Purpose
To compare the safety of on- vs off-clamp robotic partial nephrectomy (RAPN).
Methods
302 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.
Results
Due 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).
Conclusions
The on-clamp and off-clamp approaches for RAPN showed a comparable safety profile.
The purpose of this study was to assess patient frailty as a risk factor for radical cystectomy (RC) complications.
We performed an analysis of prospectively collected data of consecutive patients 80 ...years of age or older who underwent RC and ureterocutaneostomy in 6 primary care European urology centers. Frailty was measured using a simplified frailty index (sFI) with a 5-item score including: (1) diabetes mellitus; (2) functional status; (3) chronic obstructive pulmonary disease; (4) congestive cardiac failure; and (5) hypertension, with a maximum 5-item score meaning high level of frailty. Within 90 days surgical complications were scored according to the Clavien Classification System (CCS). sFI ≥3 was considered as poor frailty status. Clinical and pathological variables were analyzed as predictors of severe complications (CCS ≥3).
One hundred seventeen patients were enrolled. Most patients reported an sFI score of 2 and 3, respectively, 31/117 (26.5%) and 45/117 patients (38.5%). CCS ≥3 occurred in 17/117 patients (14.5%). Patients with sFI ≥3 were significantly older than patients with sFI <3 (median age, 85 years interquartile range (IQR), 82-86 versus 82 years IQR, 80-84; P = .001). Most CCS ≥3 scores occurred in patients with sFI ≥3: 13 (11.1%) versus 4 (3.4%; P = .02). No significative differences were detected in terms of length of hospital stay, pathological stage, and postoperative bowel canalization when related to sFI. sFI ≥3 was an independent risk factor of CCS ≥3 in univariate and multivariate analysis (respectively, odds ratio OR, 3.81 95% confidence interval (CI), 1.16-12.5; P = .02 and OR, 3.1 95% CI, 0.7-13.7; P = .01). Body mass index, age, American Society of Anesthesiologists score ≥3, and pathological stage were not related to CCS ≥3.
RC appears feasible in elderly patients with an sFI <3. In cases of sFI ≥3, this choice should be carefully valued, discussed, and possibly avoided because of a higher risk of complications.
We used the Frailty index as a risk factor for radical cystectomy (RC) complications. We performed an analysis of data of consecutive patients 80 years of age or older who had undergone RC and ureterocutaneostomy (UCS) in 6 European centers. No differences were detected in terms of length of hospital stay, pathological stage, or postoperative bowel canalization as related to the Frailty index. RC and UCS seem to be a feasible option in frail elderly patients.
Eventi di grande allarme sociale, in anni di scandali economici e finanziari, determinavano il legislatore nazionale a introdurre lazione di classe con legge 23 luglio 2009, n. 99, allarticolo ...140-bis del Codice del consumo, cui avrebbe fatto seguito il d.l. 24 gennaio 2012, n.1, cosiddetto decreto Salva Italia, convertito in legge 24 marzo 2012, n. 27. Non poche riserve, perduranti allesito delliter legislativo, segnavano tale sforzo teso a delineare una versione nostrana della class action; perplessità, e riserve, inerenti alla disciplina dellazione e allambito dei diritti tutelati. Nella versione recenziore questi avrebbero assunto caratteri di diritti individuali omogenei dei consumatori e degli utenti intendendosi confermare le compatibilità ai principi generali informanti lordinamento, ma la coerenza a una semiotica giuridica sviluppatasi nellambito di una teoresi del diritto di ispirazione neoempiristica.Carlo dOrta è dottore di ricerca in "Comparazione e Diritti della Persona" presso lUniversità degli Studi di Salerno. Autore di saggi, contributi in riviste e trattati in materia di diritto civile e diritto comparato.
Objectives: Fibrin glue (FG) endo-vesical application seems to be a promising therapy for hemorrhagic cystitis (HC). We aimed to evaluate efficacy and safety of FG instillation in patients with HC. ...Methods: Patients with HC not responsive to conventional treatments (bladder irrigation, catheterization, blood transfusions, hyperhydration and endoscopic coagulation) were treated with FG endo-vesical instillation (April 2017- December 2018). FG was prepared from 120 mL of patient blood with the Vivostat® system. After standard cystoscopy, bladder was insufflated with carbon dioxide (CO2) according to bladder compliance and autologous FG was applied to bladder wall and bleeding sites. Results: Ten patients included with grade 2 or higher HC secondary to bone marrow graft for hematological diseases (30%) or to actinic cystitis caused by prostate cancer radiotherapy (RT) (70%). The median HC onset time after RT was 4.8 (IQR 3.9- 6.3) years and 35 (IQR 27.5-62.5) days after hematopoietic stem cell transplantation (HSCT). Five patients had a complete response after one treatment, three patients had clinical response (grade < 2 hematuria, amelioration of symptoms), one of them required catheterization and bladder irrigation. One patient required a second instillation of FG achieving a clinical response. No adverse events related to the procedure were recorded, however one patient died for causes not related to the procedure. Median Interstitial Cystitis Symptoms Index was 13.0 (IQR 11.0-15.0) pre-operatively and 4.0 (IQR 2.0-5.0) post-operatively. Conclusions: Our study showed that, even in hematological patients, autologous FG instillation maybe a safe, repeatable and effective treatment modality in patients with refractory HC.
Purpose
To evaluate the relationship between warm ischemia time (WIT) duration and renal function after robot-assisted partial nephrectomy (RAPN).
Methods
The CLOCK trial is a phase 3 randomized ...controlled trial comparing on- vs off-clamp RAPN. All patients underwent pre- and postoperative renal scintigraphy. Six-month absolute variation of eGFR (AV-GFR), rate of relative variation in eGFR over 25% (RV-GFR > 25), absolute variation of split renal function (SRF) at scintigraphy (AV-SRF).
The relationships WIT/outcomes were assessed by correlation graphs and then modeled by uni- and multivariable regression.
Results
324 patients were included (206 on-clamp, 118 off-clamp RAPN). Correlation graphs showed a threshold on WIT equal to 10 min. The differences in outcome measures between cases with WIT < vs ≥ 10 min were: AV-GFR − 3.7 vs − 7.5 ml/min (
p
< 0.001); AV-SRF − 1% vs − 3.6% (
p
< 0.001); RV-GFR > 25 9.3% vs 17.8% (
p
= 0.008). Multivariable models found that AV-GFR was related to WIT ≥ 10 min (regression coefficient RC − 0.52,
p
= 0.019), age (RC − 0.35, p = 0.001) and baseline eGFR (RC − 0.30, p < 0.001); RV-GFR > 25 to WIT ≥ 10 min (odds ratio OR 1.11,
p
= 0.007) and acute kidney injury defined as > 50% increase in serum creatinine (OR 19.7,
p
= 0.009); AV-SRF to WIT ≥ 10 min (RC − 0.30,
p
= 0.018), baseline SRF (RC − 0.76,
p
< 0.001) and RENAL score (RC − 0.60.
p
= 0.028).
The main limitation was that the CLOCK trial was designed on a different endpoint and therefore the present analysis could be underpowered.
Conclusions
Up to 10 min WIT had no consequences on functional outcomes. Above the 10-min threshold, a statistically significant, but clinically negligible impact was found.
Objectives
To compare the functional outcomes of on‐ vs off‐clamp robot‐assisted partial nephrectomy (RAPN) within a randomized controlled trial (RCT).
Materials and Methods
The CLOCK study (CLamp vs ...Off Clamp the Kidney during robotic partial nephrectomy; NCT 02287987) is a multicentre RCT including patients with normal baseline function, two kidneys and masses with RENAL scores ≤ 10. Pre‐ and postoperative renal scintigraphy was prescribed. Renal defatting and hilum isolation were required in both study arms; in the on‐clamp arm, ischaemia was imposed until the completion of medullary renorraphy, while in the off‐clamp condition it was not allowed throughout the procedure. The primary endpoint was 6‐month absolute variation in estimated glomerular filtration rate (AV‐GFR); secondary endpoints were: 12, 18 and 24‐month AV‐GFR; 6‐month estimated glomerular filtration rate variation >25% rate (RV‐GFR >25); and absolute variation in ipsilateral split renal function (AV‐SRF). The planned sample size was 102 + 102 cases, after taking account crossover of cases to the alternate study arm; a 1:1 randomization was performed. AV‐GFR and AV‐SRF were compared using analysis of covariation, and RV‐GFR >25 was assessed using multivariable logistic regression. Intention‐to‐treat (ITT) and per‐protocol analyses (PP) were performed.
Results
A total of 160 and 164 patients were randomly assigned to on‐ and off‐clamp RAPN, respectively; crossover was observed in 14% and 43% of the on‐ and off‐clamp arms, respectively. We were unable to find any statistically significant difference between on‐ vs off‐clamp with regard to the primary endpoint (ITT: 6‐month AV‐GFR −6.2 vs −5.1 mL/min, mean difference 0.2 mL/min, 95% confidence interval CI −3.1 to 3.4 P = 0.8; PP: 6‐month AV‐GFR −6.8 vs −4.2 mL/min, mean difference 1.6 mL/min, 95% CI −2.3 to 5.5 P = 0.7) or with regard to the secondary endpoints. The median warm ischaemia time was 14 vs 15 min in the ITT analysis and 14 vs 0 min in the PP analysis.
Conclusion
In patients with regular baseline function and two kidneys, we found no evidence of differences in functional outcomes for on‐ vs off‐clamp RAPN.
Supine percutaneous nephrolithotomy: tips and tricks Proietti, Silvia; Rodríguez-Socarrás, Moises Elias; Eisner, Brian ...
Translational andrology and urology,
09/2019, Letnik:
8, Številka:
S4
Journal Article
Recenzirano
Odprti dostop
This paper aims to give an exhaustive overview of supine percutaneous nephrolithotomy (PCNL) illustrating some tips and tricks in order to optimize its execution in full safety. Critical review of ...Pros and cons of supine PCNL is accomplished to allow the urologist to experience the beauty of this position while being ready to overcome its minimal shortcomings.
Eventi di grande allarme sociale, in anni di scandali economici e finanziari, determinavano il legislatore nazionale a introdurre l''azione di classe' con legge 23 luglio 2009, n. 99, all'articolo ...140-bis del Codice del consumo, cui avrebbe fatto seguito il d.l. 24 gennaio 2012, n.1, cosiddetto decreto 'Salva Italia', convertito in legge 24 marzo 2012, n. 27. Non poche riserve, perduranti all'esito dell'iter legislativo, segnavano tale sforzo teso a delineare una versione nostrana della class action; perplessità, e riserve, inerenti alla disciplina dell'azione e all'ambito dei diritti tutelati. Nella versione recenziore questi avrebbero assunto caratteri di diritti individuali omogenei dei consumatori e degli utenti intendendosi confermare le compatibilità ai principi generali informanti l'ordinamento, ma la coerenza a una semiotica giuridica sviluppatasi nell'ambito di una teoresi del diritto di ispirazione neoempiristica.Carlo d'Orta è dottore di ricerca in "Comparazione e Diritti della Persona" presso l'U
niversità degli Studi di Salerno. Autore di saggi, contributi in riviste e trattati in materia di diritto civile e diritto comparato.
We sought to identify predictive factors of the transition from off clamp to on clamp robotic partial nephrectomy following an intraoperative decision.
In the multicenter, randomized, prospective ...CLOCK (CLamp vs Off Clamp the Kidney during robotic partial nephrectomy) trial 152 and 149 of the 301 patients with a localized renal mass were assigned to undergo off clamp and on clamp robotic partial nephrectomy, respectively. Surgery was done at a total of 7 referral institutions by 1 surgeon per institution. A localized renal mass was defined as having a R.E.N.A.L. (radius, exophytic/endophytic, nearness to collecting system or sinus, anterior/posterior, location relative to polar lines, hilar) score less than 10. Surgeons had similar experience with at least 100 previous robotic partial nephrectomies. All patients underwent a preoperative and a 6-month renal scan. The current study deals with one of the secondary end points of the trial, comparing cases finalized as clampless (off robotic partial nephrectomy group) with those which were converted (shift robotic partial nephrectomy group).
Of the 152 patients randomized to off clamp 61 (40%) were shifted to clamp with a median ischemia time of 15 minutes. In the shift robotic partial nephrectomy group the masses were larger (3.5 vs 2.2 cm) and more complex (R.E.N.A.L. score 7 vs 6). A significant association with transition was found for tumor diameter (OR 1.4) and the R.E.N.A.L. score continuously (OR 1.4) and when recoded in clusters, including 4-no risk (referent OR 1), 5-6-low risk (OR 1.8), 7-8-intermediate risk (OR 3.6) and 9 or greater-high risk (OR 6.6). The shift robotic partial nephrectomy group had longer operative time, higher blood loss and increased performance of 2-layer renorrhaphy. No significant differences were noted in postoperative complications or renal function after 6 months.
The transition from off to on clamp robotic partial nephrectomy is associated with renal mass diameter and complexity. Under the specific conditions of the current trial no harm was related to this decision.
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