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Keyword: Colorectal Surgery

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C: Traditional Care

O: Hospital Length of Stay

Controlled Trials: 6

Primary Research: 31

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Abstract

BACKGROUND:

Enhanced recovery after surgery (ERAS) program has shown a few advantages in colorectal cancer surgery. However, the effectiveness of the ERAS program in laparoscopic colorectal cancer surgery is still unclear. We performed a meta-analysis of randomized controlled trials (RCTs) to evaluate the effect of ERAS program in laparoscopic colorectal cancer surgery compared with traditional perioperative care (TC).

METHODS:

PubMed, EMBASE, Web of Science, The Cochrane Library, and ClinicalTrials.gov were searched for eligible RCTs comparing ERAS program with TC in laparoscopic colorectal cancer surgery. The main outcomes included the average length of postoperative hospital stay (PHS), time to first flatus and defecation, overall complication, readmission, and mortality rates were undertaken.

RESULTS:

Thirteen RCTs involving 1298 patients were included in our study (639 in ERAS group and 659 in TC group). ERAS group had shorter average length of PHS (weighted mean difference [WMD] - 2.00 day, 95% confidence interval [CI] - 2.52 to - 1.48, p = 0.00), time to first flatus (WMD - 12.18 h, 95%CI - 16.69 to - 7.67, p = 0.00), and time to first defecation (WMD - 32.93 h, 95%CI - 45.36 to - 20.50, p = 0.00) than TC group. In addition, the overall complication rates (risk ratio [RR] 0.59, 95%CI 0.40 to 0.86, p < 0.01) were significantly lower in ERAS group compared with TC group.

CONCLUSIONS:

The results indicated that ERAS program is a much better effective and safe protocol for laparoscopic colorectal cancer surgery compared with TC. Hence, ERAS program should be recommended in laparoscopic colorectal cancer surgery.

KEYWORDS:

Colorectal cancer; Enhanced recovery after surgery; Laparoscopic surgery; Meta-analysis

PMID: 30859422

DOI: 10.1007/s11605-019-04170-8

Abstract

BACKGROUND:

Enhanced recovery programmes (ERPs) have been developed over the past 10 years to improve patient outcomes and to accelerate recovery after surgery. The existing literature focuses on specific specialties, mainly colorectal surgery. The aim of this review was to investigate whether the effect of ERPs on patient outcomes varies across surgicalspecialties or with the design of individual programmes.

METHODS:

MEDLINE, Embase, CINAHL and the Cochrane Central Register of Controlled Trials were searched from inception to January 2013 for randomized or quasi-randomized trials comparing ERPs with standard care in adult elective surgical patients.

RESULTS:

Thirty-eight trials were included in the review, with a total of 5099 participants. Study design and quality was poor. Meta-analyses showed that ERPs reduced the primary length of stay (standardized mean difference -1·14 (95 per cent confidence interval -1·45 to -0·85)) and reduced the risk of all complications within 30 days (risk ratio (RR) 0·71, 95 per cent c.i. 0·60 to 0·86). There was no evidence of a reduction in mortality (RR 0·69, 95 per cent c.i. 0·34 to 1·39), major complications (RR 0·95, 0·69 to 1·31) or readmission rates (RR 0·96, 0·59 to 1·58). The impact of ERPs was similar across specialties and there was no consistent evidence that elements included within ERPs affected patient outcomes.

CONCLUSION:

ERPs are effective in reducing length of hospital stay and overall complication rates across surgical specialties. It was not possible to identify individual components that improved outcome. Qualitative synthesis may be more appropriate to investigate the determinants of success.

© 2014 BJS Society Ltd. Published by John Wiley & Sons Ltd.

PMID: 24469618

DOI:10.1002/bjs.9394

[Indexed for MEDLINE]

Abstract

BACKGROUND:

Meta-analyses in the literature show that enhanced recovery after surgery(ERAS) is associated with lower morbidity rate and shorter hospital stay after elective colorectal surgery. However, a recent Cochrane review did not indicate the ERAS pathway as being the new standard of care due to the limited number of published trials, together with their poor quality. We conducted a meta-analysis of randomized controlled trials (RCTs) to assess the impact of the ERAS pathway on overall morbidity, single postoperative complications, length of hospital stay, and readmission rate following colorectal surgery.

METHODS:

We searched BioMedCentral, PubMed, Scopus, and the Cochrane Central Register of Controlled Trials (CENTRAL) for RCTs comparing the ERAS pathway to conventional perioperative care. No language restrictions were considered. A quality score was calculated for each trial included.

RESULTS:

A total of 2,376 patients in 16 RCTs were included in the analysis. The ERAS pathway was associated with a reduction of overall morbidity [relative ratio (RR) = 0.60, (95 % CI 0.46-0.76)], particularly with respect to nonsurgical complications [RR = 0.40, (95 % CI 0.27-0.61)]. The reduction of surgical complications was not significant [RR = 0.76, (95 % CI 0.54-1.08)]. The ERAS pathway shortened hospital stay (WMD = -2.28 days [95 % CI -3.09 to -1.47]), without increasing readmission rate.

CONCLUSIONS:

The ERAS pathway reduced overall morbidity rates and shortened the length of hospital stay, without increasing readmission rates. A significant reduction in nonsurgical complications was evident, while no significant reduction was found for surgical complications.

PMID: 24368573

DOI: 10.1007/s00268-013-2416-8

[Indexed for MEDLINE]

BACKGROUND:

In recent years the Enhanced Recovery after Surgery (ERAS) postoperative pathway in (ileo-)colorectal surgery, aiming at improving perioperative care and decreasing postoperative complications, has become more common.

OBJECTIVES:

We investigated the effectiveness and safety of the ERAS multimodal strategy, compared to conventional care after (ileo-)colorectal surgery. The primary research question was whether ERAS protocols lead to less morbidity and secondary whether length of stay was reduced.

SEARCH STRATEGY:

To answer the research question we entered search strings containing keywords like “fast track“, “colorectal and surgery” and “enhanced recovery” into major databases. We also hand searched references in identified reviews concerning ERAS.

SELECTION CRITERIA:

We included published randomised clinical trials, in any language, comparing ERAS to conventional treatment in patients with (ileo-) colorectal disease requiring a resection. RCT’s including at least 7 ERAS items in the ERAS group and no more than 2 in the conventional arm were included.

DATA COLLECTION AND ANALYSIS:

Data of included trials were independently extracted by the reviewers. Analyses were performed using “REVMAN 5.0.22”. Data were pooled and rate differences as well as weighted mean differences with their 95% confidence intervals were calculated using either fixed or random effects models, depending on heterogeneity (I(2)).

MAIN RESULTS:

4 RCTs were included and analysed. Methodological quality of included studies was considered low, when scored according to GRADE methodology. Total numbers of inclusion were limited. The trials included in primary analysis reported 237 patients, (119 ERAS vs 118 conventional). Baseline characteristics were comparable. The primary outcome measure, complications, showed a significant risk reduction for all complications (RR 0.50; 95% CI 0.35 to 0.72). This difference was not due to reduction in major complications. Length of hospital stay was significantly reduced in the ERAS group (MD -2.94 days; 95% CI -3.69 to -2.19), and readmission rates were equal in both groups. Other outcome parameters were unsuitable for meta-analysis, but seemed to favour ERAS.

AUTHORS’ CONCLUSIONS:

The quantity and especially quality of data are low. Analysis shows a reduction in overall complications, but major complications were not reduced. Length of stay was reduced significantly. We state that ERAS seems safe, but the quality of trials and lack of sufficient other outcome parameters do not justify implementation of ERAS as the standard of care. Within ERAS protocols included, no answer regarding the role for minimally invasive surgery (i.e. laparoscopy) was found. Furthermore, protocol compliance within ERAS programs has not been investigated, while this seems a known problem in the field. Therefore, more specific and large RCT’s are needed.

Abstract

INTRODUCTION:

Colorectal surgery has been associated with a complication rate of 15-20% and mean post-operative inpatient stays of 6-11 days. The principles of enhanced recovery after surgery (ERAS) are well established and have been developed to optimise peri-operative care and facilitate discharge. The purpose of this systematic review is to present an updated review of peri-operative care in colorectal surgery from the available evidence and ERAS group recommendations.

METHODS:

Systematic searches of the PubMed and Embase™ databases and the Cochrane library were conducted. A hand search of bibliographies of identified studies was conducted to identify any additional articles missed by the initial search strategy.

RESULTS:

A total of 59 relevant studies were identified. These included six randomised controlled trials and seven clinical controlled trials that fulfilled the inclusion criteria. These studies showed reductions in duration of inpatient stays in the ERAS groups compared with more traditional care as well as reductions in morbidity and mortality rates.

CONCLUSIONS:

Reviewing the data reveals that ERAS protocols have a role in reducing post-operative 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. These findings help to confirm that ERAS protocols should now be implemented as the standard approach for peri-operative care in colorectal surgery.

PMID: 22041232

PMCID: PMC3566681

DOI: 10.1308/147870811X605219

[Indexed for MEDLINE]

(# of subjects/ studies, cohort definition etc. )

– Inclusion Criteria: (1) RCTs comparing ERAS group with traditional perioperative care (TC) group in patients undergoing laparoscopic colorectal cancer surgery, (2) studies describing ERAS program with clear protocol, (3) studies including at leastthree of the following parameters: average length of PHS, duration of flatus or defecation, rates of complications, readmissions, or mortality, (4) studies describing an ERAS program with at least 13 parameters in the ERAS group

– Exclusion Criteria: (1) studies were reviews, letters, cases, or bioinformatics, (2) studies were not RCTs, (3) studies only had abstracts presented at national or international conferences without full-text articles, (4) studies reported ERAS program without laparoscopic colorectal cancer surgery, (5) if duplicate publications were discovered, the latest one was included

– Thirteen RCTs selected (n = 1298 patients; 639 in ERAS group, 659 in TC group)

– Patients from China, Korea, Netherland, Italy, and Egypt with all trials published between 2011 and 2017

– RCTs included (Author Name, Year): Lee, Taek-Gu (2011); Van Bree, S.H. (2011); Vlug, M.S. (2011); Veenhof, A.A.F.A (2012); Wang, G. (2012); Wang, Q. (2011); Lee, S.M. (2013); Feng, F. (2014); Mari, G.M. (2014); Taupyk, Y. (2015); Mari, G.M. (2016); Wang, G. (2011); Shetiwy, M. (2017)

– Time to First Flatus and Defecation

– Complication, Readmission, and Mortality

– Inflammatory Response Indicators

– 9 studies reported on time to first flatus (n = 1071 patients); 7 studies reported on time to first defection (n = 678 patients): ERAS group patients have a significantly shorter time to first flatus and time to first defecation than TC group (p = 0.00)

– All 13 studies reported on postoperative complication rates (n = 1298 patients): ERAS group patients experienced a significantly lower postoperative complication rate than TC group (p<0.01)

– 5 studies reported on 30-day readmission rates and mortality rates: There is no significant difference in 30-day readmission rates and mortality rates between ERAS group patients and TC group (p = 0.77 and p = 0.61, respectively)

– 2 studies reported on interleukin-6 levels postoperatively: ERAS group patients have lower levels of IL-6 days 1,3, and 5 postoperatively than TC group

– 3 studies reported on C-reactive protein (CRP) levels postoperatively: ERAs group patients have lower levels of CRP on days 1, 3, and 5 postoperatively

– Authors utilized Begg’s test, Egger’s test, and Egger’s funnel plot to evaluate for publication bias: no significant publication bias in current meta-analysis

– Sensitivity Analysis was performed which showed that no individual study had a significant effect among all studies

– Inclusion Criteria: (1) RCTs and quasi-RCTs (allocation to intervention was decided by non-random means like alternation, digits in date of birth, or other identification number), (2) patients > or = to 16yo, undergoingany elective surgical operation under either regional or general anaesthetic, (3) Enhanced Recovery Programme (ERP) contained at least four elements from a checklist of 21 recognized elements, (4) comparison programme with at least three elements fewer than intervention group, (5) investigated at leastone of the following outcomes: mortality within 30 days of surgery, non-fatal complications within 30 days of surgery, or primary length of hospital stay

– Thirty-eight trials included (n = 5099)

– Eighteen of thirty-eight trials investigated colorectal surgical patients

– All complications within 30 days

– Mortality within 30 days

– Major complication within 30 days

– Readmission rates within 30 days

– There is no significant difference in risk of major complications between intervention group (ERP) versus comparison programme (control group)

– Twenty-three studies reported on primary length of hospital stay as a mean. Fourteen of these studies particularly investigated patients undergoing colorectal operations: There was a significant reduction in stay for patients in the ERP group versus comparison programme (control group)

– There is no significant difference in 30-day readmission rates in patients in ERP group versus comparison programme

– Subgroup analyses concluded that there was no difference in reduction of length of stay between laparoscopic and open approaches in colorectal surgery

– Subgroup analyses concluded that studies with 11 or more elements of ERPs showed a greater reduction in length of hospital

– In the discussion, the authors discuss how “For a typical stay of 5 days with a standard deviation of 1 day… an ERP will lead to a reduction in hospital stay of 1 day,” and state that “the impact of ERPs was similar across studies of colorectal, upper gastrointestinal, thoracic, and genitourinary surgery, with no indication of differences in effect between specialties.”

– There was a significant reduction in hospital stay in all specialty subgroupsexcept laparoscopic colorectal surgery

– Difficulty in conducting double-blind RCTs for ERPs interventions leading to likely performance bias

– Evidence of small-study bias for length of stay: smaller studies reported greater benefits from the use of ERPs

– Authors acknowledge that findings are only applicable to those living independently prior to surgery (many studies excluded dependent patients)

– Authors acknowledge that some studies did a poor job reporting on features of control group care

– Different studies included various ERP components like preoperative elements, intraoperative elements, or postoperative elements (or combination of them). No analysis was performed comparing the use of pre- versus intra- versus post-operative elements

– Other authors have suggested that ERP may be successful due to a mind set or psychological effect, though this is purely speculation and cannot be studied

– The lack of finding that there is a significant reduction in hospital stay in laparoscopic colorectal surgery may be attributed to the fact that only one study investigated length of hospital stay in patients undergoing laparoscopic colorectal surgery

– Inclusion Criteria: random allocation to treatment, colorectal surgery, comparison between ERAS and standard treatment with no restriction on primary or secondary outcome

– Exclusion Criteria: duplicate publications (article reporting longest follow-up was included), nonhuman experimental studies, other surgical settings, trials evaluating single aspects of ERAS, lack of data on principal outcomes

– 16 RCTs (n = 2,376 patients) included in the analysis

– RCTs included that reported on length of hospital stay (Author Name, Year): Anderson, 2003; Delaney, 2003; Garcia-Botella, 2011; Gatt, 2005; Ionescu, 2009; Khoo, 2007; Muller, 2009; Ren, 2012; Serclova, 2009; Vlug, 2011 LPS; Vlug, 2011 LPT; Wang, 2012 LPS; Wang, 2012 LPT; Wang G, 2011; Yang, 2012

– Secondary endpoints: Length of stay (LOS), readmission rate, mortality, and ileus

– ERAS pathway significantly reduced overall morbidity versus control group (p < 0.001)

– ERAS pathway significantly reduced pooled nonsurgical complications (cardiovascular, respiratory, UTI) versus control group (p <0.001)

– ERAS pathway significantly reduced respiratory complications versus control group (p = 0.005)

– ERAS pathway significantly reduced cardiovascular complications versus control group (p = 0.02)

– No statistically significant difference was observed in UTI in ERAS group versus control group (p = 0.14)

– No statistically significant difference was observed in pooled (surgical site infections, anastomotic leakage) or individual surgical complications in ERAS group versus control group (p = 0.13 for pooled; p = 0.86 for anastomotic leak alone; p = 0.14 for surgical site infection alone)

– No statistically significant difference observed in postoperative ileus between ERAS group and control group (p = 0.53)

– ERAS pathway significantly reduced mean LOS versus control group (p<0.001 – data based on meta-analysis of 15 studies)

– No statistically significant difference in readmission rate between ERAS group and control group (p = 0.25)

– Publication Bias was not identified by authors when using visual inspection of funnel plots and Begg and Egger test (this is reassuring)

– Authors recognize that a limitation includes varied implementation of the ERAS pathway (variation in number and types of ERAS components)

– Authors recognize that some RCTs, particularly earlier studies, were under-powered and of lower quality – Authors mitigated this by performing analysis of low and medium-risk-of-bias trials or new studies which confirmed the impact of ERAS on postoperative outcomes (this is reassuring)

– Databases searched included: Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects (DARE), The Cochrane Central Register of Controlled Trials (CENTRAL), NHS Economic Evaluation Database, all in the Cochrane Library, MEDLINE, EMBASE, ISI Web of Knowledge, Webcasts of the annual meetings of the American Society of Colon and Rectal Surgeons (ASCRS)

– Inclusion Criteria: (1) published randomized controlled trials (RCTs), (2) in any language, (3) comparing ERAS to conventional treatment in patients with (ileo-) colorectal disease requiring a resection, (4) at least 7 ERAS items in the ERAS group and no more than 2 in the conventional/control arm

– 4 RCTs Included (n = 237 patients, 119 ERAS vs 118 conventional); patients had comparable baseline characteristics

– RCTs included (Author Name, Year): Anderson, 2003; Gatt, 2005, Khoo, 2007, Serclova, 2009 (2 additional studies included when performing sensitivity analysis = Delaney, 2003; Muller, 200()

– Secondary Outcome: Length of Stay, operative time, mobilization, duration of surgery, pain scores and analgesia, GI function, IV fluid administration

– ERAS group patients had a significant reduction in hospital length of stay (Mean Difference (MD) -2.94 days; 95% CI -3.69 to -2.19)

– Sensitivity analysis revealed a shorter LOS for ERAS group versus conventional group (Mean Difference (MD) -2.51 days; 95% CI -3.54 to -1.47p < 0.00001)

– No statistically significant difference in readmission rate between ERAS group and control group

– No statistically significant difference in mortality between ERAS patients and conventional patients

– No statistically significant difference in major complications between ERAS patients and conventional patients

– None of the studies were blinded

– Data reported as median with interquartile range suggests large outliers in raw data

– In conventional protocol, some ERAS interventions are also used (exact contribution of separate interventions of ERAS protocols are not known)

– Publication bias was low when using funnel plots (this is reassuring)

– Measures like cost effectiveness and implementation costs have not yet been explored

– Evidence of the effects of ERAS in different operative techniques (laparoscopy) has not yet been performed

– Authors recognize that methodological quality of all studies was not high

– Results of one study may suggest that effect on length of stay between groups may be influenced by mind set of staff (though no proof of this exists)

– No studies reported on compliance with protocols or actions to prevent mixing of protocols (“cross-contamination”): effects may be over- or under-estimated

– Patients investigated were relatively healthy (most surgical candidates were ASA 1 or 2): one must be careful not to conclude that this effect will be similar in populations with multiple co-morbidities or older age

– 13 Studies included in total: Six Randomized Controlled Trials and Seven Clinical Controlled Trials fulfilled the inclusion criteria (n = 456 patients, 226 in ERAS group, 226 in control group)

– Inclusion Criteria: Required a prospective intervention group comparing ERAS perioperative programmes with traditional care in adult patients undergoing open or laparoscopic elective colorectal surgery, regardless of indication; required to document the multimodal enhanced recovery protocol implemented (must include a minimum of four elements covering the pre, intra, and postoperative periods of the ERAS protocol pathway); reported on at least one of these outcomes: length of primary postoperative hospital stay in days following surgery, length of total postoperative stay expressed as total days spent in hospital, including readmission, postoperative complications (morbidity as a percentage), readmission rates (as a percentage), and mortality (as a percentage)

– Studies included (Author Name, Year): Teewen, 2010; Muller, 2009; Serclova, 2009; Khoo, 2007; Polle, 2007; Kariv, 2007; Wichmann, 2007; Gatt, 2005; Basse, 2004; Raue, 2004; Anderson, 2003; Delaney, 2003; Stephen, 2003

– Length of total postoperative stay expressed as total days spent in hospital, including readmission

– Postoperative complications

– Readmission Rates

– Mortality

– Meta-analysis of data showed a reduction in primary hospital stay of 2.53 days (p<0.00001)  in ERAS group versus control group in patients who underwent major open colorectal surgery

– Five studies reported on total hospital stay: a meta-analysis demonstrated a statistically significant decrease in stay in the ERAS group by 2.46 days compared with traditional care (control group) (p<0.00001)

– Only two RCTs and one CCT revealed a statistically significant decrease in morbidity between ERAS groups and control groups. Other studies showed a trend that favored ERAS groups.

– No significant between readmission rates in ERAS group patients and control group

– No significant difference between mortality in ERAS group patients and control group

– Some trials utilized sealed envelope methods for allocation to various treatment arms

– Small numbers of patients with low-powered results

– Authors only required four elements of the ERAS protocol to be present for inclusion

– Some studies were unclear as to whether primary length of study was measured from admission date to point of fulfilling discharge criteria; therefore, social circumstance may influence results artificially

– Discharge criteria were not always clarified or varied from trial to trial