Colorectal Surgery Clinical Trial
Official title:
Enhanced Recovery Program in Laparoscopic Colorectal Surgery: an Observational Controlled Trial
Background: A few randomized clinical trials and meta-analysis provide evidence for enhanced
recovery programs (ERPs) in colorectal surgery. Most of the evidence, however, relies on
non-randomized controlled studies that have control groups being either historical or
operated on at different facilities. The aim of this study was to compare a prospective
series of patients undergoing elective colorectal surgery according to ERPs, with a coeval
retrospective series of patients undergoing elective colorectal surgery in a different ward
at the same hospital.
The primary outcome was hospital length of stay, which was used as a proxy of functional
recovery. Secondary outcomes included: postoperative complications, readmission rate,
mortality, and adherence to the protocol.
Materials and Methods: A prospective series of consecutive patients (N = 100) undergoing
elective colorectal resection completing a standardized ERP in 2013-2015 (ERP Group) will be
compared to patients (N = 100) operated at the same institution in the same period with a
traditional perioperative care protocol (Non-ERP group). Despite different surgeons and ward
nurses, the two groups shared the same anaesthesiologists and were located in separate wards.
The exclusion criteria were: >80 years old, ASA score of IV, a stage IV TNM, and diagnosis of
inflammatory bowel disease.
1. Introduction
One of the most important achievements in modern surgery is the implementation in
perioperative care of Enhanced Recovery Programs (ERPs), pioneered by Henrik Kehlet in
the mid-1990s [1]. ERP is an evidence-based perioperative care approach, involving a
multidisciplinary team work including surgeons, anaesthesiologists, dieticians, and
nurses, which aim to reduce the surgical stress and metabolic responses as well as organ
dysfunction, thus leading to a faster recovery after surgery [2].
Such a team works with a multimodal approach to perioperative care, sharing all the
endpoints of management throughout the perioperative phases, and acting in close
relationship with the patient along his/her "journey in hospital". In other words, each
perioperative phase comprises several core items based on solid scientific evidence that
are delivered by different professionals in different parts of the hospital [2].
A few randomized clinical trials and meta-analysis provide evidence in the literature
for the benefits of ERPs in colorectal surgery [3-6]. Most non-randomized controlled
studies have compared patients undergoing colorectal enhanced recovery surgery with
controls being either historical groups or patients operated on at different hospitals
[7-9].
In a previous investigation, the investigators showed the benefits of implementing an
ERP in elective colorectal surgery by comparing a prospective series of 100 patients
operated on receiving enhanced recovery care (ERP group), with a retrospective cohort of
100 patients operated on by the same professionals at the same institution before the
introduction of the ERP (Pre-ERP group) [10].
The present study aims to investigate the differences between a prospective series of
patients undergoing elective colorectal surgery following an ERP and a retrospective
cohort of patients operated on with traditional perioperative care in the same period by
a different team of surgeons and hospitalized in a different ward of the same hospital.
2. Materials and Methods
The study was designed as a prospective cohort with retrospective coeval control. A
prospective series of 100 consecutive patients undergoing elective colorectal surgery
completing a standardized ERP protocol at the S. Anna University Hospital in Ferrara (Italy)
in 2013-2015 (ERP group), was compared to a retrospective series of 100 consecutive patients
operated at the same hospital, in the same period of time, but with a traditional
perioperative care protocol (Non-ERP group). Despite different surgeons and ward nurses, the
two groups of patients shared the same anaesthesiologists and were located in two separate
wards.
In 2012 the enhanced recovery team was assembled, the ERP protocol was built up, according to
the fast-track protocol proposed by Kehlet and Wilmore [11], and periodical audits were then
performed. Eligible for this study were all patients between 18 and 80 years old scheduled
for elective colorectal resection. Exclusion criteria in both study groups were: age > 80
years old, American Society of Anaesthesia (ASA) score IV, TNM stage IV, and diagnosis of
inflammatory bowel disease. Discharging criteria were also the same for both groups: 1) free
oral diet, 2) complete intestinal function recovery (passage of flatus and stool), 3) dynamic
pain control (Numerical Rate Scale - NRS ≤ 3) by oral analgesia, 4) independent walking, 5)
no signs of infection [10].
The study protocol was approved by the local Ethics Committee (Ethical Committee for Human
Subject Research study number 52-2011), it complies with the Declaration of Helsinki, and all
patients provided written informed consent The primary outcome of this study was the length
of stay (LoS) in the hospital, adopted as a proxy of functional recovery. Secondary outcomes
were: postoperative complications, readmission rate, mortality, and adherence to the
protocol.
All complications were recorded until 30 days after surgery, as well as mortality and
hospital readmission. To evaluate adherence to the protocol, all ERP items were prospectively
collected, recorded and checked by an independent observer using a detailed care program for
each postoperative day. The grading of complications was defined according to a validated
classification [12].
Data were collected prospectively for patients in the ERP group and retrieved from a
prospectively maintained database for those in the Non-ERP group.
Surgery was preferably performed by laparoscopy, but alternative approaches were allowed and
discussed with patients. A converted laparoscopy was defined as an unplanned extension of the
surgical incision (either a median or a transverse suprapubic incision). All operations were
performed by surgeons experienced in colorectal surgery and advanced laparoscopy (CVF, GA).
2.1 ERP Group Patients received extensive preoperative counselling about protocol items, all
phases of perioperative care, and discharge criteria, along with an illustrated booklet
conceived by the multidisciplinary team. The patients were motivated to adhere to protocol
items by members of the team throughout the preoperative and postoperative phases and were
informed about the daily objectives to be achieved. Incentive spirometers were provided
preoperatively and patients were instructed for perioperative breathing exercises.
A normal meal was allowed on the day before surgery; a carbohydrate loaded drink was
prescribed in the evening (100 grams of maltodextrin in 800 ml liquid drink) and at least two
hours (50 grams of maltodextrin in 400 ml liquid drink) before surgery. No patient was
prescribed mechanical bowel preparation.
The nasogastric tube (NGT) and bladder catheter were removed at the end of the procedure and
within the second postoperative day [13], respectively, whereas abdominal drains were
selectively used.
Postoperative pain control was achieved with thoracic epidural analgesia within the first
three postoperative days and with Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) or
paracetamol thereafter. Resumption of liquid and solid diets and discontinuation of
intravenous fluids were all achieved within the first and the second postoperative day.
Patients were out of bed on postoperative day one and encouraged by nurses to deambulate
according to a predefined schedule.
The anaesthetic protocol was standardized as previously described elsewhere [10]. In brief, a
blended anaesthesia was performed with short-acting anaesthetic agents and mid-thoracic
epidural intraoperative analgesia. Attention was put on maintaining normothermia with forced
air warming devices during surgical procedures and a multimodal approach to prevent
PostOperative Nausea and Vomiting (PONV) was pursued. Intravenous fluid overload was avoided.
2.2 Non-ERP Group Patients were treated according to traditional perioperative care
principles in use at the institution. Specifically, on the day before surgery patients fasted
from midnight, received no carbohydrate loaded drink, and performed a mechanical bowel
preparation.
An opioid-based anaesthesia with or without thoracic epidural was used, while postoperative
pain control was achieved by intravenous opioids, thoracic epidural or NSAIDs.
The NGT was removed at the restoration of intestinal activity when oral feeding was resumed,
while the abdominal drain was removed at bowel movements.
No predefined schedule was followed for patients' mobilization and the bladder catheter was
removed at full mobilization and after discontinuation of intravenous fluids.
Patients received no daily goal assignments or specific preoperative counselling.
In order to determine in between groups perioperative care differences, an independent
observer reviewed the medical charts of all patients to evaluate the adherence to the 21
protocol items.
2.3 Statistical Analysis Clinical parameters were expressed as median (interquartile range -
IQR 25-75) and mean ± standard deviation according to distribution assessed by Shapiro-Wilk
test. Categorical data were presented as numbers. Clinical and pathological variables were
analysed with Chi-square, t-student, and Mann-Whitney tests as appropriate. The Kaplan-Meier
test method and Log-Rank test were used to compare duration of surgical operation, time to
functional recovery and hospital LoS between groups. A P value of less than 0.05 was
considered statistically significant. Statistical analysis was performed with IBM SPSS
Statistics for Windows, Version 24.0 (IBM Corp. Armonk, NY: IBM Corp.).
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