Analysis of the patients' quality of life after radical cystectomy with the orthotopic neobladder or ileal conduit formation

Introduction

Around one out of five new cases of bladder cancer are muscle-invasive, which requires a surgeon and a patient to choose one of two variants of treatment: radical cystectomy (RCE) or organ-sparing therapy (trimodal therapy) [1]. However, despite the development of new organ-sparing approaches in the treatment of muscle-invasive bladder cancer RCE with urinary intestinal diversion remains the prevailing variant of treatment [2]. RCE with different methods of urinary intestinal diversion in the postoperative period affects numerous aspects of a patient’s life and such a factor as the quality of life of patients should be considered by the surgeon along with post-operative complications, lethality, general, and recurrence-free survival [3][4]. The formation of orthotopic neobladder or ileal conduit is an optimal and widespread method of urinary intestinal diversion. Still, there is no consensus on which of the methods of urine diversion provides better quality of life [5]. The study aimed to compare the quality of life of patients that underwent RCE with the formation of orthotopic neobladder or ileal conduit formation.

Materials and Methods

A retrospective comparative study of the quality of life after cystectomy included 60 patients (46 men (76.6%) and 14 (23.4%) women) out of 132 that underwent RCE with different methods of urine diversion from August 2011 to July 2019 performed by one surgeon. The mean age of patients was 66 (47 ‒ 85) years old. The ratio of men and women was 3:1. All patients signed informed consent for participation in the study.

The criteria of exclusion from the study were neoadjuvant chemotherapy for bladder cancer in anamnesis, preoperative ASA IV ‒ V degree, cystectomy with urinary intestinal diversion not for bladder cancer, impossibility to fill in the questionnaires for the evaluation of the quality of life for any reason.

For a retrospective comparative analysis of the quality of life after RCE, all patients were divided into two groups. Group I included 26 patients (43.3%) who underwent RCE with orthotopic neobladder formation by the Studer’s technique. Group II included 34 patients (56.7%) who underwent RCE with ileal conduit formation by the method of Bricker. The characteristics of patients from both groups are presented in Table 1.

Table 1. Patient demographics

The median time of observation from the time of surgery to the time of the survey was seven months (4.5 ‒ 9.5 months). The monitoring of the postoperative quality of life of patients after RCE was performed based on questionnaires EORTC QLQ-C30, and EORTC QLQ-BLM. The preferences on the mentioned questionnaires were determined by a many-sided evaluation of the quality of life in oncourological patients. QLQ-BLM provided data directly on the functional peculiarities in the postoperative period after RCE. QLQ-C30 evaluated the physical, cognitive, and emotional condition of patients, and their social adaptation. The survey was made in the form of a phone poll. All patients received the mentioned questionnaires by e-mail in advance. Later, the results were discussed with each patient by phone.

All patients that underwent RCE were managed according to the protocol ERAS (enhanced recovery after surgery) since 2015. It is based on the correction of the respective pathology before surgery, fasting before surgery, lack of intestinal preparation and postoperative drainage, warming of the patient and infusion solutions during surgery, early activation and feeding in the postoperative period, and withdrawal of routine antibacterial therapy.

Apart from this, the study included the evaluation of the quality of life of patients after RCE. A retrospective comparative analysis of the rate of early postoperative complications was performed as a possible factor that affects the quality of life of patients after surgery and the lethality in both groups. The comparative analysis of the rate of early postoperative surgical complications after RCE was performed using the classification of Clavien-Dindo.

Statistical processing of the data was performed using electronic tables Microsoft Excel and software package Statistica for Windows v. 7.0 (StatSoft Inc., USA). In cases of normal distribution of the data in groups, methods of parametric statistics (Student’s test) were used. When the distribution was abnormal, the methods of non-parametric statistics were used (Mann-Whitney test). The dynamical parameters were evaluated with a paired Wilcoxon’s test. The qualitative parameters were coded with symbols. Their calculation was presented in absolute and relative values (%). The χ2 method with Yates’ correction for continuity was used to reveal the differences between the qualitative parameters. It was calculated using 2×2 and 3×2 nets as well as a precise Fisher’s test for small samplings. If the mentioned methods could not be used, a Z-test for shares was used. The differences were statistically significant at p < 0.05 (95% CI).

Results

The mean time of operation in Groups I and II was 280 ± 56.3 and 230 ± 60.8 minutes (р = 0.117), median blood loss was 350 (283 ‒ 380) and 270 (245 ‒ 310) ml (р = 0.213), respectively.

The retrospective analysis of the rate of early postoperative surgical complications (90-day period) after RCE by Clavien-Dindo scale revealed I ‒ II degree complications in Group I in 11 patients (42.3%), in Group II ― in 12 patients (35.2%) (p = 0.579), III-IV degree complications by Clavien-Dindo scale were revealed in Group I in five patients (19.2%), in Group II ― in seven patients (20.5%) (p = 0.896). The most frequent compilations were infectious and gastrointestinal. Intraoperative and postoperative results are presented in Table 2.

Table 2. Intraoperative and postoperative results

In the early postoperative period (up to 90 days), the lethality was 8.3% (five people). There were no statistically significant differences in the groups of patients (р = 0.241).

Based on the retrospective analysis of the questionnaire QLQ-C30 and QLQ-BLM, the authors revealed that the summed “good” quality of life in Group I was observed in 18 patients (69.2%) in comparison with Group II ― 15 patients (44.1%) (p < 0.05).

According to the QLQ-C30 questionnaire, qualitative and quantitative characteristics of the parameters of the quality of life correlate inversely: a higher score indicates a lower quality of life and vice versa. The median scores were the following: by the scale of physical condition in Group I ― 59 points, in Group II ― 85 points; by the scale of cognitive functions in Group I ― 44 points, in Group II ― 67.5 points; by the scale of emotional condition in Group I ― 40.5 points, Group II ― 60.5 points; by the scale of social adaptation in Group I ― 32 points, in Group II ― 70.5 points. The evaluation of financial issues in the postoperative period according to QLQ-C30 showed that the median score was 13 points in Group I and 20 points in Group II.

In the postoperative period, patients from both groups had such prevailing symptoms as nausea, vomit, fatigue, and pain. The analysis of functional results showed that in Group I, four patients (15.3%) had nocturnal and daytime urinary incontinence, two patients (7.6%) required self-catheterization of the intestinal reservoir periodically; in Group II, eight (23.5%) patients reported periodical urine leakage from the urostomy and skin dermatitis. Table 3 shows the results of a QLQ-C30 questionnaire on the quality of life of oncologic patients after RCE regardless of the time of surgery.

Table 3. QLQ-C30 questionnaire results for the patients QoL after RCE

Discussion

RCE with urinary intestinal diversion is one of the most complicated reconstructive surgeries in oncourological practice, which is associated with a high rate of complications (30-80%). It affects different aspects of the quality of life of a patient in the postoperative period. In the preoperative period, a surgeon and a patient need to consider all the criteria and chose the optimal method of urinary intestinal diversion after RCE, which will provide adequate quality of life for a patient [6][7]. According to the available published data, contraindications to orthotopic urinary intestinal diversion include tumor process in the bladder neck and urethra, affected lymphatic nodes at the stage N2-N3, renal failure, mental status impairment, age older than 80 years old. If there are contraindications to orthotopic urinary intestinal diversion, ileal conduit formation by Bricker should be the method of choice [8][9]. From the time of improvement of the quality of life after RCE with a urinary intestinal diversion to date, there is no common opinion in the published literature on the choice of method, which would be optimal for a patient and provide a better quality of life.

Yang et al. conducted one of the largest meta-analyses of scientific publications starting from 2000 on the evaluation of the quality of life after RCE with urinary intestinal diversion. The meta-analysis included 29 randomized comparative studies and 3754 patients. The authors used questionnaires FACT and SF-36. The study results showed that there was no statistically significant difference in the quality of life of patients with neobladder and ileal conduit. It should be mentioned that physical activity was better in patients who were formed ileal conduit, and emotional functions were better in patients with orthotopic urine diversion [10].

Cerrutо et al. performed a meta-analysis that included 18 randomized comparative studies (1980 ‒ 2015) with 1553 patients, 712 of them underwent ileal conduit formation and 841 patients underwent neobladder formation. The questionnaires included SF-36, EORTC-QOL-C30, FACT-BL-VCI, and EORTC-QOL-BLM. The authors highlighted the statistically insignificant better quality of life in patients with an orthotopic neobladder. The most significant improvements were noted in the emotional-psychologic sphere and social adaptation. There were no differences in physical activity [11].

In the present comparative study, the authors obtained the primary data on the quality of life that was better in the group of patients with orthotopic neobladder (69.2%) in comparison with the group of patients with ileal conduit (47%) (p < 0.05). The prevailing aspects of the quality of life in the group of patients with orthotopic neobladder were not only in the emotional-psychic sphere and social adaptation but also better physical activity. The authors believe that the obtained results are explained by the younger age of patients in the group with an orthotopic neobladder, lower rate of comorbidity, and initially better social adaptation. As for the symptom domain in the postoperative period, apart from sleep disturbances that prevailed in the group of patients with an orthotopic neobladder, there were no differences revealed. This is associated with the fact that patients with orthotopic neobladder have to follow the strict compulsory regimen of nocturnal and daytime urination acts, which affects the quality of sleep. The results of the present study also showed that in the group of patients with an orthotopic neobladder, patients experienced fewer financial issues in the postoperative period. The authors believe that this fact is associated with younger and employable age and better social adaptation of patients with neobladder in comparison with patients with stomas, whose quality of life decreased so much that they had to stop the professional activity. The analysis of the results of the QLQ-BLM questionnaire showed that patients with orthotopic neobladder were not satisfied with the quality of urination: four patients (15.3%) had nocturnal and daytime urinary incontinence, and in two patients (7.6%), periodic self-catheterization of the intestinal reservoir was required.

A weak side of the study was the diversity of groups of comparison by the age and stage of the disease, which can significantly influence the quality of life after the surgery. Presently, in the world practice, the majority of patients prefer the formation of ileal conduit (urostomy) during the reconstructive stage of surgery. It is associated with the opinion that Bricker surgery is simpler and more time-consuming, has a lower rate of postoperative complications, and a shorter period of postoperative rehabilitation [12, 13]. The present study demonstrated that the formation of ileal conduit was faster than the reconstruction of the neobladder but similar in the rate of complications. Urostomy had a more significant effect on the quality of life of patients after surgery than the time of surgery and the simplicity of the technique for a surgeon. The authors believe that the choice of the optimal method of intestinal urinary diversion should be made by a surgeon, who has to consider all contraindications to both methods of urine diversion and explain the choice to the patient. In turn, the patient has to evaluate the methods with the doctor’s help and understand what changes in the lifestyle to expect in each case.

Conclusion

Despite the generally accepted preference among surgeons in favor of ileal conduit formation by Bricker’s method in patients after RCE, urine diversion with the formation of orthotopic neobladder demonstrated better results in terms of quality of life of patients, especially in the young group. Long-term studies are needed with a larger sampling to obtain more reliable data on the quality of life of patients after RCE with urinary intestinal diversion.