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Article of the Week: Quality Improvement in Cystectomy Care with Enhanced Recovery (QUICCER) study

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Every Week the Editor-in-Chief selects an Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

If you only have time to read one article this week, it should be this one.

Quality Improvement in Cystectomy Care with Enhanced Recovery (QUICCER) study

Janet E. Baack Kukreja*, Maureen Kiernan*, Bethany Schempp†, Aisha Siebert, Adriana Hontar*, Benjamin Nelson*, James Dolan§, Katia Noyes, Ann Dozier, Ahmed Ghazi*, Hani H. Rashid*, Guan Wu* and Edward M. Messing*

 

*Department of Urology, Strong Memorial Hospital University of Rochester Medical Center, †School of Nursing, ‡School of Medicine and Dentistry, University of Rochester Medical Center, §Department of Public Health Sciences, and Department of Surgery, Strong Memorial Hospital University of Rochester Medical Center, Rochester, NY, USA

 

Read the full article

Objectives

To determine if patients managed with a cystectomy enhanced recovery pathway (CERP) have improved quality of care after radical cystectomy (RC), as defined by a decrease in length of hospital stay (LOS) without an increase in complications or readmissions compared with those not managed with CERP.

Subjects and Methods

The Quality Improvement in Cystectomy Care with Enhanced Recovery (QUICCER) study was a non-randomized quasi-experimental study. Data were collected between June 2011 and April 2015. The CERP was implemented in July 2013. The primary endpoint was LOS. Secondary endpoints were quality scores, complications and readmissions. Multivariable regression was performed. Propensity score matching was carried out to further simulate randomized clinical trial conditions. A CERP quality composite score was created and evaluated with regard to adherence to CERP elements.

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Results

The study included 79 patients managed with CERP and 121 who were not managed with CERP. After matching, there were 75 patients in the non-CERP group. The LOS was significantly different between the groups: the median LOS was 5 and 8 days for the CERP and non-CERP group, respectively (P < 0.001). Multivariable linear regression showed that any complication was the most significant predictor of total LOS at 90 days after RC. The higher the quality composite score the shorter the LOS (P < 0.001). There was no association between CERP and a greater number of complications or readmissions.

Conclusions

Audited quality measures in the CERP are associated with a reduction in LOS with no increase in readmissions or complications. The CERP is important for the future improvement of peri-operative care for RC and provides an opportunity to improve the quality of care provided.

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Editorial: Quality improvement in cystectomy care with enhanced recovery (QUICCER) study

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Enhanced recovery after surgery (ERAS) is a multidisciplinary, multi-element care pathway approach that aims to standardise and improve perioperative management. Since the first publication on ERAS for radical cystectomy in the BJUI in 2008, the literature on this important factor in postoperative management of patients undergoing major surgery in the field of urology is rather scarce and mainly in form of reviews [1]. This clearly reflects the very slow adoption of this approach, the reasons for which remain unclear.

Baack Kukreja et al. [2] in this issue of BJUI performed an analysis of sequential patients, before and after introduction of an ERAS protocol in their institution, using a propensity matched approach. The length of stay (LOS) could be reduced significantly from 8 to 5 days without increasing the rate of complications or increasing the number of readmissions or emergency department visits. The rate of readmissions is comparable to other published reported series. The difference in LOS of 3 days with an ERAS approach is impressive. However, the parameter of LOS has to be interpreted in the context of the medical system of each country in itself, as many factors may influence this parameter. The data presented indicates that there was no biased drive to discharge patients earlier in the study context.

The ERAS programme presented here included preoperative counselling and intra- and postoperative precautions and interventions. Preoperative counselling focused on information on surgery and the handling of the stoma if needed. Patients were assessed for medical and socioeconomic factors that might have an influence on anaesthesia/surgery outcome, recovery, and management after discharge. As foreseen by ERAS, patients received probiotics and preoperative carbohydrate loading [3, 4].

Apart from the LOS, one of the major findings of this study [2] was a distinct decrease in gastrointestinal complications, such as ileus, which is not surprising as this is one of the declared goals of ERAS, which was first introduced in colorectal surgery.

The reported decrease of myocardial infarction is another interesting finding. There is no difference in American Society of Anesthesiologists score between the two groups. However, there is a tendency to more blood transfusions in the cystectomy enhanced-recovery pathway group in the study. The current debate on whether blood transfusions may have a negative effect on oncological outcomes might have an influence on this eventually. Astonishingly, fluid management was not different between the two groups despite the declared goal to avoid salt and water overload. The use of pulse pressure variation or an oesophageal Doppler probe to guide fluid management might be complemented by restrictive deferred hydration combined with preemptive noradrenaline infusion [5, 6].

After discharge patients did not require home i.v. fluid administration and were able to drink at least 1 L. They did not require more support at home than the control group.

The authors are to be complemented for implementing an ERAS protocol and evaluating the effect in a scientific manner. Some of the findings are confirmatory of other studies, some are novel and worthy of further analysis, while others suggest a potential for further improvement. The results of this study [2] clearly indicate the usefulness and validity of an ERAS protocol and the need to implement and further develop such an ERAS approach in everyday urological practice.

Read the full article
George N. Thalmann
Department of Urology, University Hospital, Inselspital, Bern, Switzerland

 

References

 

1 Arumainayagam N, McGrath J, Jefferson KP, Gillatt DA. Introduction of an enhanced recovery protocol for radical cystectomy. BJU Int 2008; 101: 698–701

 

2 Baack Kukreja JE, Kiernan M, Schempp B et al. Quality Improvement in Cystectomy Care with Enhanced Recovery (QUICCER) study. BJU Int 2017; 119: 38–49

 

3 Wind J, Polle SW, Fung Kon Jin PH et al. Systematic review of enhanced recovery programmes in colonic surgery. Br J Surg 2006; 93: 800–9

 

4 Fearon KC, Ljungqvist O, Von Meyenfeldt M et al. Enhanced recovery after surgery: a consensus review of clinical care for patients undergoing colonic resection. Clin Nutr 2005; 24: 466–77

 

5 Wuethrich PY, Studer UE, Thalmann GN, Burkhard FC. 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. Eur Urol 2014; 66: 352–60

 

6 WuethrichPY, Burkhard FC, Thalmann GN, Stueber F, Studer UE. Restrictive deferred hydration comb ined with preemptive norepinephrine infusio n during radical cystectomy reduces postoperative complications and hospitalization time: a randomized clinical trial. Anesthesiology 2014; 120: 365–77

 

Radical cystectomy for bladder cancer – is there a changing trend?

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The first #urojc instalment of 2015 discussed the recent European Urology paper ‘Trends in operative caseload and mortality rates after radical cystectomy (RC) for bladder cancer in England for 1998-2010’. Hounsome et al., examined a total of 16,033 patients who underwent RC – over the study period 30-day and 90-day mortality rates decreased and 30-day, 90-day, 1-year and 5-year survival rates significantly improved.

Henry Woo (@DrHWoo) suggests this paper is breaking the mould in comparison to other series.

Analysis of the SEER database would suggest otherwise – there has been little or no change in the incidence, survival or mortality rates with respect to bladder cancer over an even longer study period (1973-2009). Likewise, Zehnder noticed no survival improvement in patients undergoing RC over the last three decades (1980-2005).

However, Jim Catto (@JimCatto) and Alexander Kutikov (@uretericbud) were quick to point out the differences between survival rates and mortality rates, although Hounsome et al., reported beneficial outcomes in both parameters.

 

 

 

 

 

 

 

 

In the UK, the Improving Outcomes in Urological Cancers guidance (IOG) recommends patients be considered for RC for muscle invasive bladder cancer (MIBC) and high risk recurrent non-muscle invasive bladder cancer (NMIBC). Key aspects of this guidance include – a minimum caseload requirement for performing RC, an MDT approach and specific 30day mortality rates of 50% despite no change in the incidence of bladder cancer. The reasoning for this is multifactorial but in part due to designated cancer centres are offering surgery to more candidates as a result of service improvements that include service reconfiguration, improved surgical training, neoadjuvant chemotherapy, enhanced recovery principles, and continued improvements in peri-operative care.

The on-line debate moved towards discussing the effect of centralisation of cancer services as a causative factor behind these positive results.

Rather intuitively, in a systematic review in 2011, Goossens-Laan et al., postoperative mortality after cystectomy is significantly inversely associated with high-volume providers.

Although the benefits of being treated in a cancer centre of excellence are undoubted- high volume fellowship trained surgeons, a multidisciplinary approach and improved peri-operative conditions; the impact of distance from central services was broached. O’Kelly et al., postulated a higher stage of prostate cancer based on distance from a tertiary care centre, other studies have shown for a variety of cancers (lung, colon)that distance from a central provider can impact outcomes. Outside of the impact on oncological outcomes, the impact on the patient’s lifestyle as well as the economic consequences were not discussed.

While contrary to this, Jim Catto (@JimCatto) highlighted the deskilling associated with centralisation.

 

 

 

 

 

A further significant implicating factor in the positive results seen in this study is due to the use of neo-adjuvant chemotherapy, a question often posed by the patient.

Rather contentiously, David Chan (@dytcmd) remarked that optimal surgical results have already been achieved, a statement challenged by Jim Catto (@JimCatto).

This study although examining a vast number of patients over a lengthy time period is not without its limitations. Specifically the lack of tumour stage, smoking status and the use of chemotherapy as well as issues surrounding a retrospective study looking at data collected by individual hospital coding systems.

This month’s #urojc attracted substantial coverage on Twitter – keep it up.

Many thanks to those you participated in the debate. We look forward to next month’s #urojc discussion.

Greg Nason (@nason_greg) is a Specialist Registrar in Urology, Beaumont Hospital, Dublin, Ireland

 

Article of the Month: Comparing health-related QoL outcomes for robotic cystectomy with those of traditional open radical cystectomy

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Every week the Editor-in-Chief selects the Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

Finally, the third post under the Article of the Week heading on the homepage will consist of additional material or media. This week we feature a video from Dr. Dipen Parekh discussing his paper. 

If you only have time to read one article this week, it should be this one.

Health-related quality of life from a prospective randomised clinical trial of robot-assisted laparoscopic vs open radical cystectomy

Jamie C. Messer, Sanoj Punnen*, John Fitzgerald, Robert Svatek and Dipen J. Parekh

Department of Urology, University of Texas Health Sciences Center at San Antonio, San Antonio, TX and *Department of Urology, Miller School of Medicine, University of Miami, Miami, FL, USA

Read the full article

Objective

To compare health-related quality-of-life (HRQoL) outcomes for robot-assisted laparoscopic radical cystectomy (RARC) with those of traditional open radical cystectomy (ORC) in a prospective randomised fashion.

Patients and Methods

This was a prospective randomised clinical trial evaluating the HRQoL for ORC vs RARC in consecutive patients from July 2009 to June 2011. We administered the Functional Assessment of Cancer Therapy–Vanderbilt Cystectomy Index questionnaire, validated to assess HRQoL, preoperatively and then at 3, 6, 9 and 12 months postoperatively. Scores for each domain and total scores were compared in terms of deviation from preoperative values for both the RARC and the ORC cohorts. Multivariate linear regression was used to assess the association between the type of radical cystectomy and HRQoL.

Results

At the time of the study, 47 patients had met the inclusion criteria, with 40 patients being randomised for analysis. The cohorts consisted of 20 patients undergoing ORC and 20 undergoing RARC, who were balanced with respect to baseline demographic and clinical features. Univariate analysis showed a return to baseline scores at 3 months postoperatively in all measured domains with no statistically significant difference among the various domains between the RARC and the ORC cohorts. Multivariate analysis showed no difference in HRQoL between the two approaches in any of the various domains, with the exception of a slightly higher physical well-being score in the RARC group at 6 months.

Conclusions

There were no significant differences in the HRQoL outcomes between ORC and RARC, with a return of quality of life scores to baseline scores 3 months after radical cystectomy in both cohorts.

Read more articles of the week

Editorial: Robotic and conventional open radical cystectomy lead to similar postoperative health-related quality of life

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In this month’s issue of BJU International, Messer et al. [1] devise a prospective randomised trial to compare postoperative health-related quality of life (HRQoL) after robot-assisted (RARC) vs conventional open radical cystectomy (ORC). The investigators evaluated 40 patients over a follow-up period of 1 year and found no significant difference in HRQoL between surgical approaches. Moreover, they showed that the postoperative decrease in HRQoL returns to baseline within 3 months of surgery.

RC is one of the most challenging and potentially mutilating surgical interventions in the urological field and represents the standard-of-care treatment for patients with muscle-invasive bladder cancer. It is associated with a non-negligible risk of morbidity and mortality [2]. With the advent of new technologies, such as the Da Vinci surgical robot, carefully designed studies are needed to weigh the potential benefits of a novel approach against the increased costs associated with such tools. While RARC holds the promise of combining the benefits of a minimally invasive intervention with the precise robotic translation of the surgeon’s movements, these claims remain to be definitely proven in the clinical setting. As such, further elucidating the effect of surgical approach on perioperative outcomes after RC is essential for treatment planning, patient counselling and informed decision-making before surgery.

QoL is increasingly used as a quantitative measure of treatment success [3, 4]. These measures are gaining considerable traction in the USA, as reimbursements will soon be tied to patient satisfaction. While previous retrospective studies suggest that RARC has comparable perioperative oncological outcomes with potentially lower morbidity relative to ORC [5], there is a scarcity of high-quality evidence on HRQoL outcomes of RARC vs ORC. The difficulties of conducting randomised trials in the surgical setting are reflected by the relatively few participants in the Messer et al. [1] trial. Nonetheless, in their pilot study, the authors demonstrated the feasibility of a HRQoL trial in RC patients. Furthermore, they deliver initial evidence on the impact of surgical approach on HRQoL after RC.

From a clinical perspective, the authors contribute interesting findings to the ongoing debate. Their results suggest that the potential benefits of robot-assisted surgery on HRQoL may be limited in patients undergoing complex oncological surgery such as RC. Several hypotheses may be pertinent to their conclusions. For example, performing an open urinary diversion after RARC that can take as much time as the actual extirpative RC may mitigate any potential benefit of the minimally invasive approach. Furthermore, the study findings may be largely influenced by the surgical skills of the participating surgeons. Maybe the correct interpretation of their study findings is that there was no significant difference in HRQoL outcomes between ORC and RARC, at the institution where the trial was performed.

Nonetheless, the authors suitably demonstrate the feasibility of performing a randomised trial in this field and pave the way towards adequately powered, randomised multicentre trials that can provide further evidence on what impact RARC may have on perioperative outcomes and beyond.

Read the full article

Julian Hanske, Florian Roghmann, Joachim Noldus and Quoc-Dien Trinh*

Department of Urology, Marien Hospital, Ruhr-University Bochum, Herne, Germany, and *Division of Urologic Surgery and Center for Surgery and Public Health, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA

References

1 Messer JC, Punnen S, Fitzgerald J, Svatek R, Parekh DJ. Health-related quality of life from a prospective randomised clinical trial of robot-assisted laparoscopic vs open radical cystectomy. BJU Int 2014; 114: 896–902

2 Roghmann F, Trinh QD, Braun K et al. Standardized assessment of complications in a contemporary series of European patients undergoing radical cystectomy. Int J Urol 2014; 21: 143–9

3 Cookson MS, Dutta SC, Chang SS, Clark T, Smith JA Jr, Wells N. Health related quality of life in patients treated with radical cystectomy and urinary diversion for urothelial carcinoma of the bladder: development and validation of a new disease specific questionnaire. J Urol 2003; 170: 1926–30

4 Loppenberg B, von Bodman C, Brock M, Roghmann F, Noldus J, Palisaar RJ. Effect of perioperative complications and functional outcomes on health-related quality of life after radical prostatectomy. Qual Life Res 2014. doi: 10.1007/s11136-014-0729-1

5 Kader AK, Richards KA, Krane LS, Pettus JA, Smith JJ, Hemal AK. Robot-assisted laparoscopic vs open radical cystectomy: comparison of complications and periopera

 

Video: Robot-assisted laparoscopic vs open radical cystectomy – health-related QoL from a prospective randomised clinical trial

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Health-related quality of life from a prospective randomised clinical trial of robot-assisted laparoscopic vs open radical cystectomy

Jamie C. Messer, Sanoj Punnen*, John Fitzgerald, Robert Svatek and Dipen J. Parekh

Department of Urology, University of Texas Health Sciences Center at San Antonio, San Antonio, TX and *Department of Urology, Miller School of Medicine, University of Miami, Miami, FL, USA

Read the full article

Objective

To compare health-related quality-of-life (HRQoL) outcomes for robot-assisted laparoscopic radical cystectomy (RARC) with those of traditional open radical cystectomy (ORC) in a prospective randomised fashion.

Patients and Methods

This was a prospective randomised clinical trial evaluating the HRQoL for ORC vs RARC in consecutive patients from July 2009 to June 2011. We administered the Functional Assessment of Cancer Therapy–Vanderbilt Cystectomy Index questionnaire, validated to assess HRQoL, preoperatively and then at 3, 6, 9 and 12 months postoperatively. Scores for each domain and total scores were compared in terms of deviation from preoperative values for both the RARC and the ORC cohorts. Multivariate linear regression was used to assess the association between the type of radical cystectomy and HRQoL.

Results

At the time of the study, 47 patients had met the inclusion criteria, with 40 patients being randomised for analysis. The cohorts consisted of 20 patients undergoing ORC and 20 undergoing RARC, who were balanced with respect to baseline demographic and clinical features. Univariate analysis showed a return to baseline scores at 3 months postoperatively in all measured domains with no statistically significant difference among the various domains between the RARC and the ORC cohorts. Multivariate analysis showed no difference in HRQoL between the two approaches in any of the various domains, with the exception of a slightly higher physical well-being score in the RARC group at 6 months.

Conclusions

There were no significant differences in the HRQoL outcomes between ORC and RARC, with a return of quality of life scores to baseline scores 3 months after radical cystectomy in both cohorts.

Read more articles of the week

Article of the week: Neoadjuvant chemotherapy for bladder cancer does not increase risk of perioperative morbidity

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Every week the Editor-in-Chief selects the Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an accompanying editorial written by prominent members of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

Finally, the third post under the Article of the Week heading on the homepage will consist of additional material or media. This week we feature a video from Angela Smith and David Johnson discussing their paper.

If you only have time to read one article this week, it should be this one.

Neoadjuvant chemotherapy for bladder cancer does not increase risk of perioperative morbidity

David C. Johnson*, Matthew E. Nielsen*†‡, Jonathan Matthews*†, Michael E. Woods*†, Eric M. Wallen*†, Raj S. Pruthi*†, Matthew I. Milowsky*†§ and Angela B. Smith*†

*Department of Urology, University of North Carolina at Chapel Hill, †Lineberger Comprehensive Cancer Center, Cancer Outcomes Research Group, Multidisciplinary Genitourinary Oncology, ‡Department of Epidemiology, Gillings School of Global Public Health, and §Department of Medicine, Division of Hematology/Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA

Read the full article
OBJECTIVE

To determine whether neoadjuvant chemotherapy (NAC) is a predictor of postoperative complications, length of stay (LOS), or operating time after radical cystectomy (RC) for bladder cancer.

PATIENTS AND METHODS

A retrospective review of the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database was performed to identify patients receiving NAC before RC from 2005 to 2011. Bivariable and multivariable analyses were used to determine whether NAC was associated with 30-day perioperative outcomes, e.g. complications, LOS, and operating time.

RESULTS

Of the 878 patients who underwent RC for bladder cancer in our study, 78 (8.9%) received NAC. Excluding those patients who were ineligible for NAC due to renal insufficiency, 78/642 (12.1%) received NAC. In all, 457 of the 878 patients (52.1%) undergoing RC had at least one complication ≤30 days of RC, including 43 of 78 patients (55.1%) who received NAC and 414 of 800 patients (51.8%) who did not (P = 0.58). On multivariable logistic regression, NAC was not a predictor of complications (P = 0.87), re-operation (P = 0.16), wound infection (P = 0.32), or wound dehiscence (P = 0.32). Using multiple linear regression, NAC was not a predictor of increased operating time (P = 0.24), and patients undergoing NAC had a decreased LOS (P = 0.02).

CONCLUSIONS

Our study is the first large multi-institutional analysis specifically comparing complications after RC with and without NAC. Using a nationally validated, prospectively maintained database specifically designed to measure perioperative outcomes, we found no increase in perioperative complications or surgical morbidity with NAC. Considering these findings and the well-established overall survival benefit over surgery alone, efforts are needed to improve the uptake of NAC.

Read more articles of the week

Editorial: Unveiling the surgical risk associated with neoadjuvant chemotherapy in bladder cancer

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In this issue of BJU International, Johnson et al. [1] examine the association between neoadjuvant chemotherapy (NAC) for bladder cancer and 30-day morbidity related to radical cystectomy (RC). Level 1 evidence supports use of cisplatin-based NAC for bladder cancer; a meta-analysis of 11 randomised trials including 3005 patients who received NAC found a 5% absolute increase in 5-year overall survival and a 9% absolute increase in 5-year disease-free survival compared with RC alone [2]. Despite this, recent studies have reported underutilisation of NAC at ≈20% [3], with several reasons proposed for this ‘non-compliance’ to guidelines. A 2013 National Cancer Data Base (NCDB) analysis found that increasing age, lower patient income, and treatment at a non-academic institution (P < 0.01) negatively influenced the receipt of NAC, while higher clinical stage and fewer comorbid conditions were associated with higher likelihood of receiving NAC (P < 0.01) [3].

Another relevant concern is that NAC may increase perioperative complications for RC given the toxicities associated with chemotherapy, advanced age and often high rates of renal and cardiac comorbidities among potential candidates [4]. Credit should be given to Millikan et al. [5] for first negating this fear in 2001 with a randomised trial comparing NAC vs adjuvant chemotherapy in patients with bladder cancer; this study did not find any increase in perioperative morbidity.

The present analysis by Johnson et al. [1] further debunks this misconception in contemporary practice (2005–2011), drawing on the American College of Surgeons National Surgical Quality Improvement Program (NSQIP), which prospectively collects a sample of risk-adjusted validated surgical patient data from >450 participating USA hospitals. The authors show that NAC was not an independent predictor of complications, reoperation, wound infection or dehiscence. The robustness of these findings is reinforced by the shorter adjusted length of stay among patients receiving NAC. Given that scant data exists on this topic, the authors contribute a valuable paper that substantially adds to the literature.

Despite its strengths, the study should be interpreted in light of notable limitations that the authors acknowledge. Many crucial variables are not tracked by the NSQIP and therefore cannot be accounted for, including type of chemotherapy regimen, delay between chemotherapy and surgery, surgical technique (open, laparoscopic, robotic), surgical quality (margins, extent of lymphadenectomy), clinical/pathological stage of bladder cancer, and hospital/surgeon volume. Besides, because RC is a morbid procedure with a mean length of stay of 11 days, 30-day complication rates do not capture its true morbidity as well as 90-day rates. In particular, several common complications, such as postoperative ileus or small bowel obstruction, tend to occur later during the postoperative recovery period. As such, chances are that the event rate is biased downward by the short-term duration of data capture by the NSQIP. This study also cannot fully examine the association of NAC with certain subtypes of complications, including gastrointestinal or bleeding complications, especially when other investigators examining robotic RC have reported a conflicting increase in perioperative complications associated with NAC [6] driven by a 27% rate of gastrointestinal complications, which are not tracked by the NSQIP. Of note, unadjusted rates of transfusion and bleeding events were both higher in the NAC group in the present study.

One of the relevant and heartening observations of the report is the gradual increase in the use of NAC over the study period from 4% of eligible patients to 11%, close to the NCDB estimates of 7.6% in 2006 to 20.9% in 2010 (P < 0.01) [3]. Interestingly, there was an increased probability of any complication in the most recent time period (odds ratio 0.47 for 2005–2009 relative to 2010–2011 in the primary multivariate model, P < 0.001). A plausible explanation is that as physicians have heeded the message to increase usage of NAC, treatment has expanded into a wider population with more comorbidities and therefore a greater propensity for complications. It would have been of interest to address this point by restricting the analyses to the most recent data to see if NAC does indeed predict perioperative complications in the most recent period from 2010 to 2011.

Finally, given the lack of detail available in the NSQIP, other relevant questions could not be addressed. Among them it would be relevant to know if complication rates vary between standard MVAC (methotrexate, vinblastine, doxorubicin and cisplatin) and newer chemotherapy regimens such as dose dense MVAC (DD-MVAC) or gemcitabine plus cisplatin (GC). Similarly, the role of the delay or the elapsed time between chemotherapy and surgery on complications might be helpful in future trial planning.

Additional work still needs to be done to identify prognostic factors for both perioperative complications and long-term outcomes after NAC, so that this valuable therapy can be appropriately provided to the correct patients. Indeed, given the lack of randomised controlled trial data investigating less toxic regimens than MVAC, perhaps NAC is underused because clinicians and patients are underserved by the available data. The authors should be commended for their efforts in deconstructing possible barriers to increased uptake of NAC, a therapy known to confer survival benefits for our patients with bladder cancer.

Joaquim Bellmunt,*† Jeffrey J.Leow‡ and William Martin-Doyle§
*Bladder Cancer Center, Dana-Farber/Brigham and Women’s Cancer Center, Boston, MA, USA; †University Hospital Del Mar-IMIM, Barcelona, Spain; ‡Brigham and Women’s Hospital, Division of Urology and Center for Surgery and Public Health, Boston, MA, USA; §University of Massachusetts Medical School, Worcester, MA, USA

Read the full article

References

  1. Johnson DC, Nielsen ME, Matthews J et al. Neoadjuvant chemotherapy for bladder cancer does not increase risk of perioperative morbidity. BJU Int 2014; 114: 221–228
  2. Bellmunt J, Orsola A, Wiegel T et al. Bladder cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. ESMO Guidelines Working Group. Ann Oncol 2011; 22 (Suppl. 6): 45–49
  3. Zaid HB, Patel SG, Stimson CJ et al. Trends in the utilization of neoadjuvant chemotherapy in muscle-invasive bladder cancer: results from the National Cancer Database. Urology 2014; 83: 75–80
  4. Meeks JJ, Bellmunt J, Bochner BH et al. A systematic review of neoadjuvant and adjuvant chemotherapy for muscle-invasive bladder cancer. Eur Urol 2012; 62: 523–533
  5. Millikan R, Dinney C, Swanson D et al. Integrated therapy for locally advanced bladder cancer: final report of a randomized trial of cystectomy plus adjuvant M-VAC versus cystectomy with both preoperative and postoperative M-VAC. J Clin Oncol 2001; 19: 4005–4013
  6. Johar RS, Hayn MH, Stegemann AP et al. Complications after robot-assisted radical cystectomy: results from the International Robotic Cystectomy Consortium. Eur Urol 2013; 64: 52–57
Read more articles of the week

Video: Time to increase use of multimodal therapy in bladder cancer

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Neoadjuvant chemotherapy for bladder cancer does not increase risk of perioperative morbidity

David C. Johnson*, Matthew E. Nielsen*†‡, Jonathan Matthews*†, Michael E. Woods*†, Eric M. Wallen*†, Raj S. Pruthi*†, Matthew I. Milowsky*†§ and Angela B. Smith*†

*Department of Urology, University of North Carolina at Chapel Hill, †Lineberger Comprehensive Cancer Center, Cancer Outcomes Research Group, Multidisciplinary Genitourinary Oncology, ‡Department of Epidemiology, Gillings School of Global Public Health, and §Department of Medicine, Division of Hematology/Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA

Read the full article
OBJECTIVE

To determine whether neoadjuvant chemotherapy (NAC) is a predictor of postoperative complications, length of stay (LOS), or operating time after radical cystectomy (RC) for bladder cancer.

PATIENTS AND METHODS

A retrospective review of the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database was performed to identify patients receiving NAC before RC from 2005 to 2011. Bivariable and multivariable analyses were used to determine whether NAC was associated with 30-day perioperative outcomes, e.g. complications, LOS, and operating time.

RESULTS

Of the 878 patients who underwent RC for bladder cancer in our study, 78 (8.9%) received NAC. Excluding those patients who were ineligible for NAC due to renal insufficiency, 78/642 (12.1%) received NAC. In all, 457 of the 878 patients (52.1%) undergoing RC had at least one complication ≤30 days of RC, including 43 of 78 patients (55.1%) who received NAC and 414 of 800 patients (51.8%) who did not (P = 0.58). On multivariable logistic regression, NAC was not a predictor of complications (P = 0.87), re-operation (P = 0.16), wound infection (P = 0.32), or wound dehiscence (P = 0.32). Using multiple linear regression, NAC was not a predictor of increased operating time (P = 0.24), and patients undergoing NAC had a decreased LOS (P = 0.02).

CONCLUSIONS

Our study is the first large multi-institutional analysis specifically comparing complications after RC with and without NAC. Using a nationally validated, prospectively maintained database specifically designed to measure perioperative outcomes, we found no increase in perioperative complications or surgical morbidity with NAC. Considering these findings and the well-established overall survival benefit over surgery alone, efforts are needed to improve the uptake of NAC.

Read more articles of the week

Article of the week: Mortality after cystectomy is related to hospital volume

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Every week the Editor-in-Chief selects the Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an accompanying editorial written by prominent members of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

Finally, the third post under the Article of the Week heading on the homepage will consist of additional material or media. This week we feature a video from Dr. Nielsen and Dr. Milowsky discussing their paper.

If you only have time to read one article this week, it should be this one.

Association of hospital volume with conditional 90-day mortality after cystectomy: an analysis of the National Cancer Data Base

Matthew E. Nielsen*†‡, Katherine Mallin§, Mark A. Weaver, Bryan Palis§, Andrew Stewart§, David P. Winchester§ and Matthew I. Milowsky*,**

*University of North Carolina Lineberger Comprehensive Cancer Center, †Department of Urology, and Divisions of General Medicine and Clinical Epidemiology and **Hematology and Oncology, University of North Carolina School Something like this?of Medicine, ‡Department of Epidemiology, University of North Carolina Gillings School of Global Public Health, Chapel Hill, NC, and §American College of Surgeons, National Cancer Data Base, Chicago, IL, USA

This research was presented at the Society of Urologic Oncology 2012 Annual Meeting, 29 November 2012, Bethesda, MD, USA

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OBJECTIVE

To examine the association of hospital volume and 90-day mortality after cystectomy, conditional on survival for 30 days.

PATIENTS AND METHODS

The National Cancer Data Base was used to evaluate 30- and 90-day mortality for 35 055 patients who underwent cystectomy for bladder cancer at one of 1118 hospitals.

Patient data were aggregated into hospital volume categories based on the mean annual number of procedures (low-volume hospital: <10 procedures; intermediate-volume hospital: 10–19 procedures; high-volume hospital: ≥20 procedures).

Associations between mortality and clinical, demographic and hospital characteristics were analysed using hierarchical logistic regression models. To assess the association between hospital volume and 90-day mortality independently of shorter-term mortality, 90-day mortality conditional on 30-day survival was assessed in the multivariate modelling.

RESULTS

Unadjusted 30- and 90-day mortality rates were 2.7 and 7.2% overall, 1.9 and 5.7% among high-volume hospitals, and 3.2 and 8.0% among low-volume hospitals, respectively.

Compared with high-volume hospitals, the adjusted risks among low-volume hospitals (odds ratio [95% CI]) of 30- and 90-day mortality, conditional on having survived for 30 days, from the hierarchical models were 1.5 (1.3–1.9), and 1.2 (1.0–1.4), respectively.

CONCLUSIONS

A low hospital volume was associated with greater 30- and 90-day mortality. These data support the need for further research to better understand the relatively high mortality rates seen between 30 and 90 days, which are high and less variable across hospital volume strata.

The stronger association between volume and 30-day mortality suggests that quality-reporting efforts should focus on shorter-term outcomes.

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