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Multimodal Prehabilitation to Enhance Functional Capacity Following Radical Cystectomy: A Randomized Controlled Trial.
Minnella, EM, Awasthi, R, Bousquet-Dion, G, Ferreira, V, Austin, B, Audi, C, Tanguay, S, Aprikian, A, Carli, F, Kassouf, W
European urology focus. 2021;(1):132-138
Abstract
BACKGROUND In patients with bladder cancer, poor functional status has remarkable deleterious effects on postoperative outcome and prognosis. Conditioning intervention initiated before surgery has the potential to reduce functional decline attributable to surgery. Nonetheless, evidence is lacking in patients undergoing radical cystectomy. OBJECTIVE To determine whether a preoperative multimodal intervention (prehabilitation) is feasible and effective in radical cystectomy. DESIGN, SETTING, AND PARTICIPANTS This study, conducted at an academic tertiary health care institution, enrolled adult patients scheduled for radical cystectomy. From August 2013 to October 2017, 70 patients were randomized: 35 to multimodal prehabilitation (prehab group) and 35 to standard care (control group). INTERVENTION Multimodal prehabilitation was a preoperative conditioning intervention including aerobic and resistance exercise, diet therapy, and relaxation techniques. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Primary outcome was perioperative change in functional capacity, measured with the distance covered during a 6-min walk test (6MWD), assessed at baseline, before surgery, and at 4 and 8 wk after surgery. Data were compared using robust mixed linear models for repeated measures. RESULTS AND LIMITATIONS Preoperative change in 6MWD compared with baseline was not significantly different between groups (prehab group 40.8 [114.0] m vs control group 9.7 (108.4) m, p=0.250). However, at 4 wk after surgery, a significant difference in functional capacity was detected (6MWD, prehab group -15.4 [142.5] m vs control group -97.9 [123.8] m, p=0.014). No intervention-related adverse effects were reported. CONCLUSIONS Data suggested that multimodal prehabilitation resulted in faster functional recovery after radical cystectomy. PATIENT SUMMARY After major cancer surgery, people usually feel week and tired, and have less energy to perform activities of daily living. In this study, we showed that using the time before surgery to promote exercise and good nutrition could fasten recovery after the surgical removal of the bladder.
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Enhanced recovery after surgery (ERAS) protocols in patients undergoing radical cystectomy with ileal urinary diversions: A randomized controlled trial.
Vlad, O, Catalin, B, Mihai, H, Adrian, P, Manuela, O, Gener, I, Ioanel, S
Medicine. 2020;(27):e20902
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Abstract
BACKGROUND Enhanced Recovery After Surgery (ERAS) protocols were introduced in clinical practice to reduce complication rates and hospital stay. We performed a randomized controlled single center study to evaluate perioperative benefits of an adapted ERAS protocol in patients with bladder cancer who underwent radical cystectomy (RC) and ileal urinary diversions (IUD). MATERIALS AND METHODS Forty five from 90 consecutive randomized patients were enrolled in an adapted ERAS protocol. Length of stay, diet issues, return of bowel function, readmission rates and complications were examined. RESULTS Among patients following ERAS protocol, we found a significant reduction in time to first flatus (1 vs 5 days, P < .001), time to first stool (2 vs 5 days, P < .001), time to normal diet (5 vs 6 days, P < .001) and length of stay (16 vs 18 days, P < .001). Also, postoperative ileus at less than 4 days was lower than in non-ERAS patients (15.6% vs 24.4%), but with a marginal trend toward significance (P = .05). Readmission rate was lower in the ERAS group, but the difference did not reach statistical significance. We also found a lower readmission and complication rate in patients with ERAS protocol (6.6% vs 11.1%, P = .23 and 46.6% vs 57.5%, P = .29, respectively). CONCLUSIONS Implementation of ERAS protocol for patients undergoing RC in our center was associated with a significant reduction in the time to the first flatus, time to the first stool, time to a normal diet, length of hospital stay.
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The role of Protopine associated with Nuciferine in controlling adverse events during hyperthermic intravesical chemotherapy instillations. A nutraceutical approach to control adverse event during intravesical instillations.
Chiancone, F, Carrino, M, Fedelini, M, Fabiano, M, Persico, F, Meccariello, C, Fedelini, P
Archivio italiano di urologia, andrologia : organo ufficiale [di] Societa italiana di ecografia urologica e nefrologica. 2020;(3)
Abstract
OBJECTIVES The aim of this study was to analyse the role of two alkaloid, Protopine and Nuciferine, in the prevention and the treatment of the low and mild grade adverse events related to the use of HIVEC® (Hyperthermic IntraVEsical Chemotherapy) instillations. MATERIALS AND METHODS From September 2017 to September 2019, 100 patients were prospectively randomized into two groups: Group A = Protopine and Nuciferine syrup, 10 ml, once a day, for 8 weeks; Group B = placebo (flavoured coloured water), 10 ml, once a day, for 8 weeks. The primary endpoint was the evaluation of the efficacy of the therapy with Protopine and Nuciferine in controlling of the irritative symptoms. The secondary endpoint was the evaluation of the influences of the treatment on the uroflowmetric parameters. RESULTS The patients of Group A showed a better International Prostatic Symptoms Score (IPSS) score, a better control of urgency symptoms (PPIUS) and tolerate well the pain (VAS score). The treatment doesn't modify Uroflow-Qmax and seems to improve the Uroflow-Voided Volume (ml) without influencing the Uroflow-Post Void Residual volume (PVR). Moreover, the treatment with Protopine and Nuciferine has been proven to be effective in the treatment of overactive bladder (OAB) symptoms. Patients' evaluation of the two different treatments assessed with Patient Global Impression of Improvement questionnaire (PGI-I), demonstrated improvements in the Group A, while the Group B showed a lower satisfaction. CONCLUSIONS Protopine and Nuciferine can be interesting nutraceutical compounds useful to control irritative and pain related symptoms of intravesical chemo/immunotherapy.
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Enhanced recovery after surgery for radical cystectomy with ileal urinary diversion: a multi-institutional, randomized, controlled trial from the Chinese bladder cancer consortium.
Lin, T, Li, K, Liu, H, Xue, X, Xu, N, Wei, Y, Chen, Z, Zhou, X, Qi, L, He, W, et al
World journal of urology. 2018;(1):41-50
Abstract
PURPOSE Enhanced recovery after surgery (ERAS) has played an important role in recovery management for radical cystectomy with ileal urinary diversion (RC-IUD). This study is to evaluate ERAS compared with the conventional recovery after surgery (CRAS) for RC-IUD. METHODS From October 2014 and July 2016, bladder cancer patients scheduled for curative treatment from 25 centers of Chinese Bladder Cancer Consortium were randomly assigned to either ERAS or CRAS group. Primary endpoint was the 30-day complication rate. Secondary endpoints included recovery of fluid and regular diet, flatus, bowel movement, ambulation, and length of stay (LOS) postoperatively. Follow-up period was 30-day postoperatively. RESULTS There were 144 ERAS and 145 CRAS patients. Postoperative complications occurred in 25.7 and 30.3% of the ERAS and CRAS patients with 55 complications in each group, respectively (p = 0.40). There was no significant difference between groups in major complications (p = 0.82), or type of complications (p = 0.99). The ERAS group had faster recovery of bowel movements (median 88 versus 100 h, p = 0.01), fluid diet tolerance (68 versus 96 h, p < 0.001), regular diet tolerance (125 versus 168 h, p = 0.004), and ambulation (64 versus 72 h, p = 0.047) than the CRAS group, but similar time to flatus and LOS. CONCLUSIONS ERAS did not increase 30-day complications compared with CRAS after RC. ERAS may be better than CRAS in terms of bowel movement, tolerance of fluid and regular diet, and ambulation.
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Perioperative Immunonutrition Modulates Inflammatory Response after Radical Cystectomy: Results of a Pilot Randomized Controlled Clinical Trial.
Hamilton-Reeves, JM, Stanley, A, Bechtel, MD, Yankee, TM, Chalise, P, Hand, LK, Lee, EK, Smelser, W, Mirza, M, Wyre, H, et al
The Journal of urology. 2018;(2):292-301
Abstract
PURPOSE Poor preoperative nutritional status is associated with a higher complication rate after radical cystectomy in patients with bladder cancer. Given the short interval between diagnosis and radical cystectomy, we compared the effect of short-term specialized immunonutrition to that of a standard oral nutritional supplement on the acute inflammatory response and arginine status in patients treated with radical cystectomy. MATERIALS AND METHODS In this prospective, randomized study in 29 men 14 received specialized immunonutrition and 15 received oral nutritional supplement. Each group drank 3 cartons per day for 5 days before and 5 days after radical cystectomy. The Th1-Th2 balance, plasma interleukin-6 and plasma amino acids were measured at baseline, intraoperatively and on postoperative days 2, 14 and 30. Body composition was measured by dual energy x-ray absorptiometry at baseline and on postoperative days 14 and 30. Differences in outcomes were assessed using the generalized linear mixed model. RESULTS In the specialized immunonutrition group there was a 54.3% average increase in the Th1-Th2 balance according to the tumor necrosis factor-α-to-interleukin-13 ratio from baseline to intraoperative day, representing a shift toward a Th1 response. In the oral nutritional supplement group the Th1-Th2 balance decreased 4.8%. The change in the Th1-Th2 balance between the specialized immunonutrition and oral nutritional supplement groups significantly differed (p <0.027). Plasma interleukin-6 was 42.8% lower in the specialized immunonutrition group compared to the oral nutritional supplement group on postoperative day 2 (p = 0.020). In the specialized immunonutrition group plasma arginine was maintained from baseline to postoperative day 2 and yet the oral nutritional supplement group showed a 26.3% reduction from baseline to postoperative day 2 (p = 0.0003). The change in appendicular muscle loss between the groups was not statistically significant. CONCLUSIONS Th1-to-Th2 ratios, peak interleukin-6 levels and plasma arginine suggest that consuming specialized immunonutrition counteracts the disrupted T-helper balance, lowers the inflammatory response and prevents arginine depletion due to radical cystectomy.
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Oncological and functional outcomes of postoperative total parenteral nutrition after radical cystectomy in bladder cancer patients: A single-center randomized trial.
Vidal, A, Arnold, N, Vartolomei, MD, Kiss, B, Burkhard, F, Thalmann, GN, Roth, B
International journal of urology : official journal of the Japanese Urological Association. 2016;(12):992-999
Abstract
OBJECTIVES To prospectively evaluate the long-term oncological and functional outcomes of postoperative total parenteral nutrition after radical cystectomy. METHODS A total of 157 consecutive patients (≤cT3, cN0, cM0) who underwent extended pelvic lymph node dissection, radical cystectomy and ileal urinary diversion from September 2008 to March 2011 at a single center were randomized to receive either postoperative total parenteral nutrition (group A; n = 74) or oral nutrition alone (group B; n = 83). All but two patients in group B (who were thus excluded from further analysis) had regular postoperative follow up at the Department of Urology, University of Bern, Switzerland. Computed tomography and bone scan were carried out to assess local recurrences and distal metastases. We used validated questionnaires to evaluate bowel function, sexual function and quality of life, and an institutional questionnaire to evaluate neobladder function. RESULTS The median follow up was 50 months (IQR 21-62). The rate of local recurrences (4/74 [5.4%] in group A; 4/81 [4.9%] in group B; P = 0.9) and the rate of distant metastases (23/74 [31%] in group A; 23/81 [28%] in group B; P = 0.72) did not differ between the two groups. There was no difference in cancer-specific (P = 0.86) and overall survival (P = 0.85). Group B patients had significantly better bowel function at 3 months (P = 0.03) and 12 months (P = 0.01). There was no difference in terms of quality of life, and sexual and neobladder function. CONCLUSIONS The administration of total parenteral nutrition after radical cystectomy does not impair long-term oncological outcomes. It does, however, negatively influence long-term bowel function.
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Comparing the treatment outcomes of potassium-titanyl-phosphate laser vaporization and transurethral electroresection for primary nonmuscle-invasive bladder cancer: A prospective, randomized study.
Xu, Y, Guan, W, Chen, W, Xie, C, Ouyang, Y, Wu, Y, Liu, C
Lasers in surgery and medicine. 2015;(4):306-11
Abstract
BACKGROUND AND OBJECTIVES In urology, potassium-titanyl-phosphate (KTP) laser is mainly used in the treatment of benign prostatic hyperplasia with a low rate of intraoperative and postoperative complications. A prospective, randomized study was undertaken to investigate the treatment outcomes of KTP laser vaporization for primary non-muscle-invasive bladder tumors (NMIBTs) as compared with conventional monopolar transurethral resection of bladder tumors (TURBT). MATERIALS AND METHODS This study was designed as a prospective, randomized trial. After institutional review board approval, 229 consecutive patients with NMIBTs were randomized to 2 groups. Among them, 116 patients underwent KTP laser vaporization of a bladder tumor (laser group) and 113 patients underwent standard transurethral electroresection of the bladder tumors using monopolar loop electrode (TURBT group). According to the prognostic factors for recurrence, all patients were divided into low, intermediate or high risk subgroups. The clinical data were recorded and compared between the two groups. RESULTS Eighty-nine patients in laser group and 94 in TURBT group were evaluable for the study end points. The preoperative characteristics of the patients were comparable in the two groups. There was no statistical difference in operation time between the two groups. Patients in the laser group had fewer perioperative complications and more patients needed bladder irrigation in the TURBT group. Compared with laser group, patients in the TURBT group had longer catheterization time and hospitalization duration. There were no statistical differences in the oncologic results in term of 2-year recurrence rates as compared between the two groups. CONCLUSIONS Our study demonstrated that using KTP laser, transurethral vaporization is an effective and safe treatment for the patients with primary NMIBT. Compared with traditional TURBT, the KTP laser surgery had fewer perioperative complications and similar oncological results.
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Perioperative use of crystalloids in patients undergoing open radical cystectomy: balanced Ringer's maleate versus a glucose 5%/potassium-based balanced solution: study protocol for a randomized controlled trial.
Löffel, LM, Kleeb, B, Burkhard, FC, Wuethrich, PY
Trials. 2014;:276
Abstract
BACKGROUND The optimal crystalloid solution to use perioperatively in patients undergoing open radical cystectomy remains unclear. Many of the fluids used for intravenous hydration contain supraphysiologic concentrations of chloride, which can induce hyperchloremia and metabolic acidosis, resulting in renal vasoconstriction and decreased renal function. In addition, patients receiving less fluid and less sodium show faster recovery of gastrointestinal (GI) function after colonic surgery. METHODS AND DESIGN This is an investigator-initiated, single-center, randomized, controlled, parallel group trial with assessor-blinded outcome assessment, in the Department of Urology, University Hospital Bern, Switzerland. The study will involve 44 patients with bladder cancer scheduled for radical cystectomy and urinary diversion. The primary outcome is the duration between the end of surgery and the return of the GI function (first defecation). Secondary outcomes are fluid balance (body weight difference postoperatively versus preoperatively) and the incidence of kidney function disorders according to the Risk-Injury-Failure-Loss-End Stage Renal Disease (RIFLE classification). An equal number of patients are allocated to receive Ringerfundin® solution or a glucose/potassium-based balanced crystalloid solution as baseline infusion during the entire time that intravenous administration of fluid is necessary during the perioperative period. The randomized crystalloid solution is infused at a rate of 1 ml/kg/h until the bladder has been removed, followed by 3 ml/kg/h until the end of surgery. Postoperative hydration is identical in both groups and consists of 1,500 ml of the randomized crystalloid solution per 24 hours. Postoperative patient care is identical in both groups; patients are allowed to drink clear fluids immediately after surgery, and liquid diet is started on postoperative day 1, as well as active mobilization and the use of chewing gum. Body weight is measured daily in the morning. Time of first flatus and first defecation are recorded. DISCUSSION This trial assesses the benefits and harms of two different balanced crystalloid solutions for perioperative fluid management in patients undergoing open radical cystectomy with urinary diversion, with regard to return of GI function and effects on postoperative renal function. TRIAL REGISTRATION Current Controlled Trials ISRCTN32976792 (registered on November 21 2013).
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Intraoperative continuous norepinephrine infusion combined with restrictive deferred hydration significantly reduces the need for blood transfusion in patients undergoing open radical cystectomy: results of a prospective randomised trial.
Wuethrich, PY, Studer, UE, Thalmann, GN, Burkhard, FC
European urology. 2014;(2):352-60
Abstract
BACKGROUND Open radical cystectomy (ORC) is associated with substantial blood loss and a high incidence of perioperative blood transfusions. Strategies to reduce blood loss and blood transfusion are warranted. OBJECTIVE To determine whether continuous norepinephrine administration combined with intraoperative restrictive hydration with Ringer's maleate solution can reduce blood loss and the need for blood transfusion. DESIGN, SETTING, AND PARTICIPANTS This was a double-blind, randomised, parallel-group, single-centre trial including 166 consecutive patients undergoing ORC with urinary diversion (UD). Exclusion criteria were severe hepatic or renal dysfunction, congestive heart failure, and contraindications to epidural analgesia. INTERVENTION Patients were randomly allocated to continuous norepinephrine administration starting with 2 μg/kg per hour combined with 1 ml/kg per hour until the bladder was removed, then to 3 ml/kg per hour of Ringer's maleate solution (norepinephrine/low-volume group) or 6 ml/kg per hour of Ringer's maleate solution throughout surgery (control group). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Intraoperative blood loss and the percentage of patients requiring blood transfusions perioperatively were assessed. Data were analysed using nonparametric statistical models. RESULTS AND LIMITATIONS Total median blood loss was 800 ml (range: 300-1700) in the norepinephrine/low-volume group versus 1200 ml (range: 400-2800) in the control group (p<0.0001). In the norepinephrine/low-volume group, 27 of 83 patients (33%) required an average of 1.8 U (±0.8) of packed red blood cells (PRBCs). In the control group, 50 of 83 patients (60%) required an average of 2.9 U (±2.1) of PRBCs during hospitalisation (relative risk: 0.54; 95% confidence interval [CI], 0.38-0.77; p=0.0006). The absolute reduction in transfusion rate throughout hospitalisation was 28% (95% CI, 12-45). In this study, surgery was performed by three high-volume surgeons using a standardised technique, so whether these significant results are reproducible in other centres needs to be shown. CONCLUSIONS Continuous norepinephrine administration combined with restrictive hydration significantly reduces intraoperative blood loss, the rate of blood transfusions, and the number of PRBC units required per patient undergoing ORC with UD.
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Parenteral nutrition does not improve postoperative recovery from radical cystectomy: results of a prospective randomised trial.
Roth, B, Birkhäuser, FD, Zehnder, P, Thalmann, GN, Huwyler, M, Burkhard, FC, Studer, UE
European urology. 2013;(3):475-82
Abstract
BACKGROUND After radical cystectomy, patients are in a catabolic state because of postoperative stress response, extensive wound healing, and ileus. OBJECTIVE To evaluate whether recovery can be improved with total parenteral nutrition (TPN) in patients following extended pelvic lymph node dissection (ePLND), cystectomy, and urinary diversion (UD). DESIGN, SETTING, AND PARTICIPANTS We conducted a prospective, randomised, single-centre study of 157 consecutive cystectomy patients. INTERVENTION Seventy-four patients (group A) received TPN during the first 5 postoperative days, with additional oral intake ad libitum. Eighty-three patients (group B) received oral nutrition alone. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS The primary outcome was the occurrence of postoperative complications. Secondary outcomes were time to recovery of bowel function, biochemical nutritional (serum albumin, serum prealbumin, serum total protein) and inflammatory (C-reactive protein) parameters, length of hospital stay, and costs attributed to the TPN. The Pearson χ(2) test was used for dichotomous variables; the Wilcoxon rank sum test was used for continuous variables. RESULTS AND LIMITATIONS Postoperative complications occurred in 51 patients (69%) in group A and in 41 patients (49%) in group B (p=0.013), a difference resulting from group A having more infectious complications than group B (32% vs 11%; p=0.001). Serum prealbumin and serum total protein were significantly lower in group B on postoperative day 7 but not on postoperative day 12. Time to gastrointestinal recovery and length of hospital stay did not differ between the two groups. The costs for TPN were €614 per patient. A potential limitation is the use of a glucose-based parenteral nutrition without lipids. CONCLUSIONS Postoperative TPN is associated with a higher incidence of complications, mainly infections, and higher costs following ePLND, cystectomy, and UD versus oral nutrition alone.