Cutaneous ureterostomy with definitive ureteral stent as urinary diversion option in unfit patients after radical cystectomy

PURPOSE: Simple diversions are underutilized, mostly for unfit, bedridden, and very self-limited patients requiring palliative surgical management due to life-threatening conditions. Experience with cutaneous ureterostomy (CU) as palliative urinary diversion option for unfit bladder cancer patients is reported. METHODS: We retrospectively reviewed clinical and operative parameters of 41 patients who underwent CU following RC in three specialized Cancer Centers from July/2005 to July/2010. Muscle-invasive disease (clinical Stage T2/worse), multifocal high-grade tumor, and carcinoma in situ refractory to intravesical immunotherapy were the main indications for RC. double-J ureteral stents were used in all patients and replaced every 6 months indefinitly. Peri-operative morbidity and mortality were evaluated. RESULTS: Median age was 69 years (interquartile range IQR 62, 76); 30 (73%) patients were men. Surgery in urgency setting was performed in 25 (61%) of patients, most due to severe bleeding associated with hemodynamic instability; 14 patients (34%) showed an American Society of Anesthesiologists score 4. Median operative time was 180 minutes (IQR 120, 180). Peri-operative complications occurred in 30 (73%) patients, most Clavien grade I and II (66.6 %). There was no per-operative death. Re-intervention was necessary in 7 (17%) patients. Overall survival was 24% after 9.4 months follow-up. CONCLUSIONS: CU with definitive ureteral stenting represents a simplified alternative for urinary diversion after palliative cystectomy in unfit patients. It can be performed quickly, with few early and late postoperative complications allowing RC in a group of patients otherwise limited to suboptimal alternatives. Future studies regarding the quality of life are warranted.


Introduction
In 2010, an estimated 70,530 Americans were diagnosed with bladder cancer (BC) and 14,680 died from their disease. BC represents the fourth most common cancer and is the ninth leading cause of death from cancer in the United States 1 .

Muscle invasive bladder cancer (MIBC) accounts for
approximately 20-30% of the newly diagnosed cases. Moreover, 10% to 30% of the initially non-muscle invasive cancer will progress to muscle-invasive disease 2,3 . Radical cystectomy (RC) with urinary diversion is considered the standard treatment for MIBC. 4 Age is an independent risk factor for developing bladder cancer. As result of the continuous improvement in life expectancy, more elder patients are expected to harbor the disease 4 . Bladder cancer is the fourth leading cause of cancer related mortality in men 80 years old or older 5 .
Management of MIBC in the elderly is becoming an important issue in urological practice for the continuous ageing of the population; additionally, the demands for palliative handling and/or treating unfit patients are considerable in support of aged. These patients usually have an increased probability of harboring severe co-morbidities (as diabetic, chronic renal failure, hypertension cardiac disease), with increased treatment related morbidity. Moreover, life-threatening conditions (i.e. bleeding and renal insufficiency) related to advanced disease are more prone to occur, adding an even higher risk of peri-operative complications and mortality.
While several centers have concluded that RC may be performed with a higher but acceptable morbidity rate 6-8 , its role in elderly patients is still in debate due to the associate morbidity.
Complication rates following RC have been reported in the range of 24% to 64% with some authors identifying age as a significant risk factor for peri-operative complications, mostly related to urinary diversion 9 .
Cutaneous ureterostomy (CU) represents an alternative to ileal conduct in highly ill patients, reducing surgical trauma and risk of complications. It avoids surgical and metabolic complications such as small bowel obstruction, paralytic ileum, delirium and delayed restart of deambulation 10 . We report on our experience with cutaneous ureterostomy with definitive ureteral stenting as urinary diversion option after radical cystectomy in unfit patients and after palliative handling. Complications were graded using the modified Clavien classification system 12   By 2020 there will be 52 million elderly, representing more than 20% of the United States population 13 .

Methods
Bladder cancer incidence in people over 85 years is twofold higher compared with those younger than 65 years 14 15,16 . When the decision for a radical cystectomy is made, not the real but much better the ''biological'' age of the patient should be taken into consideration.
Whether radical cystectomy for muscle-invasive bladder cancer is justified even in older patients, not only the possible improvement of the long-term survival has to be recognized, but also the impact of the therapeutical approach on the patients' quality of life is at least as important as the latter point. This aspect should be focused on future studies.
Thanks to advances in surgical technique, anesthesia, and intensive care, the mortality and morbidity rates following radical cystectomy in elderly patients have dramatically decreased, achieving similar results to those reported in younger patients 8,9 . Nevertheless, several centers specifically evaluating RC in the elderly have concluded that RC may be performed with a higher but acceptable morbidity rate 7,8,17,18 .
Regardless of age, complications after definitive treatment for invasive bladder cancer can be associated with the radical cystectomy or the urinary diversion. Therefore, choosing a less morbid urinary diversion can decrease the complications rate.
Ileal conduct has been successfully used as the urinary diversion option in patients with high risk and more advanced diseased.
However, complications related to the gastrointestinal tract violation are even frequent, mainly among elder patients.
Cutaneous ureterostomy may represent an alternative to ileal conduit. deliveliots et al compared complication rates after modified cutaneous ureterostomy and the ileal conduit in high-risk patients. CU was associated with lower early and late complication rates, as shorter length of hospitalization 10 .
Our data showed complications in 73% of patients.
Although higher than described in current RC series, our patients represent a selected poorer performance status cohort. Moreover, most of the complications are grade I and II (66.6%). There were two post-operative deaths; they occurred in highly sick patients undergoing surgery in an urgency setting due to severe bleeding, and were probably not related to the procedure, once occurred over 30 days after the procedue.
Our data confirms that in unfit high-risk patients, radical cystectomy can be safely performed, even on an urgent basis.
Furthermore, cutaneous ureterostomy might still have a role as a quick and reliable option of urinary diversion. A short operative time associated with reduced bleeding, and avoidance of enteral anastomosis might be associated with reduced morbidity after CU. Enteric fistula would be a devastating complication in such ill population, from who its incidence would be higher due associated malnutrition. The present study has the limitations of a retrospective analysis and the small number of patients in a clinical series.
Furthermore, analyzing complication data in a morbid population undergoing a major procedure for a life threatening disease is not an easy task. There is a lot of confounding overlapping variables.
Some morbidity or even death causes can be related to the disease aggressiveness and not the procedure per se. Interpretation of such data has to be done with cautious and future studies are warranted concerning CU.

Conclusions
Although underutilized, cutaneous ureterotomy represents a simplified alternative for urinary diversion after radical cystectomy in unfit patients and/or for palliative management. It can be performed quickly, with reduced morbidity, compared to other urinary diversion options, allowing RC in a group of patients otherwise limited to suboptimal and alternative multimodal bladder preservation. These advantages could be of great significance in high-risk and elderly patients. Future studies regarding the quality of life and including extreme range ages for such procedure are warranted.