Methods

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Systematic searches of the the PubMed and Embase™ databases and the Cochrane library were conducted. The search strategy comprised combining the keywords and MeSH terms: ‘enhanced recovery’, ‘fast track protocols’, ‘multimodal rehabilitation’, ‘traditional care in combination with ‘colorectal’, ‘colon’, ‘rectum’ and ‘sigmoid’. A hand search of bibliographies was conducted to identify any additional articles missed by the initial search strategy. The literature review was completed in February 2011.

In order to maintain quality control, the selection of studies was limited to randomised or clinical controlled trials (CCTs) with a prospective intervention group that compared an ERAS perioperative programme with traditional care in adult patients undergoing open or laparoscopic elective colorectal surgery, regardless of indication. The studies were required to document the multimodal enhanced recovery protocol implemented and are listed in Tables 1–4. They reported at least one of the following outcome measures:

Table 1 Study design and reviewed data

Table 2 Elements of enhanced recovery protocol included per study in the preoperative period

Table 3 Elements of enhanced recovery protocol included per study in the perioperative period

Table 4 Elements of enhanced recovery protocol included per study in the postoperative period

Included studies contained a minimum of four elements covering the pre, intra and postoperative periods of the ERAS protocol pathway.

Results

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A total of 59 relevant studies were identified, including six RCTs4,5,10,12,18,19 and seven CCTs7,13,20–24 that were deemed suitable for inclusion in the analysis. These 13 studies are listed in Table 1. The remaining 46 studies were case reports, meta-analyses or systematic reviews; although relevant and worthy of mention, they did not meet the inclusion criteria and were therefore excluded from rigorous analysis.

A previous meta-analysis15 of the RCTs identified 452 patients with 226 in each group. None of the trials were blinded but all were appropriately randomised (either by random number generator or sealed envelope methods). All six of the RCTs selected had specified inclusion and exclusion criteria and all had at least one outcome measure as previously listed. Each RCT had a minimum of four ERAS elements implemented in the intervention group. The number of ERAS protocol elements used in the RCTs ranged from 4 to 14, with a mean of 9. Seven non-randomised CCTs were selected for review.7,13,20–24 These involved small numbers of patients at solitary centres, resulting in low-powered results. All studies included in our analysis reported a 30-day follow-up period except Khoo et al,5 who reported outcome measures at 14 days.

Discussion

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Review of the published data reveals that the ERAS protocols have a role in reducing postoperative morbidity and result in an accelerated recovery following colorectal surgery. Similarly, both primary and overall hospital stays are reduced significantly. However, the available evidence suggests that ERAS protocols do not reduce hospital readmissions or mortality.

Despite these observations, a study from 2007 argued against the use of enhanced recovery protocols in clinical practice on the basis of cost-effectiveness and patient safety.26 This may stem from a reluctance to reject surgical dogma decreeing a period of postoperative enteral resting with the concurrent maintenance of a hypervolaemic state. Kehlet et al, the architects of the ERAS protocol, hypothesise that audit is an inherent and essential component of each step in the procedure.1

A potential weakness of our systematic review is that only four elements of the ERAS protocol were required for studies to be assessed. This leads to variations in the number of elements of the ERAS protocol utilised in each study. It is unlikely that each element is of equal importance in determining a patient's perioperative course.

The study by Delaney et al incorporated four elements of the ERAS protocol in the intervention group.12 This was the only trial of all those reviewed that did not demonstrate a statistically significant difference in primary length of hospital stay. Other reviewed studies included up to fourteen elements13 of the ERAS protocol and all demonstrated a statistically significant reduction in primary length of hospital stay of at least two days.

Reviewed studies also assessed other elements of the ERAS protocol including preoperative counselling, epidural use, minimally invasive/transverse incisions, absence of nasogastric tubes with enforced postoperative mobilisation and oral feeding. Laparoscopically assisted surgery demonstrates improvements in outcome measures, including length of primary hospital stay and morbidity.25

Laparoscopic resectional surgery is currently considered to be the key interventional change in traditional care that has led to improvements in recovery rates and reductions in morbidity following colorectal surgery. RCTs have demonstrated a reduction in primary length of hospital stay in association with laparoscopic colorectal surgery.36–38 The combination of ERAS protocols and laparoscopically assisted colonic resections has been evaluated in three separate trials27–29 that, unfortunately, have not yielded a pervasive message. These trials failed to elicit significant differences in outcome between groups that had undergone open as compared with laparoscopic colorectal resection within the context of an ERAS protocol. The study by Basse et al, in which laparoscopy was introduced into a well-established ERAS protocol, showed no significant difference in the length of postoperative stay or rate of readmissions in the laparoscopic group.27

The LAFA trial is a randomised multicentre trial with a 2 × 2 balanced factorial design.42 Patients are blinded for the type of intervention, ie laparoscopic or open surgery. The aim is to determine whether laparoscopic surgery, fast track perioperative care or a combination of both is to be preferred over open surgery with standard care in patients undergoing a segmental colectomy for malignant disease. Similarly, the EnROL trial aims to randomise patients to open or laparoscopic surgery with an enhanced recovery programme to try to establish best practice.43 These trials will go some way in answering these issues.

The inclusion of other aspects of the ERAS protocol is well supported by robust evidence from previous trials and meta-analyses. Bowel preparation is known potentially to cause significant fluid shifts that may result in dehydration and electrolyte deficiencies.30 Two RCTs have shown no benefit with the routine use of bowel preparation in elective colorectal surgery31,32 with another suggesting an increased risk of postoperative anastomotic breakdown.33 The evidence for avoiding routine nasogastric tube decompression and implementation of epidural anaesthesia postoperatively has been ratified by meta-analyses.34,35

Factors affecting the quality of data reviewed include a relative lack of RCTs and CCTs that compare the ERAS and traditional care pathways, and also the low numbers of patients involved. Given the nature of the ERAS interventions being compared, blinding of patients and staff is unfeasible.

Eleven trials reported the length of hospital stay as either a primary or secondary outcome measure. It was, however, unclear whether primary length of stay was measured from the admission date to the point of fulfilling discharge criteria and therefore the social circumstances of each patient may have influenced results artificially.

Another factor that may limit data homogeneity includes the fact that discharge criteria were not always clarified or, when specified, varied between trials. In the RCTs4,10,12 discharge criteria were defined for both ERAS and traditional care groups. This consisted of full mobilisation, oral analgesia and an ability to tolerate solids without nausea and vomiting. Delaney et al included the additional prerequisite of passage of flatus, prior to discharge.12 Of the CCTs, Teewen et al described identical discharge criteria for both groups, including adequate pain relief with non-opioid oral analgesia, normal food intake and a return to the preoperative mobility level,20 while Khoo et al additionally required bowel or stoma function.5

Other causes of inconsistency in the data were that two RCTs12,19 included patients who had undergone a small bowel resection. Serclova et al also limited participation in the trial to patients aged 18–70 years and to those who were undergoing bowel resection and stoma formation for non-malignant colorectal disease.19

There is evidence that the incorporation of single elements of the ERAS protocol leads to a decrease in morbidity and a reduction in primary length of hospital stay.34,39–40 Results of the RCTs, CCTs and meta-analyses reviewed in this paper strengthen those conclusions. Other, less comprehensively investigated elements of the ERAS protocol, such as the use of synbiotics and withholding premedication, may also have contributed to the reduction in morbidity and length of hospital stay. However, evidence for this is lacking and further RCTs with emphasis on total protocol compliance and homogenisation of study populations is necessary to investigate all individual elements.

Conclusions

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Following an extensive review of the literature, the available evidence supports the contention that ERAS protocols reduce healthcare costs21,41 and, importantly, that there is a significant reduction in patient morbidity with an acceleration of postoperative recovery. These findings help to confirm that ERAS protocols should now be implemented as the standard approach to perioperative care in colorectal surgery. To develop the evidence base further, future RCTs of ERAS protocols with strict pathway compliance will be required.