Key Points
Question
Are the complications after colorectal surgery frequent and are the complications associated with Enhanced Recovery After Surgery protocols?
Findings
In this cohort study of 2084 patients, 566 patients presented with moderate to severe complications. Patients receiving care at a facility that had greater adherence to the Enhanced Recovery After Surgery items had a lower number of postoperative complications, regardless of whether the center had an established Enhanced Recovery After Surgery protocol.
Meaning
An increase in adherence to the Enhanced Recovery After Surgery protocol appeared to be associated with a decrease in postoperative complications; thus, a high adherence rate to the Enhanced Recovery After Surgery protocol is recommended in the management of care for patients undergoing colorectal surgery.
Abstract
Importance
Enhanced Recovery After Surgery (ERAS) care has been reported to be associated with improvements in outcomes after colorectal surgery compared with traditional care.
Objective
To determine the association between ERAS protocols and outcomes in patients undergoing elective colorectal surgery.
Design, Setting, and Participants
The Postoperative Outcomes Within Enhanced Recovery After Surgery Protocol (POWER) Study is a multicenter, prospective cohort study of 2084 consecutive adults scheduled for elective colorectal surgery who received or did not receive care in a self-declared ERAS center. Patients were recruited from 80 Spanish centers between September 15 and December 15, 2017. All patients included in this analysis had 1 month of follow-up.
Exposures
Colorectal surgery and perioperative management were the exposures. Twenty-two individual ERAS items were assessed in all patients, regardless of whether they were included in an established ERAS protocol.
Main Outcomes and Measures
The primary study outcome was moderate to severe postoperative complications within 30 days after surgery. Secondary outcomes included ERAS adherence, mortality, readmissions, reoperation rates, and hospital length of stay.
Results
Between September 15 and December 15, 2017, 2084 patients were included in the study. Of these, 1286 individuals (61.7%) were men; mean age was 68 years (interquartile range [IQR], 59-77). A total of 879 patients (42.2%) presented with postoperative complications and 566 patients (27.2%) developed moderate to severe complications. The number of patients with moderate or severe complications was lower in the ERAS group (25.2% vs 30.3%; odds ratio [OR], 0.77; 95% CI, 0.63-0.94; P = .01). The overall rate of adherence to the ERAS protocol was 63.6% (IQR, 54.5%-77.3%), and the rate for patients from hospitals self-declared as ERAS was 72.7% (IQR, 59.1%-81.8%) vs non-ERAS institutions, which was 59.1% (IQR, 50.0%-63.6%; P < .001). Adherence quartiles among patients receiving the highest and lowest ERAS components showed that the patients with the highest adherence rates had fewer moderate to severe complications (OR, 0.34; 95% CI, 0.25-0.46; P < .001), overall complications (OR, 0.33; 95% CI, 0.26-0.43; P < .001), and mortality (OR, 0.27; 95% CI, 0.07-0.97; P = .06) compared with those who had the lowest adherence rates.
Conclusions and Relevance
An increase in ERAS adherence appears to be associated with a decrease in postoperative complications.
This cohort study examines the association between use of the Enhanced Recovery After Surgery (ERAS) protocol in patients undergoing elective colorectal surgery and the incidence of postoperative complications.
Introduction
An estimated 310 million patients undergo surgery worldwide each year.1 The International Surgical Outcomes Study reported that, globally, 26.8% of patients who underwent major surgery had postoperative complications, and 24.3% of those who underwent low abdominal surgery developed complications.2 These findings are similar to those of a previous study.3 Postoperative complications after major surgery have been shown to increase the length of stay (LOS), cost, and mortality.4,5,6 Moreover, the presence of postoperative complications after colorectal surgery was associated with decreased long-term survival, independent of patient, disease, and treatment factors.3
Enhanced Recovery After Surgery (ERAS) protocols or enhanced recovery pathways (ERPs) have become prevalent in colorectal surgery. These programs combine use of a multidisciplinary team, protocolization of perioperative management, and patient education.7
Single-center studies,8,9 multicenter observational studies,10,11,12 and meta-analyses13 have reported that the application of a perioperative ERP is associated with improvements in postoperative outcomes. Many of the components of the ERP could be considered as standard care14; nevertheless, there are still barriers for its full implementation,15 despite health systems recommendations.16 Adherence to the individual items that make up an ERP in the perioperative period has been associated with improvements in postoperative outcomes,10,17 including with reductions in postoperative complications and LOS.18,19
Although there is evidence that demonstrates the effectiveness of the ERP,12 to our knowledge, there are no large case series of patients showing better postoperative outcomes in centers that perform ERP successfully compared with centers that have the same adherence rates to individual components that make up an ERP as a whole, even though a predefined ERP is not performed. Moreover, there is uncertainty regarding the relative benefit from each component of an ERP.
Therefore, the aim of this study was to characterize the management strategies for treatment in patients who underwent elective colorectal surgery in Spain, including centers with and those without an established ERP, and analyze the association between the individual elements of the ERAS protocols and postoperative complications.
The primary end point of the study was the incidence of moderate to severe postoperative complications within 30 days after surgery. Secondary end points were ERAS adherence, readmissions, reoperations, hospital length of stay, mortality, and the occurrence of postoperative complications.
Methods
Study Design and Participants
The Postoperative Outcomes Within Enhanced Recovery After Surgery Protocol (POWER) study was a prospective, 2-month, multicenter cohort study. The study was approved by the Instituto Aragonés de Ciencias de la Salud Ethics Committee, Zaragoza, Spain and by the Spanish Medical Agency, and was registered prospectively (NCT03012802). Ethics committees or institutional review boards at each site reviewed and approved the protocol. Written informed consent was obtained for patients to take part in the study when required by local ethics committees. Participants did not receive financial compensation.
This study followed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting guideline for cohort studies.20 Hospital and investigator participation were facilitated through the Spanish Perioperative Audit and Research Network, which was established by the Grupo Español de Rehabilitación Multimodal. All Spanish hospitals were invited to participate, regardless of the number of beds and the existence of an ERP protocol.
Procedures
All consecutive adult (>18 years) patients undergoing elective primary colorectal surgery with a planned overnight stay were included during a single period of 2 months of recruitment between September 15 and December 15, 2017, in all participating centers. Each patient was followed up for 30 days after surgery. The follow-up was performed through hospital and primary care medical records.
Data were collected using Castor EDC21 and deidentified before entry into a secure, internet-based electronic case record form designed specifically for POWER, which incorporated automated checks for plausibility, consistency, and completeness.
The centers were considered ERAS centers if they had received specific training in ERAS provided by the Grupo Español de Rehabilitación Multimodal and declared having a multidisciplinary ERAS team and an ERAS protocol established and approved in their center. Data describing perioperative care facilities including the ERP application were collected for each patient. Individual data on 22 ERP items were collected prospectively for each included patient. The definition of the individual ERP components was based on the guidelines of the Enhanced Recovery After Surgery Society in colorectal surgery22,23 (eTable 1 in the Supplement). Data included patient characteristics (American Society of Anesthesiologists grade, age, sex, smoking status, body mass index, and comorbidities), procedure performed, surgical approach, perioperative interventions, ERP items, adherence, and outcomes (including postoperative complications, time to achieve targeted mobility, total LOS, and 30-day mortality). Complications were defined and graded as mild, moderate, or severe as described by European Perioperative Clinical Outcome definitions24 (eTable 2 in the Supplement) and were included if they occurred within 30 days after surgery. Data were censored at 30 days following surgery for patients who remained in the hospital. Data validation was conducted by the principal investigator at each site.
Outcomes
The primary outcome was the number of patients with 30-day in-hospital moderate to severe postoperative complications. Secondary outcome measures included ERP adherence, mortality, readmission, reoperation rates, and hospital LOS.
Statistical Analysis
We analyzed outcomes depending on whether the patient belonged to an ERAS program as declared by the hospital where the intervention was performed. The discrete and continuous variables were described as number and percentage and median (interquartile range [IQR]) and their differences analyzed using the Fisher exact or Pearson and Wilcoxon rank sum tests. Subsequently, we repeated the analysis, subdividing all of the sample into quartiles according to the adherence rate to ERAS items (regardless of whether the patients belonged to a self-declared ERAS hospital), and comparing the quartiles of higher and lower adherence and calculating a linear fit of the adherence with the variable under study. Next, we analyzed the moderate or severe complication rate for each of the ERAS items using the Fisher exact test and performed a multivariate analysis to study the association between the rate of each of the items and the clinical and demographic variables. In addition, we applied the Kaplan-Meier test to determine whether there were differences in hospital length of stay (LOS) depending on the patient’s inclusion in an ERAS program or the ERAS adherence quartile. To avoid errors by multiple comparisons, we calculated the respective q value for each P value to maintain a false discovery rate below 5%.25 We considered comparisons in which P value and q value were below .05 as being statistically significant.
Results
Participants
Data describing 2084 patients were collected in 80 Spanish hospitals (Figure 1). Of these, 1286 individuals (61.7%) were men; mean age was 68 years (IQR, 59-77). Other characteristics are shown in the Table. In accordance with the statistical analysis plan, patients from centers that recruited fewer than 10 patients were excluded from the analysis. According to the hospitals where the surgery was performed, 1304 patients (62.5%) were included in ERAS programs (Figure 2). The ERAS and non-ERAS groups showed demographic differences in the presence of congestive heart failure; hemoglobin, albumin, and creatinine levels before surgery; and cancer being the reason for surgery (Table).
Figure 1. STROBE Flow Diagram for Included Patients.
Table. Demographic and ERAS Adherence Dataa.
| Characteristic | No. (%) | P Value | ||
|---|---|---|---|---|
| Total (N = 2084) | ERAS (n = 1304) | No ERAS (n = 780) | ||
| Age, median (IQR), y | 68 (59-77) | 68 (59-77) | 69 (60-77) | .78 |
| Men | 1286 (61.7) | 797 (61.12) | 489 (62.69) | .49 |
| BMI, median (IQR) | 26.68 (24.07-29.71) | 26.67 (24.02-29.38) | 26.76 (24.16-30.12) | .17 |
| ASA classification | ||||
| I | 129 (6.19) | 86 (6.60) | 43 (5.51) | .70 |
| II | 1153 (55.33) | 718 (55.06) | 435 (55.77) | |
| III | 747 (35.84) | 468 (35.89) | 279 (35.77) | |
| IV | 55 (2.64) | 32 (2.45) | 23 (2.95) | |
| Smoking | 399 (19.15) | 251 (19.25) | 148 (18.97) | .91 |
| Diabetes | 454 (21.79) | 292 (22.39) | 162 (20.77) | .41 |
| Congestive heart failure | 129 (6.19) | 96 (7.36) | 33 (4.23) | .005b |
| Coronary artery disease | 190 (9.12) | 127 (9.74) | 63 (8.08) | .21 |
| Cirrhosis | 29 (1.39) | 20 (1.53) | 9 (1.15) | .57 |
| Metastasis | 188 (9.02) | 111 (8.51) | 77 (9.87) | .31 |
| Stroke | 118 (5.66) | 71 (5.44) | 47 (6.03) | .63 |
| COPD | 306 (14.68) | 197 (15.11) | 109 (13.97) | .52 |
| Hypertension | 1070 (51.34) | 683 (52.38) | 387 (49.62) | .24 |
| Previous transfusion | 108 (5.18) | 69 (5.29) | 39 (5) | .84 |
| Hemoglobin, median (IQR), g/dL | 13.2 (11.8-14.6) | 13.2 (11.65-14.5) | 13.3 (11.95-14.7) | .03b |
| Leukocytes, median (IQR), /μL | 6880 (5577.5-8300) | 6840 (5500-8300) | 6920 (5680-8400) | .12 |
| Albumin, median (IQR), g/dL | 4.1 (3.8-4.4) | 4.1 (3.7-4.3) | 4.2 (3.8-4.5) | <.001 b |
| Creatinine, median (IQR), mg/dL | 0.84 (0.71-1) | 0.85 (0.72-1) | 0.81 (0.7-1) | .04b |
| Surgical procedure | ||||
| Abdominoperineal amputation | 112 (5.39) | 72 (5.53) | 40 (5.15) | .008b |
| Anterior rectum resection | 490 (23.58) | 305 (23.43) | 185 (23.84) | |
| Intestinal reconstruction | 150 (7.22) | 106 (8.14) | 44 (5.67) | |
| Hemicolectomy | ||||
| Left | 168 (8.08) | 102 (7.83) | 66 (8.51) | |
| Right | 582 (28.01) | 361 (27.73) | 221 (28.48) | |
| Sigmoidectomy | 448 (21.56) | 271 (20.81) | 177 (22.81) | |
| Subtotal colectomy | 59 (2.84) | 39 (3.00) | 20 (2.58) | |
| TEM | 10 (0.48) | 1 (0.08) | 9 (1.16) | |
| Total colectomy | 33 (1.59) | 25 (1.92) | 8 (1.03) | |
| Transverse colectomy | 26 (1.25) | 20 (1.54) | 6 (0.77) | |
| Oncologic surgery | 1777 (85.27) | 1092 (83.74) | 685 (87.82) | .01b |
| Laparoscopic approach | 1234 (59.24) | 773 (59.32) | 461 (59.10) | .07 |
| Ostomy | 501 (24.04) | 322 (24.69) | 179 (22.95) | .40 |
| Analgesia | ||||
| Abdominal wall block | 209 (10.03) | 162 (12.42) | 47 (6.03) | <.001 b |
| Epidural | 642 (30.81) | 455 (34.89) | 187 (23.97) | |
| Intradural | 84 (34.03) | 55 (4.22) | 29 (3.72) | |
| Intravenous | 1149 (55.13) | 632 (48.47) | 517 (66.28) | |
| ERAS adherence | ||||
| Presurgical education | 1346 (64.59) | 977 (74.92) | 369 (47.31) | <.001 b |
| Presurgical optimization | 1453 (69.72) | 921 (70.63) | 532 (68.21) | .26 |
| Avoid bowel preparation | 1067 (51.2) | 743 (56.98) | 324 (41.54) | <.001 b |
| Avoid fasting | 1302 (62.48) | 937 (71.86) | 365 (46.79) | <.001 b |
| Carbohydrates preload | 591 (28.36) | 509 (39.03) | 82 (10.51) | <.001 b |
| Avoid sedatives | 1719 (82.49) | 1147 (87.96) | 572 (73.33) | <.001 b |
| Antithrombotic prophylaxis | 2016 (96.74) | 1265 (97.01) | 751 (96.28) | .38 |
| Antibiotic prophylaxis | 2068 (99.23) | 1295 (99.31) | 773 (99.1) | .61 |
| Standardized anesthesia protocol | 1447 (69.43) | 1023 (78.45) | 424 (54.36) | <.001 b |
| PONV prophylaxis | 1911 (91.7) | 1243 (95.32) | 668 (85.64) | <.001 b |
| Laparoscopic approach or minimal incision in open surgery | 1371 (65.79) | 860 (65.95) | 511 (65.51) | .85 |
| Avoid nasogastric tube | 1231 (59.07) | 790 (60.58) | 441 (56.54) | .07 |
| Normothermia | 2012 (96.55) | 1272 (97.55) | 740 (94.87) | .002b |
| Goal-directed fluid therapy | 635 (30.47) | 519 (39.8) | 116 (14.87) | <.001b |
| Avoid drainage | 724 (34.74) | 504 (38.65) | 220 (28.21) | <.001b |
| Avoid urinary catheterization | 1450 (69.58) | 950 (72.85) | 500 (64.1) | <.001b |
| First 24-h fluid balance <1500 mL | 1544 (74.09) | 1061 (81.37) | 483 (61.92) | <.001b |
| Postoperative multimodal analgesia | 1717 (82.39) | 1131 (86.73) | 586 (75.13) | <.001b |
| Perioperative nutritional screening, support | 1404 (67.37) | 840 (64.42) | 564 (72.31) | <.001b |
| Normoglycemia | 1572 (75.43) | 1072 (82.21) | 500 (64.1) | <.001b |
| Early mobilization | 765 (36.71) | 631 (48.39) | 134 (17.18) | <.001b |
| Early feeding | 735 (35.27) | 620 (47.55) | 115 (14.74) | <.001b |
| ERAS protocol, median (IQR), % adherence | 63.6 (54.5-77.3) | 72.7 (59.1-81.8) | 59.1 (50-63.6) | <.001b |
Abbreviations: ASA, American Society of Anesthesiologists; BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); COPD, chronic obstructive pulmonary disease; ERAS, Enhanced Recovery After Surgery; IQR, interquartile range; PONV, postoperative nausea and vomiting; TEM, transanal endoscopic microsurgery.
SI conversion factors: To convert albumin to grams per liter, multiply by 10; creatinine to micromoles per liter, multiply by 88.4; hemoglobin to grams per liter, multiply by 10; leukocytes to ×109 per liters squared, multiply by 0.001.
A complete definition of all ERAS items is presented in eTable 1 in the Supplement.
Statistically significant.
Figure 2. Postoperative Outcomes.
Moderate or severe complications and type of complication in all included patients and in patients with and without the Enhanced Recovery After Surgery (ERAS) protocol.
aStatistically significant.
Outcome Data
A total of 879 patients (42.2%) developed postoperative complications, and 566 patients (27.2%) developed complications graded as moderate or severe. The number of patients with moderate to severe complications was lower in the ERAS group (25.2% vs 30.3%; odds ratio [OR], 0.77; 95% CI, 0.63-0.94; P = .01) but not in terms of overall complications, readmission, reoperation, or mortality rate (Figure 2). In terms of type of complications, the ERAS group had a reduction in rates of paralytic ileus (OR, 0.74; 95% CI, 0.57-0.95; P = .02), urinary tract infection (OR, 0.51; 95% CI, 0.26-0.99; P = .04), and infection of uncertain origin (OR, 0.45; 95% CI, 0.2-0.99; P = .02); no significant differences were found for other specific complications (Figure 2).
ERAS Adherence and Outcome Data
The overall adherence rate to the ERAS protocol components was 63.6% (IQR, 54.5%-77.3%), with the rate for facilities self-declared as ERAS being 72.7% (IQR, 59.1%-81.8%) vs 59.1% (IQR, 50.0%-63.6%) at non-ERAS facilities (P < .001). In terms of adherence to each item, no differences were found in the rate of presurgical optimization, antithrombotic and antibiotic prophylaxis, laparoscopic approach, and no use of nasogastric tube; adherence was greater with other factors in the ERAS environment, for example, presurgical education (74.92% [977 of 1304] vs 47.31% [369 of 780]; P < .001), avoidance of fasting (71.86% [937 of 1304] vs 46.79% [365 of 780]; P < .001), carbohydrates preload (39.03% [509 of 1304] vs 10.51% [82 of 780]; P < .001), avoidance of drainage (38.65% [504 of 1304]vs 28.21% [220 of 780]; P < .001) or avoidance of urinary catheterization (72.85% [950 of 1304] vs 64.1% [500 of 780]; P < .001) (Table). The ERAS group also had less use of intraoperative fluids (1500 mL [IQR, 1000-2000] vs 1500 mL [IQR, 1185-2100]; P < .001), less time to ambulation (24 hours [IQR, 20-48] vs 30 hours [IQR, 24-48]; P < .001) and oral intake (20 hours [IQR, 6-26] vs 26 hours [IQR, 24-48]; P < .001), and shorter LOS (7 days [IQR, 5-12] vs 8 [IQR, 5-13]; P < .001) (eTable 3 in the Supplement). Among the highest adherence quartile (Q1) and lowest adherence quartile (Q4) of ERAS items, Q1 also had a decrease in the rate of moderate to severe complications (OR, 0.34; 95% CI, 0.25-0.46; P < .001), overall complications (OR, 0.33; 95% CI, 0.26-0.43; P < .001), and mortality (OR, 0.27; 95% CI, 0.07-0.97; P = .06), compared with Q4, as well as acute kidney injury (OR, 0.56; 95% CI, 0.29-1.28; P = .11), acute respiratory distress syndrome (OR, 0.05; 95% CI, 0.01-0.89; P = .04), anastomotic breakdown (OR, 0.48; 95% CI, 0.28-0.81; P = .007), arrhythmia (OR, 0.2; 95% CI, 0.04-0.9; P = .04), and superficial (OR, 0.23; 95% CI, 0.15-0.35; P < .001) and deep surgical site (OR, 0.31; 95% CI, 0.15-0.62; P = .001) infection (Figure 3), together with higher postsurgical levels of hemoglobin (11.6 g/dL [IQR, 10.4-12.9] vs 11.4 g/dL [IQR, 10.3-12.8]; P < .001 [to convert to grams per liter, multiply by 10]). The linear fit of the variables against ERAS adherence confirmed the differences between Q1 and Q4 (eFigure in the Supplement).
Figure 3. Postoperative Outcomes and Enhanced Recovery After Surgery (ERAS) Adherence.
Postoperative moderate to severe complications in all included patients depending on the quartile (Q) of adherence to the ERAS protocol.
aStatistically significant.
Multivariate analysis of ERAS items showed a statistically significant reduction of moderate to severe complications in patients who had undergone laparoscopic surgery (OR, 0.47; 95% CI, 0.38-0.57; P < .001), presurgical education (OR, 0.78; 95% CI, 0.64-0.95; P = .02) or optimization (OR, 0.78; 95% CI, 0.63-0.95; P = .02); carbohydrate preload had been implemented (OR, 0.67; 95% CI, 0.54-0.84; P < .001), had avoided fasting (OR, 0.73; 95% CI, 0.60-0.89; P = .002), surgical drainage tubes (OR, 0.56; 95% CI, 0.46-0.70; P < .001), or urinary catheters (OR, 0.40; 95% CI, 0.33-0.49; P < .001); had a fluid balance of less than 1500 mL in the first 24 hours (OR, 0.59; 95% CI, 0.47-0.72; P < .001); and had been mobilized (OR, 0.51; 95% CI, 0.42-0.64; P < .001) and fed (OR, 0.47; 95% CI, 0.37-0.58; P < .001) early; and had a significant increase in patients in whom no antibiotic prophylaxis was performed (OR, 0.38; 95% CI, 0.14-1.03; P = .09) (Figure 4). Higher levels of albumin (−0.08; 95% CI, −0.13 to −0.04; P < .01) and hemoglobin (−0.07; 95% CI, −0.12 to −0.03; P < .01) were associated with a lower incidence of moderate and severe complications (eTable 4 in the Supplement). It was not necessary to censor any P value after the multiple comparison study to adjust the false discovery rate to 5%.
Figure 4. Moderate to Severe Complications by Enhanced Recovery After Surgery (ERAS Items).
PONV indicates postoperative nausea and vomiting.
aStatistically significant.
Hospital LOS was lower in the ERAS group compared with the non-ERAS group (7 [IQR, 5-12] vs 8 [IQR, 5-13] days; P < .001). Regarding the difference by adherence quartiles, Q1 presented a median LOS of 5 days, compared with 8 days in the lowest adherence group (eTable 3 in the Supplement). The survival study confirmed the findings of hospital LOS (eFigure in the Supplement).
Discussion
This prospective observational study examined the postoperative outcomes in scheduled colorectal surgery, and the outcome associated with 22 evidence-based care components of an ERP in 80 Spanish centers and more than 2000 patients without limiting the inclusion of patients to centers with an established ERP.
A 2011 Cochrane review found that ERPs were associated with a reduction in overall complications and LOS compared with conventional perioperative care.26 The POWER study suggests that having a defined ERP is not associated with improvements in the postoperative outcomes; nevertheless, regardless of whether a particular patient is involved in an established ERP, high adherence to the ERP individual components was associated with a decrease in postoperative complications and LOS.
In centers with a well-established ERP, an association between dose effect and protocol adherence and patient outcomes has been suggested: the more that protocol components are applied, the better the patient outcomes.9,27,28 A negative association was shown between adherence and the development of complications in an international data set at 13 centers at different stages of ERAS adoption including more than 2000 patients10: less than 50% adherence, 13.1%; 75% to 90% adherence, 11.6%; and greater than 90% adherence, 9.3%. Gustafsson and colleagues27 showed that, in facilities with 70% or more adherence to ERAS components, the risk of 5-year cancer-specific death was lowered by 42% compared with the risk in facilities with less than 70% adherence. Nevertheless, to our knowledge, it has not been demonstrated that adherence to an ERAS protocol in centers that do not carry out the items in a predefined manner was associated with improvements in outcomes.
Adherence to the ERP affects all perioperative periods. Some of the items demonstrate high adherence in all facilities, such as the laparoscopic approach, antibiotic prophylaxis, antithrombotic prophylaxis, and avoidance of a nasogastric tube; in our sample, these items can be considered as standard care. However, there are other items with low adherence (<50%) in both ERAS and non-ERAS settings. After retrospectively analyzing 2876 patients in an ERP in colorectal surgery, Aarts and colleagues29 found that only 20.1% of the patients received care that fulfilled all the phases of the ERP. The poorest adherence rate was for postoperative interventions (40.3%) that were independently associated with an increase in optimal recovery. This finding confirms reports on the low adherence to protocols in the early postoperative phase30 and is consistent with the adherence found in the POWER trial for these items. In addition, we found that 2 items—early feeding and early mobilization—were independently associated with a decrease in moderate to severe postoperative complications. Randomized studies31 and observational studies32,33 demonstrated that early feeding (<24 hours postoperatively) accelerated gastrointestinal recovery and decreased the rate of complications and the LOS.31,34 We found that the average initial oral feeding was given less than 24 hours postoperatively only in the quartile of highest adherence of the ERP (adherence >77%), suggesting that a direct intervention that allows the early initiation of oral feeding was performed exclusively in specialized centers.
This study additionally supports the use of laparoscopic resection within an ERAS program as an independent factor associated with improved outcomes. Similar to previous studies,10,19 in the multivariate analysis of our cohort, the use of laparoscopy was independently associated with a reduction of complications by 17%.
There are reasons to believe that all components of the ERAS program work synergistically.35 In addition, when analyzing the association between individual items and postoperative complications, it may be possible that some of the ERAS items may influence each other, which causes difficulties in interpretation. For example, we did not find that the use of goal-directed hemodynamic therapy reduces postoperative complications, although maintaining a fluid balance less than 1500 mL on the first postoperative day was independently associated with the decrease in complications. The lack of protocolization of goal-directed hemodynamic therapy, as well as the lack of evaluation of the implementation of goal-directed hemodynamic therapy may explain these results. As with performing ERP, affirming that goal-directed hemodynamic therapy is conducted is not enough; after all, avoiding volume overload has been shown to reduce complications in multiple studies.8,19
Strengths and Limitations
This study had several strengths compared with prior studies. The first of these is the large number of consecutive patients enrolled. Only 50 eligible patients during the study period were not included, significantly reducing the risk of selection bias, allowing a representative cross-section of the population to be analyzed. Second, unlike other studies including a similar number of patients, we conducted a prospective study, with a case report form specifically designed for the study and with a 2-month recruitment period; another study analyzed data for periods as long as 5 years.10 The changes produced in the perioperative treatment of the patients, clinical experience of the surgeons, and even in the ERAS guidelines, result in the patients not being comparable during such a long period of recruitment.10
Furthermore, postoperative complications were analyzed, including centers with ERP and those without ERP, but in which the individual components of the ERP were assessed in all the patients included in the study. Despite a few randomized clinical trials, to date, auditing of ERAS has been largely performed in a manner similar to intention-to-treat analysis, such that only the treatment assignment (pre-ERAS vs ERAS) was relevant,8 or in large databases including only patients in ERAS centers.10,11,12 These types of studies obtained the same conclusions: the application of ERAS, and especially a high adherence to the protocols improve the postoperative outcomes. Because many of the individual items that make up the ERP should be considered as standard care, we decided to include centers with and without ERPs. We found that patients who receive care in settings with high adherence to the ERP had fewer postoperative complications and shorter LOS; however, this was independent of the existence of an ERP in a certain center.
The POWER study has some limitations. Because care was not randomly assigned, there may be residual confounding from either measured or unmeasured variables. Furthermore, although we defined all ERAS items in the POWER protocol, we cannot rule out measurement errors or misclassification on the part of the researchers, especially in some elements of the ERP, such as fluid balance in the first 24 hours, which implied more complex measurements and in which there could be a lack of information in the patients' medical records. In addition, the current recommendations on some items are different from those that we used; for example, we defined the avoidance of mechanical bowel preparation as part of adherence to the ERP,22,23 while the most recent guidelines recommend performing it.35 Therefore, it is possible that when reversing the definition of the item, the results may be different. However, there are interrelated items: we have found that avoiding urinary catheterization and surgical drains was associated with a reduction of complications by 20% and 11% in the multivariate analysis respectively; however, it is possible that both the presence of a urinary catheter and the insertion of surgical drains were directly related to the patients who presented complications, as a measure of treatment or prophylaxis. Further studies are necessary to evaluate the effect of ERP on longer-term outcomes, especially functional and cognitive ability after surgery.
Conclusions
This study suggests that ERP in colorectal surgery is not fully applied in daily clinical practice. In addition, there are certain elements of the ERP that have low adherence, even in specialized ERAS centers. Postoperative recovery is mainly associated with the minimally invasive surgical approach and the postoperative components, such as early oral intake and early ambulation. Therefore, adherence to these items is recommended to be mandatory in future ERAS programs. The POWER study shows that having a protocol is not enough to improve outcomes, but an increase in adherence to ERAS items is associated with a decrease in postoperative complications; therefore, continuous auditing of adherence to ERAS and postoperative outcomes is essential.
eTable 1. Definitions of ERAS Compliance for Included Individual Items
eTable 2. Predefined Postoperative Complications According EPCO Definitions
eTable 3. Results of Continuous Variables for ERAS vs Non ERAS and Quartile Compliance
eTable 4. Multivariate Analysis for Moderate to Severe Postoperative Complications
eFigure. Survival Curve
References
- 1.Weiser TG, Haynes AB, Molina G, et al. Estimate of the global volume of surgery in 2012: an assessment supporting improved health outcomes. Lancet. 2015;385(suppl 2):S11. doi: 10.1016/S0140-6736(15)60806-6 [DOI] [PubMed] [Google Scholar]
- 2.International Surgical Outcomes Study group Global patient outcomes after elective surgery: prospective cohort study in 27 low-, middle- and high-income countries. Br J Anaesth. 2016;117(5):601-609. doi: 10.1093/bja/aew316 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 3.Artinyan A, Orcutt ST, Anaya DA, Richardson P, Chen GJ, Berger DH. Infectious postoperative complications decrease long-term survival in patients undergoing curative surgery for colorectal cancer: a study of 12,075 patients. Ann Surg. 2015;261(3):497-505. doi: 10.1097/SLA.0000000000000854 [DOI] [PubMed] [Google Scholar]
- 4.Govaert JA, Fiocco M, van Dijk WA, et al. ; Dutch Value Based Healthcare Study Group . Costs of complications after colorectal cancer surgery in the Netherlands: building the business case for hospitals. Eur J Surg Oncol. 2015;41(8):1059-1067. doi: 10.1016/j.ejso.2015.03.236 [DOI] [PubMed] [Google Scholar]
- 5.Dimick JB, Chen SL, Taheri PA, Henderson WG, Khuri SF, Campbell DAJ Jr. Hospital costs associated with surgical complications: a report from the private-sector National Surgical Quality Improvement Program. J Am Coll Surg. 2004;199(4):531-537. doi: 10.1016/j.jamcollsurg.2004.05.276 [DOI] [PubMed] [Google Scholar]
- 6.Straatman J, Cuesta MA, de Lange-de Klerk ESM, van der Peet DL. Long-term survival after complications following major abdominal surgery. J Gastrointest Surg. 2016;20(5):1034-1041. doi: 10.1007/s11605-016-3084-4 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 7.Tevis SE, Kennedy GD. Postoperative complications: looking forward to a safer future. Clin Colon Rectal Surg. 2016;29(3):246-252. doi: 10.1055/s-0036-1584501 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 8.Ripollés-Melchor J, Fuenmayor-Varela ML, Camargo SC, et al. [Enhanced recovery after surgery protocol versus conventional perioperative care in colorectal surgery. A single center cohort study] [Portuguese] [published online March 31, 2018]. Rev Bras Anestesiol. 2018;68(4):358-368. doi: 10.1016/j.bjan.2018.01.003 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 9.Bona S, Molteni M, Rosati R, et al. Introducing an enhanced recovery after surgery program in colorectal surgery: a single center experience. World J Gastroenterol. 2014;20(46):17578-17587. doi: 10.3748/wjg.v20.i46.17578 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 10.ERAS Compliance Group The impact of enhanced recovery protocol compliance on elective colorectal cancer resection: results from an international registry. Ann Surg. 2015;261(6):1153-1159. doi: 10.1097/SLA.0000000000001029 [DOI] [PubMed] [Google Scholar]
- 11.Braga M, Pecorelli N, Scatizzi M, Borghi F, Missana G, Radrizzani D; PeriOperative Italian Society . Enhanced recovery program in high-risk patients undergoing colorectal surgery: results from the PeriOperative Italian Society Registry. World J Surg. 2017;41(3):860-867. doi: 10.1007/s00268-016-3766-9 [DOI] [PubMed] [Google Scholar]
- 12.Veziant J, Raspado O, Entremont A, Joris J, Pereira B, Slim K; GRACE group . Large-scale implementation of enhanced recovery programs after surgery: a francophone experience. J Visc Surg. 2017;154(3):159-166. doi: 10.1016/j.jviscsurg.2016.08.009 [DOI] [PubMed] [Google Scholar]
- 13.Greco M, Capretti G, Beretta L, Gemma M, Pecorelli N, Braga M. Enhanced recovery program in colorectal surgery: a meta-analysis of randomized controlled trials. World J Surg. 2014;38(6):1531-1541. doi: 10.1007/s00268-013-2416-8 [DOI] [PubMed] [Google Scholar]
- 14.Ripollés-Melchor J, Casans-Francés R, Abad-Gurumeta A, et al. ; Grupo Español de Rehabilitación Multimodal y Evidence Anesthesia Review Group (EAR) . Spanish survey on enhanced recovery after surgery [Spanish]. Rev Esp Anestesiol Reanim. 2016;63(7):376-383. [DOI] [PubMed] [Google Scholar]
- 15.Sutton E, Herbert G, Burden S, et al. Using the normalization process theory to qualitatively explore sense-making in implementation of the Enhanced Recovery After Surgery programme: “It’s not rocket science”. PLoS One. 2018;13(4):e0195890. doi: 10.1371/journal.pone.0195890 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 16.Calvo-Vecino JM, del Valle Hernández E Ramírez Rodríguez et al. Vía clínica de recuperación intensificada en cirugía abdominal (RICA). Ministerio de Sanidad, Servicios Sociales e Igualdad. Instituto Aragonés de Ciencias de la Salud. http://portal.guiasalud.es/contenidos/iframes/documentos/opbe/2015-07/ViaClinica-RICA.pdf. Updated March 2018. Accessed May 26, 2018.
- 17.Maessen J, Dejong CHC, Hausel J, et al. A protocol is not enough to implement an enhanced recovery programme for colorectal resection. Br J Surg. 2007;94(2):224-231. doi: 10.1002/bjs.5468 [DOI] [PubMed] [Google Scholar]
- 18.Cakir H, van Stijn MFM, Lopes Cardozo AMF, et al. Adherence to enhanced recovery after surgery and length of stay after colonic resection. Colorectal Dis. 2013;15(8):1019-1025. doi: 10.1111/codi.12200 [DOI] [PubMed] [Google Scholar]
- 19.Gustafsson UO, Hausel J, Thorell A, Ljungqvist O, Soop M, Nygren J; Enhanced Recovery After Surgery Study Group . Adherence to the Enhanced Recovery After Surgery protocol and outcomes after colorectal cancer surgery. Arch Surg. 2011;146(5):571-577. doi: 10.1001/archsurg.2010.309 [DOI] [PubMed] [Google Scholar]
- 20.von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP; STROBE Initiative . Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. BMJ. 2007;335(7624):806-808. doi: 10.1136/bmj.39335.541782.AD [DOI] [PMC free article] [PubMed] [Google Scholar]
- 21.Castor Electronic Data Capture Ciwit BV. Amsterdam, the Netherlands; 2018. [Google Scholar]
- 22.Gustafsson UO, Scott MJ, Schwenk W, et al. ; Enhanced Recovery After Surgery (ERAS) Society, for Perioperative Care; European Society for Clinical Nutrition and Metabolism (ESPEN); International Association for Surgical Metabolism and Nutrition (IASMEN) . Guidelines for perioperative care in elective colonic surgery: Enhanced Recovery After Surgery (ERAS) Society recommendations. World J Surg. 2013;37(2):259-284. doi: 10.1007/s00268-012-1772-0 [DOI] [PubMed] [Google Scholar]
- 23.Nygren J, Thacker J, Carli F, et al. ; Enhanced Recovery After Surgery Society . Guidelines for perioperative care in elective rectal/pelvic surgery: Enhanced Recovery After Surgery (ERAS) Society recommendations. Clin Nutr. 2012;31(6):801-816. doi: 10.1016/j.clnu.2012.08.012 [DOI] [PubMed] [Google Scholar]
- 24.Jammer I, Wickboldt N, Sander M, et al. ; European Society of Anaesthesiology (ESA) and the European Society of Intensive Care Medicine (ESICM); European Society of Anaesthesiology; European Society of Intensive Care Medicine . Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures. Eur J Anaesthesiol. 2015;32(2):88-105. doi: 10.1097/EJA.0000000000000118 [DOI] [PubMed] [Google Scholar]
- 25.Storey JD. A direct approach to false discovery rates. J R Stat Soc B. 2002;64:479-498. doi: 10.1111/1467-9868.00346 [DOI] [Google Scholar]
- 26.Spanjersberg WR, Reurings J, Keus F, van Laarhoven CJ. Fast track surgery versus conventional recovery strategies for colorectal surgery. Cochrane Database Syst Rev. 2011;(2):CD007635. [DOI] [PubMed] [Google Scholar]
- 27.Gustafsson UO, Oppelstrup H, Thorell A, Nygren J, Ljungqvist O. Adherence to the ERAS protocol is associated with 5-year survival after colorectal cancer surgery: a retrospective cohort study. World J Surg. 2016;40(7):1741-1747. doi: 10.1007/s00268-016-3460-y [DOI] [PubMed] [Google Scholar]
- 28.Pisarska M, Pędziwiatr M, Małczak P, et al. Do we really need the full compliance with ERAS protocol in laparoscopic colorectal surgery? a prospective cohort study. Int J Surg. 2016;36(pt A):377-382. doi: 10.1016/j.ijsu.2016.11.088 [DOI] [PubMed] [Google Scholar]
- 29.Aarts M-A, Rotstein OD, Pearsall EA, et al. ; iERAS group . Postoperative ERAS interventions have the greatest impact on optimal recovery: experience with implementation of ERAS across multiple hospitals. Ann Surg. 2018;267(6):992-997. doi: 10.1097/SLA.0000000000002632 [DOI] [PubMed] [Google Scholar]
- 30.Maessen JMC, Dejong CHC, Kessels AGH, von Meyenfeldt MF; Enhanced Recovery After Surgery (ERAS) Group . Length of stay: an inappropriate readout of the success of enhanced recovery programs. World J Surg. 2008;32(6):971-975. doi: 10.1007/s00268-007-9404-9 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 31.Boelens PG, Heesakkers FFBM, Luyer MDP, et al. Reduction of postoperative ileus by early enteral nutrition in patients undergoing major rectal surgery: prospective, randomized, controlled trial. Ann Surg. 2014;259(4):649-655. doi: 10.1097/SLA.0000000000000288 [DOI] [PubMed] [Google Scholar]
- 32.Fujii T, Morita H, Sutoh T, et al. Benefit of oral feeding as early as one day after elective surgery for colorectal cancer: oral feeding on first versus second postoperative day. Int Surg. 2014;99(3):211-215. doi: 10.9738/INTSURG-D-13-00146.1 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 33.Kawamura YJ, Kuwahara Y, Mizokami K, et al. Patient’s appetite is a good indicator for postoperative feeding: a proposal for individualized postoperative feeding after surgery for colon cancer. Int J Colorectal Dis. 2010;25(2):239-243. doi: 10.1007/s00384-009-0802-3 [DOI] [PubMed] [Google Scholar]
- 34.Zhuang C-L, Ye X-Z, Zhang C-J, Dong Q-T, Chen B-C, Yu Z. Early versus traditional postoperative oral feeding in patients undergoing elective colorectal surgery: a meta-analysis of randomized clinical trials. Dig Surg. 2013;30(3):225-232. doi: 10.1159/000353136 [DOI] [PubMed] [Google Scholar]
- 35.Carmichael JC, Keller DS, Baldini G, et al. Clinical practice guidelines for enhanced recovery after colon and rectal surgery from the American Society of Colon and Rectal Surgeons and Society of American Gastrointestinal and Endoscopic Surgeons. Dis Colon Rectum. 2017;60(8):761-784. doi: 10.1097/DCR.0000000000000883 [DOI] [PubMed] [Google Scholar]
Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
eTable 1. Definitions of ERAS Compliance for Included Individual Items
eTable 2. Predefined Postoperative Complications According EPCO Definitions
eTable 3. Results of Continuous Variables for ERAS vs Non ERAS and Quartile Compliance
eTable 4. Multivariate Analysis for Moderate to Severe Postoperative Complications
eFigure. Survival Curve