Clinical Practice Guidelines for Enhanced Recovery After Colon and Rectal Surgery From the American Society of Colon and Rectal Surgeons and Society of American Gastrointestinal and Endoscopic Surgeons

This clinical practice guideline represents a collaborative effort between the American Society of Colon and Rectal Surgeons (ASCRS) and the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). The ASCRS Clinical Practice Guidelines Committee is composed of society members who are chosen because they have demonstrated expertise in the specialty of colon and rectal surgery. In a collaborative effort, the ASCRS Clinical Practice Guidelines Committee and members of the SAGES Surgical Multimodal Accelerated Recovery Trajectory Enhanced Recovery Task Force and Guidelines Committee have joined together to produce this guideline, written and approved by both societies. The combined ASCRS/SAGES panel worked together to develop the statements in this guideline and approved these final recommendations. Through this effort, the ASCRS and SAGES continue their dedication to ensuring high-quality perioperative patient care. Previous guidelines on perioperative care for colon1 and rectal2 surgery included studies identified up to January 2012 with significant literature published since then. The combined ASCRS/SAGES committee was created to define current best-quality care for enhanced recovery after colon and rectal surgery. This clinical practice guideline is based on the best available evidence. These guidelines are inclusive and not prescriptive. Their purpose is to provide information on which decisions can be made rather than to dictate a specific form of treatment. These guidelines are intended for the use of all practitioners, healthcare workers, and patients who desire information about the management of the conditions addressed by the topics covered in these guidelines. It should be recognized that these guidelines should not be deemed inclusive of all proper methods of care or exclusive of methods of care reasonably directed toward obtaining the same results. The ultimate judgment regarding the propriety of any specific procedure must be made by the physician in light of all of the circumstances presented by the individual patient. STATEMENT OF THE PROBLEM Contemporary colorectal surgery is often associated with long length of stay (8 days for open surgery and 5 days for laparoscopic surgery),3 high cost,3 and rates of surgical site infection approaching 20%.4 During the hospital stay for elective colorectal surgery, the incidence of perioperative nausea and vomiting (PONV) may be as high as 80% in patients with certain risk factors.5 After discharge from colorectal surgery, readmission rates have been noted as high as 35.4%.6 An enhanced recovery protocol (ERP) is a set of standardized perioperative procedures and practices that is applied to all patients undergoing a given elective surgery. In general, these protocols are not intended for emergent cases, but components of them certainly could apply to the emergent/urgent patient. Also known as fast-track protocols or enhanced recovery after surgery (ERAS)1 protocols, the content of these specific protocols may vary significantly, but all are designed as a means to improve patient outcomes. Outcomes of interest to patients and providers include freedom from nausea, freedom from pain at rest, early return of bowel function, improved wound healing, and early hospital discharge.7 Although numerous perioperative protocols currently exist, this clinical practice guideline will evaluate the strength of evidence in support of measures to improve patient recovery after elective colon and rectal resections. A 2011 Cochrane review found that ERPs were associated with a reduction in overall complications and length of stay when compared with conventional perioperative patient management.8 Subsequent studies have shown that ERPs are associated with reduced healthcare costs and improved patient satisfaction.4 ERPs are also associated with improved outcomes regardless of whether patients undergo laparoscopic or open surgery.9 Studies have also shown that ERPs cannot simply be implemented and forgotten but require a continued audit process in place to guide compliance and to continue to improve quality.10–13 There are many different preoperative, intraoperative, and postoperative components in a typical ERP, and it is difficult to identify which are the most beneficial components of the bundle of measures, because they are generally all implemented simultaneously. However, one retrospective review of 8 years of compliance with an ERP identified these items as the strongest predictors of shorter length of stay: no nasogastric tube, early mobilization, early oral nutrition (early discontinuance of intravenous fluids), early removal of epidural, early removal of urinary catheter, and nonopioid analgesia.10 This clinical practice guideline will evaluate the evidence behind ERPs for colorectal surgery. METHODOLOGY Members of the SAGES and ASCRS Practice Guidelines Committee worked in joint production of these guidelines from inception to final publication. Final recommendations were approved by each society’s committee and executive council. These guidelines were built following a standardized algorithm for the creation of all of our clinical practice guidelines, which included: search for existing guidelines, formulation of key questions, a systematic review of the literature, selection and appraisal of the quality of the evidence, development of clear recommendations, and drafting of the guideline. The details of specific search strategies, including search terms, inclusion criteria, exclusion criteria, total number of studies identified, and tables of evidence for each statement, are available in the supplements, but all of the search strategies involved an organized search of MEDLINE, PubMed, EMBASE and the Cochrane Database of Collected Reviews using a variety of key word combinations (for details on key words and search strategies see https://tinyurl.com/CPG-Suppl-Tables). Systematic searches were conducted from 1990 to 2016 and were restricted to English-language articles. Directed searches of the embedded references from the primary articles were also performed in certain circumstances. Prospective randomized controlled trials (RCTs) and meta-analyses were given preference in developing these guidelines. After all of the searches were complete, a total of 12,483 citations had been identified for title/abstract review, and 764 of those articles were selected for extensive review and placed into evidence tables with ranking of the evidence based on quality of the research by 2 independent reviewers (see Tables S1–S14, https://tinyurl.com/CPG-Suppl-Tables). The final grade of recommendation was performed using the modified Grading of Recommendations, Assessment, Development, and Evaluation system outlined previously by the American College of Chest Physicians (Table 1).14 Previous guidelines on perioperative care for colon1 and rectal2 surgery included studies identified up to January 2012, with significant literature published since then.TABLE 1.: The Grading of Recommendations, Assessment, Development, and Evaluation system-grading recommendations14PREOPERATIVE INTERVENTIONS A. Preadmission Counseling 1. A preoperative discussion of milestones and discharge criteria should typically be performed with the patient before surgery. Grade of recommendation: strong recommendation based on low-quality evidence, 1C. Standardized discharge criteria for patients undergoing colorectal surgery have been defined previously in an international consensus statement, which states that patients are fit for discharge when there is tolerance of oral intake, recovery of lower GI function, adequate pain control with oral analgesia, ability to mobilize, ability to perform self care, no evidence of complications or untreated medical problems, adequate postdischarge support, and patient willingness to leave the hospital.15 Although there are few studies that look solely at the impact of preadmission counseling regarding milestones and defined discharge criteria, these concepts are a well-established cornerstone of ERPs.1,16–21 Several single-center case series,4,22–34 prospective cohort studies,35 systematic reviews,36,37 and RCTs38–41 have supported the benefits of an ERP that includes defined discharge criteria on reducing hospital length of stay. Furthermore, compliance with an ERP that includes preoperative patient education and defined discharge criteria has been shown in prospective trials and national audits to be inversely associated with length of stay and complication rates.10,42–46 The time to meeting the defined discharge criteria (time to readiness for discharge) has been proposed as a measure of short-term recovery.47 However, there are discrepancies between the time when patients are meeting defined discharge criteria and actually being discharged, with a reported 1 to 2 days of additional length of stay despite high ERP compliance.48,49 2. Ileostomy education, marking, and counseling on dehydration avoidance should be included in the preoperative setting. Grade of recommendation: strong recommendation based on moderate-quality evidence, 1B. The creation of an ostomy is an independent risk factor for a prolonged length of stay after colorectal surgery.21,50–53 The benefit of structured patient stoma education to significantly improve quality of life and psychosocial adjustment, reduce hospital length of stay, and reduce hospital costs has been affirmed in several single-center and multicenter studies, as well as a systematic review.54,55 Stoma education in general is beneficial before discharge, but a randomized trial demonstrated that patient education was most effective if undertaken in the preoperative period.50 Case–control, registry, retrospective, and prospective descriptive studies have shown that preoperative evaluation by an enterostomal therapist (including marking of the skin site and patient education) was associated with significantly improved postoperative quality of life, reduced rates of postoperative complications, and improved patient independence regardless of stoma type.56–61 Retrospective and prospective studies have confirmed the benefit of preoperative stoma education, specifically within an ERP.56,62 Counseling on dehydration avoidance is an important element of ERPs. Dehydration has been shown to be the most common cause of readmission after ileostomy creation, ranging from 40% to 43% of readmissions.63,64 By implementing an ileostomy pathway in which patients were directly engaged in ostomy management and avoiding dehydration within an enhanced recovery pathway, Nagle et al6 reduced overall readmissions from 35.4% to 21.4% and readmissions for dehydration from 15.5% to 0%. Stoma education, including dehydration avoidance, within a perioperative care pathway has been included in a systematic and expert review of process measures to reduce postoperative readmission.65 B. Preadmission Nutrition and Bowel Preparation 1. A clear liquid diet may be continued <2 hours before general anesthesia. Grade of recommendation: strong recommendation based on high-quality evidence, 1A. Patients should be encouraged to drink clear fluids <2 hours before the induction of anesthesia, because it has been shown to be safe and to improve patients’ sense of well-being.66 Since 1986, multiple randomized controlled clinical trials67–74 have supported the ingestion of clear liquids <2 hours before elective surgery. These studies have shown that ingestion of clear liquids within 2 to 4 hours of surgery versus >4 hours is associated with smaller gastric volume and higher gastric pH at the time of surgery. The current practice guidelines of the ASA66 and European Society of Anaesthesiology support this recommendation.75 2. Carbohydrate loading should be encouraged before surgery in nondiabetic patients. Grade of recommendation: weak recommendation based on moderate quality evidence, 2B. The use of preoperative carbohydrate-rich beverages should be encouraged, with the purpose to attenuate insulin resistance induced by surgery and starvation.76 A Cochrane review in 201476 identified 27 trials conducted in Europe, China, Brazil, Canada, and New Zealand, involving 1976 participants. Most beverages contained complex carbohydrates (eg, maltodextrin), as opposed to the monosaccharides (eg, fructose) or disaccharides (eg, sucrose) found in fruit juice or sports drinks. The conclusion of the review was that carbohydrate treatment was associated with a small reduction in the length of hospital stay when compared with placebo or fasting in adult patients undergoing elective surgery. Preoperative carbohydrate loading was not associated with increased or decreased perioperative complications when compared with placebo or fasting. Several studies were susceptible to bias because of a lack of blinding. A meta-analysis of 21 randomized studies including 1685 patients showed no overall difference in length of stay across all of the included studies; however, when considering the subgroup of patients undergoing major abdominal surgery, there was a benefit in terms of length of stay.77 A network meta-analysis of 43 trials evaluated whether the dose of carbohydrate was influential and found that both low and high doses of carbohydrate before surgery improved length of stay when compared with fasting.78 However, when compared with water or placebo, carbohydrate loading did not show a benefit in the length of stay. Carbohydrate loading failed to influence the rate of complications regardless of the dose or comparator group. Based on this most recent analysis, allowing clear liquids before surgery may provide similar clinical results as formal carbohydrate loading. 3. Mechanical bowel preparation plus oral antibiotic bowel preparation before colorectal surgery is the preferred preparation and is associated with reduced complication rates. Grade of recommendation: weak recommendation based on moderate-quality evidence, 2B. A 2013 guideline1 for perioperative care in elective colonic surgery stated that mechanical bowel preparation (MBP) should not be used routinely in colonic surgery based on the distress it causes patients, and a 2011 Cochrane review79 showed no benefit to MBP in randomized trials. However, recent evidence regarding the addition of oral antibiotic preparation (OBP) to MBP should be taken into account. Although there appear to be no meaningful benefits of MBP alone in terms of complications, a meta-analysis of seven RCTs (1769 patients) comparing MBP with OBP versus MBP alone showed a reduction in total surgical site infection and incisional site infection, with no difference in the rate of organ/space infection after elective colorectal surgery.80 These trial findings are consistent with population-level data. In a retrospective analysis of a large nationwide database in the United States, MBP plus OBP in left colonic resection was associated with decreased overall morbidity, superficial surgical site infection, anastomotic leakage, and intra-abdominal infections.81 Similar retrospective studies in different populations (Veterans Administration database82 and a large Polish hospital database83) showed a reduction in surgical site infection with the addition of OBP to MBP. The Michigan Surgical Quality Collaborative database showed a reduction in surgical site infection and a reduction in postoperative Clostridium difficile colitis in patients who received MBP with OBP versus patients who received no bowel preparation.84 When OBP was added as part of a larger perioperative care bundle at Duke University, a significant drop in surgical site infection was seen.85 C. Preadmission Optimization 1. Prehabilitation before elective surgery may be considered for patients undergoing elective colorectal surgery with multiple comorbidities or significant deconditioning. Grade of recommendation: weak recommendation based on moderate-quality evidence, 2B. Prehabilitation, defined as enhancement of the preoperative condition of a patient, has been proposed as a possible strategy for improving postoperative outcomes.86 Prehabilitation aims to augment functional (exercise) capacity before a surgical procedure with the intent to minimize the postoperative morbidity and accelerate postsurgical recovery.87,88 The quality of existing data is poor. Several systematic reviews were performed, using both controlled and noncontrolled data.86,89–98 These studies were of moderate to poor methodologic quality. Some of these meta-analyses and RCTs reported on the effects of exercise training only in patients who had completed colorectal cancer treatment, not prehabilitation.91–94 The applicable studies inconsistently showed physical improvement with prehabilitation. Meta-analyses including diverse patient populations had conflicting evidence for the effect of prehabilitation on function, quality of life, length of stay, and pain.89,97,98 Studies focusing on colorectal and abdominal oncologic surgery were highly heterogeneous in terms of exercise interventions studied, duration, outcome measures, follow-up period of the interventions, and compliance rates with these programs, which limited the power of comparisons and the ability to draw conclusions.99–106 However, these studies did support the feasibility of prehabilitation to improve or preserve physical function before surgery. There were additional retrospective reviews, observational and case–control studies, and longitudinal analyses that reported improvement in physical function, peak exercise capacity, mental health, vitality, self-perceived health, and quality of life with prehabilitation.101,105–111 Patients at lower baseline functional capacity may have the most to gain with prehabilitation.106 However, inherent biases in the study design, lack of control group or randomization of participants, small sample sizes, wide variances in compliance with protocols, and limited generalizability limited these studies. When looking at postoperative quality outcomes, small, single-center studies report no differences in postoperative complication rates and hospital length of stay with prehabilitation compared with control subjects or postoperative rehabilitation103,106,109 or results have been discordant.100,109 D. Preadmission Orders 1. Preset orders should be used as a part of the enhanced care pathway. Grade of recommendation: weak recommendation based on low-quality evidence, 2C ERPs are complex and require collaboration between many different stakeholders to ensure the optimal care of the surgical patient. Common to all of these protocols are preset orders, which include preoperative, intraoperative, and postoperative sections that standardize care between all surgeons and for all patients. The current number of elements has not yet been clearly elucidated, but all of the randomized studies comparing enhanced recovery versus conventional care have included preset order sets as part of the pathway. However, it is not merely the presence of standardized order sets that contribute to improved outcomes, because a study by Li et al112 reported improved outcomes for patients undergoing esophagectomy who were managed by enhanced recovery compared with a conventional care group that already included standardized preset orders. Complete protocol implementation is recommended over piecemeal implementation.113 The presence of standardized orders within an ERP is not enough to ensure optimal outcomes. Maessen et al48 demonstrated in a multi-institutional study that adherence to protocol elements was high in the preoperative and intraoperative phases but low postoperation. Patients met predefined recovery criteria at a median of 3 days, but median length of stay was 5 days. Only 31% of patients in that study were discharged on functional recovery, and institutions that had long-standing ERPs were more likely to delay discharge. A larger multi-institutional collaborative from the ERAS Society reported that patients with <50% protocol compliance experienced longer length of stay and more complications than patients with ≥75% compliance throughout all of the perioperative phases.114 A national clinical audit reported that compliance with an ERP was weakly associated with shorter length of stay.46 However, this has not been an unequivocal finding, because a single-center retrospective study reported decreased ERP compliance in routine clinical practice compared to within a randomized clinical trial, yet the study did not demonstrate any differences in length of stay, complications, or mortality between the 2 groups.115 PERIOPERATIVE INTERVENTIONS A. Surgical Site Infection 1. A bundle of measures should be in place to reduce surgical site infection. Grade of recommendation: strong recommendation based on moderate-quality evidence, 1B. A care bundle is a small set of evidence-based practices that have been proven to improve patient outcomes. In 2014, Keenan et al85 reported a reduction in superficial surgical site infections (SSIs) from 19.3% to 5.7% after implementation of a preventative SSI bundle. Preoperative measures included a chlorhexidine shower, MBP with oral antibiotics, ertapenem within 1 hour of incision, and standardization of preparation of the surgical field with chlorhexidine. Operative measures included use of a wound protector, gown and glove change before fascial closure, use of a dedicated wound closure tray, and limited operating room traffic. Postoperative measures included removal of the sterile dressing within 48 hours and daily washings of the incision with chlorhexidine. Patient education, euglycemia maintenance, and perioperative maintenance of normothermia were also components of the bundle. No significant difference was observed in deep SSIs and organ-space SSIs. A recent systematic review and cohort meta-analysis including 16 studies concluded that use of an evidence-based, surgical care bundle for patients undergoing colorectal surgery significantly reduced the risk of SSI (7.0% in bundle group vs 15.1% in the standard care group). Although none of the studies in this analysis used the identical SSI care bundles, all included elements from a core group of interventions, including appropriate antibiotic prophylaxis, normothermia, appropriate hair removal, and glycemic control for hyperglycemic patients.116 Other measures that have been included in SSI bundles are a reduction in intraoperative intravenous fluid use, supplemental oxygen, double gloving, smoking cessation, MBP omission, Penrose drains for high BMI, pulse lavage of subcutaneous tissue, and silver dressings for 5 days postoperation. Bundles vary between different protocols, and the degree to which each plays a role in reducing SSI remains difficult to determine. B. Pain Control 1. A multimodal, opioid-sparing, pain management plan should be used and implemented before the induction of anesthesia. Grade of recommendation: strong recommendation based on moderate-quality evidence, 1B. Multiple prospective studies have demonstrated that minimizing opioids is associated with earlier return of bowel function and shorter length of stay.4,10,41,117 One of the simplest techniques to limit opioid intake is to schedule narcotic alternatives, such as oral acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), and gabapentin, rather than giving them on an as-needed basis.38 The scheduled use of nonselective or selective NSAIDs (and cyclooxygenase 2 inhibitors),118 when not contraindicated, and of acetaminophen119–121 (by mouth or intravenously) have been shown to improve postoperative analgesia and reduce systemic opioid consumption and some of their dose-dependent adverse effects120,122–125 that have been shown to delay surgical recovery.126 Experimental and observational clinical studies have shown that NSAIDs may increase the risk of anastomotic leakage127–132; however, one recent meta-analysis demonstrated that, in patients receiving ≥1 dose of NSAIDs in the first 48 hours after surgery, the risk of anastomotic leakage was not significantly increased.133 This potential effect on leak rates appears to be molecule131 and class specific132 and more pronounced in patients receiving NSAIDs for a period >3 days after surgery. Another recent meta-analysis has demonstrated a higher risk of anastomotic leakage exclusively in patients undergoing emergency but not elective colorectal surgery (OR = 1.70 (95% CI, 1.11–2.68)).130 The evidence is inconclusive and does not support the avoidance of NSAIDs in patients with low cardiovascular risk.134,135 Systemic perioperative gabapentinoids,136 ketamine,137,138 and α2-agonists139–141 have also been administered to improve analgesia and reduce systemic opioid consumption and postoperative hyperalgesia, but psychotropic adverse effects,142 dizziness, and sedation may impair immediate recovery. Moreover, the optimal gabapentinoids regimen (dose, timing, and duration of administration) still needs to be determined. High doses of systemic steroids have also been shown to attenuate systemic inflammatory response and improve pulmonary function and postoperative analgesia without increasing the risk of wound dehiscence or infection.143–146 However, additional safety data are needed. Wound infiltration and abdominal trunk blocks with liposomal bupivacaine have shown promising results in patients undergoing open and laparoscopic colorectal surgery.147–150 In addition, limited data demonstrate that the transversus abdominis plane (TAP) block with a local anesthetic has been associated with decreased length of stay compared with systemic opioids in laparoscopic colorectal surgery.151 TAP blocks performed before surgery appear to provide better analgesia than TAP blocks performed at the end.152 Although many centers start a multimodal analgesic regimen preoperatively, the efficacy of preemptive analgesia remains controversial153–158 and mainly limited to epidural blockade and TAP blocks.152,159–161 2. Thoracic epidural analgesia is recommended for open colorectal surgery, but not for routine use in laparoscopic colorectal surgery. Recommendation: strong recommendation based on moderate-quality evidence, 1B. Although thoracic epidural analgesia (TEA; T6–T12) is considered the gold standard (versus patient controlled analgesia or simple parenteral opioids) to control pain in patients undergoing open colorectal surgery,162,163 the modest analgesic benefits provided by TEA do not support a faster recovery in laparoscopic surgery. Trials and meta-analyses have shown that TEA has no impact on164,165 or may even delay166 hospital discharge in laparoscopic surgery. This delay is probably related to the higher incidence of hypotension and urinary tract infections requiring additional postoperative care.164–168 TEA might still be valuable in patients at high risk of pulmonary complications,169 in whom postoperative pain management could be challenging (eg, patients chronically using opioids), with a high risk of conversion to midline laparotomy.170 When an epidural is used, an infusion of a mixture of a small dose of local anesthetic and lipophilic opioids has been shown to provide better analgesia than an epidural infusion of local anesthetic or opioids alone.162,163,171 Epidural hydrophilic opioid combined with small doses of local anesthetic can provide better analgesia for long midline incisions.172 The addition of adjuvants such as epidural adrenaline173–175 or clonidine160,161,176 can be considered to improve segmental analgesia and reduce certain opioid adverse effects. Because epidural failure rates have been reported ranging from 22% to 32%,177,178 alternative methods to increase the specificity of the conventional loss-of-resistance technique (ie, method of placement used to identify the epidural space), such as neurostimulation and waveform analysis, can be used to increase the success rate of epidural blocks.177–190 C. Perioperative Nausea and Vomiting 1. Antiemetic prophylaxis should be guided by preoperative screening for risk factors for postoperative nausea/vomiting. Grade of recommendation: strong recommendation based on moderate-quality evidence, 2B. The incidence of postoperative nausea and vomiting (PONV) across all of the patients in a postanesthesia care unit is ≈30%,181 whereas patients with documented risk factors for PONV may have an incidence of PONV as high as 80%.5 PONV increases hospital costs and significantly reduces patient satisfaction.182 Control of PONV has been shown to significantly improve patient satisfaction.183 One existing guideline supports preoperative risk assessment of all patients undergoing anesthesia and subsequent tailored multimodal therapy to prevent and treat PONV184; however, the most recent practice guideline from the ASA does not address risk assessment.185 Several validated scoring systems have been developed to help identify patients at high risk for PONV.186 Although preoperative assessment of PONV and prevention makes intuitive sense, some experts argue for the liberal use of a multimodal antiemetic protocol for all patients (regardless of risk), because antiemetics tend to be low cost and low risk.187 A recent single-center, cluster-randomized trial of 12,032 elective surgical patients showed that the simple implementation of a PONV prediction model (without specific recommendations for antiemetic prophylaxis) did not reduce the PONV incidence despite increased antiemetic prescriptions in high-risk patients.188 However, a prospective study by the same group in which risk assessment was combined with a specific recommendation for antiemetic intervention showed a significant reduction in PONV in all patients, with an even greater reduction in high-risk patients.189 A significant reduction in PONV has been seen with this type of strategy (pairing risk assessment with a specific antiemetic strategy recommendation) in sever