Patient information
1. Preoperative information and counseling
2. Preset discharge criteria
3. Stoma marking and education if indicated
4. Optimization (home incentive spirometer, smoking cessation, prehab)
Preservation of bowel function
5. Clear liquids until 2 h before surgery
6. High-carbohydrate beverage morning of surgery
7. Alvimopan, chewing gum, laxatives
8. Early feeding post-operatively
Avoiding organ dysfunction
9. Selective use of bowel prep
10. Antimicrobial and thromboembolic prophylaxis
11. Avoid hypothermia
12. Balanced use of crystalloids to optimize cardiac output and avoid excess fluid
Optimizing pain control
13. Preemptive analgesia started before surgery
14. Local anesthetic, regional blocks, or epidurals
15. Laparoscopy or minimal access incisions
16. Scheduled use of non-opioid analgesics
Promotion of patient autonomy
17. Avoid long-acting sedative premedication
18. Avoid nasogastric tubes and drains
19. Enforced early mobilization
20. Early removal of urinary catheter and IV fluids
While the theoretical benefits of ERP are clear, it is necessary to ensure that the benefits outweigh any undesirable consequences caused by deviations from conventional management. Simply achieving an earlier discharge from the hospital is insufficient if there are resultant increases in complications from feeding patients too early, readmissions from sending them out too soon, or dissatisfaction from patients’ feeling rushed out of the hospital. In this chapter we review the literature supporting ERP for open colectomy and provide an evidence-based endorsement for their routine application.
Methods
Following the GRADE approach we began by formulating an appropriate clinical question, defining the four critical components of patient population, intervention, comparison, and outcomes of interest, illustrated in a standard PICO table (Table 43.2) [2]. The patient group of interest was those undergoing open colectomy, with the intervention of treatment by ERP as compared to traditional care (TC), with the intent to answer, “Should patients undergoing open colectomy be managed by ERP rather than TC?” The outcomes considered critical in this search were morbidity, mortality, and readmission rates, recognizing the principle of nonmaleficence (do no harm) as paramount over any effects on hospital stay or costs. However, because beneficence (acting for the benefit of others), rather than simply avoidance of harm, should form the foundation of any clinical recommendation we also considered hospital length of stay (LOS), costs, and patient satisfaction or quality of life (QoL) as important outcomes. The quality of the evidence was graded for each outcome and the evidence was used to formulate a recommendation on the question of interest. The strength of our recommendation is based on our degree of confidence that the desirable effects outweigh the undesirable effects, as influenced by the magnitude of the differences between benefit and harm, the quality of the evidence, and the value placed on the outcomes of interest.
Table 43.2
PICO table
P (patient population) | I (intervention) | C (comparator) | O (outcomes of interest) |
|---|---|---|---|
Patients undergoing open colectomy | Enhanced recovery pathways (ERP) | Traditional care (TC) | Complications Readmissions Length of Stay Cost Quality of Life/Satisfaction |
Search Strategy
A systematic search of the literature was conducted using MEDLINE, PubMed, Web of Science, and the Cochrane Collaborative to identify articles related to the topic of interest. The initial search included Medical Subject Headings terms, as well as entry terms for relevant interventions and outcomes. Key words included [“colectomy” OR “colon surgery” OR “colorectal surgery”] AND [“perioperative” OR “post-operative” OR “post-surgical” OR “rehabilitation”] AND [“enhanced recovery” OR “ERAS” OR “ERP” OR “fast-track” OR “multimodal”]. The search was conducted for all dates up to November 2015 and restricted to English language titles. No age limits were applied. Titles and abstracts were screened for inclusion based on relevance. In addition, reference lists of retrieved articles were screened for additional relevant studies. Randomized controlled trials, case control trials, retrospective cohorts, systematic reviews, meta-analyses, reviews, letters, and editorials were considered. Emphasis was placed on studies comparing ERP to TC after open colectomy, with priority given to randomized controlled trials and meta-analyses where data was available for specific outcomes. For less well-studied outcomes all sources were considered.
Results
We identified over 300 articles related to the topic of interest, including 15 meta-analyses and systematic reviews of trials comparing ERP to TC (Table 43.3). These reviews encompass a total of 32 different randomized controlled trials, controlled clinical trials, and retrospective reviews, and provide some insight in each of the outcomes of interest for our clinical question.
Table 43.3
Meta-analyses and systematic reviews of enhanced recovery pathways vs. traditional care for colectomy
Author | Year | Studies | Inclusion criteria | Included studies | Primary outcomes | Secondary outcomes |
|---|---|---|---|---|---|---|
Greco et al. [3] | 2014 | RCT | Open or laparoscopic Minimum 4 ERAS elements | Overall morbidity Surgical complications Nonsurgical complications | Primary LOS Readmission Mortality Ileus | |
Lee et al. [20] | 2014 | RCT CCTa RRb | Open or laparoscopic Minimum 5 ERAS elements Cost data included | Cost | N/A | |
Lemanu et al. [29] | 2014 | RCT CCTa RRb | Open or laparoscopic No minimum ERAS elements Cost data included | Stephen [28]b | Cost | Primary LOS Readmission Morbidity |
Yin et al. [30] | 2014 | RCT | Open or laparoscopic No minimum ERAS elements | Total LOS Readmission Morbidity Mortality GI function | ||
Zhuang et al. [31] | 2013 | RCT | Open or laparoscopic Minimum 7 ERAS elements | Primary LOS Total LOS Readmission Total complications Surgical complications Nonsurgical complications Mortality | Time to first flatus and stool Hospital costs | |
Lvet al. [33] | 2012 | RCT | Open surgery only No minimum ERAS elements | Primary LOS | Readmission Morbidity Mortality | |
Adamina et al. [34] | 2011 | RCT | Open or laparoscopic Minimum 4 ERAS elements | Serclova [13] | Primary LOS Readmission Morbidity Mortality | N/A |
Rawlinson et al. [35] | 2011 | RCT CCTa RRb | Open or laparoscopic Minimum 4 ERAS elements | Serclova [13] | Primary LOS Total LOS Readmission Morbidity Mortality | N/A |
Spanjersberg et al. [41] | 2011 | RCT | Open or laparoscopic Minimum 7 ERAS elements | Mortality Total complications Major complications Minor complications | Operative time Economic impact QoL | |
Khan et al. [42] | 2010 | RCT CCTa | Open or laparoscopic No minimum ERAS elements QoL or satisfaction data included | QoL Patient satisfaction | ||
Varadhan et al. [46] | 2010 | RCT | Open surgery only Minimum 4 ERAS elements | Serclova [13] | Primary LOS | Readmission Morbidity Mortality |
Eskicioglu et al. [47] | 2009 | RCT | Open or laparoscopic No minimum ERAS elements | Primary LOS Total LOS | Readmission Morbidity Mortality | |
Gouvas et al. [48] | 2009 | RCT CCTa RRb | Open or laparoscopic No minimum ERAS elements | Primary LOS Total LOS Readmission Morbidity Mortality | NG required Lung function Pain, fatigue, quality of life scores | |
Walter et al. [50] | 2009 | RCT CCTa | Open or laparoscopic Minimum 5 ERAS elements | Primary LOS | Total LOS Readmission Morbidity Mortality | |
Wind et al. [51] | 2006 | RCT CCTa | Open or laparoscopic Minimum 4 ERAS elements | Gatt [7] | Primary LOS Total LOS Readmission Morbidity Mortality | N/A |
Complications
Several large meta-analyses of randomized controlled trials, including a Cochrane review, have examined morbidity and mortality after colectomy in patients manage by ERP versus TC (Table 43.3). Mortality is a rare event after colorectal surgery with consistent rates of around 1 % and no significant difference between ERP and TC in any series. The three largest and most recent meta-analyses to examine postoperative complications, by Greco [3], Yin [30], and Zhuang [31] respectively, all found a significant risk reduction for overall complications with ERP as compared to TC [Greco RR = 0.60 (95 % CI 0.46 – 0.76); Yin RR = 0.58 (95 % CI 0.43 – 0.77); Zhuang RR = 0.71 (95 % CI 0.58 – 0.86)]. Some reviews examined sub-categories of complications. Two studies found a significant decrease in non-surgical, but not surgical complications [3, 31] with ERP. The Cochrane review by Spanjersberg et al. found a significant reduction in overall complications with ERP [RR = 0.52 (95 % CI 0.38 – 0.71), though significance did not hold up when examining major complications or minor complications separately. The definition of complications and the way in which they were recorded is not constant and many studies fail to note whether complications occurring after discharge were measured; nonetheless, the findings remain consistent across multiple large studies and it is unlikely that major complications were missed.
Readmission
After assuring safety, the most obvious concern with implementing pathways designed to get patients home sooner, is if this makes them more likely to be readmitted to the hospital. In each of the studies cited above there was no difference in the rate of readmission among patients managed by ERP or TC [3, 30, 31, 41]. In the largest of these series, including over 1,600 patients, the overall readmission rate was 4 – 5 % in each group. This outcome is consistent and has very low heterogeneity in multiple meta-analyses. There is a risk of observational error if patients were readmitted to a different hospital, but there is no reason to suspect this phenomenon more frequently in one group versus the other.
Length of Stay
Perhaps the most consistent positive finding in the literature regarding ERP after colectomy is a decrease in hospital LOS with ERP as compared to TC. There are likely differences in the definition of “traditional” care between hospitals, and especially between countries, as evidenced by the wide variation in mean LOS in the TC cohorts of many recent series, ranging from 7 to 12 days [11–13, 15, 19]. However, there is high quality evidence showing a consistent reduction in LOS of around 2 days with implementation of ERP [3, 30, 31, 34, 46]. There is a risk for observer bias in some studies where discharge criteria were less than explicit and were assessed by non-blinded investigators.
Cost
Economic and cost-effectiveness analyses of healthcare technologies and systems are frequently plagued by imprecise and unclear methodology [52]. This is the case for the limited data available to examine cost-effectiveness of ERP as compared with TC. In 2014, two systematic reviews [20, 29] on the economic impact of ERP in colorectal surgery were published encompassing a total of 10 studies, including two randomized controlled trials (Table 43.3). The authors found significant heterogeneity in the methods used to the calculate costs and the types of factors considered. Most studies reported only direct hospital charges with few considering hospital overhead, cost of implementation of the ERP, or indirect costs such as loss of productivity by patients or caregivers. In total, eight of the 10 studies reported lower costs with ERP as compared to TC, including all four American studies [21, 22, 25, 28], two Australasian studies [12, 27], and two out of four European studies [14, 23, 24, 26]. Lee et al. were able to generate incremental cost-effectiveness ratios for five of the 10 studies, with all five showing ERP to be dominant (less costly and more effective) with regard to LOS [20]. Two studies published in 2015 reported cost data from retrospective comparisons of ERP and TC cohorts. Thiele et al. [53] reported a significant decrease of $7,129/patient in direct costs, while Ehrlich et al. [54] found a trend toward lower in-hospital costs with ERP that did not reach statistical significance.
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