P (patients)
I (intervention)
C (comparator)
O (outcomes)
Patients undergoing colorectal surgery
1. Laparoscopic- assisted approach
or
2. Enhanced recovery program/fast track pathway
1. Traditional open surgery
or
2. Conventional postoperative care
Total hospital stay, postoperative stay, complications, readmissions
Table 42.2
The GRADE system – grading recommendations
Description | Benefit vs. risk and burdens | Methodologic quality of supporting evidence | Implications | |
---|---|---|---|---|
1A | Strong recommendation, High quality evidence | Benefits clearly outweigh risk and burdens or vice versa | RCTs without important limitations or overwhelming evidence from observational studies | Strong recommendation, can apply to most patients in most circumstances without reservation |
1B | Strong recommendation, Moderate quality evidence | Benefits clearly outweigh risk and burdens or vice versa | RCTs with important limitations (inconsistent results, methodologic flaws, indirect or imprecise) or exceptionally strong evidence from observational studies | Strong recommendation, can apply to most patients in most circumstances without reservation |
1C | Strong recommendation, Low or very low quality evidence | Benefits clearly outweigh risk and burdens or vice versa | Observational studies or case series | Strong recommendation but may change when higher quality evidence becomes available |
2A | Weak recommendation, High quality evidence | Benefits closely balanced with risks and burdens | RCTs without important limitations or overwhelming evidence from observational studies | Weak recommendation, best action may differ depending on circumstances or patients’ or societal values |
2B | Weak recommendations, Moderate quality evidence | Benefits closely balanced with risks and burdens | RCTs with important limitations (inconsistent results, methodologic flaws, indirect or imprecise) or exceptionally strong evidence from observational studies | Weak recommendation, best action may differ depending on circumstances or patients’ or societal values |
2C | Weak recommendation, Low or very low quality evidence | Uncertainty in the estimates of benefits, risks and burden; benefits, risk and burden may be closely balanced | Observational studies or case series | Very weak recommendations; other alternatives may be equally reasonable |
Results
The definition of an enhanced recovery pathway for colon and rectal surgery was established by the Consensus Review of Optimal Perioperative Care in Colorectal Surgery Group in 2009. This was a succinct and easily adaptable list which describes the 20 aspects of the enhanced recovery protocol [2]. Our focus was whether adding an enhanced recovery/fast track pathway to patients undergoing laparoscopic techniques add any benefits when compared to those undergoing laparoscopy in the absence of a fast track pathway (Table 42.3).
Table 42.3
GRADE profile for laparoscopic colorectal surgery in enhanced recovery protocols
Study year | Study type | Patients numbers | Outcomes | Quality of evidence |
---|---|---|---|---|
Zhuang et al. (2015) [3] | Meta-analysis | 598 patients Lap vs. Open in ERAS program | Laparoscopic surgery ↓Total hospital stay ↓# of complications | Moderate |
Lei et al. (2015) [4] | Meta-analysis | 714 Patients 373 FT Lap 341 FT Open | Lap surgery – shorter post op stay and shorter overall hospital stay | Moderate |
Tiefenthal et al. (2015) [5] | Prospective Clinical Trial | 292 Patients Lap within ERAS program | ↓Pain control ↓Hospital stay | Moderate |
Zhao et al. (2014) [6] | Meta-analysis | 1,317 Patients 696 Lap/ERAS 621 LAP/traditional care | ↓Primary hospital stay ↓Time to first flatus ↓Time to first bowel movement ↓Complications | Moderate-High |
Vlug et al. (2012) [7] | RCT | 400 Patients 193 Lap/Open FT 207 Lap/Open standard | Factors ↓ total hospital stay Female Sex Laparoscopic resection Normal diet on POD 1, 2, 3 Enforced Mobilization | Low-moderate |
Vlug et al. (2011) [8] | RCT | 400 Patients Lap FT Lap standard Open FT Open standard | Laparoscopy within ERAS protocol ↓hospital stay to 5 days vs. 7 days in the Open and ERAS protocol | Moderate |
It is well known that using a laparoscopic approach for colorectal surgery is associated with shorter hospital stays, decreased postoperative complications, and decreased pain when compared to open surgery [9–12]. It is also well established that adding an enhanced recovery protocol to open colorectal surgery results in better patient outcomes. In theory, the addition of an enhanced recovery protocol should produce better outcomes for laparoscopic surgery as well; however, the lack of tier 1 randomized controlled trials makes this presumption difficult to definitively prove. In reality, most studies are retrospective reviews, underpowered, or lack an appropriate number of fast track elements.
However, Zhao et al. attempted to strengthen the literature by combining the data with a meta-analysis in August of 2014 [6].The authors were able to identify and deem eligible five randomized controlled trials and five clinical controlled trials for a total of 1,317 patients. The patients all underwent laparoscopic colorectal surgery, with 696 participating in an enhanced recovery protocol and 621 patients undergoing traditional care. Importantly, all patients underwent a minimally invasive approach. In addition, all studies within the meta-analysis were determined to range in quality from moderate to high. Primary hospital stay (−1.64 days; 95 % CI, −2.25 to−1.03; p < 0.001), time to first flatus (−0.40 day; 95 % CI, −0.77 to−0.04; p = 0.03), time to first bowel movement (−0.98 day; 95 % CI, −1.45 to−0.52; p < 0.001), and complication rate (RR, 0.67; 95 % CI, 0.56–0.80; p < 0.001) were all improved when an enhanced recovery program was applied in addition to the laparoscopic technique. Readmission rate and 30-day mortality were found to be non-significant, which has been consistent with other studies comparing enhanced recovery protocols within colorectal surgery. Another interesting aspect of this meta-analysis was that complication rates were found to be significantly reduced–a finding in which no other meta-analysis had identified before. The authors ultimately concluded that not only can an enhanced recovery protocol be combined with laparoscopic colorectal surgery to decrease primary hospital stay, increase time to first flatus and bowel movements, but also that using laparoscopy within these protocols may actually increase patient safety when compared to traditional perioperative colorectal care.
When looking at some of the existing primary data, a study by Vlug and colleagues provides a closer comparative evaluation. Vlug and associates provided one of the first studies looking specifically at laparoscopy versus open techniques within enhanced recovery protocols in the 2011 entitled LAparoscopy and/or FAst track multimodal management versus standard care (LAFA trial) [13]. The authors stratified 400 patients into 4 treatment groups: laparoscopic/fast track, open/fast track, laparoscopic/standard, and open/standard with the primary goal to find a minimum difference of 1 day in hospital stay [13]. They showed a total hospital stay of 5 days in the laparoscopic/fast tract group versus 7 days for the open/fast track group (p < 0.001), concluding that optimal perioperative treatment includes a laparoscopic resection within an enhanced recovery protocol [13]. On regression analysis, laparoscopy was the only independent predictive factor to reduce hospital stay and morbidity [13]. When specifically comparing laparoscopic with fast track, versus laparoscopic with standard perioperative care, the median hospital stay was lower in the fast track cohort at 5 days (interquartile range: 4–8) versus 6 days (range: 4.5–9.5). However, secondary outcomes including postoperative hospital stay, morbidity, reoperation, readmission, in-hospital mortality, and quality of life did not differ significantly amongst the groups.