Feasibility of perioperative remote monitoring of patient-generated health data in complex surgical oncology.

BACKGROUND: The feasibility of remote perioperative telemonitoring of patient-generated physiologic health data and patient-reported outcomes in a high risk complex general and urologic oncology surgery population is evaluated. METHODS: Complex general surgical/urologic oncology patients wore a pedometer, completed ePROs (electronic patient-reported outcome surveys) and record their vitals (weight, pulse, pulse oximetry, blood pressure, and temperature) via a telehealth app platform. Feasibility (% adherence) was assessed as the primary outcome measure. RESULTS: Twenty-one patients with a median age 58 (32-82) years were included. The readmission rate was 33% and the incidence of ≥Grade 3a morbidity was 24%. Adherence to vital sign and ePRO measurements was 95% before surgery, 91% at discharge, and 82%, 68%, and 64% at postdischarge d2, 7, 14, and 30, respectively. There was significant worsening of mobility, self-care and usual daily activity at postdischarge d2 compared to preoperative baseline (p < 0.05). Median daily preoperative steps taken by patients with

Prospective randomised non-inferiority trial of pelvic drain placement vs no pelvic drain placement after robot-assisted radical prostatectomy.

OBJECTIVE: To determine if eliminating the prophylactic placement of a pelvic drain (PD) after robot-assisted radical prostatectomy (RARP) affects the incidence of early (90-day) postoperative adverse events. PATIENTS AND METHODS: In this parallel-group, blinded, non-inferiority trial, we randomised patients planning to undergo RARP to one of two arms: no drain placement (ND) or PD placement. Patients with demonstrable intraoperative leakage upon bladder irrigation were excluded. Randomisation sequence was determined a priori using a computer algorithm, and included a stratified design with respect to low vs intermediate/high D'Amico risk classifications. Surgeons remained blinded to the randomisation arm until final eligibility was verified at the end of the RARP. The primary endpoint was overall incidence of 90-day complications which, based on our standard treatment using PD retrospectively, was estimated at 13%. The non-inferiority margin was set at 10%, and the planned sample size was 312. An interim analysis was planned and conducted when one-third of the planned accrual and follow-up was completed, to rule out futility if the delta margin was in excess of 0.1389. RESULTS: From 2012 to 2016, 189 patients were accrued to the study, with 92 patients allocated to the ND group and 97 to the PD group. Due to lower than expected accrual rates, accrual to the study was halted by regulatory entities, and we did not reach the intended accrual goal. The ND and PD groups were comparable for median PSA level (6.2 vs 5.8 ng/mL, P = 0.5), clinical stage (P = 0.8), D'Amico risk classification (P = 0.4), median lymph nodes dissected (17 vs 18, P = 0.2), and proportion of patients receiving an extended pelvic lymph node dissection (70.7% vs 79.4%, P = 0.3). Incidence of 90-day overall and major (Clavien-Dindo grade >III) complications in the ND group (17.4% and 5.4%, respectively) was not inferior to the PD group (26.8% and 5.2%, respectively; P < 0.001 and P = 0.007 for difference of proportions <10%, respectively). Symptomatic lymphocoele rates (2.2% in the ND group, 4.1% in the PD group) were comparable between the two arms (P = 0.7). CONCLUSIONS: Incidence of adverse events in the ND group was not inferior to the group who received a PD. In properly selected patients, PD placement after RARP can be safely withheld without significant additional morbidity.

Gold nanorod-mediated near-infrared laser ablation: in vivo experiments on mice and theoretical analysis at different settings.

PURPOSE: The aim of the present study was the in vivo assessment of the effects of gold nanorod (AuNR)-mediated laser ablation (LA) of flank xenograft tumours. We investigated: the differences between intra-tumoural (TIT) and surface tumoural temperature (TS); the influence of AuNRs concentration and laser power (P) on both these temperatures and on tumour regression. Lastly, experimental data were used to validate a theoretical model developed to predict the effects of AuNR-mediated LA. MATERIALS AND METHODS: Thirty-two nude mice were treated using near-infra-red light at two P, 3 d after injecting increasing AuNR doses. TIT and TS were recorded during the procedure by two thermocouples, one located within the tumour and the other one on the skin adjacent to the tumour. Tumour regression was assessed 2 d after near-infra-red exposure via Xenogen imaging. A three-dimensional temperature map was obtained by finite element modelling. RESULTS: TIT and TS difference is substantial when AuNRs are injected. Moreover, the maximum temperature reached is strongly influenced by both P and AuNR concentration. Tumours heated above 55 °C experienced regression. Good agreement between experimental and theoretical TIT was found (maximum difference of 4 °C). CONCLUSIONS: Data show significant influence of P and AuNR concentration on the temperatures reached during AuNR-mediated LA of solid tumours. TS and TIT difference increases with AuNRs concentration. Simulated temperatures agree quite well with experimental data. Together, these results represent the first step towards a rationally designed strategy to select the most promising laser settings and AuNRs concentration to improve solid tumour treatment outcomes.

Indiana Pouch Continent Cutaneous Urinary Diversion After Robotic-assisted Radical Cystectomy: A 16-Year Experience.

BACKGROUND: Population-based practice patterns in the United States reveal continent diversions are only performed in 8%-10.4% of patients.1-4 Ideally, for patients undergoing radical cystectomy the choice of urinary diversion should be influenced by clinical factors and patient preference, with discussions surrounding quality of life. Unfortunately, receipt of continent diversion has been shown to be influenced by a plethora of other factors such as surgeon preference/training, geography, socioeconomic status, gender, and hospital volume.1-3 Thus, by providing detailed instruction and long-term follow-up, we hope to mitigate some of these disparities by changing the perceptions regarding feasibility and complications of continent diversions. OBJECTIVE: To provide step-by-step instruction and to report long-term clinical outcomes in bladder cancer patients receiving an Indiana pouch continent cutaneous urinary diversion (CCUD) after robot-assisted radical cystectomy. DESIGN, SETTING, AND PARTICIPANTS: After Institutional Review Board approval, a prospectively maintained bladder cancer database was queried for patients with T1-T4, N0-N1, M0 bladder cancer undergoing radical cystectomy with CCUD at a tertiary referral center from 2004 to 2020. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Complications at 30- and 90-day were recorded according to the Clavien-Dindo classification. Continence rates were recorded by chart review. RESULTS AND LIMITATIONS: A total of 97 patients were included with a median follow-up of 93months. Clinically, 91.8% had ≤T2 disease and 29.9% received neoadjuvant chemotherapy. The median length of surgery was 8.0 hours, length of hospital stay was 8.3days, and urinary continence rate was 99.0%. The overall complication rate was 73.2% and 76.5% at 30- and 90-day, respectively. The major complication rate (Clavien III-V) was 17.5% at 30-day and 22.7% at 90-day. The most common major complications were abdominal infection and uretero-colonic stricture. The readmission rate was 21.4% and median overall survival was 108months. CONCLUSION: CCUD provides exceptional functional outcomes with acceptable complication rates compared to other diversion types. CCUD is a reliable reconstructive option and with this step-by-step video as a reference, we hope it will be offered to more patients.

Novel Antibiotic-Irrigating Wound Protector Reduces Infectious Complications in Robot-Assisted Radical Cystectomy with Extracorporeal Urinary Diversion.

OBJECTIVE: To determine whether use of an antibiotic-irrigating wound protector (AWP) reduces infectious complications after robotic radical cystectomy with extracorporeal urinary diversion (RCUD). METHODS: A prospectively maintained bladder cancer database was queried for patients undergoing robotic RCUD at a tertiary referral center one year prior to implementing an AWP and one year after (2018-2020). All diversions were performed extra-corporally. 92 patients total. 46 consecutive patients using a traditional wound protector (TWP) and 46 consecutive with an AWP. Infections were classified as symptomatic urinary tract infection, blood stream infection, and surgical site infection. The incidence of infectious complications at 30- and 90-days were compared. RESULTS: Baseline patient characteristics between the 2 groups showed no statistically significant differences. The overall complication rate was 65.2% in the TWP group and 26.1% in the AWP group at 30-days, and 67.4% vs 30.4% at 90-days. Focusing on infections, the 30-day complication rate was 30.4% in the TWP group compared to 6.5% in the AWP group (P =.003). This pattern persisted at 90-days with 37.0% in the TWP group compared to 6.5% in the AWP group (P =.004). Most complications were symptomatic UTI and blood stream infections, 14/24 (58%), requiring parenteral antibiotic treatment. CONCLUSION: We provide preliminary data showing use of an AWP can reduce infectious complications after RCUD. While larger prospective studies are warranted, our findings are a significant step towards decreasing morbidity of an already highly morbid procedure.

Real-time indocyanine green angiography with the SPY fluorescence imaging platform decreases benign ureteroenteric strictures in urinary diversions performed during radical cystectomy.

BACKGROUND: Ischemia is thought to contribute to benign ureteroenteric stricture (UES) after radical cystectomy with urinary diversion (RCUD). Our institution adopted the use of ureteral perfusion assessment during all RCUDs using real-time indocyanine green angiography using the SPY fluorescence imaging platform (Stryker Corp., Kalamazoo, MI, USA). This guides the location of ureteral transection prior to ureteroenteric anastomosis. We sought to compare UES rates before and after adoption of SPY. METHODS: A retrospective chart review was undertaken for the first 47 consecutive cases of RCUD using SPY as well as the previous 47 consecutive cases, which were performed without SPY. Fisher's exact and Wilcoxon rank-sum tests were used to compare benign UES rates and the length of ureter excised during anastomosis. A p < 0.05 indicated statistical significance. RESULTS: Median follow up was 12.0 months for SPY cases and 24.3 months for non-SPY cases. The UES rate for SPY RCUDs was 0% (0/93 ureters) compared with 7.5% (7/93 ureters) for non-SPY RCUDs (p = 0.01). Amongst SPY RCUDs, 86 ureters had no hydronephrosis and 7 had mild hydronephrosis with reflux on loopogram. A total of 34.4% of ureters (32/93) had poor distal perfusion, requiring a more proximal anastomosis. The median length excised for ureters with poor distal perfusion was 3.8 cm, compared with 2.2 cm for ureters with good distal perfusion (p < 0.0001). No complications attributable to the use of SPY were noted. CONCLUSION: Use of SPY to assess ureteral perfusion was associated with a decrease in the UES rate after RCUD. A total of 34.4% of ureters demonstrated poor distal perfusion, requiring a significantly more proximal ureteroenteric anastomosis.

Lymph Node Fluorescence During Robot-Assisted Radical Prostatectomy With Indocyanine Green: Prospective Dosing Analysis.

OBJECTIVE: To prospectively assess the ideal dosing and the value of fluorescent sentinel lymph node (LN) detection with indocyanine green (ICG) for the detection of LN metastases in intermediate- and high-risk patients undergoing robot-assisted prostatectomy and extended pelvic LN dissection (ePLND). PATIENTS AND METHODS: Twenty patients received transperineal prostatic injections of ICG. Patients were cycled through 5 doses (1.25, 2.5, 3.75, 5, and 7.5 mg) so optimal ICG dosing could be discovered early. RESULTS: ICG injection was able to identify fluorescent LN (FLN) packets in all 20 patients. Compared to the higher ICG doses, the 1.25 and 2.5 mg doses had fewer FLN packets and were abandoned after 1 dose each. The median number of FLN packets was 4.0, 6.0, and 4.5 for the respective doses of 3.75, 5.0, and 7.5 mg. The external iliac group was the most common site of fluorescence in 27.2% of patients, followed by the common iliac (21.3%), obturator (20.3%), internal iliac (18.5%), and node of Cloquet (7.7%). Seven (35%) of 20 patients had node-positive disease. Of the 5 patients that had fluorescent tissue outside of our ePLND template, 1 had a positive node present in the anterior bladder neck fat. Across all patients, ICG had 62% sensitivity, 50% specificity, 8% positive predictive value, and 95% negative predictive value in detecting LN metastases. CONCLUSION: The low sensitivity of ICG for the detection of LN metastases highlights why FLN dissection with ICG does not represent an alternative to ePLND.

Penile inversion through a penoscrotal incision for the treatment of penile urethral strictures.

PURPOSE: This article describes a novel technique for the repair of penile urethral strictures and establishes the safety, feasibility, and efficacy of this innovative surgical approach. MATERIALS AND METHODS: Patients with urethral strictures underwent a one-sided anterior dorsal oral mucosal graft urethroplasty through a penoscrotal inversion technique. The clinical outcome was considered a failure when any instrumentation was needed postoperatively, including dilatation. RESULTS: Five patients underwent the novel procedure. The patients' mean age was 58 years. The cause of stricture was instrumentation in 2 cases (40%), lichen sclerosis in 1 case (20%), and failed hypospadias repair in 2 cases (40%). The mean stricture length was 3 cm. The overall mean (range) follow-up was 6 months (range, 3-9 months). Of the 5 patients, 4 (80%) had a successful outcome and 1 (20%) had a failed outcome. The failure was successfully treated by use of a meatotomy. CONCLUSIONS: The penile inversion technique through a penoscrotal incision is a viable option for the management of penile urethral strictures with several advantages to other techniques: namely, no penile skin incision, a single-stage operation, and supine positioning.

Robot-assisted radical cystectomy and urinary diversion: technical recommendations from the Pasadena Consensus Panel.

BACKGROUND: The technique of robot-assisted radical cystectomy (RARC) has evolved significantly since its inception >10 yr ago. Several high-volume centers have reported standardized techniques with refinements and subsequent outcomes. OBJECTIVE: To review all existing literature on RARC and urinary diversion techniques and summarize key points that may affect oncologic, surgical, and functional outcomes. DESIGN, SETTING, AND PARTICIPANTS: The Pasadena Consensus Panel on RARC and urinary reconstruction convened May 3-4, 2014, to review the existing peer-reviewed literature and create recommendations for best practice. The panel consisted of experts in open radical cystectomy and RARC. No commercial support was received. SURGICAL PROCEDURE: The consensus panel extensively reviewed the surgical technique of RARC in men and women, extended pelvic lymph node dissection, extracorporeal urinary diversion, and intracorporeal urinary diversion. Critical aspects of the technique are described. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Preoperative, operative, and postoperative parameters from the largest and most contemporary RARC series, stratified by urinary diversion technique, are presented. RESULTS AND LIMITATIONS: Preoperative, operative, and postoperative measures of RARC technique adhere closely to the standards established in open surgery. CONCLUSIONS: Refinement of techniques for RARC and urinary diversion over the past 10 yr has made it safe, reproducible, and oncologically sound. PATIENT SUMMARY: We summarize the critical aspects of surgical techniques reviewed at the Pasadena international consensus meeting on RARC and urinary reconstruction. Preoperative, operative, and postoperative measures of RARC technique adhere closely to the standards established in open surgery.

Osteoporosis management program decreases incidence of hip fracture in patients with prostate cancer receiving androgen deprivation therapy.

OBJECTIVE: To evaluate the incidence of hip fracture in men with prostate cancer receiving androgen deprivation therapy (ADT). MATERIALS AND METHODS: One of the detrimental side effects of ADT for prostate cancer is osteoporosis. Through an osteoporosis prevention program implemented in our healthcare system, the patients at risk undergo dual x-ray absorptiometry scans and receive treatment if the T-score indicates bone loss. We evaluated the incidence of hip fracture in men with prostate cancer who were receiving ADT through a retrospective, cohort study conducted within a managed care organization. The participants were all men newly diagnosed with prostate cancer from January 2003 to December 2007 receiving leuprolide injections. Patients who had had a dual x-ray absorptiometry scan beginning 3 months before the index date through the end of study were included in the intervention group; all others were included in the comparison group. The main outcome of interest was a hip fracture occurring after the index date, excluding cancer pathologic fractures, traumatic fractures, and fractures associated with epilepsy. RESULTS: A total of 1071 patients were in the intervention group, and 411 were in the comparison group. In the intervention group, 18 hip fractures occurred compared with 17 in the comparison group. The incidence rate of hip fractures per 1000 person-years was 5.1 (95% confidence interval 3.0-8.0) in the intervention group and 18.1 (95% confidence interval 10.5-29.0) in the comparison group. CONCLUSION: The incidence rate of hip fracture in this population was reduced >70% with enrollment in an osteoporosis management system, avoiding this morbid complication of ADT.

Is the transition from open to robotic prostatectomy fair to your patients? A single-surgeon comparison with 2-year follow-up.

Robot-assisted radical prostatectomy (RARP) is a procedure thought to require experience with a significant number of cases before mastering. Most RARP series examine outcomes after the learning curve or by combining results from multiple surgeons. We review a single surgeon's experience during the transition from open radical retropubic prostatectomy (RRP) to RARP using a matched case-control model. We prospectively analyzed 50 RARP cases and made comparison with the last 50 consecutive RRP cases. Operative time was longer for RARP than RRP (341 versus 235 min, p < 0.01), and mean estimated blood loss was less for RARP than RRP (533 versus 1,540 ml, p < 0.01). There was a trend towards fewer positive surgical margins (PSM) for RARP (10%) than RRP (24%; p = 0.06). High-risk patients were found to have a greater percentage of PSM following RRP (70%) in comparison with RARP (17%; p = 0.04). The number of patients who experienced complications was no different between groups (16 versus 12, p = 0.37). Erectile function at 12, 18, and 24 months showed no difference between groups (p = 0.15, 0.92, and 0.23, respectively). There was no difference in continence at 1 year (88.6% versus 89.1%; p = 0.94). During 27.1 months of follow-up for the RARP group and 30.4 months for the RRP group, 92% and 94% of patients had an undetectable prostate-specific antigen (PSA) (defined as ≤0.1), respectively (p = 0.38). We report similar outcomes in patients undergoing RARP by a surgeon transitioning from RRP to RARP, confirming that the learning curve does not affect patient outcomes over a 2-year follow-up.