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PurposeTo compare the safety of on- vs off-clamp robotic partial nephrectomy (RAPN).Methods302 patients with RENAL masses ≤ 10 were randomized to undergo on-clamp (150) vs off-clamp (152) RAPN (CLOCK trial—ClinicalTrials.gov NCT02287987) at seven institutions by one experienced surgeon per institution. Intra-operative data, complications, and positive surgical margins were compared.ResultsDue to a relevant rate of shift from the assigned treatment, the per-protocol analysis only was considered and the data from 129 on-clamp vs 91 off-clamp RAPNs analyzed. Tumor size (off-clamp vs on-clamp, 2.2 vs 3.0 cm, p < 0.001) and RENAL score (5 vs 6, p < 0.001) significantly differed. At univariate analysis, no differences were found regarding intra-operative estimated blood loss (off- vs on-clamp, 100 vs 100 ml, p = 0.7), post-operative complications rate (19% vs 26%, p = 0.2), post-operative anemia (Hb decrease > 2.5 g/dl 26% vs 27%, p = 0.9; transfusion rate 3.4% vs 6.3%, p = 0.5; re-intervention due to bleeding 1.1% vs 4%, p = 0.4), acute kidney injury (4% vs 6%, p = 0.8), and positive surgical margins (3.5% vs 8.2%, p = 0.1). At multivariate analysis accounting for tumor diameter and complexity, considering the on-clamp group as the reference category, a significant difference was noted in the off-clamp group exclusively for blood loss (OR 0.3, 95% CI 0.09–0.52, p = 0.008).ConclusionsThe on-clamp and off-clamp approaches for RAPN showed a comparable safety profile.

Objectives This study evaluated the safety and efficacy of self-retaining barbed double-layer sutures (SRBDS) used for wound sutures in stage T1 renal cancer undergoing peritoneal robot-assisted laparoscopic partial renal resection. Methods A total of 50 patients undergoing robot-assisted laparoscopic partial nephrectomy (RAPN) for localized renal tumors (< 7 cm) in Zhejiang Provincial People’s Hospital from January 2021 to January 2022 were selected. The experimental-group and the control-group randomly included 25 patients, respectively. SRBDS was intended to be used for kidney wound repair in the experimental group, and single-needle Vicryl was applied in the control group. Results Patients in both the experimental group and the control group completed RAPN without conversion to open surgery. The operative time (80.20 ± 18.39 min) and warm ischemia time (11.76 ± 1.16 min) of the experimental group were both reduced compared to the control group (86.00 ± 15.94 min, 14.56 ± 1.04 min). The increased changes in blood creativity at one week and three months postoperatively in the experimental group were significantly lower than those in the control group, and the decreased changes in GFR level at three months postoperatively in the experimental group were significantly lower than that in the control group (5.21 ± 2.14 vs 7.81 ± 2.28, P  < 0.05). Conclusion For localized T1 renal carcinoma, SRBDS is a safe and efficient endoscopic suture technique, which may be considered as an alternative to other suturing techniques, tissue sealants, and glues for RAPN in the future.

We compared the analgesic effects of erector spinae plane block versus quadratus lumborum block following laparoscopic nephrectomy. A randomized controlled trial. A tertiary hospital in Beijing, China. Patients scheduled for elective laparoscopic nephrectomy. A total of 110 patients were enrolled and randomized to receive either erector spinae plane block (n = 55) or quadratus lumborum block (n = 55) under ultrasound guidance. Patient-controlled sufentanil analgesia was provided after surgery. Our primary outcome was cumulative opioid consumption within 24 h after surgery. Secondary outcomes included postoperative pain intensity, subjective sleep quality, and quality of recovery. All 110 patients (mean 53 years, 57.3% female) were included in the intention-to-treat analysis. Cumulative sufentanil equivalent within 24 h was lower in patients given erector spinae plane block (median 13 μg, interquartile range 4 to 33) than in those given quadratus lumborum block (median 25 μg, interquartile range 13 to 39; median difference − 8 μg, 95% CI -15 to 0, P = 0.041). Pain intensity (0–10 range where 0 = no pain and 10 = the worst pain) at 2, 6, 12, and 24 h after surgery was lower with erector spinae plane block (at rest: median differences −1 point, all P ≤ 0.009; with movement: median differences −2 to −1 points, all P < 0.001). Subjective sleep quality on the night of surgery (the Richards-Campbell Sleep Questionnaire: 0–100 range, higher score better; median difference 12, 95% CI 2 to 23, P = 0.018) and quality of recovery at 24 h (the Quality of Recovery-15: 0–150 range, higher score better; median difference 8, 95% CI 2 to 15, P = 0.012) were better with erector spinae plane block. No procedure-related adverse events occurred. Compared with quadratus lumborum block, erector spinae plane block provided better analgesia as manifested by lower opioid consumption and pain intensity for up to 24 h after laparoscopic nephrectomy. •Quadratus lumborum block and erector spinae plane block are effective in improving analgesia in patients undergoing laparoscopic nephrectomy.•We compared the analgesic effects of quadratus lumborum block versus erector spinae plane block in this patient population.•We found that erector spinae plane block provided better analgesia than quadratus lumborum block for up to 24 h after laparoscopic nephrectomy.

PurposeTo compare the outcomes of PN to those of RN in very elderly patients treated for clinically localized renal tumor.Patients and methodsA purpose-built multi-institutional international database (RESURGE project) was used for this retrospective analysis. Patients over 75 years old and surgically treated for a suspicious of localized renal with either PN or RN were included in this database. Surgical, renal function and oncological outcomes were analyzed. Propensity scores for the predicted probability to receive PN in each patient were estimated by logistic regression models. Cox proportional hazard models were estimated to determine the relative change in hazard associated with PN vs RN on overall mortality (OM), cancer-specific mortality (CSM) and other-cause mortality (OCM).ResultsA total of 613 patients who underwent RN were successfully matched with 613 controls who underwent PN. Higher overall complication rate was recorded in the PN group (33% vs 25%; p = 0.01). Median follow-up for the entire cohort was 35 months (interquartile range [IQR] 13–63 months). There was a significant difference between RN and PN in median decline of eGFR (39% vs 17%; p < 0.01). PN was not correlated with OM (HR = 0.71; p = 0.56), OCM (HR = 0.74; p = 0.5), and showed a protective trend for CSM (HR = 0.19; p = 0.05). PN was found to be a protective factor for surgical CKD (HR = 0.28; p < 0.01) and worsening of eGFR in patients with baseline CKD. Retrospective design represents a limitation of this analysis.ConclusionsAdoption of PN in very elderly patients with localized renal tumor does not compromise oncological outcomes, and it allows better functional preservation at mid-term (3-year) follow-up, relative to RN. Whether this functional benefit translates into a survival benefit remains to be determined.

The announcement of a diagnosis can be a source of anxiety for patients. Managing this anxiety is a major challenge, in terms of quality of life but also for the use of anxiolytic and analgesic therapies. The use of 3D modeling technology in partial nephrectomy surgery has proved its worth as a surgical aid but it could also help patients to manage their own care, by reducing their anxiety and increasing their understanding of the disease and its treatment. We aim to test this hypothesis with a prospective multicenter trial. R3DP-A (Rein 3D - Anxiety) is an unblinded, multicenter, randomized, prospective, superiority-controlled trial. Participants are patients with kidney tumors treated by robot-assisted partial laparoscopic nephrectomy. The 234 patients (78x3 groups) from 6 French centers will undergo a pre-operative consultation dedicated to a personalized explanation of the surgical management and its risks. They will be randomized into three (1:1:1) groups corresponding to three types of support for consultation: use of a virtual 3D model of the kidney and its tumor; a printed 3D model; or the standard information sheet from the French Association of Urology (control group). Several self-questionnaires will be sent by the UroConnect® application and completed at different times during the study. The primary endpoint will be pre-operative anxiety (STAI-state questionnaire completed the day before surgery D-1). Secondary endpoints will be changes in anxiety levels between the pre-operative and post-operative consultations (between inclusion and D15 post-op), changes in health literacy and quality of life (HLSEU-Q16 and EQ-5D-5L questionnaires at inclusion and D15), feelings of understanding of the disease and its treatment at pre-operative period (Wake questionnaire at D-1), and consultation times. We aim to highlight a benefit of using a personalized 3D model on the anxiety level of patients undergoing partial nephrectomy surgery, as well as on their level of understanding of their pathology and its surgical treatment. The use of these models could be incorporated into current practice to improve patient experience throughout care.

Background To evaluate the clinical efficacy and safety of Monofix ® -PDO compared to V-Loc™ for tumor bed suturing during robotic-assisted laparoscopic partial nephrectomy (RAPN). Methods A randomized, controlled, multicenter, single-blinded trial was conducted across four tertiary institutions. Patients with T1-2 stage renal masses scheduled for RAPN were enrolled. The exclusion criteria included patients not deemed in need of bed suturing, those with a history of prior chemotherapy or immunotherapy, and those with severe systemic diseases or high bleeding tendencies. A total of 174 patients participated and were subjected to permuted block randomization (T1a vs. others), resulting in 88 patients in the V-Loc™ group and 86 in the Monofix ® -PDO group. The primary outcome was the resection bed suture time. The secondary outcomes were total suture use time, warm ischemia time, console time (for efficacy), estimated blood loss, hemoglobin change, and 90-day treatment-related adverse events (for safety). All patients were scheduled for follow-up visits for up to three months postoperatively. Results The primary outcome, resection bed suture time, did not significantly differ between the V-Loc™ and Monofix ® -PDO groups (4.8 ± 2.6 vs. 4.5 ± 2.6 min, p  = 0.531). Secondary outcomes, including total suture used time (5.3 ± 2.8 vs. 4.8 ± 2.6 min, p  = 0.289) and warm ischemic time (15.6 ± 5.5 vs. 15.4 ± 5.4 min, p  = 0.834), were comparable between the two groups. In terms of safety outcomes, changes in serum hemoglobin levels did not show significant differences on postoperative days 1, 3, and 14 ( P  = 0.537, 0.353, and 0.840, respectively). No device-related adverse events were observed during the 90-day follow-up period in either group. Conclusions Monofix ® -PDO demonstrated non-inferior to V-Loc in terms of both safety and efficacy in patients undergoing RAPN. This trial is registered on cris.nih.go.kr as KCT0006809 (Registration date: 02/19/2021).

Introduction Total nephrectomies for the treatment of Wilms’ tumor (WT) are more and more performed by laparoscopy, although indications for this approach following the UMBRELLA guidelines are currently very restrictive. The purpose of this study was to assess the compliance to the criteria of the UMBRELLA protocol for minimally invasive approach of WT. Methods This retrospective multicenter study included children operated on by laparoscopic total nephrectomy for suspected WT before 2020. Imaging was reviewed centrally. Results Fifty-six patients (50 WT and 6 nephrogenic rests) were operated on at a median age of 3.3 ± 2.6 years. Thirteen (23%) patients had metastasis at diagnosis. The mean operative time was 213 ± 84 min. There were eight (14.3%) conversions and five peroperative complications. A local stage III was confirmed in seven (12.5%) cases, including two for tumor rupture. Only one (1.8%) of the procedures followed the SIOP-UMBRELLA indications for laparoscopy. The criterion “ring of normal parenchyma” was met only once. Conservative surgery seemed possible in ten (17.9%) cases. The extension of the tumor beyond the ipsilateral edge of the vertebra after chemotherapy and a volume over 200 mL were associated with an increased risk of conversion ( p = 0.0004 and p = 0.001 respectively). After a mean follow-up of 5.2 ± 4.0 years, although there was no local recurrence, one death occurred due to metastatic progression at 15 months postoperatively. Conclusions The laparoscopic approach of WT beyond the UMBRELLA recommendations was feasible with low risk of local recurrence. Its indications may be updated and validated.

Personalized 3D-printed kidney models could serve as valuable educational tools for patients undergoing robot-assisted partial nephrectomy (RAPN). These models facilitate patients' understanding of their pathology, surgical procedure, and anatomy. However, the costs associated with 'personalized' printing remain a barrier to their use. This study aims to thoroughly investigate the benefits of using a personalized 3D-printed kidney model as opposed to a generic 3D-printed kidney model as an educational tool for patients and as a communication tool for healthcare professionals. In this prospective single center study, 60 patients undergoing RAPN will be randomized to receive information based on their personalized 3D-printed tumoral kidney model or a generic 3D-printed tumoral kidney model. These models will accompany patients throughout their care pathway, from pre-operative consultations to the post-operative visit. The impact of these models on the management approaches of various healthcare professionals will also be examined. The data will be collected and analyzed using a mixed method, combining interviews (with patients and caregivers), observations during the presentation of the models and questionnaires (understanding of their pathology and the surgical procedure, Health-literacy, satisfaction). Three dimensional kidney models have the potential to play a central role in the preoperative information process and serve as an effective educational tool during the patient's social interactions with relatives and healthcare professionals. This study will evaluate the potential advantages of personalized 3D models of tumoral kidneys compared to their generic counterparts. The PERSONALIZE study was registered on ClinicalTrials.gov (NCT06379698) on the 5th of September 2023.

Background The role of cytoreductive nephrectomy (CN) in the treatment of metastatic renal cell carcinoma (mRCC) remains unclear in the immuno-oncology (IO) era. The results of two randomized trials, CARMENA and SURTIME, questioned the role and timing of CN. However, despite the latest advances in the systemic treatment of mRCC, previous trials have only used targeted therapy, and no studies have fully investigated the role of CN in immune checkpoint inhibitor (CPI) settings, and there is an urgent need for future studies to better define the role and timing of CN. Methods This study is an open-label, multi-center, parallel, prospective, randomized, interventional clinical study to evaluate the efficacy of CN in combination with CPIs in mRCC patients with International mRCC Database Consortium (IMDC) intermediate- and poor-risk. Synchronous mRCC patients with ≤ 3 IMDC risk features will be randomly allocated to three groups (1, upfront CN; 2, deferred CN; and 3, systemic therapy [ST] only). For ST, the nivolumab plus ipilimumab combination regimen, one of the standard regimens for intermediate- and poor-risk mRCC, is chosen. The primary endpoint is overall survival. The secondary endpoints are progression-free survival, objective response rate, number of participants with treatment-related adverse events, and number of participants with surgical morbidity. We will analyze the genetic mutation profiles of the tumor tissue, circulating tumor DNA, urine tumor DNA, and tumor-infiltrating lymphocytes. The gut and urine microbial communities will be analyzed. The study will begin in 2022 and will enroll 55 patients. Discussion This study is one of the few prospective randomized trials to evaluate the benefit of CN in the treatment of synchronous mRCC in the IO era. The SEVURO-CN trial will help identify the role and timing of CN, thereby rediscovering the value of CN. Trial registration ClinicalTrials.gov, NCT05753839. Registered on 3 March 2023.

Objective To evaluate the clinical efficacy of evidence-based Enhanced Recovery After Surgery (ERAS) nursing protocols in patients undergoing robotic-assisted partial nephrectomy using the Da Vinci system. Methods A total of 240 patients undergoing Da Vinci robot-assisted partial nephrectomy were randomized (1:1) to ERAS ( n  = 120) or conventional care ( n  = 120) groups using a stratified block randomization method. The sample size was calculated based on a power of 80%, α = 0.05, and anticipated clinically significant differences, though specific values for the standard deviation and effect size were not disclosed. Primary outcomes included operative time, estimated blood loss, and length of hospital stay. Secondary outcomes assessed complication rates (Clavien-Dindo classification) and patient-reported comfort (Kolcaba GCQ questionnaire). Categorical variables were analyzed using the Chi-square test, while continuous variables were assessed with the independent samples t-test. Bonferroni correction was applied for pairwise comparisons to control for multiple testing. All analyses adhered to the modified intention-to-treat principle using the full analysis set (FAS), and no imputation was made for missing data. A p-value < 0.05 was considered statistically significant. Results The ERAS group demonstrated superior recovery metrics compared to the control group: operative duration (228.6 ± 9.5 vs. 252.8 ± 10.1 min, mean difference [MD] − 24.2, 95% CI -27.3, -21.1; p  < 0.001), intraoperative blood loss (200.4 ± 18.2 vs. 232.6 ± 19.3 mL, MD − 32.2, 95% CI -36.8, -27.6; p  < 0.001), and shorter postoperative milestones (ambulation: 14.3 ± 1.7 vs. 18.7 ± 2.2 h, p  < 0.001; catheter removal: 2.1 vs. 3.5 days, p  < 0.001). Hospital stay was significantly reduced (6.2 ± 2.1 vs. 10.5 ± 3.3 days, MD − 4.3, 95% CI -5.0, -3.6; p  < 0.001). Complication rates were markedly lower with ERAS (14.2% vs. 39.2%, relative risk [RR] 0.36, 95% CI 0.24–0.55; p  < 0.001), particularly for urinary infections (3.3% vs. 11.7%, p  = 0.027) and wound hematomas (5.0% vs. 13.3%, p  = 0.025). GCQ scores improved significantly in the ERAS group post-intervention ( p  < 0.001). Conclusion ERAS nursing grounded in evidence-based medicine significantly enhances postoperative recovery, reduces complications, and improves patient comfort in robotic-assisted partial nephrectomy. These findings support its broader clinical adoption.