Review question
Are enhanced recovery protocols beneficial or harmful when compared to standard surgery in people undergoing major surgeries of food pipe (oesophagus), stomach, liver and pancreas?
Background
'Fast-track surgery' or 'enhanced recovery protocol' or 'fast-track rehabilitation' incorporates one or more of the following components: patient education before surgery, pain relief during and after surgery, early mobilisation after surgery, nutritional supplements, and feeding through the mouth or through a tube introduced into the gut through the nose or through the tummy wall rather than by drip to quicken the recovery after surgery. The benefits and harms of using an enhanced recovery protocol in people undergoing major surgeries of oesophagus, stomach, liver and pancreas are not known. We sought to resolve this issue by searching for existing studies on the topic. We included all studies whose results were reported until 26 March 2015.
Study characteristics
Ten studies met the inclusion criteria for the review, and nine studies provided information for the review. A total of 1014 participants received an enhanced recovery protocol (499 participants) or standard care (515 participants) in the nine trials. The decision on whether a participant received an enhanced recovery protocol or standard care was made using methods similar to the toss of a coin, ensuring that the participants in the two groups were similar. One additional trial (including 33 participants) also performed the same comparison but did not provide any information for this review. Most of the trials included persons who were healthy in aspects other than the condition requiring surgery. Eight trials incorporated more than one component of the enhanced recovery protocol.
Key results
None of the trials reported long-term deaths, medium-term health-related quality of life (three months to one year), time to return to normal activity, or time to return to work. The difference between enhanced recovery protocols and standard care was imprecise for short-term deaths, percentage of people with major complications, total number of major complications, health-related quality of life and hospital readmissions. Enhanced recovery protocols had a lower percentage of people with minor complications, fewer minor complications, shorter length of hospital stay (approximately two days shorter hospital stay per person) and lower costs (cost savings of approximately USD 6300 per person) compared to standard care. Because the trials were of poor quality and did not include clinically important end points, future high quality studies are needed in this field.
Quality of the evidence
The quality of evidence was low or very low. As a result, there is a lot of uncertainty regarding the results.
Based on low quality evidence, enhanced recovery protocols may reduce length of hospital stay and costs (primarily because of reduction in hospital stay) in people undergoing major upper gastrointestinal, liver and pancreatic surgeries. However, the validity of the results is uncertain because of the risk of bias in the trials and the way the outcomes were measured. Future RCTs should be conducted with low risk of bias, and measure clinically important outcomes for including the three months to one year period.
'Fast-track surgery' or 'enhanced recovery protocol' or 'fast-track rehabilitation', incorporating one or more elements of preoperative education, pain relief, early mobilisation, enteral nutrition and growth factors, may improve health-related quality of life and reduce length of hospital stay and costs. The role of enhanced recovery protocols in major upper gastrointestinal, liver and pancreatic surgery is unclear.
To assess the benefits and harms of enhanced recovery protocols compared with standard care (or usual practice) in major upper gastrointestinal, liver and pancreatic surgery.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL; Cochrane Library; 2015, Issue 3), MEDLINE, EMBASE and Science Citation Index Expanded until March 2015 to identify randomised trials. We also searched the references of included trials to identify further trials.
We considered only randomised controlled trials (RCTs) performed in people undergoing major upper gastrointestinal, liver and pancreatic surgery, irrespective of language, blinding or publication status for inclusion in the review.
Two review authors independently identified trials and independently extracted data. We calculated the risk ratio (RR), mean difference (MD), or standardised mean difference (SMD) with 95% confidence intervals (CIs) using both fixed-effect and random-effects models using Review Manager 5, based on available case analysis.
Ten studies met the inclusion criteria for the review, and nine studies provided information on one or more outcomes for the review. A total of 1014 participants were randomly assigned to the enhanced recovery protocol (499 participants) or standard care (515 participants) in the nine RCTs. Most of the trials included low anaesthetic risk participants with high performance status undergoing different upper gastrointestinal, liver and pancreatic surgeries. Eight trials incorporated more than one element of the enhanced recovery protocol. All of the trials were at high risk of bias. The overall quality of evidence was low or very low.
None of the trials reported long-term mortality, medium-term health-related quality of life(three months to one year), time to return to normal activity, or time to return to work. The difference between the enhanced recovery protocol and standard care were imprecise for short-term mortality (enhanced recovery protocol: 4/425 (adjusted proportion = 0.6%); standard care: 1/443 (0.2%); seven trials; 868 participants; RR 2.79; 95% CI 0.44 to 17.73; very low quality evidence), proportion of people with serious adverse events (enhanced recovery protocol: 4/157 (adjusted proportion = 0.6%); standard care: 0/184 (0.0%); two trials; 341 participants; RR 5.57; 95% CI 0.68 to 45.89; very low quality evidence), number of serious adverse events (enhanced recovery protocol: 34/421 (8 per 100 participants); standard care: 46/438 (11 per 100 participants); seven trials; 859 participants; rate ratio 0.72; 95% CI 0.45 to 1.13; very low quality evidence), health-related quality of life (four trials; 373 participants; SMD 0.29; 95% CI -0.04 to 0.62; very low quality evidence) and hospital readmissions (enhanced recovery protocol: 14/355 (adjusted proportion = 3.3%); standard care: 9/378 (2.4%); seven trials; 733 participants; RR 1.4; 95% CI 0.69 to 2.87; very low quality evidence). The enhanced recovery protocol group had a lower proportion of people with mild adverse events (enhanced recovery protocol: 31/254 (adjusted proportion = 10.9%); standard care: 51/271 (18.8%); four trials; 525 participants; RR 0.58; 95% CI 0.39 to 0.85; low quality evidence), fewer number of mild adverse events (enhanced recovery protocol: 69/499 (13 per 100 participants); standard care: 128/515 (25 per 100 participants); nine trials; 1014 participants; rate ratio 0.52; 95% CI 0.39 to 0.70; low quality evidence), shorter length of hospital stay (nine trials; 1014 participants; MD -2.19 days; 95% CI -2.53 to -1.85; low quality evidence) and lower costs (four trials; 282 participants; MD USD -6300; 95% CI -8400 to -4200; low quality evidence) than standard care group.