Refinement Surgical Technique, and Perioperative and Functional Outcomes in Patients with Robotic Intracorporeal Hautmann Orthotopic Neobladder

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Refinement Surgical Technique, and Perioperative and Functional Outcomes in Patients with Robotic Intracorporeal Hautmann Orthotopic Neobladder Xiaozhou Zhou , Ji Zheng , Peng He , Jingqi Zhang , Cong Wang , Jun Zheng , Xuemei Li , Lang Lang , Zhansong Zhou , Zhiwen Chen PII: DOI: Reference:

S0090-4295(20)30104-7 https://doi.org/10.1016/j.urology.2020.01.025 URL 21963

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Urology

Received date: Revised date: Accepted date:

29 October 2019 1 January 2020 17 January 2020

Please cite this article as: Xiaozhou Zhou , Ji Zheng , Peng He , Jingqi Zhang , Cong Wang , Jun Zheng , Xuemei Li , Lang Lang , Zhansong Zhou , Zhiwen Chen , Refinement Surgical Technique, and Perioperative and Functional Outcomes in Patients with Robotic Intracorporeal Hautmann Orthotopic Neobladder, Urology (2020), doi: https://doi.org/10.1016/j.urology.2020.01.025

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Refinement Surgical Technique, and Perioperative and Functional Outcomes in Patients with Robotic Intracorporeal Hautmann Orthotopic Neobladder

Xiaozhou Zhou†, Ji Zheng†, Peng He, Jingqi Zhang, Cong Wang, Jun Zheng, Xuemei Li, Lang Lang, Zhansong Zhou, Zhiwen Chen※

†Xiaozhou Zhou and Ji Zheng contributed equally to the study. *Corresponding author.

Xiaozhou Zhou: Department of Urology, Urology Institute of PLA, Southwest Hospital, Third Military Medical University (Army Medical University), Gao Tanyan street 29#, Sha Pingba, Chongqing，China, 400038. E-mail: [email protected] Ji Zheng: Department of Urology, Urology Institute of PLA, Southwest Hospital, Third Military Medical University (Army Medical University), Gao Tanyan street 29#, Sha Pingba, Chongqing，China, 400038. E-mail: [email protected] Peng He: Department of Urology, Urology Institute of PLA, Southwest Hospital, Third Military Medical University (Army Medical University), Gao Tanyan street 29#, Sha Pingba, Chongqing，China, 400038. E-mail: [email protected] Jingqi Zhang: Department of Urology, Urology Institute of PLA, Southwest Hospital, Third Military Medical University (Army Medical University), Gao Tanyan street 29#, Sha Pingba, Chongqing，China, 400038. E-mail: [email protected] Cong Wang: Department of Urology, Urology Institute of PLA, Southwest Hospital, Third Military Medical University (Army Medical University), Gao Tanyan street 29#, Sha Pingba, Chongqing，China, 400038. E-mail: [email protected] Jun Zheng: Department of Urology, Urology Institute of PLA, Southwest Hospital,

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Third Military Medical University (Army Medical University), Gao Tanyan street 29#, Sha Pingba, Chongqing，China, 400038. E-mail: [email protected] Xuemei Li: Department of Urology, Urology Institute of PLA, Southwest Hospital, Third Military Medical University (Army Medical University), Gao Tanyan street 29#, Sha Pingba, Chongqing，China, 400038. E-mail: [email protected] Lang lang: Department of Urology, Urology Institute of PLA, Southwest Hospital, Third Military Medical University (Army Medical University), Gao Tanyan street 29#, Sha Pingba, Chongqing，China, 400038. E-mail: [email protected] Zhansong Zhou: Department of Urology, Urology Institute of PLA, Southwest Hospital, Third Military Medical University (Army Medical University), Gao Tanyan street 29#, Sha Pingba, Chongqing，China, 400038. E-mail: [email protected] Zhiwen Chen: Corresponding author. Department of Urology, Urology Institute of PLA, Southwest Hospital, Third Military Medical University (Army Medical University), Chongqing, China Gao Tanyan street 29#, Sha Pingba, Chongqing ， China, 400038. Tel: 086-23-68754189 Fax: 086-23-65460268 E-mail: [email protected]

Conflict of interest The authors declare that they have no conflict of interest. Ethical approval All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Human and animal rights This article does not contain any studies with animals performed by any of the authors.

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Informed consent Informed consent was obtained from all individual participants included in the study.

Key Words: urinary bladder neoplasms; robotics; intracorporeal; radical cystectomy; orthotopic ileal neobladder Words count: Abstract 248 Main text 2935

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Abstract Objective: To illustrate our refinement technique for robotic intracorporeal orthotopic Hautmann neobladder with adherence to open surgical principles and evaluate perioperative and functional outcomes. Patients and Methods: Robot-assisted radical cystectomy (RARC) with intracorporeal Hautmann orthotopic neobladder was performed by the same surgeon in 40 patients with bladder cancer from November 2017 to March 2019. Baseline demographics, pathological data, 90-d complications, and functional outcomes at both 6 and 12 months were evaluated with questionnaire and urodynamic analysis. Results: Median followup was 14 months (range 4 to 20). Median operative time was 320 (230–500) min, and the estimated blood loss was 300 (100-2000) ml. No conversion to the open technique was reported. The overall 90-d complication rate was 45%, and the high-grade complication rate was only 10%. The daytime satisfactory continence rate was 90% at both 6 months (30 patients) and 12 months (20 patients), while the night-time satisfactory continence rate was 76.7% and 80.0% at 6 months and 12 months, respectively. One patient underwent clean intermittent catheterization. The cohort had minimal postvoid residual volume, normal compliance, and a mean capacity of 328.7 cm3 (range 170–500) at 6 months postoperatively. Conclusion: Our preliminary data indicate that robotic intracorporeal Hautmann neobladder configuration is a feasible surgical technique and can achieve a low pressure and sufficient capacity for satisfactory early voiding patterns. Refinement of the stepwise process can effectively decrease the time of the operation. Long-term functional and oncological outcomes remain to be evaluated with longer follow-up and more cases.

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Introduction The gold standard for patients with muscle-invasive and high-risk recurrent bladder cancer remains radical cystectomy (RC) with urinary diversion1. RC with urinary diversion is considered one of the most challenging procedures to perform due to its technical complexity. Orthotopic neobladder construction is based on the principles of configuration, accommodation, and compliance. The open surgery for Hautmann ileal neobladder conforms to the above principles, and its long-term functional outcome is promising worldwide 2–4. Robotic-assisted RC is rapidly developing and can result in decreased hospital stay, reduced blood loss and transfusion rate, compared with open surgery, and hospital readmission similar to that seen with open surgery5–7. Intracorporeal urinary diversion (ICUD) provides benefits in terms of a completely minimally invasive technique, including smaller incisions, reduced pain, decreased bowel-related complications and a decreased risk of third space loss and fluid imbalance8,9. The data from the International Robotic Cystectomy Consortium showed that the use of intracorporeal urinary diversion had dramatically increased in the previous decade10. However, the proportion of intracorporeal neobladders for all ICUDs was still lower due to technique challenges. In this paper, we present a step-by-step detailed surgical description of a total intracorporeal orthotopic robot-assisted Hautmann pouch that replicates open technique principles and a modified urethroileal anastomosis procedure. Additionally, we report and discuss our initial experience and neobladder functional outcome.

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Patients and Methods From November 2017 to March 2019, robotic-assisted RC, standard or extended pelvic lymph node dissection and intracorporeal orthotopic ileal neobladder (Hautmann pouch) were performed by one surgeon on 40 patients with bladder cancer. From this cohort, all patients, 30 patients and 20 patients had completed 90-d, 6-mo and 12-mo follow-ups, respectively. All data were consecutively entered prospectively into our institutional review board–approved database and queried retrospectively. Our inclusion criteria for RARC were identical to those for open cystectomy. The indications and contraindications for orthotopic reconstruction in this cohort conformed to the criteria set by the guidelines of the European Association of Urology on bladder cancer1. Outcome Measures Patient demographic, intraoperative and postoperative parameters, Pathological characteristics, 90 days postoperative complications were retrospectively evaluated. The 90-d postoperative complications were categorized according to the Clavien-Dindo classification11. For neobladder continence, the methods, definitions, and units conformed to the standards recommended by the International Continence Society12. Continence was classified into daytime and night-time continence and was strictly defined as good (continent) if the patient was completely dry without the need for protection, satisfactory (socially continent) if no more than 1 pad was required during the day or night, and unsatisfactory (incontinent) if the patient used more than

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1 pad during the day or night13. Urodynamic evaluation was performed using a Medtronic DUET MULTIP System (Denmark). Surgical Technique With the patient in the steep Trendelenburg position, a six-port transperitoneal approach similar to that described by Goh et al. was used14. The male patients that were scheduled to have RARC had nerve sparing surgery, unless the tumor was considered to be non-organ confined. Reproductive organ sparing was performed in the selected female patients15. We also isolated the posterior peritoneum from the posterior wall of the vagina and the uterus with a layer of the thick extraperitoneal tissue. The flap was then sutured circumferentially to the pelvic fascia and to the vaginal wall just below the ventral urethral margin with 3-0 vicryl. The technique of radical cystectomy together with lymphadenectomy is well described in literature. We therefore mainly report the critical points of intracorporeal orthotopic neobladder formation of our technique. After RARC, we selected a 40-cm ileal loop at least 15-20 cm away from the ileal-caecum valve and suspended the selected ileum at a designated point to the lateral pelvic wall above the epipubis with a straight needle (Supplementary figure 1). The 40-cm ileal segment was cut with Monopolar Endowrist scissors at the proximal and distal designated points. The mesenteric window was further developed using Ligsure™. Continuity of the small bowel was restored by a standard procedure, anatomic side to side but functional end to end anastomosis. In contrast to the open surgical procedure, the urethroileal anastomosis was

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performed first. The marking point at 10 cm from the distal end of the excluded ileum was grasped by the fourth robotic arm and retracted into the pelvis. A 1-cm section at the marking point on the antimesenteric ileal walls was cut open with Monopolar Endowrist scissors. The urethroileal anastomosis was performed in a running fashion with a single-armed 3-0 Monocryl suture (Ethicon Inc., Somerville, NJ, USA) starting at the 3 o’clock position (Fig. 1A). The anastomosis was completed over a 20F Foley catheter. After the urethroileal anastomosis, the marking point at 10 cm from the proximal end of the excluded ileum was sutured near the point of the urethroileal anastomosis with 3-0 Vicryl. Then, the 40-cm section of ileum was presented in an “M” configuration. The 40 cm of ileum was detubularized with the incision biased towards the mesenteric edge (Fig. 1B). The apposed edges of the posterior wall of the neobladder were aligned with several 3-0 absorbable interrupted sutures. Subsequently, the posterior wall of the Hautmann pouch was constructed in a watertight manner (Fig. 1C) with 3-0 running sutures. Once the posterior wall anastomosis was completed, the urethral Foley catheter was placed. The 10-cm anterior neobladder wall was closed using a 3-0 Vicryl suture from the site of the urethroileal anastomosis (Fig. 1D). The ureter was spatulated using robotic scissors for a wide anastomosis. An 8-F, single-J ureteric stent was fed into the ureteric opening. A 5-0 chromic suture was used to fix and secure the stent to prevent dislodgement. A 5-mm opening was made on the left and right sides of the lateral wing. The right and left ureters were separately

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anastomosed directly to the lateral wing of the pouch (Fig. 1E). The single-J ureteric stents were extracted through the left flank of the pouch. Once the uretero–ileal anastomosis was completed, the remaining anterior pouch wall was closed using a 3-0 Vicryl suture (Fig. 1F). An enhanced recovery after surgery (ERAS) protocol was followed in most patients when applicable. The abdominal drain was removed when the output was <100 ml/d and fluid biochemistry excluded urine. Ureteral catheters were removed during the hospital stay between 10 and 12 d after the procedure. The urethral Foley catheter was removed at two weeks if no leakage was confirmed (Supplementary figure 2). Statistical analysis Descriptive statistics were shown in cross-tables, with medians and ranges given for continuous data and proportions for categorical data. The statistical analysis was performed using SPSS 19.0 (SPSS Inc. Chicago, IL, USA). Operative time was compared using the Mann-Whitney test. Continence rates at 6 months and 12 months were compared using the Wilcoxon signed rank sum test. All p-values were double tailed, and those <0.05 were considered statistically significant.

Results Patient demographic parameters are shown in Table 1. Robotic intracorporeal bladder replacement was successfully completed in all 40 patients (28 males, 12 females) without open conversion. The median age was 62 (42-76) years, and the median BMI

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(Body Mass Index) was 23.3 (14.5-32.2) kg/m2. ASA (American Society of Anaesthesiologists) scores II and III were reported in 36 (90.0%) and 4 (10.0%) patients, respectively. One (2.5%) patient underwent prior pelvic surgery, and three (7.5%) patients underwent prior abdominal surgery. Four (10.0%) patients received neoadjuvant chemotherapy. The perioperative data are summarized in Table 1. The median operative time was 320 (230–500) min. Comparing the patient data of the first 20 with the last 20 RARC performed with intracorporeal neobladders in our series, there was a reduced median operative time of 340 min (range: 290–500 min) and 290 min (range: 230–400 min) (p = 0.001). The estimated blood loss (EBL) was 300 (100–2000) ml. The EBL in most cases was no more than 500 ml. In three cases, the EBL was more than 1000 ml due to main vessel damage, and the patients received a transfusion during the operation. No active postoperative bleeding was reported. Early complication events occurred in 45.0% (18/40) of patients within 90 d (Table 2). One patient experienced persistent fever for one week at 80 d after surgery and subsequently presented with a fistula of the ileal neobladder which was repaired via open surgery. One female patient presented with a fistula of the vagina-neobladder after removal of the urethral catheter. The fistula was about 1.0cm, located at the proximal right anterior vaginal wall close to vaginal stump, and was repaired through transvaginal approach. One patient had right ureteral dilatation and hydronephrosis secondary to benign stricture of the ureteral-neobladder anastomosis at three months after surgery. This patient was eventually cured by surgical re-anastomosis.

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Pathology confirmed organ-confined disease in 34 (85.0%) patients and locally advanced disease in 6 (15.0%) patients (Table 1). Four patients had lymph node metastasis. One patient had prostate cancer, and the Gleason score was 6. Three patients received adjuvant chemotherapy of GC. One patient with a positive lymph node refused chemotherapy and was found to have liver metastasis at 6-month follow-up. One female patient without a positive lymph node was found to have lung metastasis at the 9-month follow-up. All patients were followed up to three months, and the median follow-up was 14 (4-20) months. Thirty of the patients attended a 6-month follow-up, and twenty patients attended a 12-month follow-up. Functional evaluations are reported in Figure 2. At the 6-month follow-up, twenty-two (73.3%), five (16.7%), and two (6.7%) of the patients reported daytime continence as good, satisfactory and unsatisfactory status, respectively; 5 (16.7%), 18 (60.0%) and 6 (20.0%) of the patients reported night-time continence at each status. However, 12 months after the surgery, 15 (75.0%) patients, 3 (15.0%) patients, and 1 (5.0%) patient reported daytime continence at each status; 3 (15.0%), 13 (65.0%) and 3 (15.0%) of the patients reported night-time continence at each status. One female patient developed chronic urinary retention at 6 months after the surgery, and clean intermittent catheterization was needed. In addition, twenty-five patients received urodynamic evaluation at the 6-month follow-up (Supplementary Table 1). The mean preurodynamic postvoid residual volume (PVR) was 38.2 cm3 (range 0–200 cm3). One of the 25 patients exhibited detrusor (neobladder) overactivity during the cystometry filling phase due to small capacity. The average

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compliance was normal, with a mean 26.1 ml/cm H2O (range 10.2–72.0). The mean cystometric capacity was 328.7 cm3 (range 170–550). The pressure of maximal cystometric capacity was 14.8 cm H2O (range 2.1-37.0). The maximal flow rate and average flow rate during the voiding phase were 8.0 cm3/s (range 3-22) and 3.2 cm3/s (range 1–12), respectively. Discussion Recent data from the International Robotic Cystectomy Consortium (IRCC) showed that intracorporeal urinary diversion use increased from 9% of all urinary diversions in 2005 to 97% in 2016 in a cohort of 1,094 patients. However, use of the intracorporeal neobladder procedure only increased from 7% in 2005 to 17% in 201610. These data reflect that the intracorporeal neobladder procedure is still challenging for most surgeons. Regarding the use of the ICUD approach, which includes longer surgical times and increased complexity, operative time is likely to influence both perioperative morbidity and complications. To save time performing the neobladder procedure, some authors used endoscopic staples to construct a “U”-type pouch16. Although the application of an endoscopic stapler simplifies the surgical procedure, it can significantly increase the risk of reservoir stone development. Our unpublished data indicated that reservoir stones occurred in 42% (5/12) of patients in a series that performed the Le-bag pouch using staples in long-term survival follow-up (9-12 years). In addition, the functional outcome of the non-double-folding reconfiguration needed to be validated over a long period17. Therefore, some techniques for intracorporeal double-folding reconfiguration with

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manual suture were developed in several institutes18–20. These reconfiguration procedures, including Studer, Pyramid neobladder and Vescica Ileale Padovana14,19–21, obtained initially promising function outcomes22. However, worldwide experience with intracorporeal orthotopic neobladders (iONBs) with the ‘W’ configuration is still very limited. The first description of only one case of the robotic intracorporeal Hautmann neobladder was by Beecken et al. in 200323. Guru et al. reported initial perioperative outcomes of five intracorporeal neobladders with the ‘W’ configuration in 201724. In this paper, we presented a surgical technique and preliminary functional results for the Hautmann neobladder, a robotic surgical technique replicating the open surgical principle in our stepwise manner in a series of 40 patients. To perform the neobladder–urethral anastomosis, the initial procedure involved the most dependent part of the posterior plate of the neobladder being anastomosed to the posterior urethral plate (Supplementary figure 3) in several initial patients. This manoeuvre was fit for patients with a tension-free connection between the urethral and neobladder. Then, we also adopted the manoeuvre to perform the urethroileal anastomosis prior to ileal loop detubularization. This method is more reliable in avoiding anastomotic leakage for all patients. In addition, compared to the extracorporeal neobladder configuration, we believe that neobladder–urethral anastomosis provides less tension in the intracorporeal neobladder configuration due to less spasm of the ileum. As excess high capacity is one of the potential causes of chronic urinary retention25, we used 40 cm of ileum to construct the ‘W’ neobladder by duplicating the principles and

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techniques of the established Hautmann neobladder. The neobladder also presents the characteristics of a low-pressure, sufficient-capacity and spherical reservoir. We first suspended the candidate ileum at the beginning of the reconfiguration. This step facilitated the measurement of the length of the ileum and decreased the length bias. In the last 20 male patients, we removed the specimen at the end of the operation and avoided the re-dock procedure. Therefore, the refinement of the stepwise manner, in addition to the factor of advanced surgical skill, contributed to the decreased time of reconfiguration. RARC studies with standardized reporting of complications were recently published with overall 90-d complication rates of 48%26. This series showed that the overall 90-d complication rate was 45%. However, the high-grade complication rate was only 10%. These results were comparable to other RARC and ICUD reports10 and were lower than the open Hautmann neobladder4. The data from the systematic review in 2015 showed slightly lower risks of any-grade and high-grade complications for RARC compared with ORC at 90-d5. However, the RAZOR trail (Level I evidence) in 2018 pointed out that there were no significant differences in overall complications identified between the two groups7. Therefore, the comparison of complications between RARC with iONB and the open Hautmann neobladder needs to be further demonstrated by prospective randomized controlled study. Despite the small sample size of this initial series, we obtained continence information at both 6 months and 12 months after the operation. The day continence rates were 90.0% at both 6 months and 12 months, while the night continence rates

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were 76.7% and 80.0% at 6 months and 12 months, respectively. Regardless of whether it was day or night, there were no differences between the continence rates at 6 months and 12 months (p=0.791 and 0.838, respectively). This result indicates that the robotic intracorporeal Hautmann neobladder reconstruction could achieve satisfactory continence and is comparable to open surgery

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and the robotic

intracorporeal Studer neobladder29. To evaluate the function of the neobladder, we analysed the urodynamic parameters of the iONBs. Our robotic Hautmann iONBs achieved a mean cystometric volume of 328.7 cm3 (range 170-500), which is slightly lower than the mean volumes reported for the open orthotopic neobladder series of 430–600 cm3 for Hautmann configurations30,31 and robotic iONBs series of 339-1001 cm3 for Studer configurations22. However, the pressure of maximal cystometric capacity is in the safe range (2.1-37.0 cm H2O) and is consistent with their high compliance. The functional characteristic of the intracorporeal Hautmann neobladder is one of the foundations to ensure a satisfactory pattern of voiding in this cohort. In addition, our initial data show that CIC is 2.5% (1/40) at 6 months after the operation and lower than in other series32. We suggest that this is partially due to adequate neobladder capacity. This study was limited by its small sample size and short follow-up period. Our inclusion criteria for RARC with iONBs were the same as those for open cystectomy. But some patients didn’t receive robotic techniques which is currently not covered in Chinese medical insurance. In addition, we explored the technique that begins with female patients. Rationally, iONBs formation in female patients is more reasonable

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than in males because the specimen may be extracted through the vagina without making an additional incision in the abdomen wall. The first five patients were all female patients, which resulted in a significantly higher incidence of female patients in this series. Another limitation is that the length of hospitalization is affected by medical insurance which coves main cost of medicine and treatment only during hospital stay in China. Although an ERAS protocol was followed in them, each patient was discharged at least two weeks after operation when the urethral Foley catheter was removed in our centre. Thus, postoperative hospital stay provides limited meaningful information. Nevertheless, data from the real world illustrated our refinement technique for robotic intracorporeal orthotopic Hautmann neobladder and showed acceptable postoperative outcomes. Conclusion We describe our step-by-step technique for robot-assisted intracorporeal Hautmann neobladder reconfiguration. These pre-operation and preliminary functional results showed that constructing the intracorporeal Hautmann neobladder is feasible, producing the same advantages as the open procedure. Refinement of the stepwise process can effectively decrease the time of the operation. Increasing data from RARC plus ICUD that replicates open technique principles showed that total intracorporeal orthotopic robot-assisted neobladder is a safe surgical procedure with acceptable perioperative outcomes. The advantages of this procedure still need to be verified by multicentre, randomized controlled study with long-term follow-up.

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Appendix. Supplementary material Supplementary figure 1. A 40-cm ileal loop at least 15-20 cm away from the ileal-caecum valve and suspended the selected ileum at a designated point to the lateral pelvic wall above the epipubis with a straight needle. Supplementary figure 2. A. Cystogram at 2 weeks postoperatively demonstrated no extravasation. B. Computed Tomography three-dimensional imaging at 6 months postoperatively demonstrated a globular configuration of the pouch Supplementary figure 3. A. fixation of the bowel at both 5 and 7 clock point of urethral for ‘M’ Configuration. B. Bowel detubularisation; and construction of the posterior plate. C. Neobladder–urethral anastomosis Supplementary table 1. Urodynamic parameters at 6 months after operation in 25 patients

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Figure Legends

Fig. 1. A. Urethroileal anastomosis and fixation of the Bowel. A 40 cm bowel segment is chosen and anastomosed to the urethra in a running fashion at urethroileal anastomosis (UIA) point, which is at 10cm from the distal end of isolated ileum (upper). A stay suture is placed 20cm from the UIA point to fix the ‘M’ configuration of bowel (below). B. Bowel detubularisation and construction of the posterior plate. Right half of ileum is first incised and sutured to construct the posterior plate of the neobladder. C. Bowel detubularisation and construction of the posterior plate.

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The posterior plate is sutured caudally while exerting traction on the bowel using and the fourth arm and laparoscopic grasping forceps. D. Anterior plate construction of the neobladder. Closure of anterior neobladder wall is started caudally from site of urethroileal anastomosis. E. Uretero–ileal anastomosis. The right and left ureters are separately anastomosed to the ipsilateral wing of the pouch. The single-J ureteric stents are extracted through left flank of the pouch. F. Closure of the remaining anterior wall of neobladder.

Figure 2. Thirty of the patients attended a 6-month follow-up, and twenty patients attended a 12-month follow-up. Functional evaluations are reported according to both day-time and nighttime as good, satisfactory and unsatisfactory status, respectively. CIC: clean intermittent catheterization

Supplementary figure 1. A 40-cm ileal loop at least 15-20 cm away from the ileal-caecum valve and suspended the selected ileum at a designated point to the lateral pelvic wall above the epipubis with a straight needle. Supplementary figure 2. A. Cystogram at 2 weeks postoperatively demonstrated no extravasation. B. Computed Tomography three-dimensional imaging at 6 months

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postoperatively demonstrated a globular configuration of the pouch Supplementary figure 3. A. fixation of the bowel at both 5 and 7 clock point of urethral for ‘M’ Configuration. B. Bowel detubularisation; and construction of the posterior plate. C. Neobladder–urethral anastomosis

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Table 1- Patient demographic, intraoperative and postoperative parameters and pathological characteristics Patients, n 40 Age (yr), median (range) Gender Female, n (%) Male, n (%) BMI (kg/m2), median (range) ASA score, median (range) I-II, n (%) III-IV, n (%) Neoadjuvant chemotherapy, n (%) Prior abdominal and pelvic surgery, n

62 (42-76) 12 (30.0) 28 (70.0) 23.3 (14.5-32.2) 2 (2-3) 36 (90.0) 4 (10.0) 4 (10.0) 4 (10.0)

(%) Operative time, (min), median (range) First 20 cases Last 20 cases Estimated blood loss, (ml), median (range) Conversion rate, n (%) Intraoperative transfusion, n (%) Hospitalization time, (d), median (range) Follow-up, (months), median (range) pT stage, n (%) pT0 pTIS pTa pT1 pT2 pT3 pT4 pN stage, n (%) pN0 pN1 pN2 Positive margins, n (%) Ureteral margins

320 (230-500) 340 (290-500) 290 (230-400) 300 (100-2000) 0 (0) 3 (7.5) 16 (14-30) 14 (3-19) 2 (5.0) 1 (2.5) 0 (0) 9 (22.5) 22 (55.0) 5 (12.5) 1 (2.5) 36 (90.0) 3 (7.5) 1 (2.5) 1 (2.5)

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Soft tissue margins Incidental prostate adenocarcinoma, n

1 (2.5)

(%) Gleason score 3 + 3

1 (2.5)

BMI = body mass index; ASA = American Society of Anesthesiologists (classification).

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Table 2. 90 days postoperative complications Complications No. of patients, n (%) Clavien grade I-II 14 (35.0) Ileus 3 (7.5) Urine leakage 2 (5.0) Lymphocele 1 (2.5) Anemia need transfusion 3 (7.5) arrhythmia Upper respiratory infection Bacteremia Congestive heart failure Pyelonephritis Clavien grade III-IV Stricture of ureteral-neobladder anastomosis Fistula of ileal-neobladder Fistula of vagina-neobladder Deep vein thrombosis

Treatment

Conservative Conservative Conservative Transfusion

1 (2.5) 1 (2.5) 1 (2.5) 1 (2.5) 1 (2.5) 4 (10.0) 1 (2.5)

Drug Antibiotic Antibiotic Drug Antibiotic

1 (2.5) 1 (2.5) 1 (2.5)

Reoperation Reoperation Anticoagulation

Reoperation