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Keywords:

  • complication;
  • radical cystectomy;
  • morbidity;
  • mortality

Abstract

  1. Top of page
  2. Abstract
  3. Introduction
  4. Patients and Methods
  5. Results
  6. Discussion
  7. Acknowledgements
  8. Conflict of Interest
  9. References

Study Type – Therapy (outcomes)

Level of Evidence 2b

What's known on the subject? and What does the study add?

Radical cystectomy remains associated with comparatively high perioperative morbidity and mortality, despite improvements in surgical techniques and perioperative care. At present, most studies on the complications associated with open radical cystectomy were derived from Western academic high-volume centres, and data from Japan and other Asian countries were very limited.

Using the modified Clavien grading system and 11 category grouping reported from MSKCC, we observed that 68% of patients experienced at least one complication within 90 days of surgery, and 17% of patients experienced major complications (90-day mortality rate = 2%), which were compatible with reports from Western high-volume centres. As far as we know, our report is the largest one regarding perioperative morbidity and mortality in Asian patients who underwent radical cystectomy.

Objective

  • To determine the type, incidence and severity of 90-day morbidity after radical cystectomy in our institution and our affiliated hospitals in accordance with a standard reporting methodology. At present, most studies on complications associated with open radical cystectomy are derived from Western academic high-volume centres and data from Japan and other Asian countries remain very limited.

Patients and Methods

  • The study comprised a retrospective multi-institutional study.
  • The records were reviewed of 928 patients who underwent open radical cystectomy between 1997 and 2010.
  • All complications within 90 days of surgery were categorized into 11 specific categories and graded in accordance with the modified Clavien system.
  • Multivariate regression models were used to determine predictors of complications.

Results

  • At least one complication was observed in 635 (68%) patients and a major (grade 3–5) complication was observed in 156 (17%) patients.
  • The most common complication categories were infectious (30%), gastrointestinal (26%), wound-related (21%) and genitourinary (15%).
  • The 30-day mortality rate was 0.8% and the 90-day mortality rate was 2%.
  • A multivariate regression model showed that previous cardiovascular comorbidity and type of urinary diversion (i.e. ileal conduit or neobladder) were significant factors for any and major complications.

Conclusions

  • Surgical complication-related radical cystectomy is significant and both previous cardiovascular comorbidity and the type of urinary diversion were found to be significant factors for any and major complications.
  • The 90-day mortality rate was 2%, which is compatible with reports from Western high-volume centres.

Abbreviations
ASA

American Society of Anesthesiologists

BMI

body mass index

GC

gemcitabine and cisplatin

MSKCC

Memorial Sloan-Kettering Cancer Center

RC

radical cystectomy

Introduction

  1. Top of page
  2. Abstract
  3. Introduction
  4. Patients and Methods
  5. Results
  6. Discussion
  7. Acknowledgements
  8. Conflict of Interest
  9. References

Radical cystectomy (RC) is associated with comparatively high peri-operative morbidity and mortality, despite improvements in surgical techniques and peri-operative care. The incidence of complications after surgery has been reported to be in the range 30–70% [1-10]. At present, most studies are derived from Western academic high-volume centres and data from Japan and other Asian countries remain limited. In addition, most studies use each stratification methodology when categorizing complications and, as such, it may be difficult to compare the outcome of morbidity among institutions.

Recently, Shabsigh et al. [9] reported complications in RC cases at the Memorial Sloan-Kettering Cancer Center (MSKCC) using the modified Clavien grading system and 11 category grouping, which allows comparison among populations. In the present study, and in accordance with the the standard reporting methods of Shabsigh et al. [9], we reviewed the medical charts of patients who were undergoing RC at Hokkaido University Hospital and our affiliated hospitals, and assessed complications and deaths within 90 days of RC. The present study aimed to determine the type, incidence and severity of 90-day morbidity after RC in one region in Japan. We also explored the predictive factors of these events.

Patients and Methods

  1. Top of page
  2. Abstract
  3. Introduction
  4. Patients and Methods
  5. Results
  6. Discussion
  7. Acknowledgements
  8. Conflict of Interest
  9. References

After obtaining Institutional Review Board Approval, we reviewed the medical records of 928 patients with carcinoma invading bladder muscle or high-grade carcinoma not invading bladder muscle who were treated at Hokkaido University Hospital and our 20 affiliated institutions with the standard surgical approach of RC, pelvic lymphadenectomy and urinary diversion between 1997 and 2010. We collected data with respect to patient characteristics, peri-operative outcomes and all complications within 90 days of surgery. Each complication was then graded in accordance with an established five grade-modification of the Clavien system and grouped into 11 categories as reported by Shabsigh et al. [9]. During the study period, the type of urinary diversion (i.e. ileal conduit, ileal neobladder or cutaneous ureterostomy) was determined based on the consent decision between the patient and the surgeon, and the extent of lymph node dissection was individually determined by each surgeon. Regarding reconstructive methods of cutaneous ureterostomy, the left ureter was mobilized though the peritoneal tunnel in front of the promontrium and a cutaneous stoma was created at the right lower abdominal quadrant site in a double-barreled fashion in a patient with two functioning kidneys. In a patient with a single kidney, a stoma was created on the ipsilateral site.

Regarding peri-operative or postoperative care, we did not follow any strict prospective guidelines. However, during the study period, we actively used intermittent pneumatic compression and/or static graduated compression stockings for prophylaxis of deep vein thrombosis in accordance with a previous study [11] and National Guidelines published in 2004 [12]. Routine prophylactic anticoagulation was not given. In terms of antimicrobial prophylaxis, second-generation cephems were commonly used. Subsequent to 2007, we followed the National Guidelines, where penicillins or first/second-generation cephems were recommended within 3–4 days for bowel-utilizing surgery [13]. In addition, based on the concept of enhanced recovery after surgery protocol [14], we started oral feeding earlier after surgery late in the study period.

Statistical analysis

Univariate logistic regression models were used to identify independent predictive factors of any complications or major complications (grade 3–5). The variables analyzed were sex (man vs woman), age (continuous and ≥70 years vs <70 years), American Society of Anesthesiologists (ASA) score (I vs ≥II), body mass index (BMI) (continuous and <23 kg/m2 vs ≥23 kg/m2), mean annual cystectomy volume (<5 per year vs ≥5 annual volume <10 per year vs ≥10 per year), previous cardiovascular comorbidity (yes vs no), previous surgical history (yes vs no), previous pulmonary comorbidity (yes vs no), previous cerebrovascular comorbidity (yes vs no), organ-confined disease (yes vs no), type of urinary diversion (ileal conduit or neobladdder vs others), operating time (continuous and <400 min vs ≥400 min) and estimated blood loss (continuous and <1300 mL vs ≥1300 mL). Multivariate logistic regression models were performed with only significant factors being judged by univariate analyses. All calculations were performed using Statfex, version 6 (Artech Co. Ltd., Tsurumiku, Osaka, Japan) and JMP, version 6.03 (SAS Institute, Cary, NC, USA). P < 0.05 was considered statistically significant.

Results

  1. Top of page
  2. Abstract
  3. Introduction
  4. Patients and Methods
  5. Results
  6. Discussion
  7. Acknowledgements
  8. Conflict of Interest
  9. References

Patient characteristics

Table 1 shows the summary of patient characteristics. Men accounted for 716 (77%) of patients. The median (range) age at RC was 70 (25–91) years and the median (range) BMI was 23.0 (14.6–35.1) kg/m2. In the present study, hospitals were categorized by the mean number of cystectomies performed per year into high (≥10 per year, moderate (annual volume ≥ 5 and <10) and low (<5 per year). Of the 21 hospitals, only one hospital was in the high-volume category (n = 133), seven hospitals were in the moderate category (n = 408) and 13 hospitals were in the low category (n = 387). Urinary diversion included ileal conduit, cutaneous ureterostomy and ileal neobladder in 493 (53%), 248 (27%) and 175 (19%) patients, respectively. Regarding the type of neobladder, an orthotopic neobladder was constructed in 174 patients and a cutaneous continent diversion was employed in one patient. There were three patients who underwent percutaneous nephrostomy and nine patients did not undergo urinary diversion because they had been on maintenance hemodialysis as a result of chronic renal failure (n = 7) or they received nephroureterectomy at the same time as radical cystectomy, which resulted in an anephric state (n = 2). Median (range) operating time was 393 (100–862) min and median (range) estimated blood loss was 1300 (100–19 500) mL.

Table 1. Patient characteristics
CharacteristicValue
  1. ASA, American Society of Anesthesiologists.

Sex, n (%) 
 Male716 (77)
 Female212 (23)
Age (years), median (range)70 (25–91)
Body mass index (kg/m2) (n = 889), 
 Median (range)23 (14.6–35.1)
Mean annual cystectomy volume, n (number of hospitals) 
High (≥10 per year)133 (1)
 Moderate (5–10 per year )408 (7)
 Low (≤5 per year)387 (13)
ASA score, n (%) 
 I326 (35)
 II460 (50)
 III–IV61 (6)
 Unknown81 (9)
Previous cardiovascular comorbidity, n (%)385 (41)
Previous surgical history, n (%)150 (16)
Previous pulmonary comorbidity, n (%)47 (5)
Previous cerebrovascular comorbidity, n (%)51 (5)
Previous neoadjuvant chemotherapy, n (%)40 (4)
Form of urinary diversion, n (%) 
 Ileal conduit493 (53)
 Neobladder175 (19)
 Cutaneous ureterostomy248 (27)
 Nephrostomy3
 Not performed9
Operating time (min) (n = 905), 
 Median (range)393 (100–862)
Estimated blood loss (mL) (n = 905), 
 Median (range)1300 (100–19 500)
Organ-confined disease (n = 917), n (%)498 (54)
Postoperative hospital stay (days) (n = 906), n (%) 
 Median (range)39 (3–364)

Peri-operative complications

Of 928 patients, 635 (68%) experienced at least one complication within 90 days of surgery. Table 2 provides a summary of complications. The most common complication categories were infectious (30%), gastrointestinal (26%), wound-related (21%) and genitourinary (15%). As outlined in Table 3, major (grade 3–5) and minor complications (grade 1 and 2) occurred in 156 (17%) and 473 (51%) out of 928 patients, respectively. In terms of frequency, surgical site infection (n = 174; 19%), urinary tract infection (n = 200; 22%) or ileus (n = 211; 23%) were frequent complications and many of these events were categorized into minor complications (Tables 2 and 4). The rate of re-operation was 11% (106/928). Forty patients underwent surgical revision for wound dehiscence, 12 patients for ileus, 10 patients for ileal conduit trouble, eight patients for entero-anatomosis leakage and 11 patients for other more unusual reasons. In addition, 25 patients underwent ureteral stenting or nephrostomy as a result of hydronephrosis.

Table 2. Summary of complication types and categories
Category (% of total)ComplicationFrequency
Gastrointestinal (26%; n = 243)Ileus211
Anastomotic bowel leak16
Gastrointestinal bleeding8
Clostridium difficile colitis15
Rectal stenosis1
Gastric ulcer3
Infectious (30%; n = 279)Fever of unknown origin25
Urinary tract infection200
Sepsis14
Gastroenteritis2
Cholecystitis2
Iliopsoas muscle abscess1
Other site infection37
Wound (21%; n = 199)Surgical site infection174
Wound dehiscence38
Genitourinary (15%; n = 140)Hydronephrosis97
Urinary leak34
Renal failure5
Necrosis of ileal conduit5
Cardiac (0.6%; n = 6)Arrhythmia2
Myocardial infarction2
Congestive heart failure2
Pulmonary (1%; n = 12)Pneumonia6
Respiratory distress2
Pleural effusion1
Lung oedema2
Interstitial pneumonia1
Bleeding (0.5%; n = 5)Anaemia requiring transfusion3
Wound haematoma2
Thromboembolic (0.3%; n = 3)Deep venous thrombosis1
Pulmonary embolism2
Neurological (2%; n = 16)Cerebrovascular event7
Peripheral neuropathy3
Delirium/agitation6
Miscellaneous (3%; n = 27)Psychological illness4
Dermatitis2
Liver dysfunction3
Other rare complications18
Surgical (0.8%; n = 8)Rectal injury4
Pleural injury1
Incisional hernia3
Table 3. Summary of the highest grade of complication in each patient
Highest grade of complicationPatients, n (%)
  1. Grade 1, any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic or radiological interventions. Grade 2, requiring pharmacological treatment with drugs. Grade 3, requiring surgical, endoscopic or radiological intervention. Grade 4, life-threatening complication requiring management in an intensive care unit. Grade 5, death.

1214 (23)
2259 (28)
3138 (15)
47 (0.8)
511 (1)
Unknown6 (0.6)
Table 4. Summary of complication types in each grade
Grade 1Grade 2Grade 3Grade 4Grade 5
 Patients (n) Patients (n) Patients (n) Patients (n) Patients (n)
  1. FUO, fever of unknown origin; IHD, ischaemic heart disease; SSI, surgical site infection; UTI, urinary tract infection.

SSI85Ileus116SSI38Sepsis3Sepsis2
UTI73UTI112Hydronephrosis26Respiratory distress2Ileus2
Ileus71SSI44Wound dehiscence26Bowel infection1Anaemia requiring transfusion2
Hydronephrosis66FUO17Ileus19Urinary fistula1Bowel leak1
Wound dehiscence11Pseudomembranous colitis11UTI13Ileus1Bowel bleeding1
Others79Others65Others50Bowel fistula1Pneumonia1
     Pulmonary infarction1Interstitial pneumonia1
     IHD1Heart failure1
Total385Total365Total172Total11Total11

Regarding mortality, there were 19 deaths within 90 days of surgery. No patient died intra-operatively. Of the 19 patients, eight patients died from cancer progression after surgery. There were five patients who died from gastrointestinal events, one from cardiovascular events, two from pulmonary events, two from haemorrhagic events and one from an infectious event. The 30-day mortality rate was 0.8% (7/928) and the 90-day mortality rate was 2% (19/928).

Predictors of peri-operative complications

Tables 5 and 6 show the results of logistic regression analyses. Multivariate analysis showed that sex (P = 0.020), age (P = 0.026), previous cardiovascular comorbidity (P = 0.034), type of urinary diversion (P = 0.001) and operating time (P = 0.006) were significant predictors of any grade complications (Table 5). Regarding major complications, previous cardiovascular comorbidity (P = 0.002) and type of urinary diversion (P = 0.031) were significant in the multivariate model (Table 6). Therefore, previous cardiovascular comorbidity and the type of urinary diversion were common significant factors for any and major complications.

Table 5. Univariate and multivariate analyses for all complications
Variables analyzedPatients (n)Univariate analysisMutivariate analysis
Odds ratio (95% CI)POdds ratio (95% CI)P
  1. ASA, American Society of Anesthesiologists.

Sex     
 Male7161.55 (1.12–2.13)0.0071.49 (1.06–2.07)0.020
 Female2121 1 
Age (years)     
 Continuous9281.02 (1.00–1.03)0.019  
 Categorized     
 ≥704841.40 (1.06–1.85)0.0181.42 (1.04–1.95)0.026
 <704441 1 
ASA score     
 ≥25211.55 (1.15–2.09)0.0041.25 (0.88–1.76)0.209
 13261 1 
Body mass index (kg/m2)     
 Continuous8891.03 (0.98–1.08)0.209  
 Categorized     
 ≥234511.00 (0.75–1.33)0.999  
 <234381   
Mean annual cystectomy volume     
 High (≥10 per year)1331.15 (0.75–1.78)0.524  
 Moderate (5–10 per year )4081.03 (0.77–1.39)0.837  
 Low (≤5 per year)3871   
Previous cardiovascular comorbidity     
 Yes3851.71 (1.29–2.30)0.0011.43 (1.03–2.00)0.034
 No5431 1 
Previous surgical history     
 Yes1501.50 (1.01–2.26)0.0481.47 (0.97–2.26)0.074
 No7781 1 
Previous pulmonary comorbidity     
 Yes471.22 (0.65–2.43)0.554  
 No8811   
Previous cerebrovascular comorbidity     
 Yes512.23 (1.12–4.96)0.0321.78 (0.87–4.03)0.135
 No8771 1 
Organ-confined disease     
 No4190.88 (0.66–1.16)0.372  
 Yes4981   
Types of urinary diversion     
 Ileal conduit or neobladder6681.81 (1.34–2.44)<0.0011.79 (1.29–2.49)0.001
 Others2601 1 
 Operating time (min)     
 Continuous9051.00 (1.00–1.00)0.001  
 Categorized     
 ≥4004381.65 (1.24–2.20)0.0011.53 (1.13–2.09)0.006
 <4004671 1 
Estimated blood loss (mL)     
 Continuous9051.00 (1.00–1.00)0.035  
 Categorized     
 ≥13004601.28 (0.96–1.70)0.089  
 <13004451   
Table 6. Univariate and multivariate analyses for major complications
Variables analyzedPatients (n)Univariate analysisMutivariate analysis
Odds ratio (95% CI)POdds ratio (95% CI)P
Sex     
 Male7161.51 (0.98–2.39)0.072  
 Female2121   
Age (years)     
 Continuous9281.02 (0.99–1.04)0.084  
 Categorized     
 ≥704841.15 (0.82–1.63)0.415  
 <704441   
ASA score     
 ≥25211.48 (1.02–2.19)0.0441.12 (0.73–1.73)0.609
 13261 1 
Body mass index (kg/m2)     
 Continuous8891.04 (0.98–1.10)0.163  
 Categorized     
 ≥234511.09 (0.77–1.55)0.610  
 <234381   
Mean annual cystectomy volume     
 High (≥10 per year)1330.58 (0.30–1.06)0.091  
 Moderate (5–10 per year )4081.34 (0.93–1.94)0.112  
 Low (≤5 per year)3871   
Previous cardiovascular comorbidity     
 Yes3851.94 (1.37–2.76)0.0011.83 (1.24–2.70)0.002
 No5431 1 
Previous surgical history     
 Yes150a0.960  
 No7781   
Previous pulmonary comorbidity     
 Yes471.55 (0.74–3.02)0.220  
 No8811   
Previous cerebrovascular comorbidity     
 Yes512.17 (1.13–4.00)0.0151.90 (0.97–3.57)0.052
 No8771 1 
Organ-confined disease     
 No4190.87 (0.62–1.24)0.450  
 Yes4981   
Types of urinary diversion     
 Ileal conduit or neobladder6681.62 (1.08–2.50)0.0231.63 (1.06–2.58)0.031
 Others2601 1 
Operating time (min)     
 Continuous 1.01 (1.00–1.00)0.044  
 Categorized     
 ≥4004381.50 (1.06–2.13)0.0221.25 (0.85–1.85)0.250
 <4004671 1 
Estimated blood loss (mL)     
 Continuous9051.00 (1.00–1.00)0.0071  
 Categorized     
 ≥13004601.47 (1.04–2.09)0.0321.36 (0.94–1.98)0.110
 <13004451 1 

Discussion

  1. Top of page
  2. Abstract
  3. Introduction
  4. Patients and Methods
  5. Results
  6. Discussion
  7. Acknowledgements
  8. Conflict of Interest
  9. References

Using the modified Clavien grading system and 11 category grouping reported by Shabsigh et al. [9], we observed that 68% of patients experienced at least one complication within 90 days of surgery and 17% of patients experienced major complications. Our observation was comparable with the study by Shabsigh et al. [9] reporting that the overall complication rate was 64% and the major complication rate was 13%. Hautman et al. [10] also reported complications in RC and ileal neobladder cases using the same standards, where 58% experienced at least one complication within 90 days of surgery, even in the most experienced hands. Regarding the type of complication, we observed that an infectious complication was the most common (30%), followed by gastrointestinal (26%), wound-related (21%) and genitourinary complications (15%). This distribution was similar to the results obtained from the MSKCC and the University of Ulm [9, 10]. In the MSKCC series, the most common complication categories were gastrointestinal (29%), infectious (25%), wound-related (15%) and genitourinary (11%). As far as we are aware, the present study is the largest investigation of peri-operative morbidity and mortality in Asian patients who underwent RC. The standardized reporting method allowed us to compare our observations with other populations [15]. In the present study, the incidence of both cardiac (0.6%) and thromboembolic (0.3%) complications was much lower than the MSKCC series or in other Western centres [2-4, 8, 9]. Although such differences may be derived from a bias in our cohort, we consider that these differences may arise as a result of ethnic differences in terms of susceptibility to such diseases. For example, the Hisayama study, comprising a long-term cohort study in Japan, showed that the incidence of myocardial infarction was 1.6 events per 1000 per year for men and 0.7 events per 1000 per year for women, whereas the Framingham study reported 7.1 events per 1000 per year for men and 4.2 events per 1000 per year for women [16-19]. The lower level of BMI (median 23 kg/m2), as well as the favorable ASA score distribution (85% of the patients were categorized into I or II), in our cohort, which could reflect the better general health of the Japanese population, may also influence the lower development of such events and appeared to result in low mortality rates in the present cohort. The active use of intermittent pneumatic compression and/or static graduated compression stockings may be beneficial for the prevention of deep vein thrombosis. Finally, the lower development of such events appeared to result in low mortality rates in the present cohort. In another Japanese cohort, Iwai et al. [20] also reported lower cardiac (3/193; 1.6%) or thromboembolic events (1/193; 0.5%) and no death within 90 days of RC.

Multiple logistic regression models showed that previous cardiovascular comorbidity and the type of urinary diversion (ileal conduit or neobladder) were significant predictive factors for any and major complications. In addition, operating time was an independent risk factor for all complications. A longer operating time itself would cause additional adverse effects, such as bowel oedema, which may result in a delay in bowel movements or prolonged exposure to microorganisms in the operative field, thus increasing the risk of surgical site infection. Regarding preoperative physical status, several studies have shown that a high ASA score was identified as a negative prognostic factor [4-6, 9, 10]. Although ASA scores were not significant in our cohort, ASA data could not be collected in 81 patients as a result of the retrospective nature of the present study, which may have influenced the final result. We consider that preoperative physical assessment (e.g. ASA scoring) is very important, as well as the need to consider the comorbidity history.

Compared to other Western series, a significant proportion of patients underwent cutaneous ureterostomy in the present series. Although we do not have data available about the precise reason for the decision regarding the type of urinary diversion in each patient, it was assumed that the preoperative physical status of patients or the surgeon's preference influenced the decision. Our observation of lower complications in a diversion where the ileum was not involved was consistent with previous studies [21, 22]. In a comparison of the complication categories between ileal conduit/neobladder and cutaneous ureterostomy, gatrointestinal, infectious and genitourinary complications were more frequent in patients who were undergoing ileal conduit/neobladder (data not shown). The use of the intestinal tract may give rise to potential risks of anastomotic leakage, ileus, digestive fistula or peritonitis. Ureteroenteroanastomosis may also cause insufficient anastomosis or urinary drainage failure. Our observations reconfirmed that complications after RC are strongly associated with urinary diversion.

In the present study, no association was observed between the rate of complications and annual surgical volume. Most patients underwent RC at relatively low annual volume centres with acceptable morbidity rates and low mortality rates. Although volume–outcome studies suggest that regionalization of complex procedures to high-volume centres would improve the quality of surgery [7, 23] (and we agree with this conclusion), the concept would be limited by several factors, such as the rigidity of administration in hospital districts, as well as the prospect of surgeons who are unwilling to refer patients to other hospitals or patients who are unwilling to move to other hospitals. In Japan, because of universal health coverage as a result of the establishment of employee-based and community-based social health insurance, where ‘equality’ is emphasized in society, almost everyone became insured in 1961 and patients (except for elderly people and children) need only pay 30% of the total cost, which allows for long hospital stays after RC with an acceptable self-pay burden [24]. The length of hospital stay in the present cohort (median 39 days) was longer than those reported in previous studies (7–34 days) [1, 2, 8]. Such a background may help us detect complications earlier, which may also contribute to the low mortality rate in the present cohort.

Several randomized trials and meta-analysis have shown the survival benefit of neoadjuvant chemotherapy in patients with clinical T2–4 tumours [25, 26]. However, in the present study, it was only offered in 4% of patients. The same trend was observed in other Western series [27, 28]. For example, Yafi et al. [28] reported that only 3.1% of patients received neoadjuvant chemotherapy in 2287 patients who were treated with radical cystectomy between 1998 and 2008 in eight Canadian academic centres. This may reflect a delay in implementing the results of randomized trials or the surgeon's reluctance to perform chemotherapy as a result of a delay in definitive surgical treatment or the potential toxicities of chemotherapy (although the precise reasons remain unknown). Based on the data where gemcitabine and cisplatin (GC) replaced methotrexate, vinblastine, doxorubicin and cisplatin as the preferred regimen as a result of similar response rates and reduced toxicity [29], GC has been studied in the neoadjuvant setting. In a retrospective review from MSKCC, Dash et al. [30] reported that 42 patients were treated with four cycles of neoadjuvant GC, with downstaging to pT0 in 26% of patients and to no residual disease invading bladder muscle in 36%. In our hospital, we also used the GC regimen in a neoadjuvant setting, with the impression of good tolerability. We consider that the number of patients undergoing neoadjuvant chemotherapy will grow in future studies.

The present study has important limitations, including its retrospective design. It is possible that some minor complications were not recorded. Regarding the definition of ileus, we did not have strict prospective criteria and each doctor collected data from medical charts, which may lead to an under-reporting of postoperative paralytic ileus. However, major complications or deaths were probably not missed because these events are described in the medical charts by the use of numerous notes. Regarding surgical techniques and postoperative management, we did not follow any strict prospective guidelines and, as such, there could have been some variation among institutions, as well as over the study period; however, we could not identify any significant differences in complication rates during the study periods (all complications: 65% between 1999 and 2003; 71% between 2004 and 2010; χ2 test, P = 0.052; major complications: 17% between 1999 and 2003; 17% between 2004 and 2010; χ2 test, P = 0.95). Nevertheless, we consider that our cohort reflected the general patient population in Japan and that several important observations were made in the present study.

In conclusion, surgical complication-related RC is significant and previous cardiovascular comorbidity and the type of urinary diversion were found to be significant factors for any and major complications. The 90-day mortality rate was 2%, which is compatible with reports from Western high-volume centres.

Acknowledgements

  1. Top of page
  2. Abstract
  3. Introduction
  4. Patients and Methods
  5. Results
  6. Discussion
  7. Acknowledgements
  8. Conflict of Interest
  9. References

We thank R. Matsumoto, N. Murahashi, A. Hashimoto, S. Kanzaki, T. Demura, T. Kaneda, Y. Kanno, H. Seki, T. Harabayashi, H. Matsuda, K. Miura, I. Takeuchi, M. Kitahara, S. Nagamori, S. Suzuki, K. Kanagawa, M. Murakumo, J. Shindo, K. Morita, K. Matsumura, M. Nantani, S. Sakashita and T. Mori for data collection.

References

  1. Top of page
  2. Abstract
  3. Introduction
  4. Patients and Methods
  5. Results
  6. Discussion
  7. Acknowledgements
  8. Conflict of Interest
  9. References
  • 1
    Soulié M, Straub M, Gamé X et al. A multicenter study of the morbidity of radical cystectomy in select elderly patients with bladder cancer. J Urol 2002; 167: 13251328
  • 2
    Novotny V, Hakenberg OW, Wiessner D et al. Perioperative complications of radical cystectomy in a contemporary series. Eur Urol 2007; 51: 397402
  • 3
    Svatek RS, Fisher MB, Matin SF et al. Risk factor analysis in a contemporary cystectomy cohort using standardized reporting methodology and adverse event criteria. J Urol 2010; 183: 929934
  • 4
    Bostrom PJ, Kossi J, Laato M et al. Risk factors for mortality and morbidity related to radical cystectomy. BJU Int 2009; 103: 191196
  • 5
    Chang SS, Cookson MS, Baumgartner RG et al. Analysis of early complications after radical cystectomy: results of a collaborative care pathway. J Urol 2002; 167: 20122016
  • 6
    Hollenbeck BK, Miller DC, Taub D et al. Identifying risk factors for potentially avoidable complications following radical cystectomy. J Urol 2005; 174: 12311237
  • 7
    Konety BR, Allareddy V, Herr H. Complications after radical cystectomy: analysis of population-based data. Urology 2006; 68: 5864
  • 8
    Lowrance WT, Rumohr JA, Chang SS et al. Contemporary open radical cystectomy: analysis of perioperative outcomes. J Urol 2008; 179: 13131318
  • 9
    Shabsigh A, Korets R, Vora KC et al. Defining early morbidity of radical cystectomy for patients with bladder cancer using a standardized reporting methodology. Eur Urol 2009; 55: 164174
  • 10
    Hautmann RE, de Petriconi RC, Volkmer BG. Lessons learned from 1,000 neobladders: the 90-day complication rate. J Urol 2010; 184: 990994
  • 11
    Hirsh J, Hoak J. Management of deep vein thrombosis and pulmonary embolism. A statement for healthcare professionals. Council on Thrombosis (in consultation with the Council on Cardiovascular Radiology), American Heart Association. Circulation 1996; 93: 22122245
  • 12
    Japanese Circulation Society. Guidelines for the diagnosis,treatment and prevention of pulmonary thromboembolism and deep vein thrombosis (JCS 2004). J Cardiol 2005; 45: 349366
  • 13
    Matsumoto T, Kiyota H, Matsukawa M et al. Japanese guidelines for prevention of perioperative infections in urological field. Int J Urol 2007; 14: 890909
  • 14
    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: 466477
  • 15
    Donat SM. Standards for surgical complication reporting in urologic oncology: time for a change. Urology 2007; 69: 221225
  • 16
    Kubo M, Kiyohara Y, Kato I et al. Trends in the incidence, mortality, and survival rate of cardiovascular disease in a Japanese community: the Hisayama study. Stroke 2003; 34: 23492354
  • 17
    Kitabatake A. Guidelines for the primary prevention of ischemic heart disease revised version. Circ J Suppl 2006; 19
  • 18
    Lerner DJ, Kannel WB. Patterns of coronary heart disease morbidity and mortality in the sexes: a 26-year follow-up of the Framingham population. Am Heart J 1986; 111: 383390
  • 19
    Wolf PA, D'Agostino RB, Kannel WB et al. Cigarette smoking as a risk factor for stroke. The Framingham Study. JAMA 1988; 259: 10251029
  • 20
    Iwai A, Koga F, Fujii Y et al. Perioperative complications of radical cystectomy after induction chemoradiotherapy in bladder-sparing protocol against muscle-invasive bladder cancer: a single institutional retrospective comparative study with primary radical cystectomy. Jpn J Clin Oncol 2011; 41: 13731379
  • 21
    Pycha A, Comploj E, Martini T et al. Comparison of complications in three incontinent urinary diversions. Eur Urol 2008; 54: 825832
  • 22
    Kilciler M, Bedir S, Erdemir F et al. Comparison of ileal conduit and transureteroureterostomy with ureterocutaneostomy urinary diversion. Urol Int 2006; 77: 245250
  • 23
    Barbieri CE, Lee B, Cookson MS et al. Association of procedure volume with radical cystectomy outcomes in a nationwide database. J Urol 2007; 178: 14181421
  • 24
    Ikeda N, Saito E, Kondo N et al. What has made the population of Japan healthy? Lancet 2011; 378: 10941105
  • 25
    Grossman H, Natale R, Tangen C et al. Neoadjuvant chemotherapy plus cystectomy compared with cystectomy alone for locally advanced bladder cancer. N Engl J Med 2003; 349: 859866
  • 26
    Advanced Bladder Cancer (ABC) Meta-analysis Collaboration. Neoadjuvant chemotherapy in invasive bladder cancer: update of a systematic review and meta-analysis of individual patient data advanced bladder cancer (ABC) meta-analysis collaboration. Eur Urol 2005; 48: 202205
  • 27
    Shariat SF, Karakiewicz PI, Palapattu GS et al. Outcomes of radical cystectomy for transitional cell carcinoma of the bladder: a contemporary series from the Bladder Cancer Research Consortium. J Urol 2006; 176: 24142422
  • 28
    Yafi FA, Aprikian AG, Chin JL et al. Contemporary outcomes of 2287 patients with bladder cancer who were treated with radical cystectomy: a Canadian multicentre experience. BJU Int 2011; 108: 539545
  • 29
    von der Maase H, Hansen SW, Roberts JT et al. Gemcitabine and cisplatin versus methotrexate, vinblastine, doxorubicin, and cisplatin in advanced or metastatic bladder cancer: results of a large, randomized, multinational, multicenter, phase III study. J Clin Oncol 2000; 18: 30683077
  • 30
    Dash A, Pettus JA, Herr HW et al. A role for neoadjuvant gemcitabine plus cisplatin in muscle-invasive urothelial carcinoma of the bladder: a retrospective experience. Cancer 2008; 113: 24712477