The relationship between type of urinary diversion and quality of life after radical cystectomy: Ileal conduit versus orthotopic bladder

Abstract Objectives We aimed to compare health‐related quality of life (HrQoL) in patients who underwent ileal conduit (IC) vs orthotopic neobladder (ONB) as a method of urinary diversion (UD) after radical cystectomy (RC) for invasive bladder cancers. Methods The questionnaires of the Functional Assessment of Cancer Therapy‐Bladder Cancer (FACT‐BL) were used to evaluate and compare the HrQoL in 113 patients with 1 year follow‐up. Results Forty‐nine patients were included in the ONB group and 64 patients in the IC group. Patients with IC showed superior scores in all domains of the FACT‐BL questionnaire and this reached statistical significance in physical well‐being (PWB), functional well‐being (FWB), over all FACT‐G, Bladder‐Specific Subscale and FACT‐BL total scores (P‐values = .01, .01, .001, .001, and .001, respectively). Conclusions Our findings demonstrate marginally improved HrQoL in IC patients when compared with patients undergoing ONB which may be attributed to an increased morbidity and postoperative complications in the ONB group.

patients with various types of UD has been evaluated by several studies, but without a definitive conclusion. 5 The aim of the present study is to compare HrQoL between patients who underwent ONB or IC following RC using a validated bladder cancer-specific questionnaire.

| PATIENT AND ME THODS
Through a prospective, observational, comparative, hospital-based study, patients who underwent RC with UD (either IC or ONB) were included in our study in the period between September 2015 and November 2018. The shared-decision to utilize one method of reconstruction over another was made between the surgeon and patient following a discussion of the benefits and risks of each modality. All cystectomies were performed using an open technique and ONB were performed using a consistent method utilized in our center. Patients in both groups were followed up routinely at 3, 6, and 12 months postoperatively.
Our exclusion criteria were the presence of metastatic or recurrent disease, patients' preference to not be included in the study, missed preoperative data, patients who died and patients who received palliative therapy during the 12 month follow-up period.
Our demographic data included age, sex, body mass index (BMI), comorbidities, pathological tumor stage, histopathology of the specimen, postoperative complications, and adjuvant therapy undertaken. The FACT-BL questionnaire is designed to evaluate QoL in patients with bladder cancer and consists of two parts. The first part is the general version (FACT-G) assessing four domains (physical well-being, social/family well-being, emotional well-being, and functional well-being), with patients responding to statements on a fivelevel ordinal Likert Scale, ranging from "not at all" to "very much." Higher scores indicate a better QoL.
The second part is a bladder cancer-specific module. It evaluates urinary, intestinal, and sexual function, with a total of 10 statements, plus two more for patients with a stoma.
The questions are scored based on a scale from 0 to 4, with 0 being not at all and 4, very much, with the higher the score again indicating a better QoL. 6 The questionnaires were completed by participants in clinic 12 months postoperatively.

| Sample size
A study sample size was calculated using G* power software version 3.1.9.4. Test family (t tests), type of power analysis (A priori: Compute required sample size-given , power and effect size), input parameters, effect size = 0.64, error = 0.05, power (1 − ) = 0.8, and with assuming allocation ratio N1/N2 = 1. The resulting output parameters provided a total sample size of 80 patients with 40 patients in each group.

| Statistical analysis
All statistical calculations were done using computer programs SPSS (Statistical Package for the Social Science; SPSS Inc., Chicago, IL, USA) version 19 for Microsoft Windows. Differences in the mean of continuous variables were analyzed using parametric test (Paired sample t test) for variables before and after intervention in the same group while the independent sample t test was used to compare variables in between the two study groups. Differences between categorical variables were analyzed using the Chi-Square test. The associations between continuous variables were determined using Pearson Product-Moment Correlation while associations between categorical variables were assessed in each group by independent sample t test. For all tests, a P-value of < .05 was regarded as statistically significant.

patients who underwent RC between September 2015 and
November 2018 were included in our study. Three patients refused to participate in the study, six patients with missing preoperative data were excluded, seven patients died during the postoperative follow-up period, five patients developed local recurrence, and three patients developed distant metastasis, and therefore, were excluded from the study. The final analysis included 64 patients in the IC group and 49 in the ONB group who had available follow-up for 12 months.
There was no significant difference between the groups in terms of age, BMI, sex, pathological tumor stage, and adjuvant therapy (Table 1).
Patients undergoing IC showed higher scores in all domains than ONB patients in physical well-being (PWB), functional well-being (FWB), over all FACT-G score, Bladder-specific subscale score and FACT-BL total score (P-value = .01, .01, .001, .001, and .001, respectively). These data are demonstrated in Table 2 and Figure 1.
No significant difference was recorded between FACT-BL total score and age, sex, and comorbidities as shown in Table 3.
In patients undergoing ONB, FACT-BL total score, and postoperative complications were found to be significantly correlated (P = .04). This was not the case for the IC group (P = .6) as shown in Table 4. favor ONB in terms of higher QoL scores after RC. 13 In contrast, a large meta-analysis of observational HrQoL studies that using validated questionnaires found no statistically significant difference in HrQoL scores between ONB or IC patients. However, QoL outcomes were significantly better among patients treated with an ONB in a sub-analysis of studies based on the EORTC QLQ-C30 questionnaire. 14 Dutta et al used FACT-G in 72 patients with an IC or ONB and found no significant differences in total FACT-G score between the two groups. 9 However, they noted that patients with an ONB had a significantly better QoL than those with an IC in the areas of EWB and FWB.

| D ISCUSS I ON
In our study, IC patients showed better scores in all domains than those who underwent ONB reconstruction and this reached statistical significance in PWB, FWB, over all FACT-G, Bladder-specific

| CON CLUS IONS
Based on our prospective, observational, comparative, hospitalbased study with 1 year follow-up, patients with an IC UD showed marginally better QoL scores when compared with patients with an ONB.
However, further multicenter studies with larger sample sizes and longer-term follow-up periods may be required to determine subtle differences between both techniques.

S TATE M E NT O F E TH I C S
All procedures performed were in accordance with the ethical standards of the institutional and/or national research committee.
All subjects had given informed consent.

D I S C LO S U R E S TAT E M E N T
The authors have no conflicts of interest to declare.

AUTH O R CO NTR I B UTI O N S
All authors have made a significant contribution to the findings and methods in the paper.

TA B L E 4
Comparison between postoperative complication and total FACT-BL score in both groups (Using Clavien-Dindo score)