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Table of Contents
ORIGINAL ARTICLE
Year : 2020  |  Volume : 31  |  Issue : 4  |  Page : 177-182

Modified enhanced recovery after surgery protocol versus nonenhanced recovery after surgery in radical cystectomy surgery (preliminary study)


1 Department of Urology, Hasan Sadikin Academic Medical Center, Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia
2 Department of Pathology, Hasan Sadikin Academic Medical Center, Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia
3 Hasan Sadikin Academic Medical Center, Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia

Date of Submission21-Dec-2019
Date of Decision12-May-2020
Date of Acceptance30-May-2020
Date of Web Publication25-Jul-2020

Correspondence Address:
Sawkar Vijay Pramod
Jalan Pasteur No. 38, Bandung 40161, West Java
Indonesia
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/UROS.UROS_8_20

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  Abstract 


Purpose: Enhanced recovery after surgery (ERAS) protocol has proven to lower both length of stay and recovery time, while being cost-effective at the same time. There are three ERAS protocols implemented for radical cystectomy (RC). All of those were published by different institutions, such as the European Association of Urology, the Société Internationale d'Urologie, and the American Urological Association. We modified and proposed ERAS components from preoperative care until postoperative care to evaluate the implementation of ERAS for RC. Standard ERAS protocol is not fully applicable in Hasan Sadikin General Hospital due to financial factors and the limited list of drugs available to choose from our universal health coverage prescription system; thus, we had to make some modifications. This study aims at evaluating the preliminary results of an implementation of modified ERAS protocol in RC at our hospital. Materials and Methods: A cohort retrospective study of 21 consecutive patients who underwent RC (9 ERAS vs. 12 non-ERAS). The primary outcomes were the reduced length of stay (LOS) and hospitalization cost. The secondary outcomes included less intraoperative blood loss, faster bowel movement, lower transfusion rates, and decreased readmission rates. Results: Patients with ERAS had lower blood loss (ERAS median [range]: 1100 [500–2000] ml vs. 1650 [100–3000] ml for non-ERAS, P = 0.219), lower transfusion rates (ERAS: 55.6% vs. 91.7% for non-ERAS, P = 0.119), and fewer readmissions (ERAS: 0% vs. 8.3% for non-ERAS, P = 1.000). Bowel movement was faster in ERAS group (ERAS mean [range]: 6.11 ± 2.977 [3.00–12.00] h vs. 12.50 ± 5.385 [6.00–24.00] h for non-ERAS, P = 0.005). Duration of hospitalization was shorter with ERAS (5 [3–7] days) than without ERAS (8 [5–20] days, P = 0.003). The total mean costs were significantly higher in the non-ERAS group compared to the ERAS group ($1529 ± 346 for ERAS vs. $2580 ± 1415 for non-ERAS, P=0.028). Conclusion: Modified ERAS protocols for RC at our institution reduced the LOS and hospitalization cost and lead to faster bowel movement and no readmission.

Keywords: Bladder cancer, enhanced recovery after surgery, radical cystectomy


How to cite this article:
Pramod SV, Safriadi F, Hernowo BS, Dwiyana RF, Partogu B. Modified enhanced recovery after surgery protocol versus nonenhanced recovery after surgery in radical cystectomy surgery (preliminary study). Urol Sci 2020;31:177-82

How to cite this URL:
Pramod SV, Safriadi F, Hernowo BS, Dwiyana RF, Partogu B. Modified enhanced recovery after surgery protocol versus nonenhanced recovery after surgery in radical cystectomy surgery (preliminary study). Urol Sci [serial online] 2020 [cited 2020 Aug 9];31:177-82. Available from: http://www.e-urol-sci.com/text.asp?2020/31/4/177/290859




  Introduction Top


Recently, there are rapid development and improvement in perioperative care. Enhanced recovery after surgery (ERAS) protocol is one of the perioperative treatments used in major surgical procedures that show improvements in patients' metabolic and functional conditions.[1] ERAS is a program that aims at modifying the body responses to major surgery by reducing complications and prolonged hospitalization, by improving the cardiopulmonary functions, by achieving faster intestinal function recovery, and by attaining faster recovery of other normal activities.[2] ERAS programs are multidisciplinary, multi-element care pathways that aim to standardize and improve perioperative care management.[3],[4] In spite of standardization of surgical techniques, improved anesthesia, and perioperative care protocols, postopen radical cystectomy (RC) morbidity, with lymph node dissection, urine diversion, and bladder reconstruction, increases by 30%–64%. RC patients may be ideal candidates for the ERAS protocol because of potential stress reduction and postsurgical complications.[5],[6]

The good results are shown in colorectal surgery. The use of multimodal ERAS systems has reduced morbidity that is found in postsurgery and length of stay (LOS).[7],[8] ERAS introduces several preoperative, perioperative, and postoperative care steps to improve the patient pathway.[8] Many ERAS components are generic to abdominal surgery and so implemented in RC without prospective evidence.[8]

At present, studies about ERAS protocol applications in urologic surgical procedures are not widely conducted. Since the ERAS protocol already showed good results in colorectal surgery, researchers aimed at examining the application of the ERAS protocol, which is widely recommended for the perioperative management for surgical patients, in patients undergoing RC procedures.[7],[8]

There are three ERAS protocols implemented for RC. All of those were published by different institutions such as European Association of Urology, Société Internationale d'Urologie, and American Urological Association.[5],[9],[10],[11] We modified and proposed the ERAS components from preoperative care until postoperative care to evaluate the implementation of ERAS for RC. We relied on all the three published ERAS protocols to make our modified ERAS protocol.

This study aimed at investigating the effect of ERAS protocol to post-RC patients.


  Materials and Methods Top


Patients

IRB Name and Approval Number: LB.02.01/X.6.5/167/2020. A cohort retrospective study was a preliminary study to observe the modified ERAS done in 21 consecutive patients who underwent RC (9 ERAS vs. 12 non-ERAS). The inclusion criteria are patients with bladder tumors who underwent RC procedures. This study was conducted in the Urology Department at the Hasan Sadikin General Hospital in Bandung for patients who underwent RC procedures at Hasan Sadikin General Hospital in Bandung from January 2018 to January 2019. All patients underwent ureterocutaneostomy (UCN) as a urinary diversion. The primary outcomes were the reduced LOS and hospitalization cost. The secondary outcomes included less intraoperative blood loss, lower transfusion rates, and decreased readmission rates also observed.

Enhanced recovery after surgery protocol

In this study, we modified and proposed the ERAS components from preoperative care until postoperative care to evaluate the implementation of ERAS for RC, as seen in [Table 1].
Table 1: Modified enhanced recovery after surgery protocol recommendation for radical cystectomy

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Standard ERAS protocol is not fully applicable in the Hasan Sadikin General Hospital due to financial factors and the limited list of drugs available to choose from our universal health coverage prescription system; thus, we made some modifications, as seen in [Table 2]. The differences between the standard and modified protocols are mainly in diet, fluid, antibiotic prophylaxis, and postoperative care plan. For bowel functions, we only evaluate the bowel sound to check whether there is a paralytic ileus or not since we performed as our urinary diversion technique.
Table 2: Standard enhanced recovery after surgery compared to modified enhanced recovery after surgery

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Radical cystectomy

RC was done in this study. Conventionally, RC is recommended for patients with MIBC T2-T4a, N0-Nx, M0. Other indications include high-risk and recurrent nonmuscle-invasive tumors, as well as an extensive papillary disease that cannot be controlled with transurethral resection of the bladder and intravesical therapy alone.[12]

In men, standard RC includes removal of the bladder, prostate, seminal vesicles, distal ureters, and regional lymph nodes. In women, standard RC includes removal of the bladder, entire urethra and adjacent vagina, uterus, distal ureters, and regional lymph nodes.[12]

Statistical analysis

Data were collected from the patient's medical records, processed, and the statistical test used was the Chi-square test (significance of 95%, 5% deviation limit). Result considered as statistically significant if P < 0.05.

The primary outcomes were the reduced LOS and hospitalization cost. The secondary outcomes included less intraoperative blood loss, lower transfusion rates, faster bowel movement, and decreased readmission rate.

LOS, mean of total cost, and blood loss volume were the numerical data. They were tested by unpaired t-tests when data were normally distributed. Mann–Whitney test was an alternative test when data were not normally distributed.

Transfusion rates and the readmission rates were categorical data that were tested by the Chi-square test. Kolmogorov–Smirnov and Fisher's exact tests were alternatives if Chi-square prerequisites were not fulfilled.


  Results Top


Patients

Twenty-one consecutive patients underwent RC [Table 3] from February 2018 to January 2019. In ERAS group, we found eight patients of transient cell carcinoma (TCC) and only one patient with squamous cell carcinoma (SCC). In non-ERAS group, we found 8 patients with TCC, 2 patients with SCC, and 2 patients with adenocarcinoma. There was no difference in age or gender between the two groups. The mean age of ERAS group was 68.9 years and the non-ERAS group was 67.5 years. The gender ratio was 75% male in both ERAS and non-ERAS group. The local tumor stage in both ERAS and non-ERAS group was mostly T3 (63.5%).
Table 3: Subject characteristics

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Primary outcomes

Duration of hospitalization was shorter with ERAS (5 [3–7] days) than without ERAS (8 [5–20] days, P = 0.003) [Table 4], which means that there is a statistically significant average difference between the duration of hospitalization in the ERAS and non-ERAS groups.
Table 4: Primary and secondary outcomes in enhanced recovery after surgery and nonenhanced recovery after surgery patients

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The total mean costs were significantly higher in the non-ERAS group compared to the ERAS group (ERAS: $ 1529 ± 346 vs. non-ERAS: $ 2580 ± 1415, P = 0.028) [Table 4], which means that there is a statistically significant percentage difference between the variable costs of care in the ERAS and non-ERAS groups.

Secondary outcomes

Patients with ERAS had lower blood loss (median [range]: 1100 [500–2000] ml for ERAS vs. 1650 [100–3000] ml for non-ERAS, P = 0.219) [Table 4] and lower transfusion rates (55.6% for ERAS vs. 91.7% for non-ERAS, P = 0.119) [Table 4], which means that it is not statistically significant or not meaningful; thus, there is no significant difference between the bleeding amount variables and intraoperative transfusion in the ERAS and non-ERAS groups.

The difference in readmission status based on the followed method is listed in [Table 4]. There was no readmission patient in the ERAS group. In non-ERAS group, only one patient who got readmission (0% for ERAS vs. 8.3% for non-ERAS, P = 1.000). P value was more than 0.05, which means that the difference in both groups was not statistically significant. A summary of the primary outcomes and secondary outcomes is shown in [Table 5]. As for the bowel movement, the ERAS group recovered faster than the non-ERAS group, as stated in [Table 6] (mean [range]: 6.11 ± 2.977 [3.00–12.00] h for ERAS vs. 12.50 ± 5.385, [6.00–24.00] h for non-ERAS, P = 0.005).
Table 5: The difference of each variables based on enhanced recovery after surgery or nonenhanced recovery after surgery group

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Table 6: Comparison between bowel movements based on the method used

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  Discussion Top


ERAS programs have improved the outcomes for many patients undergoing a diverse array of surgical procedures.[7] The ERAS Society (www.erassociety.org) has protocols within several surgical specialties, including RC. Since many RC patients develop complications during recovery,[6] these patients may benefit from the refinements in postoperative care management. Our data support the use of ERAS protocols and demonstrate excellent improvements in postoperative recovery and reduction of total costs.

Diet time can be reduced in patients with modified ERAS compared to non-ERAS. Modifications cover six out of 22 ERAS items, which are no oral mechanical bowel preparation, epidural analgesia, anesthetic protocol, preventing hypothermia during intraoperative, antimicrobial prophylaxis, and removal of an early nasogastric tube. Morbidity and time to first bowel movement were similar in the two groups, but LOS was significantly reduced (from 17 to 13 days) in the enhanced recovery group. Another implementation of ERAS protocols after cystectomy was applied to 262 patients and compared to non-ERAS protocols; the most recent 100 patients had better postoperative recoveries. ERAS pathways clearly improve patient care, reduce morbidity, and shorten LOS. All studies evaluating elements of the ERAS care pathways in RC have found benefits in postoperative morbidity, return to bowel function, or LOS.[13],[14],[15]

Since intraoperative fluid replacement during surgery is a critical component of ERAS protocol, low intraoperative fluid regimens were associated with lower transfusion, which resulted in better clinical outcomes. This study showed that there was no significant difference in intraoperative blood transfusion between the ERAS and non-ERAS group groups. This was most likely associated with some technical considerations, the local status tumor, and the experience of the surgeon. Our study was performed in pT3 and pT4 bladder carcinoma patients, who have high-risk bleeding and need blood transfusion; thus, there was no significant difference between ERAS and non-ERAS groups in this particular field. This result is consistent with a meta-analysis report by Yang et al.[16] that may be associated with the professional level and good cooperation of the operator, anesthesiologist, and operating room nurse, which is indicated in our center.

According to the available data, ERAS protocols improved recovery, accelerated discharge home, and reduced the burden of care to the patient and their medical/nursing teams. In previous studies, there was an evaluation of bowel functions, and there was a significant difference between ERAS and non-ERAS groups found in the patients with ileal conduit or neobladder.[5] In this study, we performed UCN, and we evaluated the bowel functions as a postoperative follow-up to see whether there was a postoperative paralytic ileus or not. In our study, we found that bowel sounds in the ERAS group are significantly better than the non-ERAS group. We also found that the return rate of the patient's bowel movement in the ERAS group is as follows: (mean [range]: 6.11 ± 2.977 [3.00–12.00] h for ERAS vs. 12.50 ± 5.385, [6.00–24.00] h for non-ERAS, P = 0.005). We report that none of both groups developed paralytic ileus. There has been one prospective randomized controlled trial of ERAS in RC patients,[11] in which ERAS use led to fewer complications, faster improvement in return of quality of life, more rapid bowel recovery, and shorter stays in intermediate care, but no change in LOS. However, our modified ERAS protocol improved recovery, accelerated discharge home, and reduced hospitalization costs.

Nevertheless, there were several limitations to this study. We did not observe mobilization function and voiding function. In addition, there has not been any previous research that compared the standard ERAS protocols and the modified ERAS protocols; therefore, we cannot decide which of them are better.


  Conclusions Top


Modified ERAS protocols for RC at our institution reduced the LOS and hospitalization cost; they led to faster bowel movement and no readmission, which indicates that our modified ERAS protocols are feasible for patients who underwent RC.

Financial support and sponsorship

This study was supported by Universitas Padjadjaran Internal Research Grant.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

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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. 6
    
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Lemanu DP, Singh PP, Stowers MD, Hill AG. A systematic review to assess cost effectiveness of enhanced recovery after surgery programmes in colorectal surgery. Colorectal Dis 2014;16:338-46.  Back to cited text no. 7
    
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Patel HR, Cerantola Y, Valerio M, Persson B, Jichlinski P, Ljungqvist O, et al. Enhanced recovery after surgery: Are we ready, and can we afford not to implement these pathways for patients undergoing radical cystectomy? Eur Urol 2014;65:263-6.  Back to cited text no. 8
    
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Karl A, Buchner A, Becker A, Staehler M, Seitz M, Khoder W, et al. A new concept for early recovery after surgery for patients undergoing radical cystectomy for bladder cancer: Results of a prospective randomized study. J Urol 2014;191:335-40.  Back to cited text no. 11
    
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Witjes JA, Bruins HM, Cathomas R, Compérat E, Cowan NC, Gakis G, et al. EAU guidelines on muscle-invasive and metastatic bladder cancer. Eur Assoc Urol 2019;23-4  Back to cited text no. 12
    
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Daneshmand S, Ahmadi H, Schuckman AK, Mitra AP, Cai J, Miranda G, et al. Enhanced recovery protocol after radical cystectomy for bladder cancer. J Urol 2014;192:50-5.  Back to cited text no. 13
    
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Arumainayagam N, McGrath J, Jefferson KP, Gillatt DA. Introduction of an enhanced recovery protocol for radical cystectomy. BJU Int 2008;101:698-701.  Back to cited text no. 14
    
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Vukovic N, Dinic L. Enhanced recovery after surgery protocols in major urologic surgery. Front Med (Lausanne) 2018;5:93.  Back to cited text no. 15
    
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Yang R, Tao W, Chen YY, Zhang BH, Tang JM, Zhong S, et al. Enhanced recovery after surgery programs versus traditional perioperative care in laparoscopic hepatectomy: A meta-analysis. Int J Surg 2016;36:274-82.  Back to cited text no. 16
    



 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]



 

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