Urologic Oncology: Seminars and Original Investigations ] (2014) ∎∎∎–∎∎∎

Original article

Short-term morbidity and mortality of Indiana pouch, ileal conduit, and neobladder urinary diversion following radical cystectomy M. Francesca Monn, M.D., M.P.H.*, Hristos Z. Kaimakliotis, M.D., K. Clint Cary, M.D., M.P.H., Jose A. Pedrosa, M.D., Chandra K. Flack, B.S., Michael O. Koch, M.D., Richard Bihrle, M.D. Department of Urology, Indiana University School of Medicine, Indianapolis, IN Received 12 March 2014; received in revised form 11 April 2014; accepted 12 April 2014

Abstract Purpose: Literature surrounding Indiana pouch (IP) urinary diversion suggests a higher incidence of complications and longer operative time compared with ileal conduit (IC) and neobladder (NB). We sought to assess short-term complications of IP diversions compared with other diversions at our institution. Materials and methods: Using institutional National Surgical Quality Improvement Program data, we identified radical cystectomy cases performed for bladder cancer at Indiana University from January 2011 until June 2013. During this time period, the National Surgical Quality Improvement Program randomly evaluated approximately 70% of radical cystectomies performed for urothelial carcinoma at our institution. Multivariable logistic regression was performed to identify factors associated with Clavien grade III–V complications. Results: A total of 233 cases were identified, 139 IC, 39 IP, and 55 NB. Mean (standard deviation) operative times for IC, IP, and NB were 257 (84), 383 (78), and 327 (88) minutes, respectively (P o 0.001). Half of the patients required blood transfusion during the hospitalization. The overall rate of complications was significantly lower among NB (P ¼ 0.009). Overall, 12% of patients developed a Clavien grade III–V complication, with no difference observed between groups (P ¼ 0.884). After controlling for preoperative confounders, IP patients were not at increased odds of developing a Clavien III–V complication compared with IC (odds ratio ¼ 1.38, P ¼ 0.599). Conclusions: At a high-volume center, the incidence of serious complications was similar between diversion types. IP patients were more likely to experience minor complications. Patients should be counseled regarding rates of short-term complications and blood transfusion. r 2014 Elsevier Inc. All rights reserved. Keywords: Bladder cancer; Urinary diversion; Radical cystectomy; NSQIP

1. Introduction Urinary diversion following radical cystectomy is classified as incontinent or continent, with continent forms reserved for patients who have normal renal and hepatic function along with the mental and physical capacity to selfcatheterize. The most common methods of continent diversion are orthotopic neobladder (NB) and continent urinary reservoir, also known as the Indiana pouch (IP). These methods for continent diversion have been regularly used since the 1980s [1,2]. Many urologists prefer the NB over the IP to avoid stoma creation, to potentially reduce Corresponding author. Tel.: þ1-317-847-5647; fax: þ1-317-948-2619. E-mail address: [email protected] (M.F. Monn). *

http://dx.doi.org/10.1016/j.urolonc.2014.04.009 1078-1439/r 2014 Elsevier Inc. All rights reserved.

long-term complications with catheterization or stone formation, and to decrease operative times [3,4]. Despite improvements in radical cystectomy with urinary diversion techniques, less than 20% of patients in contemporary national cohorts undergo continent diversion [5,6]. In spite of the national data, individual high-volume institutions have reported rates of continent diversion closer to 40% although there is a trend toward decreased use of continent diversion among lower-volume surgeons [3,7]. Perioperative morbidity is relatively high in radical cystectomy patients ranging from 30% to 60% in the literature [8–11]. The cause of this is likely multifactorial; radical cystectomy patients have an aggressive malignancy, multiple comorbidities, and undergo an extensive procedure that not only involves surgical extirpation but also includes

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M.F. Monn et al. / Urologic Oncology: Seminars and Original Investigations ] (2014) 1–7

bowel reconstruction for urinary transport and storage [9]. Studies have noted mortality in 1% to 3% of patients, deep vein thrombosis (DVT) or pulmonary embolism (PE) in 3% to 5%, and fascial dehiscence in 5% to 9% of urinary diversion patients [6,10,12]. We hypothesized that when performed at a high-volume academic institution, there would be no difference in the incidence of perioperative complications between the diversion types. Recognizing that our institution performs a large number of cystectomies with urinary diversion each year, we sought to compare 30-day postoperative complication rates between diversion types using institutional data from the National Surgical Quality Improvement Project (NSQIP). 2. Materials and methods 2.1. Data and inclusion criteria NSQIP is a validated system created by the American College of Surgeons and has enrolled nonfederal hospitals since 2004 to aid hospitals in systematic tracking of 30-day postoperative morbidity and mortality [13]. NSQIP data are collected in a uniform fashion by trained Surgical Clinica Reviewers who collect standardized preoperative and 30-day postoperative data for each randomly selected case. The data include details on the index operation and subsequent operations within the 30-day postoperative period. Data are collected using electronic records and phone calls to patients to capture all complications, readmissions, and outcomes [13]. Using institutional NSQIP data, we conducted a retrospective cohort analysis on cystectomy cases performed between January 2011 and June 2013. Currently, 60% to 70% of cystectomies performed annually at Indiana University are captured by NSQIP. We linked the institutional NSQIP cystectomy data with the Indiana University Cystectomy Database (n ¼ 303) and, subsequently, eliminated partial cystectomies (n ¼ 7). Most eliminated radical cystectomies were performed for neurogenic bladder (n ¼ 27), interstitial or radiation cystitis (n ¼ 9), fistula or incontinence (n ¼ 12), and nongenitourinary malignancies (n ¼ 15). The final 233 cases represent 71% of all radical cystectomies performed at our institution for bladder cancer during the collection period. 2.2. Variables Variables of interest were divided into preoperative, intraoperative, and postoperative. Preoperative variables included age, sex, body mass index (BMI), comorbid conditions (hypertension, diabetes, and chronic obstructive pulmonary disease), smoking status, steroid use within 30 preoperative days, and reception of neoadjuvant chemotherapy. Intraoperative variables were American Society of Anesthesiologists (ASA) class, operative time, estimated

blood loss (EBL), and diversion type. Postoperative variables were length of stay, units of blood transfused throughout the hospitalization, and unplanned readmission. Complications were classified using an adapted modified Clavien-Dindo system [14,15], in which Clavien V was defined as mortality within 30 days, Clavien IV was defined by a complication likely to require intermediate or intensive care unit level care, Clavien III was defined by any unplanned reoperation, and all other complications were considered Clavien I or II. Complications that qualified as Clavien IV were septic shock, PE, myocardial infarction, cardiac arrest, unplanned intubation, requirement of ventilator assistance 48 hours postoperatively, renal failure requiring dialysis, stroke, and coma. Clavien I and II complications included superficial incisional surgical site infection (SSI), deep incisional SSI, and organ space SSI, fascial dehiscence, pneumonia, DVT, conservatively managed bowel obstruction, ileus, urine or bowel leak, Clostridium difficile infection, and total parenteral nutrition requirement. Ileus was defined as prolonged nothing by mouth or nasogastric tube use at postoperative day 6 or reinstatement of nothing by mouth status or nasogastric tube reinsertion within 30 days. It is noteworthy that bowel obstruction, ileus, urine or bowel leak, C. difficile infection, and total parenteral nutrition requirement are not routinely captured by NSQIP. These data were obtained through retrospective electronic and paper chart review. Regarding case selection for IP, patients with normal renal function, appropriate manual dexterity, and willingness to catheterize a continent urinary reservoir are considered candidates. Given the use of a large bowel segment for reservoir creation, polyethylene glycol was used for bowel preparation the day before the procedure. Patients undergoing ileal conduit (IC) or NB were counseled to undergo a clear liquid diet only 24 hours before surgery. No antibiotics were used as part of the preoperative bowel preparation. DVT prophylaxis at our institution consists of enoxaparin 40 mg, which is initiated 6 hours postoperatively. Cefoxitin is given to patients immediately before the operation and continued for 24 hours. 2.3. Statistical analyses Descriptive analysis of the data was performed using the Fisher exact test for categorical and analysis of variance for continuous variables. The primary outcome of interest was developing a postoperative Clavien grade III–V complication. Multivariable logistic regression was used to evaluate the association between diversion type and postoperative Clavien III–V complication when controlling for age, sex, BMI, comorbidities, neoadjuvant chemotherapy, preoperative creatinine level, and preoperative hematocrit level. Comorbidities were defined as having 0, 1, or 2þ of hypertension, diabetes, chronic obstructive pulmonary disease, smoking, or preoperative steroids. ASA class was omitted because all patients with ASA class higher than 3 developed a complication. A priori, P o 0.05 was considered statistically significant for

M.F. Monn et al. / Urologic Oncology: Seminars and Original Investigations ] (2014) 1–7

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Table 1 Characteristics of patients undergoing radical cystectomy

Age, mean (SD), y Sex (female) Race (nonwhite) BMI category Normal Overweight Obese Severely obese

Ileal conduit n (%) ¼ 139

Indiana pouch n (%) ¼ 39

Neobladder n (%) ¼ 55

P value

72.6 (10) 32 (23) 7 (5)

61.5 (9) 10 (26) 1 (3)

59.6 (9) 6 (11) 2 (4)

o0.001 0.108 0.999

47 41 33 18

(34) (29) (24) (13)

13 19 3 4

(33) (49) (8) (10)

Smoker Hypertension Diabetes COPD Steroids within 30 d Neoadjuvant chemotherapy Preoperative creatinine ng/mL, mean (SD) Preoperative hematocrit, mean (SD)

31 91 39 17 6 29 1.2 37.4

(22) (65) (28) (12) (4) (21) (0.5) (6)

14 17 10 2 2 12 1.1 38.6

ASA class II III IV

0 131 (94) 8 (6)

9 24 16 6

(16) (44) (29) (11)

0.021

(36) (44) (26) (5) (5) (31) (0.4) (5)

14 (25) 25 (45) 14 (25) 0 0 19 (33) 1.2 (1.0) 39.3 (5)

0.224 0.007 0.935 0.007 0.267 0.153 0.433 0.055

4 (10) 33 (85) 2 (5)

0 55 (100) 0

0.001

ANOVA ¼ analysis of variance; SD ¼ standard deviation; COPD ¼ chronic obstructive pulmonary disease. P values represent the Fisher exact test for categorical variables and ANOVA for continuous variables.

2-tailed tests. Stata version 12.1 (Stata Corp. LP, College Station, TX) was used for all statistical analyses. Approval for the conduct of this study was granted by the Indiana University institutional review board.

diversion was 1.2 ng/mL (Table 1). A total of 139 patients underwent IC diversion, 39 patients (17%) IP, and 55 (23%) NB. Patients undergoing NB and IP were younger than IC patients (P o 0.001), but there were no differences in sex or race distributions between the groups. Hypertension was most common among the IC patients (P ¼ 0.007). There were no differences in the proportion of patients undergoing neoadjuvant chemotherapy (Table 1). Mean (standard deviation) operative time for IC patients was 257 (84) minutes compared with 383 (78) minutes for IP and 327 (88) minutes for NB (Table 2). There was no difference in EBL between the procedures, with average EBL

3. Results There were 233 patients identified for inclusion. Mean age of radical cystectomy patients was 67.7 years [11], and 20% of patients were women. Mean BMI was 28. The mean preoperative creatinine value for all patients undergoing

Table 2 Operative and pathologic characteristics in patients undergoing radical cystectomy

Operative time, mean (SD), min Estimated blood loss, mean (SD), ml Number of units transfused during hospitalization, mean (range) LOS, median (IQR) Unplanned readmission

Ileal conduit n (%) ¼ 139

Indiana pouch n (%) ¼ 39

Neobladder n (%) ¼ 55

P value

257 487 1.5 8 17

383 494 1.6 9 5

327 577 0.9 7 6

(88) (359) (0–15) (6–8) (11)

o0.001 0.207 0.292 0.002 0.999

(64) (16) (16) (4)

o0.001

13 (24)

0.519

(84) (313) (0–12) (6–10) (12)

Pathologic stage rpT1 pT2 pT3 pT4

42 34 38 25

Positive lymph nodes

43 (31)

(30) (24) (27) (18)

15 12 11 1

(78) (293) (0–13) (7–14) (13) (38) (31) (28) (3)

13 (33)

ANOVA ¼ analysis of variance; SD ¼ standard deviation; LOS ¼ length of stay; IQR ¼ interquartile range. P values represent the Fisher exact test for categorical variables and ANOVA for continuous variables.

35 9 9 2

M.F. Monn et al. / Urologic Oncology: Seminars and Original Investigations ] (2014) 1–7

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Fig. Clavien complications among radical cystectomy patients. (Color version of figure is available online.)

of 510 ml (P ¼ 0.207). Similarly, there was no difference in the average units of blood transfused during the hospitalization, with an overall average of 1.4 (range: 0–17) units. The proportion of patients developing any complication was significantly higher for the IP patients (P ¼ 0.009); however, there was no difference in patients developing Clavien grade III–V complications between the groups (P ¼ 0.884) (Fig.). Specific complications are shown in Table 3. Overall, 17% of the cystectomy patients developed any SSI, with the highest incidence of superficial incisional, deep incisional, and organ space SSIs observed among the IP patients (Table 3). Ileus was identified in 33% of IP and IC patients. Urine and bowel leaks were uncommon for all diversion types. Five patients died and 7 required a second operation (Table 3). On multivariable logistic regression when controlling for age, sex, BMI, comorbidities, neoadjuvant chemotherapy, preoperative creatinine level, and hematocrit level, neither IP nor NB patients were at an increased adjusted odds of developing a Clavien grade III–V complication compared with IC patients (Table 4).

Table 3 Postoperative complications among patients undergoing radical cystectomy Ileal conduit n (%) ¼ 139

Indiana pouch n (%) ¼ 39

Neobladder n (%) ¼ 55

P value

11 (8) 1 (1) 6 (4) 1 (1) 8 (6) 3 (2) 6 (4) 46 (33) 1 (1) 2 (1) 11 (8) 19 (14)

9 (23) 6 (15) 4 (10) 3 (8) 1 (3) 1 (3) 2 (5) 13 (33) 0 2 (5) 5 (13) 8 (21)

2 (4) 1 (2) 0 1 (2) 2 (4) 1 (2) 1 (2) 9 (16) 1 (2) 1 (2) 1 (2) 5 (9)

0.008 o0.001 0.044 0.033 0.752 0.999 0.712 0.052 0.645 0.280 0.104 0.291

Clavien grade III Return to the OR

3 (2)

2 (5)

2 (4)

0.493

Clavien grade IV Septic shock Pulmonary embolism Myocardial infarction Unplanned intubation Requiring ventilator assistance Acute renal failure requiring dialysis Stroke Cardiac arrest

7 (5) 4 (3) 5 (4) 4 (3) 4 (3) 1 (1) 0 0

2 (5) 1 (3) 1 (3) 1 (3) 2 (5) 0 1 (3) 0

3 (5) 3 (5) 0 2 (4) 1 (2) 0 1 (2) 1 (4)

0.999 0.605 0.427 0.999 0.745 0.999 0.162 0.366

Clavien grade V Death within 30 d

3 (2)

0

2 (4)

0.679

19 (35) 7 (13)

0.009 0.884

Clavien grades I–II Superficial incisional SSI Deep incisional SSI Organ space SSI Fascial dehiscence Pneumonia Deep vein thrombosis Bowel obstructiona Ileus Urine leak Bowel leak Clostridium difficile infection TPN required

Any complication Any Clavien grades III–V complication

68 (49) 16 (12)

26 (67) 5 (13)

ANOVA ¼ analysis of variance; OR ¼ operating room; TPN ¼ total parenteral nutrition. P values represent the Fisher exact test for categorical variables and ANOVA for continuous variables. a All bowel obstructions resolved with conservative management.

M.F. Monn et al. / Urologic Oncology: Seminars and Original Investigations ] (2014) 1–7 Table 4 Factors associated with developing Clavien grades III–Va Factor

Odds ratio

95% CI

P value

Diversion type Ileal conduit Indiana pouch Neobladder

reference 1.38 1.32

– 0.42–4.55 0.42–4.20

– 0.599 0.634

Age, y Sex (female) Body mass index

1.02 0.71 1.03

0.97–1.07 0.22–2.24 0.96–1.11

0.441 0.554 0.401

Comorbidities 0 1 2þ Neoadjuvant chemotherapy Preoperative creatinine Preoperative hematocrit

reference 1.38 1.51 1.41 1.14 0.99

– 0.44–4.36 0.47–4.91 0.51–3.90 0.66–1.97 0.91–1.09

– 0.582 0.491 0.510 0.630 0.938

a Multivariable logistic regression model is adjusted for all variables within the table.

4. Discussion At a high-volume institution with approximately 200 cystectomies performed on average each year, we did not find increased odds of 30-day postoperative severe complications for patients undergoing IC, IP, or NB. Higher incidence of Clavien I and II complications were observed in the IP population. The differences in complications between the diversion types may not be surprising, given the high volume of cystectomies performed annually at our institution. Previous studies have demonstrated high rates of both early and late complications from urinary diversion, but many lack data specifically regarding IPs [8–11,16,17]. A recent study found an overall proportion of 44% of patients developing early complications and 51% developing late complications (defined as occurring beyond 30 postoperative days), with up to one-third of patients experiencing urinary tract infections as late complications [10]. They further identified no difference in the proportion of patients developing early complications based on diversion type; however, continent diversion patients developed late complications more frequently than IC diversion patients did. A recent population-based study in the United States found that the overall rate of in-hospital complications was 51% for continent diversion and 54% for IC diversion, which was statistically different although they were unable to assess posthospitalization complications or the severity of the complications [6]. Despite this 3% statistical difference between diversion types, the clinical effect and how this affects decision making for selecting diversion type for individual patients are unclear. These rates of complications are similar to the rates of 30-day postoperative complications that we identified in our population. We found it interesting that although the IP patients were more likely to develop less severe complications, which was largely driven

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by the high proportion of IP patients developing SSI, there was no difference in the proportion developing major complications. This reassures us that IPs that are performed at a high-volume institution are a safe, continent alternative for patients undergoing radical cystectomy. One of the presumed benefits of continent urinary diversion with either IP or NB is improved health-related quality of life (QOL) compared with that of IC diversions. Few studies have identified significantly improved QOL for patients undergoing continent diversion [16,18–20]; however, the degree to which this is related to a lack of validated bladder cancer–specific instruments is unclear [19,20]. Mansson et al. [21] compared health-related QOL between orthotopic NB and IP patients and reported that there were no differences identified by the QOL instruments but that IP patients reported less difficulty controlling their urine, whereas NB patients reported better erectile function. An interesting study from Ohrstrom et al. [22] reported on the working capacity and metabolic status of patients with IP diversion compared with an age- and activity level– matched group of peers. They found that despite a slight hyperchloremic metabolic acidosis in the IP patients, there was no difference in the ability to perform short, strenuous exercise between the groups [22]. Additionally, Nieuwenhuijzen et al. [10] reported that 96% of IP patients had complete continence at long-term follow-up. These findings suggest that despite QOL instruments being unable to detect a QOL difference for IP, one may exist. The initial goal and benefit of the IP was providing patients with a continent option for urinary diversion, even with the onset of bladder replacement. Benefits for patients specific to the IP have remained, particularly for patients concerned with the potential of nocturnal incontinence and in the setting of urethrectomy during cystectomy [2,23,24]. The most commonly reported long-term complications are stomal stenosis, infection, stones, and leakage [10,17,25]. Nieuwenhuijzen et al. [10] reported that 13% of their IP patients required surgery for stomal stenosis, which was significantly higher than for IC, and that 8% of their IP patients developed a fistula; however, they found no overall difference in the rate of long-term major complications when comparing between the diversion groups. Although they do not provide a comparison with other diversions performed at their center, Holmes et al. [25] reported that 52% of IP patients required reoperation for stenosis, ureteral stricture, pouch stones, or parastomal hernia. Most of these complications occurred in association with the efferent limb of the pouch. Furthermore, Holmes et al. [25] report leakage or incontinence in 28% of their patients, which is higher than other reports that suggest 3% to 25% nighttime incontinence but 3% to 4% daytime incontinence [10,17]. These data highlight the complexity and intricacies involved with creation of an IP and would suggest the importance of referral to institutions and surgeons who perform a high volume of IPs to minimize the short- and long-term morbidity of the procedure.

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The Agency for Healthcare Research and Quality publishes provider and area level patient safety indicators that include postoperative infectious complications, wound dehiscence, and venous thromboembolism (DVT and PE). These patient safety indicators and the Center for Medicare and Medicaid Services “never events” are slowly being incorporated into hospital and physician pay-forperformance reimbursement schemas [26,27]. As the current health care climate evolves with the goals of cost cutting and quality optimizing, recognizing that high rates of perioperative complications are a reality in certain patient populations is imperative to ensure that reimbursement changes do not affect patient access to quality medical care [27]. Endeavors such as NSQIP should continue being encouraged to identify potential areas of intervention for the reduction of complications in these complex patient cases; however, health care providers and policy makers must remain cognizant of unexpected consequences of these interventions. Our current study suggests that regardless of being performed at a highvolume institution, a large percentage of urinary diversion patients will develop postoperative complications. Reductions in reimbursement for these complex cases based on postoperative complications would negatively affect patient care and potentially reduce access to physicians willing to perform radical cystectomy. There are limitations worth discussing related to this project. NSQIP has been collecting data on cystectomy patients at our institution for a limited period of time and only captures approximately 70% of our cystectomy cases, which results in a small cohort of patients to include in this study. Additionally, the data examined here are retrospective and from a single institution, resulting in potential selection biases. However, until more extensive data are available, we feel that this study provides important insights into 30-day postoperative morbidity and mortality for patients undergoing IP urinary diversion, particularly considering the extensive experience our institution has in performing this type of diversion over the years. Furthermore, this is one of the largest contemporary series examining complications among IP patients as most previous studies span a much broader period throughout which surgical techniques have evolved. Despite patients undergoing radical cystectomy at highvolume institutions, rates of Clavien grade III–V postoperative complications are significant. These complications persist regardless of diversion type and should not serve as a deterrent to urologists considering IP. Acknowledgment The authors thank Molly Kilbane, the NSQIP surgical clinical reviewer at our hospital, whose hard work and dedication to the ideals of NSQIP enabled the current project.

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