Prophylactic Use of Biologic Mesh in Ileal Conduit (PUBMIC): A Randomized Clinical Trial.

PURPOSE: We assessed the effect of prophylactic biologic mesh on parastomal hernia (PSH) development in patients undergoing cystectomy and ileal conduit (IC). MATERIALS AND METHODS: This phase 3, randomized, controlled trial (NCT02439060) included 146 patients who underwent cystectomy and IC at the University of Southern California between 2015 and 2021. Follow-ups were physical exam and CT every 4 to 6 months up to 2 years. Patients were randomized 1:1 to receive FlexHD prophylactic biological mesh using sublay intraperitoneal technique vs standard IC. The primary end point was time to radiological PSH, and secondary outcomes included clinical PSH with/without surgical intervention and mesh-related complications. RESULTS: The 2 arms were similar in terms of baseline clinical features. All surgeries and mesh placements were performed without any intraoperative complications. Median operative time was 31 minutes longer in patients who received mesh, yet with no statistically significant difference (363 vs 332 minutes, P = .16). With a median follow-up of 24 months, radiological and clinical PSHs were detected in 37 (18 mesh recipients vs 19 controls) and 16 (8 subjects in both arms) patients, with a median time to radiological and clinical PSH of 8.3 and 15.5 months, respectively. No definite mesh-related adverse events were reported. Five patients (3 in the mesh and 2 in the control arm) required surgical PSH repair. Radiological PSH-free survival rates in the mesh and control groups were 74% vs 75% at 1 year and 69% vs 62% at 2 years. CONCLUSIONS: Implementation of biologic mesh at the time of IC construction is safe without significant protective effects within 2 years following surgery.

Severity Grading Systems for Intraoperative Adverse Events. A Systematic Review of the Literature and Citation Analysis.

INTRODUCTION: The accurate assessment and grading of adverse events (AE) is essential to ensure comparisons between surgical procedures and outcomes. The current lack of a standardized severity grading system may limit our understanding of the true morbidity attributed to AEs in surgery. The aim of this study is to review the prevalence in which intraoperative adverse event (iAE) severity grading systems are used in the literature, evaluate the strengths and limitations of these systems, and appraise their applicability in clinical studies. METHODS: A systematic review was conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-analysis guidelines. PubMed, Web of Science, and Scopus were queried to yield all clinical studies reporting the proposal and/or the validation of iAE severity grading systems. Google Scholar, Web of Science, and Scopus were searched separately to identify the articles citing the systems to grade iAEs identified in the first search. RESULTS: Our search yielded 2957 studies, with 7 studies considered for the qualitative synthesis. Five studies considered only surgical/interventional iAEs, while 2 considered both surgical/interventional and anesthesiologic iAEs. Two included studies validated the iAE severity grading system prospectively. A total of 357 citations were retrieved, with an overall self/nonself-citation ratio of 0.17 (53/304). The majority of citing articles were clinical studies (44.1%). The average number of citations per year was 6.7 citations for each classification/severity system, with only 2.05 citations/year for clinical studies. Of the 158 clinical studies citing the severity grading systems, only 90 (56.9%) used them to grade the iAEs. The appraisal of applicability (mean%/median%) was below the 70% threshold in 3 domains: stakeholder involvement (46/47), clarity of presentation (65/67), and applicability (57/56). CONCLUSION: Seven severity grading systems for iAEs have been published in the last decade. Despite the importance of collecting and grading the iAEs, these systems are poorly adopted, with only a few studies per year using them. A uniform globally implemented severity grading system is needed to produce comparable data across studies and develop strategies to decrease iAEs, further improving patient safety.

A Urine-based DNA Methylation Marker Test to Detect Upper Tract Urothelial Carcinoma: A Prospective Cohort Study.

PURPOSE: We explored the accuracy of a urine-based epigenetic test for detecting upper tract urothelial carcinoma. MATERIALS AND METHODS: Under an Institutional Review Board-approved protocol, urine samples were prospectively collected from primary upper tract urothelial carcinoma patients before radical nephroureterectomy, ureterectomy, or ureteroscopy between December 2019 and March 2022. Samples were analyzed with Bladder CARE, a urine-based test that measures the methylation levels of 3 cancer biomarkers (TRNA-Cys, SIM2, and NKX1-1) and 2 internal control loci using methylation-sensitive restriction enzymes coupled with quantitative polymerase chain reaction. Results were reported as the Bladder CARE Index score and quantitatively categorized as positive (>5), high risk (2.5-5), or negative (<2.5). The findings were compared with those of 1:1 sex/age-matched cancer-free healthy individuals. RESULTS: Fifty patients (40 radical nephroureterectomy, 7 ureterectomy, and 3 ureteroscopy) with a median (IQR) age of 72 (64-79) years were included. Bladder CARE Index results were positive in 47, high risk in 1, and negative in 2 patients. A significant correlation was found between Bladder CARE Index values and tumor size. Urine cytology was available for 35 patients, of whom 22 (63%) results were false-negative. Upper tract urothelial carcinoma patients had significantly higher Bladder CARE Index values compared to the controls (mean 189.3 vs 1.6, P < .001). The sensitivity, specificity, positive predictive value, and negative predictive value of the Bladder CARE test for detecting upper tract urothelial carcinoma were 96%, 88%, 89%, and 96%, respectively.Conclusions:Bladder CARE is an accurate urine-based epigenetic test for the diagnosis of upper tract urothelial carcinoma, with much higher sensitivity than standard urine cytology.

Assessment and Reporting of Perioperative Adverse Events and Complications in Patients Undergoing Inguinal Lymphadenectomy for Melanoma, Vulvar Cancer, and Penile Cancer: A Systematic Review and Meta-analysis.

BACKGROUND: Inguinal lymph node dissection (ILND) plays a crucial role in the oncological management of patients with melanoma, penile, and vulvar cancer. This study aims to systematically evaluate perioperative adverse events (AEs) in patients undergoing ILND and its reporting. METHODS: A systematic review was conducted according to PRISMA. PubMed, MEDLINE, Scopus, and Embase were queried to identify studies discussing perioperative AEs in patients with melanoma, penile, and vulvar cancer following ILND. RESULTS: Our search generated 3.469 publications, with 296 studies meeting the inclusion criteria. Details of 14.421 patients were analyzed. Of these studies, 58 (19.5%) described intraoperative AEs (iAEs) as an outcome of interest. Overall, 68 (2.9%) patients reported at least one iAE. Postoperative AEs were reported in 278 studies, combining data on 10.898 patients. Overall, 5.748 (52.7%) patients documented ≥1 postoperative AEs. The most reported ILND-related AEs were lymphatic AEs, with a total of 4.055 (38.8%) events. The pooled meta-analysis confirmed that high BMI (RR 1.09; p = 0.006), ≥1 comorbidities (RR 1.79; p = 0.01), and diabetes (RR 1.81; p = < 0.00001) are independent predictors for any AEs after ILND. When assessing the quality of the AEs reporting, we found 25% of studies reported at least 50% of the required criteria. CONCLUSION: ILND performed in melanoma, penile, and vulvar cancer patients is a morbid procedure. The quality of the AEs reporting is suboptimal. A more standardized AEs reporting system is needed to produce comparable data across studies for furthering the development of strategies to decrease AEs.

Robotic-assisted repair of colovesical anastomosis after Hartmann's reversal procedure.

PURPOSE: Hartmann's procedure is the resection of the rectosigmoid colon with an end colostomy formation and closure of the anorectal stump (1). Its reversal has a morbidity rate up to 58% (2, 3) with an incidence of fistulae formation of 4.08% (1). Herein, we present a robotic-assisted repair of a complex fistula that occurred as complication of Hartmann's reversal when the stapler was introduced inadvertently through the vaginal canal. PATIENT AND METHODS: Eighty-three-year-old female with past medical history of hysterectomy and ischemic colitis that required colectomy and colostomy placement in December 2020. In March 2022, the patient underwent a colostomy takedown, after which she reported fecaluria, urine leakage per vagina, and recurrent urinary tract infections. Cystoscopy and vaginoscopy revealed a large colovesical fistula, a staple in the bladder trigone, and several staples in the anterior vaginal wall. Robotically, extensive adhesiolysis was performed, the sigmoid was separated from the bladder, and the intact rectal stump was dissected free. The staple from the bladder trigone was removed. Bladder was closed in two layers with 3-0 V-Loc. Colorectal anastomosis was not feasible due to the short length of both ends. Therefore, a permanent colostomy was placed. RESULTS: Operative time was 454min., and estimated blood loss was 100cc. Discharged on postoperative day 4 with a JP drain and a 20Fr Foley catheter. Drain, and Foley were removed on postoperative days 9 and 23, respectively. No postoperative complications were reported. CONCLUSION: Robotic-assisted repair represents an effective approach for the management of colovesical fistulae after Hartmann's reversal.

Long-term oncological and surgical outcomes after Video Endoscopic Inguinal Lymphadenectomy (VEIL) in patients with penile cancer.

OBJECTIVE: To report outcomes from the largest multicenter series of penile cancer patients undergoing video endoscopic inguinal lymphadenectomy (VEIL). MATERIALS AND METHODS: Retrospective multicenter analysis. Authors of 21 centers from the Penile Cancer Collaborative Coalition-Latin America (PeC-LA) were included. All centers performed the procedure following the same previously described standardized technique. Inclusion criteria included penile cancer patients with no palpable lymph nodes and intermediate/high-risk disease and those with non-fixed palpable lymph nodes less than 4 cm in diameter. Categorical variables are shown as percentages and frequencies whereas continuous variables as mean and range. RESULTS: From 2006 to 2020, 210 VEIL procedures were performed in 105 patients. Mean age was 58 (45-68) years old. Mean operative time was 90 minutes (60-120). Mean lymph node yield was 10 nodes (6-16). Complication rate was 15.7%, including severe complications in 1.9% of procedures. Lymphatic and skin complications were noted in 8.6 and 4.8% of patients, respectively. Histopathological analysis revealed lymph node involvement in 26.7% of patients with non-palpable nodes. Inguinal recurrence was observed in 2.8% of patients. 10y- overall survival was 74.2% and 10-y cancer specific survival was 84.8%. CSS for pN0, pN1, pN2 and pN3 were 100%, 82.4%, 72.7% and 9.1%, respectively. CONCLUSION: VEIL seems to offer appropriate long term oncological control with minimal morbidity. In the absence of non-invasive stratification measures such as dynamic sentinel node biopsy, VEIL emerged as the alternative for the management of non-bulky lymph nodes in penile cancer.

Robotic-assisted vesicovaginal fistula repair using a vaginal cuff flap.

INTRODUCTION AND HYPOTHESIS: Vesicovaginal fistula (VVF) is an abnormal communication between the bladder and the vagina. Complex fistulae include those after failed repair attempts, radiotherapy, measuring ≥ 2 cm, located in the trigone, or with concomitant ureteric strictures or fistulae. We aimed to describe a technique for the robotic repair of a complex VVF using a vaginal cuff flap. METHODS: A 56-year-old woman with a history of ovarian debulking surgery and radiotherapy underwent repair for VVF and rectovaginal fistula. In lithotomy, cystoscopy was performed for fistulous tract cannulation. Port placement, extensive adhesiolysis, and robot docking followed. The vaginal apex was dissected, the VVF excised, and the bladder closed. The rectum was separated from the posterior vaginal wall, the rectovaginal fistula excised, and the rectum closed. A vaginal cuff flap was harvested and interposed between the bladder and the vagina. RESULTS: Operative time was 9 h, estimated blood loss was 300 cc, and no intraoperative complications occurred. The patient was discharged on postoperative day 8. Further management included 37 sessions in a hyperbaric chamber and a transvesical endoluminal bladder closure 10 months after the initial surgery. Follow-up at 30 months shows no fistula recurrence. CONCLUSIONS: Vaginal cuff flaps represent a feasible interposition tissue in patients with hysterectomy for managing complex VVF in the case of omentum unavailability.

Complications of robotic surgery in urological diseases: are we using standardized methodology to report complications?

PURPOSE OF REVIEW: The current data on complications reporting related to robot-assisted procedures (RAPs) in the urology literature are not comparable and do not use a validated classification. In this review, findings from various studies reporting positive and negative outcomes will be outlined. RECENT FINDINGS: Robotic procedures have outcomes similar to open and laparoscopic techniques but generally cause fewer adverse events. However, the lack of standards for presenting surgical morbidity related to RAP leads to underreporting of surgical complications, makes comparisons of surgical outcomes difficult and prevents adequate knowledge about the outcomes of procedures. SUMMARY: Although a reasonable number of positive outcomes of RAP have been reported in the literature, the extent of underreporting with this process is unknown. Further research and the development of a validated classification for reporting surgical complications will facilitate a better understanding of the actual outcomes.

Robotic simple prostatectomy plus panniculectomy and Giant umbilical hernia repair.

INTRODUCTION: Simple prostatectomy is the gold standard for prostates >80 grams, robotic system has proven to help into speed the recovery of the patient and in morbid obesity the advantages of the robotic system can help to perform a successful surgery. CASE: 80 years old male with morbid obesity (BMI 45) and several other comorbidities, with history of an umbilical hernia and obstructive lower urinary tract symptoms in acute urinary retention. PSA was 7 ng/dl, DRE demonstrates a >100gr prostate gland. A robotic simple prostatectomy, urethropexy, umbilical hernia repair and panniculectomy in Fleur-de-Lis was performed. RESULTS: Operative time (OT) and estimated blood loss (EBL) were 438 min and 160 ml respectively. A JP drain was placed in the pelvis and 2 additional were left in the abdominal cavity with several Penrose drains. No immediate or intraoperative complications were observed. The length of stay (LOS) was 6 days without complications. Pathology report showed prostate of 304gr and benign prostatic tissue. DISCUSSION: In patients with multiple comorbidities robot-assisted surgery provides advantages of shorter LOS, EBL, less transfusion and lower rate of complications. In patients with morbid obesity where the increased girth makes difficult the open approach, robotic surgery is an ideal way to provide definitive treatment; concomitant, Fleur-de-Lis panniculectomy can correct the abdominal contour in both vertical and horizontal orientation at the same time that provides a better plane for trocar insertion, an accurate location of the needle tip and a proper position of the remote center decreasing the possible complication of port placement.

Impact of Host Factors on Robotic Partial Nephrectomy Outcomes: Comprehensive Systematic Review and Meta-Analysis.

PURPOSE: Host factors (tumor size/complexity, patient comorbidities) impact outcomes of robotic partial nephrectomy. We report a comprehensive systematic review and meta-analysis to critically evaluate the impact of host factors on operative, perioperative, functional, oncologic and survival outcomes of robotic partial nephrectomy. MATERIALS AND METHODS: All full text English language publications on robotic partial nephrectomy comparing host factors were evaluated. We followed the PRISMA (Preferred Reporting Items for Systematic Review and Meta-Analyses) statement and AHRQ (Agency for Healthcare Research and Quality) guidelines to evaluate PubMed®, Scopus® and Web of Science® databases (January 1, 2000 to June 31, 2017). Weighted mean difference and odds ratio were used to compare continuous and dichotomous variables, respectively. Sensitivity analyses were performed as needed. To condense the sheer volume of analyses the data are presented using novel summary forest plots. This study is registered with PROSPERO, number CRD42017062712. RESULTS: Our meta-analysis evaluated 41 studies including 10,506 patients. In terms of tumor factors, compared to patients with complex tumors, those with noncomplex tumors had lesser operating room time (WMD -44.95, p=0.003), estimated blood loss (WMD -160, p <0.003), warm ischemia time (WMD -8.56, p ≤0.00001) and postoperative complications (OR 0.42, p=0.01). Tumors larger than 4 cm were associated with greater operating room time (WMD 30.11, p ≤0.00001), estimated blood loss (WMD 39.26; 95% CI 28.77, 49.74; p ≤0.00001), warm ischemia time (WMD 5.17, p ≤0.00001), transfusions (OR 3.15, p=0.003), postoperative complications (OR 1.88, p=0.004) and length of stay (WMD 0.56, p=0.0004). Hilar tumors involved greater estimated blood loss (WMD 51.34, p=0.03), warm ischemia time (WMD 8.17, p ≤0.00001) and conversion to open partial nephrectomy (OR 14.14, p=0.006). Tumor location, anterior vs posterior, did not impact robotic partial nephrectomy outcomes. As for patient factors, older patients (70 years or older) trended nonsignificantly toward greater percentage decrease of estimated glomerular filtration rate and overall mortality. The abnormal body mass index cohort reported greater operating room time (WMD 13.47, p <0.001), estimated blood loss (WMD 45.44, p <0.0001) and postoperative complications (OR 1.48, p=0.03). The chronic kidney disease cohort had a lesser reduction in postoperative percentage estimated glomerular filtration rate (WMD 7.16; 95% CI 2.74, 11.59; p=0.002) and increased postoperative complications (OR 2.05; 95% CI 1.47, 2.85). CONCLUSIONS: Robotic partial nephrectomy outcomes are impacted by host factors, including tumor and patient characteristics. Awareness of this increased risk and its mitigation with expert patient selection are important for excellent robotic partial nephrectomy outcomes. Our meta-analysis provides comprehensive, objective, summary data of 10,506 patients, detailing discrete outcomes for discrete host factors to better inform urologists and patients considering robotic partial nephrectomy.

Impact of Surgical Factors on Robotic Partial Nephrectomy Outcomes: Comprehensive Systematic Review and Meta-Analysis.

PURPOSE: Utilization of robotic partial nephrectomy has increased significantly. We report a literature wide systematic review and cumulative meta-analysis to critically evaluate the impact of surgical factors on the operative, perioperative, functional, oncologic and survival outcomes in patients undergoing robotic partial nephrectomy. MATERIALS AND METHODS: All English language publications on robotic partial nephrectomy comparing various surgical approaches were evaluated. We followed the PRISMA (Preferred Reporting Items for Systematic Review and Meta-Analyses) statement and AHRQ (Agency for Healthcare Research and Quality) guidelines to evaluate PubMed®, Scopus® and Web of Science™ databases (January 1, 2000 to October 31, 2016, updated June 2017). Weighted mean difference and odds ratio were used to compare continuous and dichotomous variables, respectively. Sensitivity analyses were performed as needed. To condense the sheer volume of analyses, for the first time data are presented using novel summary forest plots. The study was registered at PROSPERO (https://www.crd.york.ac.uk/prospero/, ID CRD42017062712). RESULTS: Our meta-analysis included 20,282 patients. When open partial nephrectomy was compared to robotic partial nephrectomy, the latter was superior for blood loss (weighted mean difference 85.01, p  <0.00001), transfusions (OR 1.81, p <0.001), complications (OR 1.87, p <0.00001), hospital stay (weighted mean difference 2.26, p = 0.001), readmissions (OR 2.58, p = 0.005), percentage reduction of latest estimated glomerular filtration rate (weighted mean difference 0.37, p = 0.04), overall mortality (OR 4.45, p <0.0001) and recurrence rate (OR 5.14, p <0.00001). Sensitivity analyses adjusting for baseline disparities revealed similar findings. When robotic partial nephrectomy was compared to laparoscopic partial nephrectomy, the former was superior for ischemia time (weighted mean difference 4.21, p <0.0001), conversion rate (OR 2.61, p = 0.002), intraoperative (OR 2.05, p >0.0001) and postoperative complications (OR 1.27, p = 0.0003), positive margins (OR 2.01, p <0.0001), percentage decrease of latest estimated glomerular filtration rate (weighted mean difference -1.97, p = 0.02) and overall mortality (OR 2.98, p = 0.04). Hilar control techniques, selective and unclamped, are effective alternatives to clamped robotic partial nephrectomy. An important limitation is the overall suboptimal level of evidence of publications in the field of robotic partial nephrectomy. No level I prospective randomized data are available. Oxford level of evidence was level II, III and IV in 5%, 74% and 21% of publications, respectively. No study has indexed functional outcomes against volume of parenchyma preserved. CONCLUSIONS: Based on the contemporary literature, our comprehensive meta-analysis indicates that robotic partial nephrectomy delivers mostly superior, and at a minimum equivalent, outcomes compared to open and laparoscopic partial nephrectomy. Robotics has now matured into an excellent approach for performing partial nephrectomy for renal masses.

Robotic Intracorporeal Continent Cutaneous Diversion.

PURPOSE: Robotic intracorporeal urinary diversion has mostly been done for ileal conduit or orthotopic neobladder diversion. We present what is to our knowledge the initial series, detailed technique and outcomes of the robotic intracorporeal Indiana pouch with a minimum 1-year followup. MATERIALS AND METHODS: Ten patients underwent robotic radical cystectomy, pelvic lymphadenectomy and intracorporeal Indiana pouch urinary diversion for cancer in 9 and benign disease in 1. Data were collected prospectively. Baseline demographics, pathology data, and 1-year complication rates and functional outcomes were assessed. RESULTS: All 10 cases were successfully completed intracorporeally without open conversion. Median total operative time was 6 hours, including 3.5 hours for pouch creation. Median blood loss was 200 cc and median hospital stay was 10 days. Four Clavien grade 1-2 and 3 Clavien 3-5 complications occurred. None of the patients had a bowel leak. One noncompliant patient requested undiversion to an ileal conduit. The remaining 9 patients successfully catheterized the ileal channel and were completely continent at the last followup at a median of 13.7 months (range 12.3 to 15.2). Study limitations include small sample size and short followup. CONCLUSIONS: We present what is to our knowledge the initial series of robotic completely intracorporeal Indiana pouch diversion. Early perioperative data indicate acceptable operative efficiency and complication rates. Longer followup is required to assess the functional outcomes of this less commonly performed diversion.

American Confederation of Urology (CAU) experience in minimally invasive partial nephrectomy.

PURPOSE: To describe the perioperative and oncology outcomes in a series of laparoscopic or robotic partial nephrectomies (PN) for renal tumors treated in diverse institutions of Hispanic America from the beginning of their minimally invasive (MI) PN experience through December 2014. METHODS: Seventeen institutions participated in the CAU generated a MI PN database. We estimated proportions, medians, 95 % confidence intervals, Kaplan-Meier curves, multivariate logistic and Cox regression analyses. Clavien-Dindo classification was used. RESULTS: We evaluated 1501 laparoscopic (98 %) or robotic (2 %) PNs. Median age: 58 years. Median surgical time, warm ischemia and intraoperative bleeding were 150, 20 min and 200 cc. 81 % of the lesions were malignant, with clear cell histology being 65 % of the total. Median maximum tumor diameter is 2.7 cm, positive margin is 8.2 %, and median hospitalization is 3 days. One or more postoperative complication was recorded in 19.8 % of the patients: Clavien 1: 5.6 %; Clavien 2: 8.4 %; Clavien 3A: 1.5 %; Clavien 3B: 3.2 %; Clavien 4A: 1 %; Clavien 4B: 0.1 %; Clavien 5: 0 %. Bleeding was the main cause of a reoperation (5.5 %), conversion to radical nephrectomy (3 %) or open partial nephrectomy (6 %). Transfusion rate is 10 %. In multivariate analysis, RENAL nephrometry score was the only variable associated with complications (OR 1.1; 95 % CI 1.02-1.2; p = 0.02). Nineteen patients presented disease progression or died of disease in a median follow-up of 1.37 years. The 5-year progression or kidney cancer mortality-free rate was 94 % (95 % CI 90, 97). Positive margins (HR 4.98; 95 % CI 1.3-19; p = 0.02) and females (HR 5.6; 95 % CI 1.7-19; p = 0.005) were associated with disease progression or kidney cancer mortality after adjusting for maximum tumor diameter. CONCLUSION: Laparoscopic PN in these centers of Hispanic America seem to have acceptable perioperative complications and short-term oncologic outcomes.

Minimally invasive management of urological fistulas.

PURPOSE OF REVIEW: Urological fistulas are an underestimated problem worldwide and have devastating consequences for patients. Many urological fistulas result from surgical complications and/or inadequate perinatal obstetric healthcare. Surgical correction is the standard treatment. This article reviews minimally invasive surgical approaches to manage urological fistulas with a particular emphasis on the robotic techniques of fistula correction. RECENT FINDINGS: In recent years, many surgeons have explored a minimally invasive approach for the management of urological fistulas. Several studies have demonstrated the feasibility of laparoscopic surgery and the reproducibility of reconstructive surgery techniques. Introduction of the robotic platform has provided significant advantages given the improved dexterity and exceptional vision that it confers. SUMMARY: Fistulas are a concern worldwide. Laparoscopic surgery correction has been developed through the efforts of several authors, and difficulties such as the increased learning curve have been overcome with innovations, including the robotic platform. Although minimally invasive surgery offers numerous advantages, the most successful approach remains the one with the surgeon is most familiar.