantly higher in men 65 years (n=37) (50.2 vs. 37.3 vs. 30.8; p =30) (44.8 vs. 41.0 vs. 35.5), this did not achieve significance (p=0.130). Analgesic usage was also not different based on race, PSA, stage, OR time, or EBL. In addition, post-op analgesic usage did not correlate with longterm functional outcomes of continence (pad use) or potency. CONCLUSIONS: In patients undergoing robotic prostatectomy, analgesic usage is higher in younger men and trends higher in patients with lower BMI. No other differences were observed based on demographic, operative, pathologic, or functional outcomes.