Long-term outcome of spiral ileal neobladder with orthotopic ureteral reimplantation

This study was approved by the ethics committee of The First People’s Hospital of Huzhou, and all patients provided written informed consent and underwent clinical and laboratory evaluations before surgery. Seventy-two consecutive male patients with bladder cancer who underwent radical cystectomy in The First People’s Hospital of Huzhou between January 2007 and January 2013 were selected for this study. All patients underwent pelvic MRI or enhanced CT examination before surgery, and they were confirmed to have muscle-invasive bladder cancer by both cystoscopy biopsy before surgery and postoperative pathology. No urothelial carcinoma was found in the neck of the bladder. Patients with the following conditions were excluded from the study: serum creatinine > 200 pmol/L, severe impaired liver function, urinary stress incontinence, inflammatory bowel disease, tumor infiltration of the distal prostatic urethra in men, inadequate intellectual capacity, and neurological and psychotic disorders. The clinical and pathologic characteristics of patients are shown in Table 1.

All operations were performed by a single surgeon. Radical cystectomy with pelvic lymphadenectomy was performed according to the guidelines established by (The National Institute for Health and Care Excellence) NICE [7]. A 40- to 45-cm-long ileal segment was isolated 30 cm proximal to the ileocecal valve, and the bowel continuity was then restored by a single-layer running suture. The ileal segment was dissected along its entire length of the contralateral border of the mesentery, and the mucus from the surface of the intestinal mucosa was cleared by an aspirator. In this step, surface mucus cells of the intestinal tract are sufficiently destroyed by anhydrous ethanol. To construct the reservoir, the prepared ileal segment was closed in a “spiral-shaped” manner (Fig. 1a, c). The end of the ureter was split 1 cm and everted in a “sleeve shape” for antirefluxing (Fig. 1b, d), and it was then anastomosed to the reservoir using a ureteral stent. To complete this procedure, two intestinal incisions slightly larger than the ureteral circumference were made at the contralateral edge of the bilateral mesangium intestine at the top of the new bladder, and the ureteral papilla and ureteral stent were clamped and pulled into the new bladder with noninvasive forceps, ensuring that the ureteral nipple and stent were located in the new bladder. This process was the same as that of the ureter entering the bladder. The ureter was anastomosed to the new bladder with a 4-0 absorbable line using the split-cuff nipple nonrefluxing technique. Ureteral stents were exposed through the reservoir and the anterior abdominal wall. The lowest end of the new bladder was cut 1 cm to insert an 18F urethral catheter, and a 2-0 absorbable line was used to suture the corresponding sites (2, 5, 7, and 10 o’clock positions) at the bottom of the new bladder for four stitches. After a suprapubic catheter was placed into the new bladder through the fat of the mesoileum, the pouch was closed completely. Ureteral stents were removed 7–10 days later, and the suprapubic catheter was removed 2 weeks later. The urethral catheter was removed 16–21 days after the operation to restore urethral urination.

A 5-year follow-up was completed after the surgery, and the patients were reexamined every 3 months for the first year, every 6 months for the second year, and every 12 months for the third to fifth year after the surgery. The main parameters assessed or recorded were as follows: (1) early complications (≤ 3 months) and late complications (> 3 months) were observed and classified by the Clavien–Dindo classification score (CCS) [8]. (2) Intravenous urographies were performed 3 months after the surgery. (3) A computed tomography (CT) scan of the thorax and abdomen was performed once a year to observe the morphology of the new bladder and the upper urinary tract. (4) Urinary control function was assessed by a bladder diary recorded by the patient himself. Three grades of urinary function were recorded: complete autonomic control, satisfactory control, and unsatisfactory control. Complete autonomic control was defined as complete urination control during the day and at night without the need for a urinal pad. Satisfactory control was defined as the need for only one pad during the day or at night. Unsatisfactory control was defined as requiring two pads or more during the day or at night. (5) Urodynamic studies were performed once a year. (6) HR-QoL was assessed by the Functional Assessment of Cancer Therapy for Bladder Cancer (FACT-BL) instrument in every re-examination.

All patients completed the surgery without massive hemorrhage, and no perioperative deaths occurred. The operative time was 305.7 ± 37.2 min (range 235–342), the estimated blood loss was 802.3 ± 214.7 mL (range 505–1104), the gastrointestinal function recovery time was 3.8 ± 1.6 days (range 3–5), and the hospital stay time of patients was 22.9 ± 3.3 days (range 18–27). Figures 2 and 3 show imaging examination results of a typical case in the follow-up.

A follow-up for 5 years after the surgery was performed. The total survival rate at 3 years and 5 years after surgery was 76.4% (55/72) and 65.3% (47/72). In 3 months after the surgery, there were 34 (47.2%) early complications in 23 (31.9%) patients, including 8 major complications (CCS III–V, 11.1%) and 26 minor complications (CCS I–II, 36.1%). In 60 months after the surgery, there were 42 (58.3%) late complications in 35 (48.6%) patients, including 33 major complications (CCS III–V, 45.8%) and nine minor complications (CCS I–II, 12.5%). Tables 2 and 3 provide an overview of the management of these complications.

As shown in Table 4, urinary incontinence was common in 3 months after surgery, and the total satisfactory control rate was only 48.6% (35/72); however, the continence rate increased substantially over time. By 1 year of follow-up, the total satisfactory control rate was 72.9% (52/70), and none of the patients required pads at daytime. Nighttime urinary incontinence was more prevalent in long-term follow-up, and the total satisfactory control rate was 69.1% and 66.0% at 3 years and 5 years after the surgery, respectively. In addition, urodynamic studies were performed in half of the patients (Table 5). To better understand the relationship between urodynamics and survival, we analyzed the predictive ability of urodynamics at 1 year after the surgery for mortality. The ROC curve (Fig. 4) showed that pressure at maximum capacity ([area under the curve (AUC)] = 0.859 and 0.875), compliance (AUC = 0.800 and 0.796), and post void residual urine (AUC = 0.837 and 0.717) had predictive value for mortality at 3 and 5 years after surgery (P < 0.05), respectively.

As shown in Table 6, the total FACT-BL scores of patients at 1, 3, and 5 years postoperation were 125.0 ± 15.2, 127.0 ± 16.2, and 120.6 ± 13.5, respectively. There was no significant difference in total FACT-BL scores between 1 year and 3 years postoperation, while the score decreased at 5 years postoperation (P < 0.05).