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.
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