Enhanced Recovery Program in Laparoscopic Colorectal Surgery: An Observational Controlled Trial

Abstract

Background:

Most of the evidence for enhanced recovery programs (ERPs) in colorectal surgery relies on nonrandomized studies with control groups either historical or operated on at different facilities. The aim of this study was to investigate ERP in coeval groups admitted in different wards at the same hospital.

Materials and Methods:

A prospective cohort of consecutive patients (n = 100) undergoing elective laparoscopic colorectal resection completing a standardized ERP (ERP group) was compared with patients (n = 100) operated with traditional perioperative care in the same period at the same institution (non-ERP group). The two groups were located in separate wards and shared the same anesthesiologists. The exclusion criteria were: >80 years old, American Society of Anesthesia (ASA) IV, metastatic disease, and inflammatory bowel disease. The primary outcome was hospital length of stay (LoS), used as a proxy of functional recovery. Secondary outcomes included: postoperative complications, readmission rate, mortality, and protocol adherence.

Results:

The ERP group protocol adherence was 81%. The LoS was significantly reduced in the ERP group (4 versus 7 days). The number of 30-day postoperative complications was lower in the ERP group (P < .001). No increase was found in 30-day readmission or mortality. Conventional perioperative protocol was the only predictor of any postoperative complication and, together with male sex and age 65–74 years old, was the only factor associated with prolonged LoS.

Conclusion:

Implementing a colorectal ERP is feasible, safe, and efficient for functional recovery, but high protocol adherence is needed. Following traditional perioperative care is associated with more postoperative complications and prolonged LoS.

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 The ERP is an evidence-based perioperative care approach, involving a multidisciplinary team work including surgeons, anesthesiologists, dieticians, and nurses, that aims at reducing 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 is 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 nonrandomized 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, we showed the benefits of implementing an ERP in elective colorectal surgery by comparing a prospective series of 100 patients operated on and 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

This study aims at investigating the differences between a prospective series of patients undergoing elective colorectal surgery after 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.

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 with a retrospective series of 100 consecutive patients operated at the same hospital, in the same period, but with a traditional perioperative care protocol (non-ERP group). Despite different surgeons and ward nurses, the two groups of patients shared the same anesthesiologists 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. All patients between 18 and 80 years old and who were scheduled for elective colorectal resection were eligible for this study. Exclusion criteria in both study groups were: age >80 years old, American Society of Anesthesia (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 ≤3) by oral analgesia, (4) independent walking, and (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), and it complied with the Declaration of Helsinki; 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 (C.V.F., G.A.). All patients underwent outpatient office visits, which were scheduled 10 and 30 days after the surgical operation.

ERP group

Patients received extensive preoperative counseling 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 about perioperative breathing exercises.

A normal meal was allowed on the day before surgery; a carbohydrate-loaded drink was prescribed in the evening (100 g of maltodextrin in 800 mL liquid drink) and at least 2 hours (50 g 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 1 and encouraged by nurses to deambulate according to a predefined schedule.

The anesthetic protocol was standardized as previously described elsewhere.¹⁰ In brief, a blended anesthesia was performed with short-acting anesthetic agents and mid-thoracic epidural intraoperative analgesia. Attention was focused on maintaining normothermia with forced air warming devices during surgical procedures, and a multimodal approach to prevent postoperative nausea and vomiting was pursued. Intravenous fluid overload was avoided.

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 anesthesia with or without thoracic epidural was used, whereas 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, whereas 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 counseling.

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.

Statistical analysis

Clinical parameters were expressed as median (interquartile range 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 analyzed with chi-square, t-student, and Mann–Whitney tests as appropriate. The Kaplan–Meier test method and Log-Rank test were used to compare the duration of surgical operation, time to functional recovery, and hospital LoS between groups. A P value of <.05 was considered statistically significant. Statistical analysis was performed with IBM SPSS Statistics for Windows, Version 24.0 (IBM Corp. Armonk, NY: IBM Corp.).

Results

We compared 100 patients in the ERP group with 100 control patients in the non-ERP group.

The key elements and adherence to the protocol in the two groups are illustrated in Table 1. The median compliance with ERP elements was 81.0% (range, 76.2%–85.7%) in the ERP group and 28.6% (range, 9.5%–47.6%) in the non-ERP group.

Table 1.

Key Elements of the Enhanced Recovery Program Protocol

Variables	Non-ERP group (n = 100)	ERP group (n = 100)	P
Pre-admission counseling	0	100	<.0001
Booklet	0	100	<.0001
No mechanical bowel preparation	0	100	<.0001
No preoperative fasting	0	100	<.0001
Preoperative oral carbohydrate loading	0	95	<.0001
No premedication	89	94	.191
Mid-thoracic epidural anesthesia	63	91	<.0001
Short-acting anesthetic agent	1	88	<.0001
Avoidance of intraoperative fluid overload (≤5 mL/kg/hour)	1	6	.065
Intraoperative maintenance of normothermia	94	96	.999
Prevention of nausea and vomiting	60	85	<.0001
Minimally invasive surgery	93	89	.459
No abdominal drains	2	43	<.0001
No nasogastric tube	5	95	<.0001
Early mobilization (day ≤2)	8	59	<.0001
Postoperative breathing exercises	0	94	<.0001
Mid-thoracic epidural analgesia	63	91	<.0001
Non-opiate oral analgesics/NSAIDs	44	85	<.0001
Stimulation of gut motility	45	39	.474
Early removal of bladder catheter (day ≤2)	23	68	<.0001
Early oral nutrition (day ≤1)	0	84	<.0001

ERP, enhanced recovery program; NSAID, nonsteroidal anti-inflammatory drug.

Baseline and demographic characteristics of the two groups are shown in Table 2. The two groups were similar with respect to gender, age, and body mass index. Patients were comparable in concomitant diseases, except for diabetes, which prevailed in the non-ERP group as well as ASA class III, as opposed to ASA II that prevailed in the ERP group.

Table 2.

Baseline Characteristics

Variables	Non-ERP group (n = 100)	ERP group (n = 100)	P
Gender			.395
Male	57	50
Female	43	50
Age (years)			.842
<65	38	42
65–74	38	35
≥75	24	23
BMI^a (Kg/m²)			.848
<25	44	45
25–29.9	39	38
≥30	17	17
ASA score			.018
I	3	2
II	45	65
III	52	33
Diabetes	18	4	.003
Hypertension	57	52	.570
Asthma	5	2	.445
COPD	6	3	.498
Valvular heart disease	4	1	.369
Ischemic heart disease	7	8	.999
Atrial fibrillation	6	4	.748
Hypercholesterolemia	13	8	.357
Chronic renal insufficiency	3	1	.621
Depressive disorder	14	13	.999
MUST score			.062
0	96	91
1	2	3
2	0	6
3	1	0
Preoperative hemoglobin, median (IQR 25–75)	12.7 (11.1–14.2)	13.1 (11.1–14.5)	.553

BMI was not available in one patient of the non-ERP group.

ASA, American Society of Anesthesia; BMI, body mass index; COPD, chronic obstructive pulmonary disease; ERP, enhanced recovery program; IQR, interquartile range; MUST, malnutrition universal screening tool.

Table 3 shows intraoperative variables. No difference was detected between groups regarding operation type and surgical approach (laparoscopy ≥89%), but there was a prevalence of malignant tumors in the ERP group (P = .032). The duration of intervention was about 30 minutes less in the non-ERP group (P ≤ .0001). The median total intraoperative fluid infusion rate was about 4.4 mL/kg/hour lower in the ERP group (P < .0001). No difference was detected as to intraoperative red blood cell transfusion.

Table 3.

Intraoperative Characteristics and Variables

Variables	Non-ERP group (n = 100)	ERP group (n = 100)	P
Disease			.032
Cancer	73	84
Benign tumor	27	14
Diverticular disease	0	2
Type of operation			.019
Right colectomy	50	50
Left colectomy	13	15
Transverse colon resection	3	4
Rectosigmoid resection	31	26
Segmental resection	2	4
Subtotal colectomy	1	1
New stoma	0	1	.999
Surgical approach			.549
Laparotomy	4	5
Laparoscopy	93	89
Laparoscopy with conversion	3	6
Length of procedure (minutes)^a	162.0 (135.5–183.8)	190.0 (165.8–230.0)	<.0001
Intraoperative intravenous fluids (mL/kg/hour)^a	14.5 (10.7–18.4)	10.1 (7.5–12.5)	<.0001
Intraoperative red blood cell transfusion	8	8	.999
Intraoperative red blood cell transfusion (mL)^a	425 (312–700)	350 (300–365)	.279
Urine output (mL)^a	475 (250–722)	500 (300–810)	.574

Median (interquartile range 25–75).

ERP, enhanced recovery program.

Complete functional recovery was achieved earlier in the ERP group, with no difference between groups as to postoperative vomiting, re-insertion of NGT, and resumption of intravenous fluids (Table 4). The use of a central venous catheter was similar between groups, whereas an epidural catheter prevailed in the ERP group (63% versus 91%, P < .001). A higher number of patients maintained the NGT postoperatively in the non-ERP group, whereas pain control by oral analgesics was achieved earlier in the ERP group with no difference in pain scores (Table 4).

Table 4.

Postoperative Variables and Outcomes

Variables	Non-ERP group (n = 100)	ERP group (n = 100)	P
Positioning of
Central venous catheter	14	5	.051
Epidural catheter	63	91	<.0001
NGT	95	5	<.0001
Drainage	98	57	<.0001
Day of removal of, median (IQR 25–75)
Epidural catheter	3 (2–4)	3 (3–3)	.143
NGT	3 (2–3)	1 (0–1)	<.0001
Abdominal drain	5 (4–5)	3 (3–5)	.001
Foley catheter	3 (3–4)	2 (2–3)	<.0001
Postoperative red blood cell transfusion	10	5	.283
Vomiting ≤24 hours	3	10	.082
Vomiting >24 hours	14	14	.999
Reinsertion of NGT	9	7	.795
Resumption of intravenous fluids	2	7	.170
Postoperative intravenous opioids	56	5	<.0001
Postoperative NSAID's	38	85	.001
NRS maximum, median (IQR 25–75)
Day 0	2 (1–3)	2 (1–5)	.798
Day 1	3 (1–5)	3 (1–6)	.808
Day 2	2 (1–3)	2 (1–5)	.125
Day 3	2 (1–2)	1 (1–2)	.259
Day 4	1 (1–2)	1 (0–1)	<.795
Stimulation of gut motility	45	39	.474
Time to liquid diet (days)	3 (2–4)	1 (1–1)	<.0001
Time to solid food (days)	5 (4–6)	3 (2–3)	<.0001
Time to intestinal activity (days)	3 (2–4)	2 (1–2)	<.0001
Time to bowel movements (days)	4 (3–5)	3 (2–4)	<.0001
Time to pain control on oral analgesic (days)	5 (4–6)	3 (3–4)	<.0001
Time to full mobility and autonomy (days)	4 (3–6)	2 (2–3)	<.0001
Postoperative day fit for discharge (days)	6 (5–8)	4 (4–5)	<.0001
Hospital length of stay (days)	7 (6–8)	4 (4–5)	<.0001
Postoperative complications (Clavien-Dindo)			<.0001
Grade I	50	7
Grade II	26	26
Grade IIIa	2	1^a
Grade IIIb	5	1^b
Grade IVb	2	0
In-hospital mortality	0	0	—
30-day readmission	4	3	.999
30-day mortality	0	0	—

Percutaneous drain of sub-hepatic abscess.

Re-intervention for hemoperitoneum by hepatic injury.

ERP, enhanced recovery program; IQR, interquartile range; NGT, nasogastric tube; NRS, Numeric Rating Scale; NSAID, nonsteroidal anti-inflammatory drug.

Hospital LoS and the postoperative day when patients reached discharge criteria (i.e., fit for discharge) were significantly lower in the ERP group, as opposed to the non-ERP group (P < .001). The total number of 30-day postoperative complications was lower in the ERP group compared with the non-ERP group (P < .001), in particular for grade I complications, and there was a trend toward less severe complications. No increase was detected in 30-day readmission and mortality. In the non-ERP group, half of the patients readmitted in hospital within 30 days were reoperated on, as opposed to none in the ERP group.

Logistic regression analysis showed that using a traditional perioperative care protocol was the only predictor of any postoperative complication (Table 5). According to Cox regression analysis, male sex, age between 65 and 74 years old, and following a traditional perioperative care protocol were the only factors associated with prolonged hospital LoS (Table 6).

Table 5.

Association Between Baseline Characteristics, Intraoperative Variables, and Type of Perioperative Protocol and Prolonged Length of Hospital Stay According to Logistic Regression Analysis Adjusted for Potential Confounders

Variable	Any postoperative complication
	Unadjusted model		Full adjusted model
	OR (95% CI)	P	OR (95% CI)	P
Gender (ref. female)
Male	1.34 (0.76–2.34)	.311	1.21 (0.59–2.52)	.605
Age (ref. <65 years)
65–74	1.61 (0.84–3.06)	.149	1.95 (0.82–4.62)	.132
75	1.47 (0.71–3.06)	.297	1.59 (0.57–4.42)	.377
BMI (ref. <25 kg/m²)
25–29.9	0.96 (0.52–1.77)	.890	0.86 (0.36–2.01)	.719
30	1.02 (0.46–2.27)	.959	0.90 (0.30–2.69)	.856
ASA (ref. I)
II	1.56 (0.25–9.68)	.636	2.53 (0.27–23.83)	.417
III	2.75 (0.44–17.38)	.282	2.41 (0.24–24.48)	.458
Intraoperative intravenous fluids (mL/kg/hour) (ref. ≤5 mL/kg/hour)
5.1–10.0	1.81 (0.33–10.04)	.500	1.38 (0.20–9.71)	.747
10.1–15.0	4.45 (0.81–24.48)	.087	2.53 (0.36–18.0)	.354
15.1	5.14 (0.91–29.10)	.064	1.41 (0.18–11.08)	.747
Surgical approach (ref. laparoscopy)
Laparotomy/laparoscopy with conversion	0.59 (0.22–1.56)	.284	0.65 (0.19–2.28)	.501
Perioperative protocol (ref. ERP)
Traditional	14.57 (7.23–29.38)	<.0001	14.88 (6.69–33.10)	<.0001

ASA, American Society of Anesthesia; BMI, body mass index; CI, confidence interval; ERP, enhanced recovery program; OR, odds ratio.

Table 6.

Association Between Baseline Characteristics, Intraoperative Variables, and Type of Perioperative Protocol and Prolonged Length of Hospital Stay According to Cox Regression Analysis Adjusted for Potential Confounders

Variable	Prolonged hospital length of stay
	Unadjusted model		Full adjusted model
	OR (95% CI)	P	OR (95% CI)	P
Gender (ref. female)
Male	0.70 (0.53–0.94)	.017	0.71 (0.53–0.97)	.030
Age (ref: <65 years)
65–74	0.73 (0.53–1.00)	.050	0.69 (0.49–0.97)	.032
75	0.75 (0.52–1.07)	.112	0.72 (0.48–1.07)	.105
BMI (ref: <25 kg/m²)
25–29.9	0.99 (0.73–1.35)	.960	1.00 (0.72–1.39)	.998
30	1.26 (0.85–1.87)	.259	1.40 (0.92–2.12)	.117
ASA score (ref: I)
II	0.69 (0.28–1.70)	.423	0.66 (0.26–1.70)	.391
III	0.55 (0.22–1.37)	.202	0.65 (0.25–1.69)	.373
MUST score (ref: 0)
1	0.84 (0.45–1.55)	.569	0.81 (0.42–1.55)	.517
Surgical approach (ref. laparoscopy)
Laparotomy/laparoscopy with conversion	1.14 (0.70–1.86)	.601	0.96 (0.58–1.60)	.879
Perioperative protocol (ref. ERP)
Traditional	0.47 (0.36–0.63)	<.0001	0.46 (0.34–0.62)	<.0001

ASA, American Society of Anesthesia; BMI, body mass index; CI, confidence interval; ERP, enhanced recovery program; MUST, malnutrition universal screening tool; OR, odds ratio.

No patient was lost to the 30-day follow-up.

Discussion

In this study, implementing a colorectal ERP program for patients undergoing elective surgical resection, we were able to reduce the time to functional recovery, postoperative hospital LoS, and complications, with no increase in 30-day readmission rate and mortality.

We compared two series of 100 consecutive patients undergoing elective colorectal surgery in 2013–2015 at an Italian University Hospital; One, prospective, comprised patients who followed a standardized ERP and the other, retrospective, included patients retrieved from a prospectively maintained database who had followed traditional perioperative care principles. The patients were admitted in two different wards of the same hospital, and they were operated on and assisted by different surgeons and nurses' teams; although a specific multimodal anesthesia–analgesia protocol was adopted in the ERP group, they shared the same anesthesiologists.

Previous studies have suggested that more than 50% of patients stay in hospital after discharge criteria are achieved.^14–16 Hospital LoS is one of the outcome measures most commonly reported to evaluate in-hospital recovery after colorectal surgery, although it may be influenced by organizational issues and medical decisions. Thus, in light of such limitations, time to achieve discharge criteria may provide a superior measure of functional recovery than LoS.¹⁷ However, both LoS and time to achieve discharge criteria are measures that can be interchangeably used to assess functional recovery in ERPs.¹⁷ In two recent studies,^15,16 the median difference between time to achieve discharge criteria and LoS was 1 day and up to 70% of patients stayed in hospital despite achieving discharge criteria.

In our study, ERP patients achieved discharge criteria on postoperative day 4 (median) and were actually discharged from hospital on the same day, suggesting that LoS was a valid surrogate of functional recovery and that ERP was well established in our hospital. Moreover, 46% of patients in the ERP group stayed in hospital despite achieving discharge criteria, which is in line with the cohort study by Maessen, who considered medically inappropriate a prolonged hospitalization after achieving discharge criteria in more than 70% of patients undergoing elective colorectal surgery within an ERP.¹⁴

In a recent review and meta-analysis including 25 trials, Greer et al. showed a significant reduction in LoS and perioperative morbidity adopting ERPs, whereas 30-day all-cause mortality and 30-day readmission rates were similar between enhanced recovery and traditional care groups.¹⁸ In a multi-institutional controlled study by Ota et al., only two out of 159 patients (1.3%) were readmitted to the hospital,¹⁹ confirming our results in terms of safety for early discharge within ERPs.

Among several studies, some have shown a reduction of overall complications in colorectal surgery adopting ERPs whereas others have not.^19–21 For instance, a Cochrane review by Spanjersberg et al. showed a reduction in overall complications in patients with ERP; however, stratifying into major and minor complications, such a reduction was not confirmed.²⁰ In a meta-analysis of randomized trials, Greco et al. detected less nonsurgical complications only with ERPs, whereas surgical complication rates were similar.²¹ By contrast, in a recent multi-institutional controlled study, Ota et al. showed that ERP, despite determining earlier functional recovery, did not reduce both surgical and nonsurgical complications.¹⁹

In our study, patients on the ERP developed less postoperative complications, in particular low-grade complications (50% versus 7%, P < .001). This could be partly explained by the prevalence of ASA III patients in the non-ERP group, possibly due to differences in the referral patterns among the two surgical units. However, in the regression analysis, after adjusting for potential confounders, neither ASA III class nor a higher volume of intraoperative intravenous fluids was associated to greater complications, but only the use of a traditional perioperative care protocol was associated with a higher rate of complications. We also found a reduction in high-grade complications within the ERP group, as 5 patients with surgical complications were re-operated on in the non-ERP group versus one patient in the ERP group.

In a review of care processes in colorectal ERP, Wu et al. showed that the implementation of the anesthesiology protocol only, preceding the surgical and nursing ones, may lead to a reduction in LoS of 2 days.²² However, it has been well documented that is of utmost importance for the combination and synergy of a multimodal approach carried out by different professionals (surgeons, anesthesiologists, nurses, dieticians, physiotherapists) to achieve improvements in outcomes with ERPs.^2,23 Further, it has been suggested that a compliance with at least 70%–80% of protocol elements is required to guide the effective implementation of ERPs.¹

In our study, implementing the ERP may well have influenced the anesthesiology team in the traditional care setting. Nevertheless, patients with ERP achieved functional recovery earlier than non-ERP patients, which supports the importance that adherence to at least 80% of items is critical to improve outcomes. It also suggests, in accordance to the literature, that a three-way multimodal approach is fundamental in ERPs to reduce the time to functional recovery and postoperative LoS, without increasing morbidity, mortality, or 30-day readmissions.^2,11 Cox regression analysis confirmed that following a traditional perioperative care protocol (together with male sex and age between 65 and 74 years) was the only factor associated with a prolonged LoS and thus with worse outcomes.

Strengths and limitations

One of the limitations of our study is the retrospective nature of the control group, bringing possible selection or information bias. However, we tried to reduce such risks by enrolling all consecutive patients and by retrieving information from a prospectively maintained database. Second, the higher number of ASA III class patients in the control group may have favored the ERP group; whereas, by contrast, the shorter operative time may have favored the non-ERP group. However, regression analysis showed that the only factor associated to postoperative complications was following a traditional perioperative care protocol.

Due to the difficulty of delivering simultaneous perioperative care in the hospital after enhanced recovery and traditional principles, in most randomized studies and controlled clinical trials patients of the intervention and control groups were not in the same hospital, but they were part of a multi-institutional trial, thus introducing possible bias. In our study, we had the unique opportunity to investigate two coeval groups of patients both in the same hospital, as only one team of surgeons and nurses operating in a different ward were involved in the implementation of the ERP during the study period.

In conclusion, implementing an ERP in colorectal surgery is feasible; reduces time to functional recovery, morbidity, and postoperative LoS, with no increase in mortality and 30-day readmission. High protocol adherence is needed to achieve enhanced functional recovery. Following a traditional perioperative care protocol is associated with more postoperative complications and prolonged hospital LoS.

Footnotes

Acknowledgments

This study was registered at (NCT04378465). The data of the article were accepted for an oral presentation at the 3rd National Congress of the PeriOperative Italian Society (P.O.I.S.)—E.R.A.S. Italian Chapter that was supposed to be held in Turin (Italy), March 13–14, 2020. The meeting has been postponed to March 12–13, 2021 due to the Coronavirus (COVID-19) pandemic.

Disclosure Statement

No competing financial interests exist.

Funding Information

This work was supported by the Italian Ministry of Health (RF-2010-2322017).

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