Off-clamp Versus On-clamp Robot-assisted Partial Nephrectomy: A Propensity-matched Analysis.

BACKGROUND: Partial nephrectomy is the preferred treatment option for the management of small renal masses. On-clamp partial nephrectomy is associated with a risk of ischemia and a greater loss of postoperative renal function, while the off-clamp procedure decreases the duration of renal ischemia, leading to better renal function preservation. However, the efficacy of the off- versus on-clamp partial nephrectomy for renal function preservation remains debatable. OBJECTIVE: To compare perioperative and functional outcomes following off- and on-clamp robot-assisted partial nephrectomy (RAPN). DESIGN, SETTING, AND PARTICIPANTS: This study used the prospective multinational collaborative Vattikuti Collective Quality Initiative (VCQI) database for RAPN. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary objective of this study was the comparison of perioperative and functional outcomes between patients who underwent off- and on-clamp RAPN. Propensity scores were calculated for age, sex, body mass index (BMI), renal nephrometry score (RNS) and preoperative estimated glomerular filtration rate (eGFR). RESULTS AND LIMITATIONS: Of the 2114 patients, 210 had undergone off-clamp RAPN and others on-clamp procedure. Propensity matching was possible for 205 patients in a 1:1 ratio. After matching, the two groups were comparable for age, sex, BMI, tumor size, multifocality, tumor side, face of tumor, RNS, polar location of the tumor, surgical access, and preoperative hemoglobin, creatinine, and eGFR. There was no difference between the two groups for intraoperative (4.8% vs 5.3%, p = 0.823) and postoperative (11.2% vs 8.3%, p = 0.318) complications. Need for blood transfusion (2.9% vs 0, p = 0.030) and conversion to radical nephrectomy (10.2% vs 1%, p < 0.001) were significantly higher in the off-clamp group. At the last follow-up, there was no difference between the two groups for creatinine and eGFR. The mean fall in eGFR at the last follow-up compared with that at baseline was equivalent between the two groups (-16.0 vs -17.3 ml/min, p = 0.985). CONCLUSIONS: Off-clamp RAPN does not result in better renal functional preservation. Alternatively, it may be associated with increased rates of conversion to radical nephrectomy and need for blood transfusion. PATIENT SUMMARY: With this multicentric study, we noted that performing robotic partial nephrectomy without clamping the blood supply to the kidney is not associated with better preservation of renal function. However, off-clamp partial nephrectomy is associated with increased rates of conversion to radical nephrectomy and blood transfusion.

Robot-assisted partial nephrectomy in morbidly obese patients: a VCQI database study.

To compare perioperative outcomes following robot-assisted partial nephrectomy (RAPN) in patients with morbid obesity (body mass index (BMI > 40 kg/m2)) and non-obese patients. Using the Vattikuti Collective quality initiative (VCQI) database for RAPN, data for morbidly obese and non-obese patients was obtained. Propensity scores were calculated for two treatment groups (morbidly obese vs. non-obese) for the following variables i.e. age, sex, tumor size, RNS, surgical access (retroperitoneal/transperitoneal) and estimated glomerular filtration rate (eGFR) to ensure comparability. The primary outcome for the study was comparison of trifecta between the two groups. In this study, 158 morbidly obese patients were matched with 158 non-obese patients undergoing RAPN. Two groups matched well for age, sex, tumor size, eGFR and RNS. There was no difference between two groups for ischemia time, blood loss, blood transfusion, conversion to radical nephrectomy, length of stay, intraoperative and postoperative complications. Operative time was longer in morbidly obese patients (median 210 min vs. 120 min, p = 0.000). On pathological analysis, malignant tumors were more likely in the morbidly obese group (83.1% vs.73.4%, p = 0.018). Trifecta outcomes were comparable between the two groups (60.1% vs. 63.3%, p = 0.563). The Median duration of follow-up was 12 months (1-96 months). The morbidly obese group had significantly higher day one creatinine (1.25 ± 0.7 vs. 1.07 ± 0.37, p = 0.001) and significantly lower day one eGFR (62.1 ± 19 vs. 69.2 ± 21, p = 0.018). However, there was no difference between the two groups for the last follow-up creatinine and eGFR. RAPN in morbidly obese patients is associated with equivalent perioperative outcomes compared to non-obese patients.

Development and Validation of a Nomogram Predicting Intraoperative Adverse Events During Robot-assisted Partial Nephrectomy.

BACKGROUND: Ability to predict the risk of intraoperative adverse events (IOAEs) for patients undergoing partial nephrectomy (PN) can be of great clinical significance. OBJECTIVE: To develop and internally validate a preoperative nomogram predicting IOAEs for robot-assisted PN (RAPN). DESIGN, SETTING, AND PARTICIPANTS: In this observational study, data for demographic, preoperative, and postoperative variables for patients who underwent RAPN were extracted from the Vattikuti Collective Quality Initiative (VCQI) database. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: IOAEs were defined as the occurrence of intraoperative surgical complications, blood transfusion, or conversion to open surgery/radical nephrectomy. Backward stepwise logistic regression analysis was used to identify predictors of IOAEs. The nomogram was validated using bootstrapping, the area under the receiver operating characteristic curve (AUC), and the goodness of fit. Decision curve analysis (DCA) was used to determine the clinical utility of the model. RESULTS AND LIMITATIONS: Among the 2114 patients in the study cohort, IOAEs were noted in 158 (7.5%). Multivariable analysis identified five variables as independent predictors of IOAEs: RENAL nephrometry score (odds ratio [OR] 1.13, 95% confidence interval [CI] 1.02-1.25); clinical tumor size (OR 1.01, 95% CI 1.001-1.024); PN indication as absolute versus elective (OR 3.9, 95% CI 2.6-5.7) and relative versus elective (OR 4.2, 95% CI 2.2-8); Charlson comorbidity index (OR 1.17, 95% CI 1.05-1.30); and multifocal tumors (OR 8.8, 95% CI 5.4-14.1). A nomogram was developed using these five variables. The model was internally valid on bootstrapping and goodness of fit. The AUC estimated was 0.76 (95% CI 0.72-0.80). DCA revealed that the model was clinically useful at threshold probabilities >5%. Limitations include the lack of external validation and selection bias. CONCLUSIONS: We developed and internally validated a nomogram predicting IOAEs during RAPN. PATIENT SUMMARY: We developed a preoperative model than can predict complications that might occur during robotic surgery for partial removal of a kidney. Tests showed that our model is fairly accurate and it could be useful in identifying patients with kidney cancer for whom this type of surgery is suitable.

Perioperative outcomes following robot-assisted partial nephrectomy in elderly patients.

OBJECTIVE: To compare perioperative outcomes following robot-assisted partial nephrectomy (RAPN) in patients with age ≥ 70 years to age < 70 years. METHODS: Using Vattikuti Collective quality initiative (VCQI) database for RAPN we compared perioperative outcomes following RAPN between the two age groups. Primary outcome of the study was to compare trifecta outcomes between the two groups. Propensity matching using nearest neighbourhood method was performed with trifecta as primary outcome for sex, body mass index (BMI), solitary kidney, tumor size and Renal nephrometery score (RNS). RESULTS: Group A (age ≥ 70 years) included 461 patients whereas group B included 1932 patients. Before matching the two groups were statistically different for RNS and solitary kidney rates. After propensity matching, the two groups were comparable for baselines characteristics such as BMI, tumor size, clinical symptoms, tumor side, face of tumor, solitary kidney and tumor complexity. Among the perioperative outcome parameters there was no difference between two groups for operative time, blood loss, intraoperative transfusion, intraoperative complications, need for radical nephrectomy, positive margins and trifecta rates. Warm ischemia time was significantly longer in the younger age group (18.1 min vs. 16.3 min, p = 0.003). Perioperative complications were significantly higher in the older age group (11.8% vs. 7.7%, p = 0.041). However, there was no difference between the two groups for major complications. CONCLUSION: RAPN in well-selected elderly patients is associated with comparable trifecta outcomes with acceptable perioperative morbidity.

Comparison of perioperative outcomes following transperitoneal versus retroperitoneal robot-assisted partial nephrectomy: a propensity-matched analysis of VCQI database.

OBJECTIVE: To compare perioperative outcomes following retroperitoneal robot-assisted partial nephrectomy (RPRAPN) and transperitoneal robot-assisted partial nephrectomy (TPRAPN). METHODS: With this Vattikuti Collective Quality Initiative (VCQI) database, study propensity scores were calculated according to the surgical access (TPRAPN and RPRAPN) for the following independent variables, i.e., age, sex, side of the surgery, RENAL nephrometry scores (RNS), estimated glomerular filtration rate (eGFR) and serum creatinine. The study's primary outcome was the comparison of trifecta between the two groups. RESULTS: In this study, 309 patients who underwent RPRAPN were matched with 309 patients who underwent TPRAPN. The two groups matched well for age, sex, tumor side, polar location of the tumor, RNS, preoperative creatinine and eGFR. Operative time and warm ischemia time were significantly shorter with RPRAPN. Intraoperative blood loss and need for blood transfusion were lower with RPRAPN. There was a significantly higher number of intraoperative complications with RPRAPN. However, there was no difference in the two groups for postoperative complications. Trifecta outcomes were better with RPRAPN (70.2% vs. 53%, p < 0.0001) compared to TPRAPN. We noted no significant change in overall results when controlled for tumor location (anteriorly or posteriorly). The surgical approach, tumor size and RNS were identified as independent predictors of trifecta on multivariate analysis. CONCLUSION: RPRAPN is associated with superior perioperative outcomes in well-selected patients compared to TPRAPN. However, the data for the retroperitoneal approach were contributed by a few centers with greater experience with this technique, thus limiting the generalizability of the results of this study.

Robotic Freyer's prostatectomy: Operative technique and single-center experience.

INTRODUCTION: Transurethral resection of prostate replaced open surgery and remained the gold standard in surgical management of benign prostatic hyperplasia (BPH). Holmium laser enucleation and bipolar resection of prostate managed even larger glands. Open simple prostatectomy remains an option for large glands and concurrent pathologies. Minimally invasive laparoscopic simple prostatectomy lacks general acceptance. Surgeons have now started exploring the robotic platform due to its advantages. Herein, we present the technique and initial outcomes of robotic Freyer's prostatectomy (RFP). MATERIALS AND METHODS: Thirteen transperitoneal RFPs were performed using the DaVinci Xi platform. We evaluated perioperative characteristics and functional outcomes. RESULTS: Median patient age was 67.8 years and the mean prostate volume was 105.8 ml. The median International Prostate Symptom Score (IPSS) and American Urological Association quality of life (AUA-QoL) score was 19.6 and 5.3. There were no intraoperative complications or conversion to open surgery. The mean console time and estimated blood loss were 107.30 min and 92.5 ml, respectively. One patient required redo-surgery by robotic technique due to urine leak (Clavien-Dindo Grade 3b complication). Mean hospital stay and catheter duration were 4.9 days and 5.2 days, respectively. Change (preoperative vs. postoperative) in IPSS (19.6 vs. 4.67 points), maximum flow rate (6.8 vs. 15.1 ml/s), AUA-QoL score (5.3 vs. 2.2 points) and PVR (179.4 vs 7.1 ml) were significant (P < 0001). CONCLUSIONS: RFP is a safe and effective option for managing BPH, especially for large glands. It confers minimally invasive surgery benefits with good functional outcomes.

Outcomes in robot-assisted partial nephrectomy for imperative vs elective indications.

OBJECTIVES: To assess and compare peri-operative outcomes of patients undergoing robot-assisted partial nephrectomy (RAPN) for imperative vs elective indications. PATIENT AND METHODS: We retrospectively reviewed a multinational database of 3802 adults who underwent RAPN for elective and imperative indications. Laparoscopic or open partial nephrectomy (PN) were excluded. Baseline data for age, gender, body mass index, American Society of Anaesthesiologists score and PADUA score were examined. Patients undergoing RAPN for an imperative indication were matched to those having surgery for an elective indication using propensity scores in a 1:3 ratio. Primary outcomes included organ ischaemic time, operating time, estimated blood loss (EBL), rate of blood transfusions, Clavien-Dindo complications, conversion to radical nephrectomy (RN) and positive surgical margin (PSM) status. RESULTS: After propensity-score matching for baseline variables, a total of 304 patients (76 imperative vs 228 elective indications) were included in the final analysis. No significant differences were found between groups for ischaemia time (19.9 vs 19.8 min; P = 0.94), operating time (186 vs 180 min; P = 0.55), EBL (217 vs 190 mL; P = 0.43), rate of blood transfusions (2.7% vs 3.7%; P = 0.51), or Clavien-Dindo complications (P = 0.31). A 38.6% (SD 47.9) decrease in Day-1 postoperative estimated glomerular filtration rate was observed in the imperative indication group and an 11.3% (SD 45.1) decrease was observed in the elective indication group (P < 0.005). There were no recorded cases of permanent or temporary dialysis. There were no conversions to RN in the imperative group, and seven conversions (5.6%) in the elective group (P = 0.69). PSMs were seen in 1.4% (1/76) of the imperative group and in 3.3% of the elective group (7/228; P = 0.69). CONCLUSION: We conclude that RAPN is feasible and safe for imperative indications and demonstrates similar outcomes to those achieved for elective indications.

Omission of Cortical Renorrhaphy During Robotic Partial Nephrectomy: A Vattikuti Collective Quality Initiative Database Analysis.

OBJECTIVES: To analyze the outcomes of patients in whom cortical (outer) renorrhaphy (CR) was omitted during robotic partial nephrectomy (RPN). METHODS: We analyzed 1453 patients undergoing RPN, from 2006 to 2018, within a large multi-institutional database. Patients having surgery for bilateral tumors (n = 73) were excluded. CR and no-CR groups were compared in terms of operative and ischemia time, estimated blood loss (EBL), complications, surgical margins, hospital stay, change in estimated glomerular filtration rate (eGFR), and need of angioembolization. Inverse probability of treatment weighting with Firth correction for center code was performed to account for selection bias. RESULTS: CR was omitted in 120 patients (8.7%); 1260 (91.3%) patients underwent both inner layer and CR. There was no difference in intraoperative complications (7.4% CR; 8.9% no-CR group; P = .6), postoperative major complications (1% and 2.8% in CR and no-CR groups, respectively; P = .2), or median drop in eGFR (7.3 vs 10.4 mL/min/m2). The no-CR group had a higher incidence of minor complications (26.7% vs 5.5% in CR group; P < .001). EBL was 100 mL (IQR 50-200) in both groups (P = .6). Angioembolization was needed in 0.7% patients in CR vs 1.4% in no-CR group (P = .4). Additionally, there was no difference in median operative time (168 vs 162 min; P = .2) or ischemia time (18 vs 17 min; P = .7). CONCLUSION: In selected patients with renal masses, single layer renorrhaphy does not significantly improve operative time, ischemia time, or eGFR after RPN. There is a higher incidence of minor complications, but not major perioperative complications after no-CR technique.

Predicting intra-operative and postoperative consequential events using machine-learning techniques in patients undergoing robot-assisted partial nephrectomy: a Vattikuti Collective Quality Initiative database study.

OBJECTIVE: To predict intra-operative (IOEs) and postoperative events (POEs) consequential to the derailment of the ideal clinical course of patient recovery. MATERIALS AND METHODS: The Vattikuti Collective Quality Initiative is a multi-institutional dataset of patients who underwent robot-assisted partial nephectomy for kidney tumours. Machine-learning (ML) models were constructed to predict IOEs and POEs using logistic regression, random forest and neural networks. The models to predict IOEs used patient demographics and preoperative data. In addition to these, intra-operative data were used to predict POEs. Performance on the test dataset was assessed using area under the receiver-operating characteristic curve (AUC-ROC) and area under the precision-recall curve (PR-AUC). RESULTS: The rates of IOEs and POEs were 5.62% and 20.98%, respectively. Models for predicting IOEs were constructed using data from 1690 patients and 38 variables; the best model had an AUC-ROC of 0.858 (95% confidence interval [CI] 0.762, 0.936) and a PR-AUC of 0.590 (95% CI 0.400, 0.759). Models for predicting POEs were trained using data from 1406 patients and 59 variables; the best model had an AUC-ROC of 0.875 (95% CI 0.834, 0.913) and a PR-AUC 0.706 (95% CI, 0.610, 0.790). CONCLUSIONS: The performance of the ML models in the present study was encouraging. Further validation in a multi-institutional clinical setting with larger datasets would be necessary to establish their clinical value. ML models can be used to predict significant events during and after surgery with good accuracy, paving the way for application in clinical practice to predict and intervene at an opportune time to avert complications and improve patient outcomes.

Conversion of Robot-assisted Partial Nephrectomy to Radical Nephrectomy: A Prospective Multi-institutional Study.

OBJECTIVE: To assess the incidence and factors affecting conversion from robot-assisted partial nephrectomy (RAPN) to radical nephrectomy. METHODS: Between November 2014 and February 2017, 501 patients underwent attempted RAPN by 22 surgeons at 14 centers in 9 countries within the Vattikuti Collaborative Quality Initiative database. Patients were permanently logged for RAPN prior to surgery and were analyzed on an intention-to-treat basis. Multivariable logistic regression with backward stepwise selection of variables was done to assess the factors associated with conversion to radical nephrectomy. RESULTS: Overall conversion rate was 25 of 501 (5%). Patients converted to radical nephrectomy were older (median age [interquartile range] 66.0 [61.0-74.0] vs 59.0 [50.0-68.0], P = .012), had higher body mass index (BMI) (median 32.8 [24.9-40.9] vs 27.8 [24.6-31.5] kg/m2, P = .031), higher age-adjusted Charlson comorbidity score (median 6.0 [4.0-7.0] vs 4.0 [3.0-5.0], P <.001), higher American Society of Anesthesiologists score (score ≥3; 13/25 (52.0%) vs 130/476 (27.3%), P = .021), Preoperative estimated glomerular filtration rate (P = .141), clinical tumor stage (P = .145), tumor location (P = .140), multifocality (P = .483), and RENAL (radius, exophytic/endophytic properties, nearness of tumor to the collecting system or sinus in millimeters, and anterior/posterior location relative to polar lines) nephrometry score (P = .125) were not significantly different between the groups. On multivariable analysis, independent predictors for conversion were BMI (odds ratio [95% confidence interval]; 1.070 [1.018-1.124]; P = .007) and Charlson score (odds ratio [95% confidence interval]; 1.459 [1.179-1.806]; P = .001). CONCLUSION: RAPN was associated with a low rate of conversion. Independent predictors of conversion were BMI and Charlson score. Tumor factors such as clinical stage, location, multifocality, or RENAL score were not associated with increased risk of conversion.

'Trifecta' outcomes of robot-assisted partial nephrectomy in solitary kidney: a Vattikuti Collective Quality Initiative (VCQI) database analysis.

OBJECTIVES: To analyse the outcomes of robot-assisted partial nephrectomy (RAPN) in patients with a solitary kidney in a large multi-institutional database. PATIENTS AND METHODS: In all, 2755 patients in the Vattikuti Collective Quality Initiative database underwent RAPN by 22 surgeons at 14 centres in nine countries. Of these patients, 74 underwent RAPN with a solitary kidney between 2007 and 2016. We retrospectively analysed the functional and oncological outcomes of these 74 patients. A 'trifecta' of outcomes was assessed, with trifecta defined as a warm ischaemia time (WIT) of <20 min, negative surgical margins, and no complications intraoperatively or within 3 months of RAPN. RESULTS: All 74 patients underwent RAPN successfully with one conversion to radical nephrectomy. The median (interquartile range [IQR]) operative time was 180 (142-230) min. Early unclamping was used in 11 (14.9%) patients and zero ischaemia was used in 12 (16.2%). Trifecta outcomes were achieved in 38 of 66 patients (57.6%). The median (IQR) WIT was 15.5 (8.75-20.0) min for the entire cohort. The overall complication rate was 24.1% and the rate of Clavien-Dindo grade ≤II complications was 16.3%. Positive surgical margins were present in four cases (5.4%). The median (IQR) follow-up was 10.5 (2.12-24.0) months. The median drop in estimated glomerular filtration rate at 3 months was 7.0 mL/min/1.72 m2 (11.01%). CONCLUSION: Our findings suggest that RAPN is a safe and effective treatment option for select renal tumours in solitary kidneys in terms of a trifecta of negative surgical margins, WIT of <20 min, and low operative and perioperative morbidity.

Management of the lymph nodes in penile cancer.

A comprehensive literature study was conducted to evaluate the levels of evidence (LEs) in publications on the diagnosis and staging of penile cancer. Recommendations from the available evidence were formulated and discussed by the full panel of the International Consultation on Penile Cancer in November 2008. The final grades of recommendation (GRs) were assigned according to the LE of the relevant publications. The following consensus recommendations were accepted. Fine needle aspiration cytology should be performed in all patients (with ultrasound guidance in those with nonpalpable nodes). If the findings are positive, therapeutic, rather than diagnostic, inguinal lymph node dissection (ILND) can be performed (GR B). Antibiotic treatment for 3-6 weeks before ILND in patients with palpable inguinal nodes is not recommended (GR B). Abdominopelvic computed tomography (CT) and magnetic resonance imaging (MRI) are not useful in patients with nonpalpable nodes. However, they can be used in those with large, palpable inguinal nodes (GR B). The statistical probability of inguinal micrometastases can be estimated using risk group stratification or a risk calculation nomogram (GR B). Surveillance is recommended if the nomogram probability of positive nodes is <0.1 (10%). Surveillance is also recommended if the primary lesion is grade 1, pTis, pTa (verrucous carcinoma), or pT1, with no lymphovascular invasion, and clinically nonpalpable inguinal nodes, but only provided the patient is willing to comply with regular follow-up (GR B). In the presence of factors that impede reliable surveillance (obesity, previous inguinal surgery, or radiotherapy) prophylactic ILND might be a preferable option (GR C). In the intermediate-risk group (nomogram probability .1-.5 [10%-50%] or primary tumor grade 1-2, T1-T2, cN0, no lymphovascular invasion), surveillance is acceptable, provided the patient is informed of the risks and is willing and able to comply. If not, sentinel node biopsy (SNB) or limited (modified) ILND should be performed (GR B). In the high-risk group (nomogram probability >.5 [50%] or primary tumor grade 2-3 or T2-T4 or cN1-N2, or with lymphovascular invasion), bilateral ILND should be performed (GR B). ILND can be performed at the same time as penectomy, instead of 2-6 weeks later (GR C). SNB based on the anatomic position can be performed, provided the patient is willing to accept the potential false-negative rate of /=2 nodes on one side, contralateral limited ILND with frozen section analysis can be performed, with complete ILND if the frozen section analysis findings are positive (GR B). If clinically suspicious inguinal metastases develop during surveillance, complete ILND should be performed on that side only (GR B), and SNB or limited ILND with frozen section analysis on the contralateral side can be considered (GR C). Endoscopic ILND requires additional study to determine the complication and long-term survival rates (GR C). Pelvic lymph node dissection is recommended if >/=2 proven inguinal metastases, grade 3 tumor in the lymph nodes, extranodal extension (ENE), or large (2-4 cm) inguinal nodes are present, or if the femoral (Cloquet's) node is involved (GR C). Performing ILND before pelvic lymph node dissection is preferable, because pelvic lymph node dissection can be avoided in patients with minimal inguinal metastases, thus avoiding the greater risk of chronic lymphedema (GR B). In patients with numerous or large inguinal metastases, CT or MRI should be performed. If grossly enlarged iliac nodes are present, neoadjuvant chemotherapy should be given and the response assessed before proceeding with pelvic lymph node dissection (GR C). Antibiotic treatment should be started before surgery to minimize the risk of wound infection (GR C). Perioperative low-dose heparin to prevent thromboembolic complications can be used, although it might increase lymph leakage (GR C). The skin incision for ILND should be parallel to the inguinal ligament, and sufficient subcutaneous tissue should be preserved to minimize the risk of skin flap necrosis (GR B). Sartorius muscle transposition to cover the femoral vessels can be used in radical ILND (GR C). Closed suction drainage can be used after ILND to prevent fluid accumulation and wound breakdown (GR B). Early mobilization after ILND is recommended, unless a myocutaneous flap has been used (GR B). Elastic stockings or sequential compression devices are advisable to minimize the risk of lymphedema and thromboembolism (GR C). Radiotherapy to the inguinal areas is not recommended in patients without cytologically or histologically proven metastases nor in those with micrometastases, but it can be considered for bulky metastases as neoadjuvant therapy to surgery (GR B). Adjuvant radiotherapy after complete ILND can be considered in patients with multiple or large inguinal metastases or ENE (GR C). Adjuvant chemotherapy after complete ILND can be used instead of radiotherapy in patients with >/=2 inguinal metastases, large nodes, ENE, or pelvic metastases (GR C). Follow-up should be individualized according to the histopathologic features and the management chosen for the primary tumor and inguinal nodes (GR B).

A prospective, randomized trial evaluating the safety and efficacy of fibrin sealant in tubeless percutaneous nephrolithotomy.

PURPOSE: We performed a prospective, randomized trial to assess the safety and efficacy of fibrin sealant in tubeless percutaneous nephrolithotomy. MATERIALS AND METHODS: A total of 63 patients undergoing tubeless percutaneous nephrolithotomy were randomized to receive Tisseel vapor heated sealant at the end of the procedure. Fibrin sealant was instilled under direct vision in the nephrostomy tract at the end of the procedure. Patients younger than 14 years and those undergoing staged percutaneous nephrolithotomy or bilateral simultaneous percutaneous nephrolithotomy were excluded from study. Patients needing greater than 2 percutaneous tracts, those with significant bleeding or associated pyonephrosis and those with a residual stone burden were also excluded from study. The perioperative outcome in these patients (experimental group) was compared with the outcome in those undergoing tubeless percutaneous nephrolithotomy without fibrin sealant (control group). RESULTS: Fibrin sealant was instilled in 32 patients. There was no difference in the hematocrit decrease and blood transfusion requirement in the 2 groups. Patients in the experimental group experienced less postoperative pain and required less analgesia. They were discharged home 5 hours earlier than patients in the control group. However, this difference was not statistically significant. Complete stone clearance was achieved in 87.5% of patients in the experimental group and in 90.32% of controls. CONCLUSIONS: The instillation of Tisseel fibrin glue is safe for tubeless percutaneous nephrolithotomy. It is associated with less postoperative pain and a lower analgesic requirement. Additional prospective, randomized studies are required to better define its clinical role in the future.