REVIEW URRENT C OPINION

Neobladders and continent catheterizable stomas for the bladder cancer survivor Andrew C. James, Daniel W. Lin, and Jonathan L. Wright

Purpose of review Health-related quality of life (HRQOL) following radical cystectomy for bladder cancer is an important outcome measure following radical cystectomy. Understanding HRQOL issues related to continent urinary diversion is crucial in the care and counseling of patients undergoing radical cystectomy. The goals of this review are to give a broad overview of the major types of continent urinary diversions and to review recent literature examining HRQOL in patients undergoing orthotopic neobladders and continent catheterizable urinary reservoirs following radical cystectomy. Recent findings Generic questionnaires that broadly address physical, social, and mental functioning and bladder cancerspecific questionnaires that more specifically address urinary, bowel, and sexual function have been utilized to measure HRQOL following radical cystectomy. Although existing studies indicate that overall quality of life may be similar in patients with continent and noncontinent urinary diversions, more specific comparisons of urinary and sexual function are conflicting and complicated by sex-specific concerns. Uterine preservation may improve urinary function in women with continent urinary diversions. Summary Although the development of disease-specific validated questionnaires has improved our understanding of HRQOL following radical cystectomy, a lack of prospective studies limits conclusions regarding the superiority of diversion type. Appropriate preoperative consultation may facilitate realistic expectations, thereby optimizing outcomes. Keywords bladder cancer, continent cutaneous reservoir, neobladder, quality of life, radical cystectomy

INTRODUCTION Radical cystectomy is the gold standard for treatment of muscle-invasive bladder cancer, in select cases of nonmuscle invasive bladder cancer, and other unique clinical scenarios [1–4]. Following radical cystectomy, urinary reconstruction is performed with either a noncontinent or continent urinary diversion. In the case of noncontinent urinary diversion, a primary goal is low pressure urine transport and drainage. Previously, a noncontinent urinary diversion, for example, ileal conduit urinary diversion, was the major type of diversion. However, continent urinary diversions, either through the creation of an orthotopic neobladder or a continent cutaneous urinary reservoir (CCUR), are being performed more commonly, although the overall utilization is low. For example, in the USA, a continent diversion is performed in approximately 20% of all cases, however, it is estimated that up to 80% of men and 65% of women may be candidates for this

diversion type [5,6]. Given that the cancer control between continent and noncontinent urinary diversions is similar [7], quality of life (QOL) becomes an extremely important factor to consider in the decision-making process. Health-related quality of life (HRQOL) has been defined as the value assigned by individuals, groups, or society to the duration of survival modified by impairments, functional states, perceptions, and social opportunities influenced by disease, injury, or treatment [8]. Emphasis on issues related to Department of Urology, University of Washington School of Medicine, Seattle, Washington, USA Correspondence to Jonathan L. Wright, MD, MS, Department of Urology, University of Washington School of Medicine, 1959 NE Pacific, Box 356510, Seattle, WA 98195, USA. Tel: +1 206 543 4740; fax: +1 206 543 3272; e-mail: [email protected]. Curr Opin Urol 2014, 24:407–414 DOI:10.1097/MOU.0000000000000069

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KEY POINTS  The development of disease-specific validated questionnaires has improved our understanding of HRQOL following radical cystectomy, but a lack of prospective studies limits conclusions regarding the superiority of urinary diversion type.  Specific comparisons of urinary and sexual function in patients with continent versus noncontinent urinary diversions are conflicting and complicated by sexspecific concerns.  Appropriate preoperative consultation regarding the advantages and disadvantage of each urinary diversion type is important in optimizing individual patient outcomes by helping patients have realistic expectations regarding each option.

treatment decisions that affect QOL both in the immediate perioperative period and in the longer term following convalescence is extremely important, in particular with regards to patient expectations. In the context of radical cystectomy wherein urinary diversions are a major source of short-term complications and long-term functional outcomes, understanding the issues of QOL related to continent urinary diversion is paramount in the care and counseling of patients undergoing radical cystectomy. The two goals of this review are to give a broad overview of the major types of continent urinary diversions and their associated complications and to address recent literature examining QOL in patients undergoing orthotopic neobladder diversion and continent catheterizable urinary reservoirs following radical cystectomy for bladder cancer.

OVERVIEW OF DIVERSION TYPES CCURs allow urine to be drained through a catheterizable channel. The most commonly performed CCURs create a catheterizable pouch from the right colon; examples include the Indiana and Florida pouches [9,10]. Pouch construction involves the creation of a stoma made either from the appendix or, more commonly, from a tubularized segment of terminal ileum that incorporates the ileocecal valve to increase resistance to the outflow of urine from the pouch, thereby improving continence. Less commonly, the pouch is created entirely from small bowel. In this instance, continence is created by intussuscepting the small bowel upon itself to increase outflow resistance. Orthotopic neobladder urinary diversions attempt to preserve normal anatomic voiding from 408

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the urethra. Two commonly performed methods of neobladder construction are the Hautmann and Studer pouches [11,12]. Both typically utilize approximately 60 cm of ileum that is detubularized and fashioned into a pouch with one or two afferent limbs to which the ureters are anastomosed. The urethral stump is anastomosed to the most dependent portion of this pouch. Both pouches expand with time to typically accommodate 500 ml of urine. Alternatively, neobladders may be constructed from colonic segments, from a combination of both ileal and colonic segments, or by utilizing other techniques with alternative configurations of terminal ileum including the T-pouch, Kock reservoir, and Camey II [13–18]. A detailed explanation of the techniques involved in performing these diversion types is beyond the scope of this review.

COMPLICATIONS OF CONTINENT URINARY DIVERSIONS Radical cystectomy is a morbid procedure associated with a 35–50% complication rate and 26–35% hospital readmission rate [19,20], largely attributable to the extensive extirpative and reconstructive components of radical cystectomy. In addition to the complications to which all cystectomy patients are susceptible, such as ureteroenteric anastomotic stricture, wound complications, and small bowel obstruction, among others, there are inherent complications particularly associated with continent urinary diversions. Both CCUR and neobladder diversions are susceptible to pouch perforation and leak, calculi, urinary incontinence, and infection. It is noteworthy that although incontinence of CCUR can lead to wetness of the abdomen and overlying clothing, urinary incontinence from neobladder contributes to wetness that is confined to the perineum. This requires different solutions for managing the incontinence associated with each (i.e., urinary pads with neobladder and stomal bags with CCUR). Complications specific to CCURs are stomal stenosis and problems due to the efferent limb that precludes adequate catheterization and drainage. Holmes et al. [21] examined a series of 125 patients who underwent Indiana Pouch with a mean followup of 41 months. One hundred and twelve (89.6%) patients had at least one complication. Fifty-eight percent were related to the efferent limb (incontinence in 28%, stomal stenosis in 15%, and difficult catheterization in 10%). Pouch stone formation occurred in 10%, perioperative pouch leaks in 4%, pouch perforations in 3%, and the reoperation rate was 52%. In a smaller series by Rowland [22] (n ¼ 81), the authors found a continence rate of Volume 24  Number 4  July 2014

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93%, stomal stenosis in 4%, and a late reoperation rate of 14.8%. Neobladders are also associated with complications secondary to the nature of the reconstruction. A two-surgeon series containing 845 patients who underwent radical cystectomy with neobladder urinary diversion had an early complication rate of 21.1% and a late complication rate of 30.5% [23]. Complications included neobladder outlet obstruction (8%), mucus obstruction (5.6%), metabolic derangements (4%), and neobladder-enteric fistula (1%). Other complications include pyelonephritis/ sepsis (15%), incisional hernia (8%), and ureteroenteric anastomotic stricture (7%). Continence following neobladder has been reported in several series. In one, urinary continence was evaluated through a questionnaire returned by 179 patients at a mean follow-up of 4.5 years following radical cystectomy [24]. Of these patients, 39.7% had daily urinary incontinence with 16.8% reporting frequent dribbling throughout the day. Fortythree percent of patients reported daily mucous leakage. Continence rates were much worse during the night-time, with 54.7% of patients reporting night-time incontinence, including 53.1% of patients reporting no control/frequent dribbling during the night. Pads were worn by 47% of patients during the day and 72% at night. A series by Studer et al. [11] of 200 patients reported daytime and night-time continence rates of 90 and 80%, respectively, whereas a series by Hautmann et al. [25] of 363 patients reported daytime and night-time continence rates of 96 and 95%, respectively, with continence being defined as requiring no more than one urinary pad during the day or night. The major difficulty in comparing continence rates among series is the utilization of several definitions of continence, some based upon subjective parameters, whereas others are based upon objective measurements, making true comparison difficult. Unlike ileal conduit urinary diversions, both CCUR and neobladder urinary diversions require meticulous postoperative care to minimize the risk of complications. It is imperative that patients understand the commitment required to properly care for their urinary diversions before radical cystectomy. Such care may have a considerable impact on a patient’s QOL, and overall satisfaction is likely dependent upon a patient’s preoperative understanding of the long-term maintenance requirements. Additionally, although patients may be capable of caring for continent urinary diversions in the foreseeable future, consideration of the ability to perform self-care of continent diversions as a patient ages should be considered and discussed thoroughly as part of preoperative counseling.

MEASURING HEALTH-RELATED QUALITY OF LIFE IN PATIENTS FOLLOWING RADICAL CYSTECTOMY HRQOL has been assessed through QOL questionnaires that can vary in terms of their specificity for a given treatment. Generic questionnaires focus on energy, stamina, and physical function; these domains are applicable to all individuals, whereas urologic disease-specific instruments may focus on items, such as urinary leakage, self-image following urinary diversion, and sexual function. The Short Form Health Survey (SF-36), the quality of being scale, and the Sickness Impact Profile are all examples of generic questionnaires that are applicable to patients undergoing various treatments of essentially any condition [26–28]. An advantage of these less specific questionnaires is that they may be able to better capture QOL changes resulting from unanticipated factors. For example, although a more urinaryspecific questionnaire may adequately assess the effect of urinary incontinence in a patient with a neobladder, if an unanticipated side-effect develops and is not addressed in the disease-specific instrument’s questions, the changes in HRQOL may be better assessed with a generic HRQOL instrument. General cancer-specific questionnaires, which are specific to cancer but not to a specific cancer type, include the European Organization for Research and Treatment of Cancer – QOL (EORTC-QLQ-C30) and the Functional Assessment of Cancer Therapy (FACTG) [29,30]. The EORTC-QLQ-C30 more specifically examines physical, psychological, and social health of patients diagnosed with cancer and assesses symptoms such as fatigue, nausea, vomiting, and pain [31]. Likewise, the FACT-G addresses physical, functional, social, and emotional well-being in patients undergoing treatment for different malignancies [30]. Although more specific than general HRQOL questionnaires, these do not specifically address patients undergoing radical cystectomy for bladder cancer. Several bladder cancer-specific HRQOL instruments have been developed, including Functional Assessment of Cancer Therapy- Bladder (FACT-BL), Functional Assessment of Cancer Therapy – Vanderbilt Cystectomy Index (FACT-VCI), the European Organization for Research and Treatment of Cancer (EORTC) QLQ-BLM30, and the Bladder Cancer Index (BCI). The FACT-BL is based upon the FACT-G that also includes 12 additional bladder cancer-specific items, including incontinence, diarrhea, body image, sexual function, and stoma care [32]. FACT-BL is one of the oldest bladder cancer QOL questionnaires, and thus has been frequently utilized. The FACT-VCI combines the FACT-G with 17 additional items more specific to treatment radical cystectomy, including self-body image, urinary and bowel function, impact

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on social interactions, and sexual function [33]. The EORTC-QLQ-BLM30, is based upon the less specific EORTC-QLQ-C30 and incorporates 30 additional questions specific to the treatment of bladder cancer [32]. The BCI is a more recently developed QOL assessment that examines patients undergoing an array of treatments for bladder cancer, including endoscopic therapies, intravesical therapies, and radical cystectomy [34]. The BCI specifically examines urinary, bowel, and sexual health domains, and unlike the FACT-BL and FACT VCI, the BCI reports a score for each of these domains instead of reporting a single score that incorporates all aspects of the assessment. A summary of these HRQOL instruments is given in Table 1.

CHALLENGES IN MEASURING HEALTHRELATED QUALITY OF LIFE FOLLOWING RADICAL CYSTECTOMY One of the major challenges in measuring HRQOL in patients following radical cystectomy is the sexspecific concerns that make utilization of a single HRQOL instrument difficult. For example, sexual concerns affecting women that are not applicable to men include vaginal shortening, lack of vaginal lubrication, and dyspareunia, whereas potential concerns, such as erectile dysfunction, anejaculation, and climacturia are specific to men. Additionally, other issues, such as need for intermittent catheterization and the impact on body image, may affect men and women differently. Because of this, HRQOL assessments, particularly in regards to sexual function, may only be comparable within each individual sex. Although this review focuses mainly on HRQOL in those undergoing a continent urinary diversion, it is apparent that factors affecting patients undergoing urinary diversion via ileal conduit, such as the impact on self-image of a urinary stoma or a leaking collection bag, will not affect patients undergoing continent urinary

diversion. Thus, capturing the impact of all these factors on HRQOL in a single questionnaire that is comparable between the different urinary diversions is a difficult task. Another difficulty in developing tools to measure HRQOL in radical cystectomy patients is that more specific questionnaires may lose the ability to capture the impact of unforeseen consequences of treatment that may impact QOL. For example, questionnaires focused on sexual, bowel, and urinary function, such as the BCI that is incredibly specific to patients treated for localized bladder cancer, may not be able to capture the impact of unforeseen consequences of treatment, such as nerve injury secondary to treatment that may limit mobility and affect the ability to perform previous activities.

CURRENT LITERATURE EXAMINING HEALTH-RELATED QUALITY OF LIFE OUTCOMES FOLLOWING RADICAL CYSTECTOMY Early studies utilizing generic questionnaires and general cancer questionnaires have shown that although overall HRQOL is similar in patients with noncontinent urinary diversions (e.g., ileal conduit) and continent urinary diversions [35,36], continent diversions may mitigate the impact on more specific QOL domains, such as anxiety related to urinary leakage, improved self-confidence, and less detrimental impact on social functioning, shown through improved restoration of leisure, professional, and traveling activities [37]. Other studies have indicated that patients undergoing continent urinary diversion have improved sexual function as compared with those undergoing ileal conduit urinary diversion [38]. In a prospective study of patients undergoing radical cystectomy for bladder cancer with either CCUR (n ¼ 20) or ileal conduit diversion (n ¼ 24), the authors used the generic

Table 1. Health-related quality of life instruments Domains

Validated

Physical, mental, social, and emotional

Yes

EORTC-QLQ-C30)

Functional scales, symptom scales, and global health

Yes

FACT-G

Physical, social, and emotional

Yes

FACT-BL

Urinary, bowel, and sexual

Pending

EORTC-QLQ-BLM30)

EORTC-QLQ-C3C) and urinary, bowel, and sexual

Pending

FACT-VCI (cystectomy specific)

FACT-G and urinary, bowel, and sexual

Yes

General SF-36 Cancer specific

Bladder cancer specific

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1 and 6 months, and 1,2,4,6, and 8 years after radical cystectomy. Baseline urinary function and bother was slightly better in the neobladder group. After ileal conduit, urinary function scores improved, whereas following neobladder the scores initially decreased but then improved over time although not returning to baseline (Fig. 1) [43 ]. As compared to those with neobladder, those with ileal conduit had better urinary function postradical cystectomy (P < 0.0001). Of note, urinary bother was similar with both diversions (P ¼ 0.32) suggesting patient adaptability postradical cystectomy regardless of diversion type. While both groups had similar body image scores and both experienced worsening of body image scores following radical cystectomy, these scores improved over time. This study is important in that it illustrates the HRQOL changes over time from baseline in patients undergoing urinary diversion. &

Continent urinary diversion in women Owing to the lower incidence of bladder cancer in women, and the fact that fewer women have been

Mean BCI urinary function subdomain score

Mean BCI urinary function subdomain score for bladder cancer patients having cysteotomy

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SF-36 instrument. In this study, they found that life satisfaction and social functioning improved to preoperative baseline by 1 year following radical cystectomy with CCUR, whereas these scores decreased among patients with an ileal conduit diversion. Importantly, overall satisfaction was similar among both groups, with 75% of patients stating they would choose the same type of diversion if they could make the choice again [35]. Another study by Somani et al. [39] prospectively examined body image and QOL utilizing the EORTC-QLQ-C30 and the Satisfaction with Life Scale (SWLS) in 32 patients who either received an ileal conduit diversion or a neobladder and found no significant differences in preoperative QOL and QOL at 9–12 months postoperatively. Although these studies do offer insight into HRQOL issues in patients undergoing radical cystectomy, there are limitations to these and similar studies, which include the utilization of ad hoc (nonvalidated) HRQOL tools or the lack of disease-specific instruments. More recent studies have utilized bladder cancer-specific questionnaires to examine differences between continent and noncontinent urinary diversions, although most have been cross-sectional studies without baseline data. Metcalfe et al. [40] mailed the FACT-VCI questionnaire to 84 patients following radical cystectomy (median follow-up 5.6 years) and found no statistically significant association between type of urinary diversion and QOL on multivariate analysis. Erber et al. [41] examined QOL in patients undergoing radical cystectomy at a single institution by using the EORTC-QLQBLM30. QOL questionnaires were sent to 126 surviving patients in 2008 who underwent radical cystectomy between 1993 and 2007 and were returned by 24 patients with ileal conduit and 34 patients with neobladder. They found that patients receiving neobladder reported significantly better overall QOL. Gilbert et al. [42] utilized the BCI to compare HRQOL in 122 patients with neobladder and 66 patients with ileal conduit. They found that men undergoing neobladder diversion reported decreased urinary function scores as compared with ileal conduit, specifically because of urinary incontinence and lack of urinary control. There were no significant differences within the bowel and sexual domains. These studies yield important data on the HRQOL in patients after radical cystectomy, but are limited by the lack of baseline data to account for selection bias. Hedgepeth et al. [43 ] examined body image and HRQOL in 139 patients with neobladder and 85 with ileal conduit using the BCI to assess urinary, bowel, and sexual outcomes and the EORTC body image scale to assess patient body image at baseline, &

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FIGURE 1. Urinary function and bother for patients treated with cystectomy. Data from [43 ].

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historically offered orthotopic neobladders, there are fewer data on HRQOL in women. However, as discussed earlier, there are specific HRQOL issues that are sex specific. In a recent study, Rouanne et al. [44] examined HRQOL in 31 women undergoing radical cystectomy with neobladder from 2000 to 2011. This study utilized the Short Form-12 Health Survey that broadly examines mental and physical health factors, the Urinary Symptom Profile that broadly examines urinary factors, such as incontinence and dysuria, and the Contilife questionnaire that was developed for women suffering from stress urinary incontinence. These questionnaires were administered once at a mean follow-up period of 5.7 years postradical cystectomy. Seventy-seven percent of patients considered their health as good, very good, or excellent with physical and mental health summary scores that were not significantly different from the general French population normative data. In this cohort, 65% of patients reported complete continence, whereas 31% of patients required long-term intermittent catheterization. Some degree of stress urinary incontinence was reported in 26% of the women during the daytime, and 29% reported night-time urinary incontinence. Incontinence was significantly associated with age above 65 years of age at the time of cystectomy. Similarly, a study of 49 women explored factors associated with urinary incontinence following neobladder [45]. Postoperative daytime incontinence, night-time incontinence, and hypercontinence were seen in 43, 55, and 31% of women, respectively. Severity of daytime incontinence was significantly associated only with preoperative stress incontinence (P < 0.02), whereas severity of nighttime incontinence was only associated with age at cystectomy (P ¼ 0.005). Gacci et al. [46] examined QOL in 16 women undergoing ileal conduit and nine women undergoing neobladder. Utilizing the EORTC-QLQ-C30, the EORTC-QLQ-BLM-30, and the FACT-BL, they found no significant differences among any of the measured domains between the two groups. Recently, 68% of women from a single institution who had undergone neobladder responded to a mailed Bladder Cancer Index. Complete hypercontinence was reported by 44%, and an additional 18% required some catheterization. Age above 65 years was associated with a greater likelihood of need for self-catheterization [47]. Concerns over hypercontinence in women have limited utilization of neobladder in women. However, recent work suggests that uterine preservation may decrease the risk of hypercontinence due to providing anatomic support. A recent series reported that 15 female patients with a mean age 412

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of 42 underwent radical cystectomy and neobladder with preservation of the uterus, vagina, and ovaries [48 ]. Of the 12 patients who remained free of disease with a mean follow-up of 70 months, no patients required catheterization. Additionally, urinary continence, defined as dryness not requiring any pads, was 100% during the day and 92% at night. Another series of 30 female patients undergoing neobladder with preservation of the uterus, vagina, and ovaries also found that no patients required catheterization to empty residual urine [49]. &

Additional health-related quality of life aspects of cystectomy and urinary diversion Several studies have identified additional important factors associated with HRQOL after radical cystectomy. In one study, there was recognition of the importance of the support network and other nonhealth issues in posturinary diversion HRQOL [39]. In that study, family, relationships, and finances were listed as of greatest importance to patients. No patient identified body image as an important factor in overall QOL. In another study, Mohamed et al. [50 ] examined patients’ perceived unmet informational and supportive needs along the spectrum of illness from the diagnosis of bladder cancer, to the postoperative period following radical cystectomy, and to the survivorship period 6–72 months postoperatively. Preoperatively, patients identified lack of discussion regarding diversion option and their associated side-effects, the requirements for self-care, and a detailed discussion of recovery as unmet informational needs. The most common unmet needs postoperatively were a lack of support for medical needs associated with treatment and the initial recovery period, including associated pain, bowel, and urinary dysfunction. Further, in this immediate postoperative period, patients reported an inadequate understanding and lack of sufficient support for help with equipment such as stomal appliances and catheters. Six months following radical cystectomy, the most commonly identified unmet needs were lack of support for psychological issues, such as depression, poor body image, and sexual dysfunction secondary to diagnosis and treatment and difficulty adjusting to changes in daily living. These results highlight the continuum of care needs for patients over time following radical cystectomy and diversion. Along these lines, Benner et al. [51] highlighted the importance of continued assessment of HRQOL in the postoperative period. Six months following radical cystectomy, patients were still bothered by considerable pain, fatigue, anxiety, and decreased spiritual well-being, all of &

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which contributed to a persistently decreased QOL 6 months following radical cystectomy. These identified needs represent areas in which support may be targeted in hopes of improving HRQOL following radical cystectomy. These issues also highlight topics on which clinicians should focus on in the preoperative patient consultation and expectation management.

CONCLUSION Continent urinary diversions through both orthotopic neobladder and CCURs are an excellent option for many patients undergoing radical cystectomy. Although benefits include maintenance of volitional voiding and minimizing the impact of having a stoma, it is uncertain whether these diversions offer better HRQOL outcomes than conduit urinary diversions, as each option has its own shortcomings that may have substantial impact on the QOL of patients. Although our understanding of HRQOL in patients undergoing radical cystectomy has improved with an increase in the number of valid health questionnaires, a dearth of well designed, prospective studies utilizing validated HRQOL tools prevents any firm conclusions regarding the superiority of any particular diversion. Appropriate preoperative consultation regarding the advantages and disadvantage of each diversion is crucial to optimizing individual patient outcomes by helping patients have realistic expectations regarding their options of urinary diversion. Acknowledgements Funding: none. Financial Disclosures: none. Conflicts of interest There are no conflicts of interest.

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Volume 24  Number 4  July 2014

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Neobladders and continent catheterizable stomas for the bladder cancer survivor.

Health-related quality of life (HRQOL) following radical cystectomy for bladder cancer is an important outcome measure following radical cystectomy. U...
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