JOURNAL OF THE
ROYAL MEDICAL SERVICES

Official Publication for the Jordanian Royal Medical Services


Enhanced Recovery Protocol After Radical Cystectomy for Urinary Bladder Cancer at The Prince Hussein Urology Center.


Dr.Ashraf AL-Majali MD*, Tareq AL-Nasser, MD*, Dr. Bilal Abu-Naja MD*, Dr.Mohammad AL-Qudah MD*, Mutaz AL-Atoum MD*, Motasem Smadi, MD*, Dr. Firas Khori MD*, Dr. Ahmad AL-Hiari MD*, Dr.Mohammad Abd AL-Dyeam MD*, Anees AL-Hjazeen RN**, Dr.Mohanad Naser MD*



 

ABSTRACT

Objectives: The main objective of this study was to evaluate the effect of Enhance Recovery After Surgery (ERAS) on radical cystectomy for muscle invasive bladder cancer, including hospital stay, the early mobilization, and the complications.

Methods and materials: Retrospectively, 400 medical files were reviewed for patients who underwent radical cystectomy with ileal conduit in the Prince Hussein Urology Center between May 2011 and March 2020. These files were divided into two teams (group-1: 187 patients underwent radical cystectomy with application of the ERAS protocol; group-2: 213 patients underwent radical cystectomy without the ERAS protocol. Pre, peri and postoperative parameters of both teams were compared. The ERAS elements were bowel preparation, carbohydrate loading, body warming and regional anesthesia, the decrease of drains use, early postoperative mobilization, early oral feeding with nasogastric tube removal.  Follow-up amount was from 1st day to 90-days postoperatively.

Results: concerning the demographic data of both groups (age, gender, and body mass index), there have been no vital variations (The P value was greater than “0.05”). On the opposite hand, there have been significant differences in respect to the categorical data (hospital stay, early mobilization, the quality of hospital stays, postoperative complications, readmission rates, operative time, blood transfusion rates, and hospitalization costs) (The P-value was lower than “0.05”)

Conclusion: The ERAS protocol plays an effective role in decreasing patients’ hospital stays and costs, complication rates, readmission rates, operative time, and blood transfusion rates. Also, it increases the early mobilization rate and the quality of hospital stays.

Keywords: Radical cystectomy, Enhanced Recovery after Surgery, hospital stay, post-operative complications.

RMS December 2023; 30 (3): 10.12816/0061655






Introduction

Radical cystectomy has proved to be the most suitable choice for muscle invasive bladder cancer; this kind of cancer mainly occurs in the in elderly comorbid patients with a mean age of sixty-eight years. The early complications of this surgery (during hospitalization or within the period of the thirty days of surgery) accounts for 20-57% (1). Also, bladder cancer patients are exposed to extend the danger of specific nutrients deficiencies on account of the cancer itself (2); therefore, patients at a nutritional process risk are increasingly susceptible to complications upon major urological procedures (3).



Consequently, wonderful perioperative management could contribute to the interference of morbidity and mortality of RC (4). This results in the employment of enhanced recovery after surgery (the ERAS) protocols which are multimodal perioperative care pathways which are designed to attain early recovery after surgical procedures by maintaining preoperative organ function and reducing the profound stress response following surgery. The key elements of the ERAS protocols include: preoperative counselling, the improvement of nutrition, standardized analgesic and anesthetic regimens and early mobilization (5).

Due to the best morbidity that are related to the RC among all urological surgical procedures, enhanced recovery after surgery (the ERAS) protocols will facilitate to reduce the surgical stress response which is caused by radical cystectomy (6).  With time, there have been several enhancements in the ERAS protocols to boost the first recovery hospital keeping the post major abdominal procedures (7, 8). Moreover, the use of the ERAS protocols pre, intra and postoperative for radical cystectomy patients was suggested (9). Finally, the ERAS protocols for radical cystectomy were found cost-effective in 30-days prices which are relative to straightforward management (10).

We tend to hypothesize that the ERAS protocols would improve the nutritional status of radical cystectomy patients, and therefore, patients’ care, and decreasing complications beside the hospital stays.

 

 


Materials and methods

The Enrollment of four hundred patients who underwent between May 2011 and March 2020 in the Prince Hussein Urology Center. Among these patients, 187 patients underwent the RC with the ERAS protocol being applied starting from the year 2014 till March 2020 (the ERAS was initially applied in our center in June 2014), while the other 213 patients underwent the RC starting from May 2011 to August 2019 without undergoing the ERAS protocol.

The ages of these patients were between (38 and 76 years), whereas the inclusion criteria were: patients with correctable clotting profile, normal kidney function tests, controlled diabetes mellites and hypertension; The exclusion criteria were: the existence of another malignancy either urological or gastrointestinal, inflammatory bowel disease (IBD),  previous major abdominal surgery or radiotherapy that prevent the establishment of the ileal conduit and patients with advanced bladder cancer.

All patients got antibiotics like cephalosporins (second or third generation) to cover gram +ve and -ve bacteria plus metronidazole for anaerobes or ertapenem (Invanz) preoperatively. The follow-up amount of all patients was between the primary day to ninety days postoperatively.

The hospital stays and the times of early ambulation postoperatively, quality of hospital stays, postoperative complications, readmission rates, operative times, blood transfusion rates and hospitalization prices between each team were all compared.

 

The ERAS protocol

There have been three components of this protocol:

1- Preoperatively: the data was given to the patients regarding surgical and anesthetic procedures, stoma siting education, mechanical bowel preparation ( preoperative mechanical bowel preparation including a clear liquid diet, and an enema before surgery), medical optimization (albumin level), smoking cessation four weeks before assigned time of surgery, anticoagulation like: Clexan was given one day before surgery (at 6 p.m.) and stocking application. Within the day of surgery; fasting to food before six hours. However, to water before two hours. Carbohydrate loading and antibiotics before one hour. Before the skin incision (ertapenem (Invanz) 1 gr intramuscularly or intravenously) was applied.

2- Intraoperatively: epidural anesthesia, body warming, drains, ileal conduit catheter, and wound infiltration.

3- Postoperatively:  On Day “0”: observing nausea and vomiting, epidural anesthesia, parenteral analgesia, oral analgesia, oral fluids, set outside bed in two hours. Gum chewing and NG tube removal.  On Day One: observing nausea and vomiting, blood count and kidney function tests, oral fluid, then soft gastric diet, early walk for six hours., chest physiotherapy, oral analgesia, non-oral analgesia (PCA; patient control analgesia, IM, IV), lactulose 15 ml x 2, ileal conduit catheter and energy drink (Ensure) 50 ml x 2.  On Day Two: regular diet, stop non-oral analgesia, notice if patient passed flatus or stool and encourage a lot of ambulation. On Day Three: noticing flatus or stool and discharge to home if patient ingestion and drinking are well, walking, passed flatus or stool, no pain and no fever. On Day Four: the same as Day-3. (Criteria for discharge are: no fever, no vomiting, normal white blood count, tolerating diet, good urine output and passed flatus).

 

The non-ERAS group protocol includes the following: -

 

1- Preoperative measures consisted of a liquid diet and 12 hours fasting the day before surgery,

2- An oral mechanical bowel preparation was performed in the day before surgery.

3- he NGT was kept in place normally at least 3 days or until return of bowel function.

4-   The liquid intake was normal during surgery.

5-   Intraoperative antimicrobial prophylaxis was made with cephalosporin before surgery and at least 7 to 10 days after surgery. After surgery.

6-Patients received no fluids by oral intake; pain medication was administered intravenously (I.V.) using mostly non-opioid drugs.

7-    Mobilization was mostly started after pain relief from surgery, after at least 2 to 3 days.

8-  A normal diet was started after return of bowel movement.

 



Statistics

Statistical analysis in relevance to the previously mentioned variables between every team was done by using the SPSS computer program version-24; the results were expressed as mean ± SD (standard deviation) or number, the comparison between the mean values of both groups continuous clinical variables was carried out by using Mann-Whitney U test. The Comparison between both groups regarding the categorical data (N (%)) was performed by the chi-square test. The P-value < 0.05 was considered statistically significant.

We have attained approval from our institution in the Royal Medical Services ethical committee for publication.

 


Results

In total, 400 patients were enclosed during this study (the ERAS group n= 187; non- the ERAS group n=213). The demographic data (ages, genders, and body mass indexes) between both had of no significant differences; (the P value is worth = 0.065, 0.073, 0.096, respectively). Cluster one ages (38- 72 years), whereas group-2 (41-76 years). Body mass indexes in the ERAS group (24-31 kg\m2), while within the different groups it was (23.4-32.1 k\m2). Table I. The significant P value under 0.05.

 



Table I: demographic data.

 

Variables

Group-1 (the ERAS)

Group-2 (the non-ERAS)

the “P” value

Ages (mean± SD©)

(54.64±7.76)

(57.27±8.94)

0.0653

Gender (N*\%) male

  Gender (N *\%) female                      

101(54%)

86(46%)

108(51%)

105(49%)

0.0733

Body mass index (BMI) (mean± SD)

(26.87±1.37)

(26.89±1.81)

0.0962

            

              N*: stands for the number of the patients

                SD©: stands for standard deviation

 

In Table II, the comparison was created between each team concerning the hospital stays, the time of early mobilization, the quality of hospital stays, the postoperative complications; vomiting, urine leak, intestinal obstruction, urinary tract infection, deep venous thrombosis (according to Clavien-Dindo classification of surgical complications), readmission rates, operative times and the blood transfusion rates). The significant P value was lower than 0.05.Concerning hospitalization costs, we estimated it to be lower from over all stay length in hospital but exact numbers is not available as military hospital. The ERAS group used dramatically less opioids overall and on each postoperative day. Overall complication rates were lower the ERAS group compared to the historical control group.

Fever was the most common reason for readmission, accounting for 57% of all readmissions. Other causes were abdominal pain and/or gastrointestinal symptoms (25%), dyspnea or chest pain and flank pain

 

Table II: the categorical data of both groups and the comparison.

Variables

Group-1 (the ERAS)

Group-2 (the non-ERAS)

the “P” value

The time for early ambulation \hrs. (mean± SD*)

 

(10±1.4)

 

(56.2±4.8)

 

0.012

Hospital stays\ days (mean ± SD)

(4.5±1.6)

(7.8±2.1)

0.033

Quality of hospital stays

(Without complications) (n©\%)

(166\89%)

(170\80%)

0.009

Readmission rates (n\%)

30 days

90 days

(16\8.5%)

(10\5.3%)

(6\3.2%)

(43\20.1%)

(28\13.1%)

(15\7%)

0.026

Blood transfusion rates (n\%)

(18\9.6%)

(35\16.4%)

0.0153

Operative times \min. (mean ± SD)

(266 ±27.8)

(283± 32.3)

0.021

Complication rates (regarding Clavien-Dindo classification) (n\%)

Grade Ι

Grade II

Grade III a, b

Grade IV a, b

Grade V

 

 

 

 

 

(8\4.2%)

(13\6.9%)

(2\1%)

-

-

 

 

 

 

(15\7%)

(27\12.7%)

(6\2.8%)

-

-

 

 

 

 

0.031

 

 

 



Discussion

There have been significant differences between patients who underwent ERAS and those who did not had the ERAS in terms of the time of early ambulation, hospital stays, the quality of hospital stays, operative times, the blood transfusion rates, readmissions, the hospital costs and the complication rates were all in favor of group-1 (the ERAS) (the P value lower than 0.05).In our study, median length of stay decreased from 8 days in the historical control group to 5 days in the ERAS group, to the benefit of patients who would rather be at home and to the benefit of the healthcare system in terms of cost and resource utilization.

The same findings were reported by Chunxiao Wei and colleagues in the year 2018 with significant leads with regard to patients’ rehabilitation, readmissions, costs (11), hospital stays (12), and postoperative complications (13). Therefore, the expansion of the idea of the ERAS protocol with a significant variation of surgical procedures was recommended (14).

Regarding Gastrointestinal (GI) complications; the ERAS protocol decreases these complications (15) by expedites bowel function recovery (16) through a big reduction within the time to the primary flatus, the time of the first stool and the time of a standard diet (17), and so decrease the GI interventionism by reducing the requirement for nasogastric tubing and total parenteral nutrition besides the reduction of orotracheal intubation for mechanical ventilation (18). Reduced paralytic ileus and cardiovascular complications were also noticed (19).

Within the different hand, some studies reported that ERAS have not nevertheless been widely-enforced in urology and the proof for individual interventions is restricted or unavailable (20); therefore, a lot and expanded studies are required to prove the efficacy of the ERAS for patients undergoing Open RC (21). Also, H. Djaladat and associates reported that sadly despite the use of an ERAS protocol, the major and minor complication rates were high. The readmission with infectious complications being the foremost common reason for readmission. Thus, the minimum of during the study of open radical cystectomy with urinary diversion still has high complication and readmission rates even with an ERAS protocol (22).

Robotic radical cystectomy conjointly had an opportunity for the ERAS protocol and it was found that the patient undergoing robotic radical cystectomy is probably going to boost morbidity and mortality, and shorten the hospital keep (23).

Several small studies evaluating elements of the ERAS care pathways in RC found benefits in postoperative morbidity, return to bowel function (Roth et al. 2013; Jensen et al. 2015; Lee et al. 2014). A few studies of early fast track, multimodal, or enhanced recovery programs have also been published, showing improvements in length of stay, time to GI recovery, and post-operative ileus (Maffezzini et al. 2007; Arumainayagam et al. 2008; Pruthi et al. 2010; Bazargani et al. 2017; Daneshmand et al. 2014; Baack Kukreja et al. 2017). Adding anesthesia-related elements to an existing surgical enhanced recovery program reduced transfusions and nausea, while continuing to demonstrate good results in time to GI recovery and length of stay (Patel et al. 2018). Reviews and meta-analyses of these early studies have shown similar improvements in length of stay and return of bowel function with no change or an improvement in complications (Di Rollo et al. 2015; Mir et al. 2015; Tyson and Chang 2016).

Finally, the protocol is not a substitute for major urological surgeries, neither is it a method of imposing patients to be discharged sooner to receive their postoperative care within the home. It is an associate degree evidence-based protocol designed to boost the patients’ expertise and recovery from cystectomy (24).

 



Conclusion 

The ERAS protocol once was utilized in major urological procedures like Radical cystectomy; it decreases the hospital stays, the readmission rates, the hospital costs, the post-operative complications and will increase the standard of patients’ recovery with early walk and quick come back of bowel habits, and so probably reducing health care expenditure. We tend to advise the employment of the ERAS protocol with major urological procedures because it has been proved based mostly protocol for the enhance recovery upon these surgeries.

 

 



References

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