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    Evidence-Based Decision Making in Colon and Rectal Surgery Naja N. Mahmoud | Emily Carter Paulson Videncebase surgical practices rapidly becoming Fearne i gain atin pie idence based care n colorectal surgery are imnense and diese, and many have been covered tn other chapters ofthis textbook. Tn the felon page we atenpe to highlight aess of interest coloectal Shrgery ne preity conred that inte evidenced Gaol the coloreeal surgery patton ENHANCED RECOVERY PATHWAYS. Daring the past decade, there has been much interest in postoperative recovery pathways designed to stream Ind codify postoperative care following a variety of pro- cedures. Although these protocols differ from hospital to hospital, there are basic elements that are included in most enhanced recovery pathways (ERPs) (Table 1S1.1)." ‘The most common elements inclade preoperative counse- ing, avoidance of bowel preparation (see discussion later), no preoperative fasting, opioid-sparing analgesia and midthoracie epidurals, antibiotic prophytaxs, short incl sions, no nasogastric tubes, normothermia, operative and postoperative fluid restrictions, no abdominal drains ora {ict at wil, and early mobilization, ‘An early review by Wind et al published in 2006, included shx studies, three randomized controlled trials (RCTS), and three single-arm controlled clinical trials, published between 1998 and 2005.” These were single- Institution studies, and the number of ERP elements included ranged from 4to 12, though all studies included early mobilization and diet. In five of sx studies hospital, stay was significantly shorter in the FRP patients, and in pooled analysis the ERP patients had a hospital stay almost 2 days shorter than patients ina traditional pathway (TP). There was no difference seen in the rate of readmissions One study reported significantly lower morbidity in the ERP group, especially cardiovascular and pulmonary complications. In pooled analysis, this trend was also observed. There was no difference seen in rates of anas- tomotic leakage or moriaty. Postoperative ileus (POT), measured by time (o first bowel movement (BM) and tolerance ofa solid diet, was reduced in the ERP group. ‘There were mixed results regarding the outcomes of pain and fatigue, with some studies reporting no difference ietween ERP and TP groups, whereas others reported increased pain and fatigue in the TP group compared with the ERP group, These authors concluded that ERP programs result in improved recovery after surgery with {reduction in morbidity rates and hospital stay: These findings were confirmed by a review published in 2009, by Gots etal, which evaluated 11 studies-—four RCTS Downend fx VIVEK GOEL (vine goorisealbee cm) st Fut Heath Mi CHAPTER 181 and seven controlled clinical trialscomparing ERP with TP’ These authors conclude that ERPs contribute to a quicker recovery of patients after colorectal surgery and result in lower morbidity and shorter hospital stays ‘Two more recent metasanalyses have further examined the impact of ERPS in colorectal surgery. In 2013 Zhuang et al. analyzed 13 studies (1910 patients) comparing ERP with TP’ The mean number of enhanced recovery after surgery (ERAS) elements incorporated in each study was 11. The ERPs were associated with significantly decreased. length of primary stay (-24 days; P< 001), total days in hospital (including readmission, ~2.89 days; P< .001), and overall complications (relative risk [RR] = 0.68; P= 0006). There were no differences noted in readmission rates, surgerspecific complications, or mortality In 2014 Greco et al. performed a meta-analysis of 16 RCTs that included 2876 patients. In 11 of the 16 studies, at least 10 ERP elements were included in the ERPs; the most common elements included early postoperative feeding and mobilization, no postoperative nasogastric tube, epidural analgesia, and no preoperative fasting ‘Their analysis demonstrated a reduction in overall morbid- ity (RR = 0.60, 95% confidence interval [CI], 0.46 to 0.70) and length of stay (-2.28 days; 95% CI, ~8.09 to -1.47 days) associated with ERP. “Although the individual elements differ among studies, the existing evidence is robust that a codified ERP can reduce length of stay and morbidity following colorectal surgery. Interestingly, many of the early studies in ERP were performed when open surgery was more common. The benefit associated with ERPs has been questioned in the setting of laparoscopic procedures, which are becoming increasingly common. Several studies have addressed this specific question. In 2011, Viug et al. randomized 427 patients into four treatment arms—open colectomy with TP, open colectomy with ERP, laparoscopic colectomy with TP, and laparoscopic colectomy with ERP. The shortest length of primary hospital stay (median, 5 days) was noted in the laparoscopic/ERP group. In the laparoscopic/TP group, median length of stay was 6 days (P< 001). A similar and significant difference was noted {or total hospital stay (including readmission days). These authors concluded that optimal treatment for colorectal patients is laparoscopy in conjunction with ERP. In 2012 Haverkamp et al. compared ERP and TP in 186 patients undergoing only laparoscopic colectomies.” The median length of stay in the ERP cohort was 4 days compared with 6 days for the TP patients (P= .007). Return to bowel function was noted 1 day earlier in the ERP group (2 vs. 8 days; P< 001), No diflerences were noted in postoperative complications, readmission, or 2185 Ll om Cia com by Eero Mach 18,2018. Pe potoal ue Gay No aber as wibourpeucane, Capyig O20 Elvi ln Alehoveed Edence- Based Decision Making in Clon and Rectal Surgery CHAPTER 181 2185.01 KEYWORDS Enhanced recovery pathway, antibiotic prophylaxis, venous thromboembolism prophylaxis, mechanical bowel preparation Dewan fr VIVEK GOEL (ine poooibenlbae cm) a Fes Health Maszemcnt Noh lm CieaKy com by Eero Mach 16,2018. Pe potoal ue Gay No aber as wibourpeucane, Capyig O20 Elvi ln Alehoveed 2186 SECTION IV coin, Rectum, and Aras TABLE 181.1 Components of a Standard Enhanced Recovery Pathway for Colorectal Surgery Enhanced Recovery Pathway Components Level of Evidence Preoperative counseling Grade B Preoperative feeding—minimizaton of Grade A tasting Synbioties Not discussed in No bowel preparation Grade A No premedication Grade A Fluid restriction Grade A Perioperative high O, concentrations Not discussed in ‘Active prevertion of hypothermia Grade A Epicural analgesia Grade A Minimaly invasivertransverse incisions Grade 8 No routine use of nasogastric tubes. Grade A No use of drains above peritoneal Grade A rellecton Enforced postoperative mobilization Grade 8 Enforced early postoperative feeding Grade A Balanced analgesia—multimadal, low/ Grade A ro opioids ‘Standard laxatives and antiemetics Grade 8 Early removal of urinary catheter Not discussed in ‘Grade A, Based on at eat two good-qually randomized conrosed Wak (RCTs) or one meta-analysis of RCTs with Momogene'y: Grade 8, {genau recommendation based onthe bat ave evicenoe, “Level of etigence ftom Lassen K. Soop M, Nygren J, etal. Consensus revlew of optimal perloperative care i colorectal surgery: Enhanced Recovery After Surgery ERAS) Group recommendations. Arch Surg. 200814410}: 961-260. mortality. Again, these authors conclude that ERPs are beneficial even in the setting of laparoscopic approaches to resection. In 2014 Kennedy et al. reported the results of the EnRol (ENhanced Recovery Open versus Laparoscopic) tial, an RCT of 204 patients randomized to either open surgery or laparoscopic resection within an ERP’ There was no difference in the primary outcome, physical fatigue at L-month postoperatively, between the «wo groups, nor was there any diflerence in complications or other patient reported outcomes, The total hospital stay was significantly shorter in the laparoscopy cohort (median, 5 days vs. 7 days; P=.083). Based on these results, the authors conclude dat, within an ERP, laparoscopy can significantly reduce length of hospital stay. Finally, two meta-analyses published in 2015 attempted to clarify overlapping benefits of laparoscopy and ERP. ‘Zhuang et al. analyzed five RCTs, including 598 patients, to look at the benefit of laparoscopy when all patients are enrolled in an ERP” The authors noted that the overall, quality of existing evidence was low to moderate, with, several of the included trials using suboptimal ERPs. They concluded that total hospital stay following laparoscopic resection in the setting of an ERP was reduced compared with open resection but that more robust evidence is needed to wuly prove that laparoscopy provides other benefits in the setting of optimal ERPs, Spanjersberg et al, analyzed three RGTS and six con- trolled clinical trials in'an attempt to answer two questions: (1) docs laparoscopy offer benefit within an ERP, and (2) does ERP offer an advantage when all patients get laparoscopic resection.” In the laparoscopic patients, the length of stay was shorter in patients enrolled in an ERP (-23 days; P= 001). In the ERP patients, postoperative morbidity was lower in the laparoscopic group than the ‘open ([odds ratio] OR = 0.42; P= .006). As with the previously mentioned review, the quality of the included. studies was graded to be moderate to poor. Despite this, the authors conclude that both ERP and laparoseopy are associated with independent benefit but that better designed ials are needed to more definitively answer these questions Overall, there has been a great deal of effort put into designing ERPs based on the best evidence available. In ‘general, there are elements supported by extremely strong ‘evidence, such as earl initiation of diet and mobilization, and antibiotic prophylaxis (see discussion later), whereas ‘other elements are less well supported. In 2009 the ERAS Group published a consensus review of optimal periopera- tive care in colorectal surger:' They reviewed the evidence for and made recommendations about 20 ERP elements Again, although the evidence is not robust forall elements, this remains a good summary of the most common ele- ments of standard ERPs for colorectal surgery. A more recent set of guidelines drew from these recommendations and was reviewed in 2013 by Gustafsson et al., as part of the ERAS Society. The strength of recommendations ranged from low to high for individual elements of the pathway. Although adherence to all elements is difficult and requires multidisciplinary coordination in the peri- ‘operative period, there is evidence to suggest that increas- ing compliance with ERPs is associated with reduced hospital stays and possibly, fewer complications (ERAS. Compliance Group). In the 2013 review the authors concluded that there was high-quality evidence that ERPs result in shorter length of hospital stay following colorectal resections. However, the existing evidence suggesting that ERPs result in fewer complications and hospital readmis- sion was deemed to be lov: MECHANICAL BOWEL PREPARATION “Mechanical bowel preparation before elective colorectal resection remains a common practice among general and colorectal surgeons. However, is use over the past decade has been decreasing, primarily in response to many RCTs and meta-analyses that have not only failed to show a benefit to mechanical bowel preparation but also have demonstrated an increase in complications following bowel preparation. ‘Two of the earliest RCTS to examine this issue were performed in 1994 by Burke et al. and Santos et al." In both of these studies the authors concluded that bowel prepasation does not influence outcome alter elective Colorectal surgery: Since that time, continued controversy lover the use of bowel preparation has spawned several more RGIS bn 2007 PenaSoria etal examined the relation- ship between bowel preparation and suzgical-site infection and anastomotic leak in 97 patients.” They found no Dewan fr VIVEK GOEL (ine poooibenlbae cm) a Fes Health Maszemcnt Noh lm CieaKy com by Eero Mach 16,2018. Pe potoal ue Gay No aber as wibourpeucane, Capyig O20 Elvi ln Alehoveed Edence-Based Decision Making in Clon end Rectal Surgery CHAPTER 181 2187 difference in surgical site infection between the two groups, but a higher rate of anastomotic dehiscence in the non prepped group (8.3% vs. 4.1%; P=.05). The largest RCT examining this question was published in 2007 by Contant etal. and included more than 1400 patients at 13 hospi- tals." Patients were consented to receive either no bowel preparation, which included a regular diet the day before surgery versus a bowel preparation of either polyethylene glycol or sodium phosphate and a clear liquid diet the day before surgery. In this study the rate of anastomotic leak, 4.8% in patients who received bowel prep and 5.4% in patients who did not, did not differ significantly between groups (P= .69). Patients who had mechanical bowel preparation did have fewer abscesses after anastomotic Teak than those who did not (0.3% vs. 2.5%; P= 001) Other complications, such as fascial dehiscence, superficial infection, and mortality, did not differ between groups. These authors concluded that mechanical bowel prepara- tion before clective colorectal surgery can safely be abandoned. Several studies supported these conclusions for left-sided colon and rectal resections as well.” Further buttressing the argument against mechanical bowel prep were multiple large meta-analyses synthesizing the results from the almost 20 years of tials examining this issue. In 2004, Slim et al analyzed the results of seven, randomized trials, including 1454 patients, comparing bowel preparation with no preparation in colorectal surgery.” They reported significantly higher rates of anastomotic leak alter bowel preparation (5.6% vs. 3.2% P= 032). All other end points (wound infection, other septic complications, and nonseptic complications) also favored the no-preparation regimen. In 2010 Zhu et al specifically analyzed five RCTs that compared mechanical bowel preparation with polyethylene glycol with no prepara- tion.” They found no significant differences in rates of surgical site infection, organ/space infection, mortality, or anastomotic leak between the groups. Finally, the largest and most thorough meta-analysis was published by Guenaga etal. in 2009. ’ These authors analyzed 13 RCTs, including. 4777 patients, comparing bowel preparation with no bowel preparation. They found that rates of anastomotic leakage, although slightly higher in the bowel preparation groups, were not significantly different following either low anterior rectal resections or colonic resections. Rates of secondary complications, such as wound infection and extraabdomi- nal complications, were not different between the two groups. They concluded that there was no statistically significant evidence that patients benefit from mechanical Dowel preparation. Based on this robust body of evidence, many surgeons began to reduce their use of bowel preparation prior to colorectal surgery. However, interestingly, new evidence is emerging that mechanical bowel preparation with oral antibiotic administration is beneficial prior to elective colorectal surgery. In almost all of the trials mentioned previously, oral antibioties were not included as part of the mechanical bowel preparation pathway. Many investiga- tors believe that the benefit from bowel preparation stems from the delivery of the oral antibiotics to the colon, lumen and mucosa, a process that is enhanced by the mechanical colon cleanse. In light of these concerns regarding the existing bowel preparation literature, a new series of studies have been published evaluating the efficacy of bowel preparations that include oral antibiotics. The results of these studies, which are discussed in more detail later, indicate that, although mechanical preparation alone may not be of benelit, mechanical preparation with oral antibiotics is beneficial in reducing surgical site infection and anastomotic leak following colorectal surgery In 2012 Cannon et al. evaluated almost 10,000 patients undergoing elective colorectal surgery within the Veterans Administration Health System. They compared patients receiving no bowel prep to those receiving mechanicalonly bowel prep, mechanical bowel prep plus oral antibiotics, or oral antibiotics alone. They reported that oral antibiotics plus mechanical bowel preparation was associated with 4.57% decrease in surgical site infection occurrence compared with no bowel prep (OR = 0.45; 95% CI, 0.34 t0 0.55 Following that study, in 2013 Toneva et al. reported on the association between oral antibiotic bowel preparation and length of stay and readmissions in a similar Veterans ‘Administration Health System cohort of 8140 patients.” They report that oral antibiotic bowel preparation was associated with a significantly reduced length of stay, a8 well as a significant reduction in the number of readmissions, due mostly to a reduction in readmission for infection. In 2014 Kim et al, used the Michigan Surgical Quality Collaborative data to examine almost 1000 pairs of patients undergoing elective colectomy who differed only by administration of bowel preparation.” The bowel prepara: tion group received mechanical bowel preparation with nonabsorbable oral antibioties, and the control group received no bowel prep. These authors found that patients receiving lull preparation were less likely to have any surgical site infection (5.0% vs. 9.7%; P=.0001), ongan/ space infection (1.6% vs. 3.1%; P=.024), and superficial surgical site infection (3.0% vs. 6.0%; P= .001). They were also less likely to develop postoperative Clostridium dificie colitis (0.5% vs. 1.8%; P= 01) In 2015 four retrospective studies using American College of Surgeons National Surgical Quality Impros ment Program-targeted colectomy data were published. Moghadamyeghaneh et al. reported on just more than 5000 patients undergoing elective colorectal resections between 2012-2013.” They reported no difference in postoperative morbidity between patients receiving no preparation and either mechanical preparation alone or oral antibiotic preparation alone, Multivariable analysis revealed that the combination of oral antibiotics and mechanical bowel preparation significantly reduced the risk of overall morbidity (OR = 0.63; P< 01), surgical site infection (OR=0.31; P<.01), and anastomotic disrup- tion (OR = 0.44; P< 01), especially following leftsided resections. Morris etal. examined 8145 patients undergo- ing elective colon and rectal resections.” They found that patients receiving oral antibiotics had significantly lower risk of surgical site infection than either those patients, receiving no bowel preparation or those receiving mechani- cal preparation only. This was consistent for both open and minimally invasive approaches and for both colon, and rectal resections. Searborough et al. reported on the outcome of almost 5000 patients undergoing elective colorectal resections.” Again, they found that patients " etn oly No th ss win peti. Copigt O2V18 lst nc Algal ierene 2188 SECTION IV. coin, Rectum, and Anus receiving oral antibiotics combined with mechanical preparation had the lowest rate of surgical site infection, anastomotic leak, and procedure-related readmission. “There was no difference noted among the no preparation, oral antibiotic alone preparation, or mechanical prepara- tion alone groups. Finally, Kiran et al. reported on 8442 patients undergoing clective colorectal procedures.” After their multivariable analysis, mechanical bowel preparation with oral antibiotics was independently associated with reduced surgical site infection (OR = 0.40; 95% Cl, 0.31 to 0.53), anastomotic leak (OR = 0.57; 95% Cl, 0.35 to 0.94), and ileus (OR = 0.71, 95% CI, 0.56 to 0.90), All of these studies have countered the increasingly held belief that bowel preparation prior to elective colorectal surgery is not necessary and may be harmful Each of these provides retrospective evidence that oral antibiotic administration in combination with a mechanical bowel preparation can have significant beneficial effects for colorectal surgery patients, including decreased risks of wound infection, anastomotic leak, ileus, and readmis- sion. Based on this body of evidence, many providers are routinely using the combination of oral antibiotics and ‘mechanical bowel preparation for their colorectal surgery patients, Randomized controlled data would add to this ample body of retrospective data as the debate around the appropriate use of preoperative bowel preparation continues to evolve. ANTIBIOTIC PROPHYLAXIS Tehas long been recognized that antibiotic prophylaxis for patients undergoing surgery on the large intestine reduces the risk of postoperative wound infection. In 1981 Baum cecal. published the results of a metaanaljss evaluating a series of studies comparing the rate of wound infection in patients receiving antibiotic prophylaxis to patients receiving no prophylaxis.” They concluded that the risk ‘of wound infection was so diminished in the prophylaxis ‘group that, in the future, studies investigating prophylactic antibiotic use could not ethically include a no-treatment ‘group. Since that time, the use of preoperative antibiotics has become routine, but the choice of antibiotic, the timing of antibiotic dosing, and the use of postoperative therapy continues to dey easy standardization There have been hundreds of studies looking at the type of antibiotic used, the timing of antibiotic dosing, and the need for intraoperative redosing and postoperative dosing. These are too numerous to deseribe in detail in this text. Based on these innumerable studies, the current Glinical Practice Guidelines for Antimicrobial Prophylaxis in Surgery were published in 2013 as a collaboration between several infectious disease, surgical infection, pharmacy, and epidemiology societies." In addition, a recent, extensive metaanalsis, published in 2014, sought to distill the results of the RCTs into several coherent conclusions for the colorectal surgery population.” Avail- able evidence was combined and analyzed to address the need for prophylaxis, the spectrum of bacterial coverage needed, and the optimal timing and route of antibiotic administration Most surgeons, based on reviews of practice patterns, recognize that prophylactic antibiotic dosing is beneficial in patients undergoing large bowel surgery. This practice is clearly supported by a large body of evidence, including 10 placebo-controlled trials in the 1980s. The combined analysis ofthese trials indicates that prophylactic antibiotics reduce the wound infection rate from 39% to 10%, with all 10 wials individually finding a significant or neatly significant benefit in favor of prophylaxis. There is no debate that antibiotic prophylaxis is standard of care for elective clean-contaminated colorectal surgery procedures. Both the 2013 guidelines and the 2014 meta-analysis conclude that, for the majority of intravenous (IV) antibiot- ies, the optimal time for administration is within 60 minutes before surgical incision. However, the use of postoperative antibiotics and the need for intraoperative redosing is more controversial. In particular, many prescribe 24 hours Of postoperative prophylactic antibioties or favor redosing, of IV anubiotics during lengthy cases. Nelson’s metwanalysis evaluated 33 trials chat compared a single preoperative dose of antibiotics to longer duration of dosing. There ‘was no evidence that longer duration of antibiotic dosing reduced the risk of wound infection more than a single preoperative dose (RR = 1.10; CI, 9.93 to 1.30; P= .26) ‘These results are supported by the Clinical Practice Guidelines, which recommend stopping antibiotics when the procedure is completed and the incision is closed, The guidelines state that, at most, antibiotics should be continued for no more than 24 hours postoperatively Conflicting recommendations regarding intraoperative redosing of antibiotics also exist. In a 2014 meta-analysis, ‘Nelson et al. concluded based on a review of nine studies that evidence is lacking to support intraoperative redosing of antibiotics. This isin contradiction to several published studies and the 2013 practice guidelines. In a study by Morita et al. in 2005, wound infection was double in patients who underwent procedures greater than 4 hours and who did not get redosing of antibiotics compared to those patients who did receive a second intraoperative dose (P=.008).”” The 2013 Clinical Practice Guidelines, based on review of mukiple trials, recommends intra- operative redosing of the IV antibiotic if the length of the operation exceeds two halflives of the antibiotic or if there is excessive blood loss. The spectrum of antibiotics used for prophylaxis is another area in which practice patterns vary widely, However, there are many studies indicating that treatment with antibiotics covering both aerobic and anaerobic bacteria provides the greatest benefit in the reduction of postoperative wound infection. Based on the metaanalysis of existing randomized tials, the addition of anaerobie coverage to a regimen including aerobic coverage reduced. ‘wound infections by 43% (RR= 0.47; P= 0004). Similarly, adding acrobic coverage to a regimen of anacrobie cover- age reduced wound infection by more than 45% (RR 0:44; P= 0002), Based on an evaluation of 260 randomized studies that included almost 44,000 patients, Nelson et al. made several conclusions regarding the use of prophylactic antibiotics for colorectal surgery.” Not surprisingly, they found that there is overwhelming evidence to support the use of antibiotic prophylaxis in patients undergoing colorectal surgery. They also concluded that the antibiotics used should cover both anaerobic and aerobic bacteria, In owl fr VIVEK GEL (ie oe ital com) t Fase Mangenen Neh LA am lly coy Ebvo Mich 8,208 ecto eel No abr asc witha pease. Cap G2018 sera. Alig eave Edence-Based Decision Making in Clon end Rectal Surgery CHAPTER 181 2189 addition, the evidence indicates that preoperative dosing of IV antibiotics, preferably approximately | hour prior to incision, is imperative. They found no evidence sup- porting redosing of antibiotics during long cases or the routine administration of postoperative antibiotics follow- ing uncomplicated, elective colorectal surgery. Finally, based on the evidence reviewed in this analysis, it appears that the combination of oral (discussed previously) and IV antibiotics provides the optimal prophylactic regimen in patients receiving a bowel preparation. For the most, part the current clinical practice guidelines mirror these findings with one key exception, The published guidelines do recommend intraoperative redosing of IV antibiotics, as discussed previously. POSTOPERATIVE ORAL INTAKE Resumption of oral intake following colorectal surgery is often the prime factor limiting patient's discharge from the hospital. Traditionally, oral intake has been withheld until patients demonstrate return of bowel function, either by passing flatus or having a BM. Following this conservative pathway, the average patient tolerates a regular diet on day 5 following colorectal resection. Although there is, litte evidence to support this approach, many still use it to guide postoperative diet management. In reality, there are numerous studies that support the idea that early oral nutrition following colorectal surgery has no deleterious effect on patient outcome and, in fact, can be beneticial in terms of patient satisfaction and length of hospital stay. More than 20 years ago, Binderow ct al. performed a small RCT in patients undergoing laparotomy and colon, resection, comparing traditional diet advancement with allowance of regular diet on postoperative day I." These investigators found that a slightly higher percentage of the early diet patients requited replacement of a nasogastric tube but that bowel function as evidenced by return of fatus or BM still occurred at the same time in both groups. In addition, in patients who tolerated early oral intake, there was a trend toward shorter hospitalizations, This, seminal, small study concluded that early oral intake is possible after laparotomy and colorectal resection. Several years later, Hartsell etal. performed another randomized study, again comparing early institution of oral intake to traditional diet management.” In this trial, early oral intake consisted of liquids on postoperative day 1, followed by regular diet as soon as the patient could lerate a liter of fluid during the day; regardless of flatus or BM. No significant differences were seen in rates of nausea and vomiting or nasogastric tube replacement, There was aso no difference noted in length of hospital stay In 2007 a randomized trial by Han-Geurts et al. come pared early institution of oral intake as tolerated by the patient (a “free diet” group) with traditional advancement Of dict based on retum of bowel function.” They observed that more patients in the free diet group requited reins tion of a nasogastric tube (20% vs. 10%; P= 213) but that this was not statistically significant. There was no difference observed in the complication rate, and the return of gastrointestinal (GI) function was similar in both groups. A normal diet was tolerated after a median of 2 days in the free diet group compared with 5 days in the conventional group (P< 001). These authors again showed that early resumption of oral intake does not lead to significantly increased rate of nasogastic tube reinser- tion or complications. The lack of traditional markers of GI functional recovery, namely flatus and BMs, did not affect the tolerance of oral diet. They concluded that there is no reason to withhold oral intake in the early postoperative period following open colorectal surgery. In 2009 a meta-analysis was published evaluating RCTs published through 2006, which compared traditional diet advancement with early oral intake following colorectal surgery." These authors included 18 RCTs, with a total of 1173 patients. Overall, there were few dilferences noted between the two treatment groups in terms of complica: tions. There was a trend toward fewer anastomotic dchiscences and shorter hospital stays, by approximately 1 day, in the early oral intake groups, although these did not reach significance. There was a slightly higher inci- dence of vomiting noted across the trials in the patients treated with carly initiation of oral intake, but again, return of bowel function, recorded as flatus or BM, was unaffected. The conclusion of this meta-analysis, the largest to date, was that there is no advantage to the traditional conservative management of oral intake fol lowing colorectal surgery. In 2013 a meta-analysis of seven RCTs and almost 600 patients, confirmed this conclusion, In this analysis, early feeding was associated with reduced length of stay (71.58 days; P=.009) and fewer postoperative complications (RR = 0.70; P=.04).”" MU-OPIOID RECEPTOR ANTAGONISTS Peripherally acting mu-opioid receptor antagonists are a class of agents that specifically block the action of opiates 6n intestinal mu receptors, thereby mitigating the effects of opioid-indueed constipation. The most commonly used. US Food and Drug Administration (FDA)-approved drug, in this class is alvimopan, Alvimopan was approved in May 2008 as an orally administered drug for the treatment of POL. Itis.a novel, selective, peripherally active mu-opioid receptor antagonist that works by blocking the mu-opioid receptor, minimizing the paralytic effect opiates have on the intestines, while, because it does not cross the blood brain barrier having lite effect on analgesia. The promise of pharmaceutical reduction of POI has spurred great interest in this and other mu-opioid antagonists, In 2004 an RCT of 451 patients undergoing bowel resection was performed by Wolff etal.” Patients were randomized to receive 6 mg of alvimopan, 12 mg of alvimopan, or placebo 2 hours preoperatively and twice a day postoperatively. The time to GI recovery, defined as tolerance of regular food and passage of a BM, was accelerated with 6 oF 12 mg of alvimopan, with a mean diflerence of 15 hours (P<.005) and 22 hours (P<.001), respectively, compared with placebo, In the 12-mg group, time to hospital discharge was also improved by an average (of 28 hours compared with placebo (P=.003). Complica- tions and adverse reactions were not different among the groups. These authors concluded that alvimopan was well {olerated and accelerated GI recovery and time to hospital discharge compared with placebo in patients undergoing. bowel resection Dewan fr VIVEK GOEL (ive gore cm) a Fats ah Mansgeent Noth La fr Chaealey cum by Eutie ot Marck 18,2018 ecto uel Noor iba parses, Cipygh O20 Hae a Al ge frend. 2190 SECTION IV coin, Rectum, and Aras Two subsequent RGTs by Delaney et al. and Viscusi ‘etal, respectively, confirmed the findings from this initial trial.” A pooled analysis of these three trials was per formed in 2007 by Delaney et al.” This pooled analysis included more than 1100 patients randomized to ‘or 12 mg of alvimopan or placebo in patients who under- ‘went laparotomy and bowel resection. In pooled analysis, alvimopan reduced the time to GI recovery by 12 to 18 hours in both the 6- and 12mg alvimopan groups com- pared to placebo. Additionally, the time to placement of a discharge order was reduced by 16 hours (P<.001) in the 6mg group and 18 hours (P< 001) in the 12mg group. There was no significant difference in opioid use between the groups. In addition, the rate of adverse effects was lower in the alvimopan group, with lower rates of nausea and POL Two RCTs in 2008 confirmed the efficacy and safety of alvimopan. Ludwig et al. compared 12-mg alvimopan to placcbo administered before surgery and twice per day afterward in 629 patients undergoing laparotomy and bowel resection.” All patients were managed postopera tively with standard ERPs that included early ambulation, and carly institution of oral feeding. In this study, the mean times to recovery of GI function and hospital dis- charge were accelerated by 20 hours (P <.001) and 17 hours (P< .001), respectively, in the alvimopan group compared with placebo, In addition, significantly fewer patients who received alvimopan remained in the hospital for 7 postoperative days or longer (18% ys. 30.8%; P< (001). Alvimopan patients were almost 60% less likely to develop a POI and more than 40% less likely to require nasogastric tube insertion. Opioid consumption did not differ significantly between the two groups In the same year, Buchler et al. published the results, of another RCT evaluating the safety and efficacy of alvimopan (6 and 12 mg every 12 hours) compared with placebo in patients undergoing laparotomy and either small or large bowel resection." Overall, unlike the prior studics, they did not show a significant reduction in time to tolerate solid food and first BM or flatus, although the trend was in favor of alvimopan. However, patients in this trial received either opioid patientcontrolled analgesia (PCA) or opioids without PCA delivery. In the other trial, all patients received opioid analgesia via a PCA. In this study, the opioid use differed significantly between the PCA and non-PCA patient groups. For example, in the placebo patients the PCA group received an average of 92.1 morphine sulfate equivalents (MSEs), whereas the non-PCA group received only 45.3 MSEs. Differences were similar in the alvimopan treatment groups. In the PCA group, return of bowel function and time to first BM were significantly aecelerated in the alvimopan teatment groups ‘compared with placebo, whereas in patients treated with intermittent morphine and no PCA, no reductions in mean time to Gl recovery were observed. Tis tral offered unique perspective on alvimopan use, suggesting that alvimopan, although safe in all patients, is most useful in patients receiving opioid analgesia in higher total quantities, via a PCA. Despite the apparent efficacy of alvimopan, its use has not been widespread. One factor likely curtailing its use is its relatively high cost. However, several studies in the past 5 years have examined the cost effectiveness of alvimopan following bowel resection. In 2011 Poston et al, performed a retrospective matched-cohort study of 480 alvimopan patients and 960 matched controls." They found that there was a $1040 reduetion in hospital cost in the alvimopan group (P=.03), most likely due to the shorter length of stay in the alvimopan group (5.6 days Ws. 6.5 days; P< .001). A retrospective study of patients undergoing segmental colectomy in the University Health System Consortium from 2008-2009 was published by Simorov et al. in 2014.” These authors found that regard less of approach (laparoscopic or open), alvimopan was associated with shorter length of stay (4.4 days ws. 5.9 days: P< .001) and reduced hospital costs ($9974.00 vs '$11,303.00; P< .001). Another study by Adam etal. in 3016 compared 197 coloreetal surgery patients receiving, alvimopan to 463 colorectal surgery patients not receiving alvimopan."' Alvimopan was again associated with faster return of bowel function, lower incidence of ileus, and shorter length of stay. These benefits tanslated into a ‘cost savings of $1492.00 per patients treated with alvimopan (P= 01). In 2016 Ehlers et al. reported on more than 14,000 patients undergoing elective colorectal surgery"; 11% of the patients received alvimopan. In the alvimopan, ‘cohort, length of stay was 1.8 days shorter (P°< .01) and costs were $2017.00 lower (P<.01) than the cohort not receiving alvimopan, Finally, a meta-analysis by Earnshaw et al, in 2015 combined data from several bowel resection trials and specifically examined the efficacy and cost of alvimopan in the setting of an ERP." They found that the incidence of ileus was significantly reduced (7% vs. 15%; P< 0001) and that the time to discharge was also shorter (8.4 days ys. ILI days; P< .0001) in the alvimopan cohort. The average hospital costs were more than $700.00 less in the alvimopan patients, POSTOPERATIVE ANALGESIA ‘There has been debate over the years as to the optimal postoperative analgesia regimen for patients undergoing colon resection, both following laparotomy and laparos- «copy. Ithas long been recognized that IV opioids, although ‘effective for pain relief, can prolong POI, delaying return ‘of bowel function and possibly tolerance of regular diet Assuch, there has been interest in using epidural analgesia in the postoperative period. There have been numerous randomized trials comparing epidural and IV analgesia following open colon resection. -\ few of the largest of these tials, as well as a meta-analysis evaluating 16 of these RCTs, are discussed briefly later. In addition, there have been a few studies and reviews examining the same issue following laparoscopic colon resection, These are also discussed briefly atthe end of this section. One of the early randomized trials evaluating the efficacy and safety of epidural analgesia versus TV analgesia fol- lowing colorectal resection was published in 2001 by Cari etal.” In this study, patients received either morphine PCA or a bupivacaine and fentanyl infusion via an epidural catheter for 4 days postoperatively. Analgesia was discon- tinued on postoperative day 4, and acetaminophen and codeine were then used orally as needed. Diet (in this study, liquid and protein drinks were started on all patients, = ec powon te cly Ne oir tse heat psaoe, Capi G20 swt ae Augie reened Edence-Based Decision Making in Clon end Rectal Surgery CHAPTER 181 2191 on postoperative day 1) and mobilization were the same between the two groups. The cumulative pain score (measured by the Visual analog scale (VAS]) was signifi cantly improved in the epidural patients with rest, cough+ ing, and movement on the fist 3 postoperative days. Pain scores were the same between groups by day 4. There was, no difference in the incidence of postoperative nausea and vomiting between the two groups, but the time from surgery to first flatus and BM was significantly shorter in the epidural group. Twelve of 21 epidural patients passed fats and 7 of 21 had a BM during the fust 2 postoperative days, compared with 4 of 21 (P=,001) and 1 of 21 (P= 005), respectively in the PGA group. Length of stay and. rate Of complications were the same between the two groups, A trial published by Zutshi et al, in 2005 evaluated epidural versus IV analgesia in patients undergoing lapa- rotomy and bowel resection, all of whom were enrolled in an enhanced recovery program including carly ambulae tion and oral intake. Postoperatively, patients in the epidural group received a continuous infusion of bupi- vacaine and fentanyl, supplemented by a patientcontrolled bolus. The epidural was removed on postoperative day 2, and oral pain medications were offered. Patients in the IV group received a PCA that delivered IV analgesia on demand and were switched to oxycodone starting 48 hours after surgery. There was no difference in length of stay between the two groups. Although patients in the epidural group passed stool earlier than the PCA group (2 days, vs. 4 days), there was no difference in time to tolerance of a regular diet. The epidural patients did have a lower pain score during the first 2 days (mean score, 2.46 vs, 3.33; P= 01). In addition, there was no significant dif- ference between groups for quality of life, satisfaction with hospital stay, oF return to normal activities at discharge Or at postoperative days 10 and 30. These authors cone cluded that for patients undergoing bowel resection who are enrolled in an ERP following surgery, epidural anesthesia offers no benefit In 2007 Marret et al. published a metacanalysis evaluat- ing 16 randomized trials comparing epidural analgesia versus IV opioid analgesia after colorectal surgery.” More than 800 patients were included in the stud, 406 in the epidural group and 400 in the TV group. Length of stay was not significantly different in the two groups across the 13 trials that measured this outcome. Interestingly, in the later studies that used an ERP for all patients, length of stay was generally significantly shorter than in studies using a more traditional recovery pathway. As in the previously discussed study, the use of epidural analgesia in patients treated with an enhanced pathway did not shorten length of stay compared with the TV analgesia group. Pain relief, as measured by the VAS in 11 studies, was improved in the epidural groups at 24 and 48 hours. In addition, in 15 studies, POT was shortened in the epidural groups by an average of 36 hours. The rate of ‘major postoperative complications was the same between groups, but there was a higher rate of complications, such as hypotension and urinary retention in the epidural groups. Overall, this metasanalysis concluded that epidural analgesia does decrease VAS pain score and the duration of ileus, which results in improved patient comfort and facilitates more prompt resumption of oral intake. Despite these benefits, the use of epidural analgesia does not shorten length of hospital stay: Based on this meta-analysis, the authors conclude that hospital stay is most affected by “fast-track postoperative care,” regardless of analgesia method used. Until recently, there were very few studies examining. the efficacy of epidural versus TV analgesia in patients undergoing laparoscopic colectomy. An article published in 2010 by Levy et al. reviewed the eight studies that examined analgesia regimens specifically following lapa- roscopie colorectal resections." Based on the three ran- domized trials included, there was no difference in length of stay between the epidural and IV analgesia groups. Although there was heterogeneity in the studies, the average time to tolerance of a regular diet was approxie mately 1 day shorter in the epidural group (28 vs. 39 days). The one randomized trial that included time to passage of flatus found the epidural group to have a significantly shorter time to passing flatus (2 vs. 3 days) Similarly, the two RCTs that looked at time to first BM found that this was shorter in the patients receiving epidural analgesia. Both RCTs that evaluated pain as an outcome reported that the visual analog pain seores (1-10) were significantly lower in the epidural groups (25 vs. 5.4), Overall, there was no difference in the rates of complications and readmissions between the two groups. These authors concluded that there is still a paucity of data assessing the most appropriate analgesia regimen following laparoscopic colon resection. A more recent metaanalysis was published in 2013 examining the effect of epidural analgesia on bowel funetion in laparoscopic colorectal surgery. These authors evaluated six RCTs published between 1999-2011, Time to first BM and pain scores were significantly better in the epidural patients, but there was no difference in hospital stay: Adverse ellects were also not different between the groups, Another meta-analysis by Liu et al. was published in 2014" and reviewed seven RCTs specifically evaluating thoracic epidural analgesia in the setting of laparoscopic colectomy. Shortterm pain scores were improved in the epidural patients with no difference in complications, Tength of stay, or return of bowel function. The ERAS Society commented on the use of epidural anesthesia in their 2013 Guidelines for Perioperative Care in Elective Golonic Surgery.’ They recommend, based on a high level of evidence, that midthoracic epidurals be used for open colorectal surgery. There is less evidence supporting the benefits of epidural analgesia in laparo- scopic colorectal surgery. Based on moderategrade exi- dence, they recommended opioid-PCA or spinal analgesia in the setting of laparoscopie colorectal resection, VENOUS THROMBOEMBOLIC PROPHYLAXIS Venous thromboembolic (VIE) events, including deep vein thrombosis (DVT) and pulmonary embolus (PE) are relatively common complications after major abdominal surgery, and VTE prevention isa common focus of patient safety measures. Following colorectal surgery, the incidence of postoperative VIE, even with appropriate prophylaxis, has been reported to be as high as 9% to 10%." There is Dowload fr VIVEK GOK (ve scree cit Fi Heath Manage! Nah Ld lm sly com y Eker ot Mach 18,2018 ec puoa a ely Nor uss at patson Coit GOVT, ovr ae. Al ape seve 2192 SECTION IV sion, Rectum, and Aras little controversy around the use of postoperative VTE pro= phylaxis in the inpatient setting. Based on the most recent ‘CHEST guidelines, there is solid evidence (grade IB) to support postoperative prophylaxis with both intermittent pneumatic compression devices and also pharmacologic prophylaxis with low-molecular-weight heparin or low-dose ‘unfractionated heparin.” In a 2015 study, it was reported that in-hospital, postoperative VTE prophylaxis was used in 91.4% of patient undergoing colorectal resections by 2011." More controversial is the use of postdischarge, extended VTE prophylaxis. Many of the studies and subsequent fecommendations stem from a pivotal study published in 2002 in the New England Journal of Medicine” This random ized trial found that enoxaparin prophylaxis for 4 weeks after surgery for abdominal pelvie cancer was safe and reduced the incidence of venographically demonstrated venous thrombosis compared with only 1 week of enoxa- parin treatment. In 2014 a similar study was performed specifically in patients undergoing laparoscopic colorectal cancer surgery." In this study of 301 colorectal cancer patients, the $month incidence of VTE was 9.7% in the group randomized to 1 week of prophylaxis and 0.9% in the extended prophylaxis group (P= .001), with no dit ference in bleeding complications. Based on these and other studies, multiple societies have published guidelines regarding the use of extended (postdischarge) VTE. prophylaxis, although none target colorectal surgery patients directly. The CHEST guidelines published in 2012 recommend that patients at high risk for VTE undergoing abdominal or pelvic surgery for cancer receive extended-duration, postoperative pharma- cologic prophylaxis (4 weeks) with low-molecular-weight heparin.” The American Society of Clinical Oncology guidelines published in 2014 also recommend that extended prophylaxis (4 weeks) be used in high-risk patients undergoing major cancer surgery, such as those with restricted mobility, obesity, and history of VTE. Despite the evidence and existing guidelines, the use of extended prophylaxis in postoperative colorectal cancer patients is hot as common as its use in the inpatient setting. In the 2015 study by the Colorectal Writing Group, only 11.7% ‘of colorectal surgery patients were discharged on extended prophylaxis.”” Although the exact numbers were not reported, the majority of these patients had a diagnosis, ‘of malignancy. Although most ofthe evidence and guidelines regarding. use of extended prophylaxis involves cancer patients, there is evidence that other indications for colorectal surgery may carry as high, or higher, risk of VTE. The use of extended prophylaxis in these patients remains an active area of investigation, Several studies report a higher rate of postoperative VIE in patients undergoing, surgery for inflammatory bowel disease compared with those undergoing cancer resection.”””"”* In addition, many studies report a high incidence of postdischarge VIE, even for noncancer colorectal surgery patients.” There are currently no guidelines regarding the use of ‘extended prophylaxis in the noncancer colorectal surgery population, Future studies are clearly needed to clavify the risk of postoperative VTE in all colorectal surgery patients and to help answer the questions regarding ovale fr VIVEK GOEL ave enlifati Forplay Me the use of extended VIE prophylaxis in this diverse population. 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