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 ¤  Abstract
 ¤ Introduction
 ¤ Methods
 ¤ Results
 ¤ Discussion
 ¤ Conclusions
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 Table of Contents     
ORIGINAL ARTICLE
Year : 2018  |  Volume : 14  |  Issue : 4  |  Page : 298-303
 

Is robot-assisted radical cystectomy superior to standard open radical cystectomy? An Indian perspective


1 Department of Surgical Oncology, Rajiv Gandhi Cancer Institute and Research Center, New Delhi, India
2 Department of Uro-oncology, Rajiv Gandhi Cancer Institute and Research Center, New Delhi, India
3 Department of Urological Services, Max Superspeciality Hospital, New Delhi, India

Date of Submission27-Jul-2017
Date of Acceptance07-Dec-2017
Date of Web Publication3-Sep-2018

Correspondence Address:
Dr. Dharma Ram
Rajiv Gandhi Cancer Institute and Research Center, New Delhi - 110 085
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jmas.JMAS_150_17

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 ¤ Abstract 

Introduction: Open radical cystectomy (ORC) has been the standard treatment for muscle-invasive bladder cancer, but this is associated with significant morbidity and mortality. Robot-assisted radical cystectomy (RARC) has been proposed as minimally invasive alternative with improved morbidity and acceptable oncological outcomes, but a large series featuring RARC and their comparison with ORC is still lacking in India despite more than a decade of its inception. We have conducted this study with an objective to see the feasibility of RARC in the Indian context and compare it with contemporary standard.
Methods: This is a prospective cohort study conducted at two tertiary cancer institutes. We have evaluated the patients pertaining to operative and early post-operative factors from January 2014 to December 2015. Necessary statistical tests applied to see comparability of the arms and their outcomes.
Results: A total of 170 patients underwent surgery for carcinoma bladder (45 ORC while 125 RARC). Intraoperative blood loss (RARC and ORC: 228 and 529 ml) and average transfusion rate were lower with RARC. A trend towards benefit was noted in favour of robotic arm in terms of mean complication rate (RARC and ORC: 54 and 39%).
Conclusions: The present study has shown comparable surgical and early post-operative outcomes with clear advantage of robotic approach in terms of intraoperative blood transfusion and lymph node yield. Although the study was non-randomised in nature, it should provide substantial evidence on safety and feasibility of RARC in the Indian context and a reference point of evidence to look ahead.


Keywords: Bladder cancer, India, open radical cystectomy, robotic-assisted radical cystectomy, urothelial carcinoma


How to cite this article:
Ram D, Rajappa SK, Rawal S, Singh A, Singh PB, Dewan AK. Is robot-assisted radical cystectomy superior to standard open radical cystectomy? An Indian perspective. J Min Access Surg 2018;14:298-303

How to cite this URL:
Ram D, Rajappa SK, Rawal S, Singh A, Singh PB, Dewan AK. Is robot-assisted radical cystectomy superior to standard open radical cystectomy? An Indian perspective. J Min Access Surg [serial online] 2018 [cited 2020 Sep 29];14:298-303. Available from: http://www.journalofmas.com/text.asp?2018/14/4/298/225849



 ¤ Introduction Top


Urinary bladder cancer represents 4.4% of all newly diagnosed cancer cases and is the 6th most common cancer in the U.S.A. It is responsible for 2.6% of all cancer-related deaths in the U.S.A with an incidence rate of 20.7/100,000 populations.[1] The incidence of urinary bladder cancer in India ranges from 0.6 to 6.8/100,000 population with highest incidence rate at Delhi and has an age-adjusted incidence rate of 7.4/100,000.[2]

Radical cystectomy (RC) is the treatment of choice for patients with muscle-invasive and high-risk non-muscle invasive bladder cancer.[3] Despite advances in surgical technique, it remains a complex and morbid procedure, with perioperative mortality ranging from 0% to 8% with morbidity ranging from 30% to 65%.[4] Sanchez de Badajoz et al. introduced laparoscopic RC in 1995, but it did not gain widespread acceptance owing to difficult intracorporeal suturing and a long learning curve.[5]

Since Menon et al. reported the first series of robot-assisted RC (RARC), several case series have been published comparing RARC and open RC (ORC), and have shown to be comparable if not better in terms of surgical morbidity and mortality.[6],[7],[8] Despite increasing evidence about RARC, it is still too premature to draw any firm conclusions about its superiority as most studies come from high-volume referral centres.[7],[8] RARC was introduced in India about 10 years ago, but a large series is still lacking. We are reporting our experience demonstrating the feasibility of RARC and comparing it with a standard ORC.


 ¤ Methods Top


A prospective cohort study was conducted at two of the high-volume centres from January 2014 to December 2015. The Institutional Review Board and scientific committee approval was taken. CECT abdomen and CT chest were used as staging methods and staging was done according to the 2010 AJCC TNM classification. Patient with enlarged pelvic nodes or having gross extravesical disease was referred for neoadjuvant chemotherapy. The decision regarding the type of surgical approach was left on patient preferences.

Inclusion criteria

  • Biopsy-proven bladder cancer at participating institute
  • European Clinical Oncology Group performance status 0, 1 or 2
  • Bladder cancer with any of these:


    • Muscle-invasive tumours without evidence of distant metastasis (clinical T 2–4a, N0, M0) or
    • Recurrent multifocal non-muscle invasive disease that is refractory to repeated transurethral resection and intravesical therapy or refractory carcinoma in situ.


Exclusion criteria

  • Patient not willing for RARC
  • Palliative cystectomy or cystectomy for benign conditions.


Surgical intervention and data collection

ORC was performed through classical midline infra-umbilical incision.[9] RARC was performed by surgical procedure as described by Menon et al.[6] All RARC was performed by single surgeon having rich experience in robotic surgeries, while ORC was performed two highly experienced surgeons one at first centre and other at another centre. Frozen section assessment was done in all patients for margin status and revised in case of positive margin.

The clinicopathologic parameters were prospectively collected, including demographic details including age, gender, body mass index (BMI), American Society of Anaesthesiologists (ASA) score, pre-operative chemotherapy, intraoperative parameters including total operative duration, duration of resection, estimated blood loss (EBL), intraoperative complication and interventions, early post-operative recovery parameters like Intensive Care Unit stay, time to bowel activity, hospital stay, 30-day complications and pathological factors such as histological type, pathological staging, pathological margin status and lymph node (LN) yields. Intraoperative complication was defined as any aberrant event during surgical procedure, which needed additional intervention. Early complications (30 days) were measured using the modified Clavien-Dindo classification system.

Statistical analysis

The data were entered into MS Excel spreadsheet and analysis was done using Statistical Package for Social Sciences (SPSS) version 21.0. Categorical variables were presented in number and percentage (%) and continuous variables were presented as mean ± standard deviation (SD) and median. Normality of data was tested by Kolmogorov–Smirnov test. If the normality was rejected then non-parametric test was used. Statistical tests were applied as follows:

  1. Quantitative variables were compared using unpaired t-test/Mann–Whitney Test (when the data sets were not normally distributed) between the two groups
  2. Qualitative variables were correlated using Chi-square test/Fisher's exact test.


P < 0.05 was considered statistically significant.


 ¤ Results Top


Patient characteristics

A total of 170 patients underwent surgery for bladder cancer that fits the selection criteria. Open RC was done in 45 of them while 125 underwent RARC. The clinicodemographic details are depicted in [Table 1]. Most common presenting feature was haematuria (92%), and 3% of our patients were diagnosed as incidental bladder cancer. There was no difference in the distribution of patients in relation to age, gender, ASA score, stage of disease, BMI, number of patients receiving NACT, prevalence of smoking, urinary diversion method and prior abdominal surgery, histological types and pathological nodal staging. The most common histological type was transitional cell carcinoma-93%, followed by small cell, neuroendocrine, squamous, sarcomatoid differentiation and micropapillary variant. About 17% of the patients were referred for pre-operative chemotherapy in both the study groups. Gemcitabine with cisplatin was the most commonly used chemotherapy protocol.
Table 1: Distribution of cases according to clinical and demographic profile of patient of robotic-assisted radical cystectomy and open radical cystectomy

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Perioperative details

Perioperative results are described in [Table 2]. The mean operative duration in ORC group was 355.33 min (SD-85.17) and was 364.35 min (SD-93.35) (P = 0.815) in RARC group. The mean duration of resection was 123 min in RARC group and 128 min in ORC group (P = 0.142). The operative duration was comparable in relation to urinary diversion methods also.
Table 2: Perioperative outcomes of patient of robotic-assisted radical cystectomy and open radical cystectomy

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Robotic approach showed statistically significant benefit in terms of blood loss and blood transfusion rates. The mean EBL (529.11 ml: ORC and 228.56 ml: RARC, P < 0.05), mean blood transfusion units (2.07 units: ORC and 0.44 Units: RARC group, P < 0.05) were better with robotic approach. Only 28% of RARC patients needed any form of transfusion, while 75% of ORC group needed a transfusion (P < 0.001).

One patient in each group had bowel injury (ORC: rectal RARC: sigmoid), which was repaired primarily. Two patients in each in both arms had injury to external iliac vein, which was repaired with prolene 4-0. None of the patients in robotic arm needed conversion to open surgery.

Post-operative recovery and pathological outcomes

The mean duration to bowel activity was 4.02 days in RARC arm, while 4.14 days in ORC arm (P = 0.9). The mean duration of hospital stay was significantly shorter in RARC arm as compared to ORC (10.2 vs. 12.4 days) and the difference was same even when the type of urinary diversion was considered [Table 3].
Table 3: Post-operative recovery and pathological outcomes of patient of robotic-assisted radical cystectomy and open radical cystectomy

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The mean LN yield was 23.64 (6–63) in RARC and 20.82 (5–47) in ORC group (P = 0.04) with the mean benefit of 2.82 nodes. Surgical margin positivity rate was comparable in both the study groups with two of the patients from ORC and 8 from RARC were had margin positive on final HPE (P = 1.00). In both groups, ureteric margins were most frequent margin positive site.

Distribution of early post-operative complications is depicted in [Table 4] and [Table 5]. Overall complications were observed in 39% of RARC and 54% of ORC group patients (30-day). About two-fifths of the complications were classified as major (Grade 3–5), while three-fifth had minor complications (Grade 1–2) on both the study groups. Most of the patients had only one complication, 42% in ORC and 29.60% in RARC group (P > 0.05). The most common complication was wound-related in ORC group (24.4%) and was significantly more than RARC arm (9.60). Post-operative ileus was the most common complication (9.60) in RARC group and but still overall incidence was lower than ORC group (11.11%). Local wound-related complication was significantly better with robotic approach. Other complications, however, were numerically more common in ORC group but the difference was not statistically significant.
Table 4: Early post-operative complications (30 days) of patient of robotic-assisted radical cystectomy and open radical cystectomy

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Table 5: Distribution of complications in both study arms

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 ¤ Discussion Top


There is a great amount of data already available regarding the feasibility and safety of RARC and evidence is summarised in three of the published meta-analysis comparing RARC with ORC. They concluded that RARC is an alternative to ORC with overall low perioperative complications, more LN yield, less EBL, less need for a perioperative transfusion and shorter length of stay.[3],[6],[7] However, they also highlight the fact that most published series come from single high-volume centres and only feature limited number of patients. The lack of solid and high-quality evidence limits the strength of data.[7],[8],[10] Results from two large randomised control trials are awaited which can show the effectiveness of the robotic approach and whether it can be a standard of care or not.[11],[12] RARC was introduced more than a decade ago in India, but there is no significant data available comparing RARC with ORC till date.[13],[14]

The mean duration of complete surgery (RARC arm was 364.35 min while 355.3 min in ORC arm) and resection were comparable which is similar to most of the published literature including randomised study by Parekh et al. where they reported mean operative duration of RARC: 300 and ORC: 285.5 min.[3],[7],[8],[15],[16] However, other RCTs by Khan et al. (RARC 389 and ORC: 293 min) and Bochner et al. (RARC: 464 min ORC: 330 min) noted significant longer surgical duration in RARC arm.[17],[18] Overall studies are heterogeneous in term of mean operative duration.

The mean EBL was 529.11 ml ORC arm (SD-516.43) and 228.56 (SD-121.98) ml in RARC arm (P < 0.05) and data are in concordance with most reported series.[7],[8],[16],[19] Khan et al. noted 800 ml mean blood loss in ORC compared to 585 ml in RARC arm.[17] Likewise, Nix et al. reported mean blood loss of 575 and 258 ml in ORC and RARC, respectively.[20] Recent meta-analysis by Novara et al. concluded that RARC is significantly better in terms of mean blood loss (ORC: 480 ml, RARC: 375 ml).[3] Mean transfusion rate is 7%–40% with robotic approach.[3],[8] Robotic approaches significantly decrease the necessity for transfusion (28% RARC and 75% ORC, P < 0.001).

About 3%–5% intraoperative complications have been described in the literature with RARC[3],[18] and it was 0.20% in RARC arm and 6.6% in ORC in our study. There was no conversion to open surgery in the present study of consecutive 125 patients of RARC. Conversion rate has been below 10% in other series consistently over decade ranging from 0% to 8.3% showing short learning curve for this new innovation.[7],[8]

The mean total hospital stay was 10.24 days in RARC group, while it was 12.45 days in ORC group. The difference was statistically significant on analysis.[7],[18],[20] The mean stay in RARC, NB group was 12.25 days, while 15.91 days in ORC, NB group. Overall RARC is associated with shorter hospital stays irrespective of the type of urinary diversion. The recent meta-analysis has shown average hospital stay in RARC IC arm: 8.7 days, RARC NB arm: 8.6 days, ORC IC arm: 8 days and ORC NB: 8.5 days, P > 0.05.[3]

Current literature shows mixed results in terms of 30-day complications with the majority showing better complication rates in RARC arm. We found about 15% difference in overall 30-day complication, but this benefit did not reach statistical significance. Our results are in concordance with various contemporary studies.[3],[16],[18],[19] Ng et al. have shown 41% overall complications in RARC arm, while Bochner reported 62% complication in RARC arm.[18],[21]

Few of the series Khan et al. (ORC: 18.8 and RARC: 16.3, P > 0.05) and Parekh et al. (ORC: 23 and RARC: 11, P < 0.05) have shown poor LN retrieval with RARC.[16],[17] While Bochner et al. ORC: 18.9 and RARC: 19.5, Nix et al. ORC: 18.0 and RARC: 19.0) have shown better results with RARC.[18],[20] We observed a significant improvement (23.64: RARC and 20.82: ORC group [P = 0.04]) in mean LN yield. Overall margin positivity is reported up to 0%–15% in RARC approach.[3],[7],[8] Recent trial by Bochner from MSKCC has shown in ORC: 4.8 and RARC: 3.6%, (P > 0.05).[18] In Khan et al. and Parekh et al. reported 10% positive surgical margin in ORC and 15% in RARC approach; however, the difference was not significant.[16],[17]

The present study, to the best of our knowledge, is the largest to evaluate the perioperative factors in the Indian context, but with certain limitations, which are worth mentioning. First of all, this is a non-randomised study, and we have only assessed early post-operative outcomes. However, the randomised trial in Indian setting seems difficult to conduct owing to practice orientation, logistic and financial constraints.[13],[14] The assessment of post-operative bladder functions is another important factor which needs further study. We, in this study, have also not evaluated the financial and psychological impact, which is a significant factor in these patients. The study also needs longer follow-up data which will determine whether robotic will replace open approach as the standard of care.


 ¤ Conclusions Top


RARC is a safe and feasible approach with comparable perioperative outcomes and should be taken as valid alternative to ORC. We noted improved outcomes such as intraoperative complications, intraoperative blood loss; transfusion rate, LN yield and hospital stay with RARC. Robotic approach did not show inferiority in any variant including surgical duration, early complications and margin positivity rate.

As a prospective observational comparative study, this should provide substantial evidence on safety and feasibility of robotic cystectomy in the Indian context and a reference point for evidence to look ahead. However, in the absence of long-term functional and oncological outcomes robotic approach should be regarded as surgical option but not as the standard of care.

Acknowledgements

I would like to thank Mrs. Bhavana for statistical help on her part.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
 ¤ References Top

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Surveillance, Epidemiology, and End Results Program. Available from: http://www.seer.cancer.gov/statfacts/html/urinb.html. [Last retrieved on 2016 Jun 18].  Back to cited text no. 1
    
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Novara G, De Marco V, Aragona M, Boscolo-Berto R, Cavalleri S, Artibani W, et al. Complications and mortality after radical cystectomy for bladder transitional cell cancer. J Urol 2009;182:914-21.  Back to cited text no. 3
    
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Shabsigh A, Korets R, Vora KC, Brooks CM, Cronin AM, Savage C, et al. Defining early morbidity of radical cystectomy for patients with bladder cancer using a standardized reporting methodology. Eur Urol 2009;55:164-74.  Back to cited text no. 4
    
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Haber GP, Campbell SC, Colombo JR Jr., Fergany AF, Aron M, Kaouk J, et al. Perioperative outcomes with laparoscopic radical cystectomy: “pure laparoscopic” and “open-assisted laparoscopic” approaches. Urology 2007;70:910-5.  Back to cited text no. 5
    
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Menon M, Hemal AK, Tewari A, Shrivastava A, Shoma AM, El-Tabey NA, et al. Nerve-sparing robot-assisted radical cystoprostatectomy and urinary diversion. BJU Int 2003;92:232-6.  Back to cited text no. 6
    
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Stein JP, Skinner DG. Surgical atlas. Radical cystectomy. BJU Int 2004;94:197-221.  Back to cited text no. 9
    
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European Association of Urology (EAU). Robot-Assisted Radical Cystectomy: Still not the New Standard. EAU. Available from: http://www.eaumadrid2015.uroweb.org/news/detail/robot-assisted-radical-cystectomy-still-not-the-new-standard/47. [Last accessed on 2015 Apr 15].  Back to cited text no. 10
    
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Open vs. Robotic-Assisted Radical Cystectomy: A Randomized Trial. Available from: https://www.clinicaltrials.gov/ct2/show/NCT01157676. [Last retrieved on 2016 Jun 18].  Back to cited text no. 11
    
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Smith ND, Castle EP, Gonzalgo ML, Svatek RS, Weizer AZ, Montgomery JS, et al. The RAZOR (randomized open vs. robotic cystectomy) trial: Study design and trial update. BJU Int 2015;115:198-205.  Back to cited text no. 12
    
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Desai M, Chabra J, Ganpule AP. Robotic surgery is ready for prime time in India: For the motion. J Minim Access Surg 2015;11:2-4.  Back to cited text no. 13
    
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Jain S, Gautam G. Robotics in urologic oncology. J Minim Access Surg 2015;11:40-4.  Back to cited text no. 14
    
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Galich A, Sterrett S, Nazemi T, Pohlman G, Smith L, Balaji KC, et al. Comparative analysis of early perioperative outcomes following radical cystectomy by either the robotic or open method. JSLS 2006;10:145-50.  Back to cited text no. 15
    
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Parekh DJ, Messer J, Fitzgerald J, Ercole B, Svatek R. Perioperative outcomes and oncologic efficacy from a pilot prospective randomized clinical trial of open versus robotic assisted radical cystectomy. J Urol 2013;189:474-9.  Back to cited text no. 16
    
17.
Khan MS, Gan C, Ahmed K, Ismail AF, Watkins J, Summers JA, et al. A single-centre early phase randomised controlled three-arm trial of open, robotic, and laparoscopic radical cystectomy (CORAL). Eur Urol 2016;69:613-21.  Back to cited text no. 17
    
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Bochner BH, Dalbagni G, Sjoberg DD, Silberstein J, Keren Paz GE, Donat SM, et al. Comparing open radical cystectomy and robot-assisted laparoscopic radical cystectomy: A Randomized clinical trial. Eur Urol 2015;67:1042-50.  Back to cited text no. 18
    
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Knox ML, El-Galley R, Busby JE. Robotic versus open radical cystectomy: Identification of patients who benefit from the robotic approach. J Endourol 2013;27:40-4.  Back to cited text no. 19
    
20.
Nix J, Smith A, Kurpad R, Nielsen ME, Wallen EM, Pruthi RS, et al. Prospective randomized controlled trial of robotic versus open radical cystectomy for bladder cancer: Perioperative and pathologic results. Eur Urol 2010;57:196-201.  Back to cited text no. 20
    
21.
Ng CK, Kauffman EC, Lee MM, Otto BJ, Portnoff A, Ehrlich JR, et al. A comparison of postoperative complications in open versus robotic cystectomy. Eur Urol 2010;57:274–82.  Back to cited text no. 21
    



 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5]



 

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