ORIGINAL CONTRIBUTION
Process Control to Measure Process Improvement in Colorectal Surgery: Modifications to an Established Enhanced Recovery Pathway Deborah S. Keller, M.S., M.D.1 • Jonah J. Stulberg, M.D., Ph.D., M.P.H.2 Justin K. Lawrence, M.D.1 • Conor P. Delaney, M.D., M.Ch., Ph.D., F.R.C.S.I.1 1 Division of Colorectal Surgery, Department of Surgery, University Hospitals-Case Medical Center, Cleveland, Ohio 2 Department of Surgery, University Hospitals-Case Medical Center, Cleveland, Ohio
BACKGROUND: After more than a decade of
improvement, our enhanced recovery pathway had patients who had undergone laparoscopic colectomy going home a mean 3.7 days postoperatively. We wondered if adding a transverse abdominus plane block and intravenous acetaminophen to an established pathway would improve outcomes and resource use. OBJECTIVE: The aim of this study was to evaluate the impact of modification of an enhanced recovery pathway on patient outcomes. DESIGN: This was a case-matched study. METHODS: After the addition of transverse abdominus
plane blocks and acetaminophen to the enhanced recovery pathway 12 months ago, review of a prospective database was performed. Patients were matched by procedure type, age, and sex. SETTINGS: This study was performed at a tertiary referral
center. PATIENTS: Patients undergoing elective major
laparoscopic colorectal surgery from 2010 to 2012 were included.
Financial Disclosure: None reported. Poster presentation at the meeting of The American Society of Colon and Rectal Surgeons, Phoenix, AZ, April 27 to May 1, 2013. Correspondence: Conor P. Delaney, M.D., M.Ch., Ph.D, F.R.C.S.I., Division of Colorectal Surgery, Department of Surgery, University Hospitals Case Medical Center, Case Western Reserve University, 11100 Euclid Ave, Cleveland, OH 44106–5047. E-mail: [email protected] Dis Colon Rectum 2014; 57: 194–200 DOI: 10.1097/DCR.0b013e3182a62c91 © The ASCRS 2014
194
MAIN OUTCOME MEASURES: The primary outcome measures were hospital length of stay, readmission rate, postoperative complications, and the cost of the hospital episode before and after the amendment of our enhanced recovery pathway. RESULTS: Two hundred eight elective major laparoscopic cases were evaluated. Both groups were similar in demographics and comorbidities. Length of stay was significantly shorter once transverse abdominus plane blocks and acetaminophen were introduced (p < 0.01), dropping from 3.7 to 2.6 days. There were significantly more complications in the prechange group (p = 0.02), but no significant differences in readmissions or mortality. Direct costs were similar, but there was a $500 increase in total margin per case (p = 0.004) with the pathway changes. With the use of statistical process control to examine the effect on outliers, there was significantly less variation in the mean length of stay (2.29 vs 1.90 days, p < 0.01) after the addition of transverse abdominus plane blocks and intravenous acetaminophen. LIMITATIONS: The single-surgeon, single-institution
design was a limitation of this study. CONCLUSIONS: The addition of a transverse abdominus plane block and acetaminophen significantly reduced length of stay more than that seen with a previously established pathway. Statistical process control demonstrated that our pathway changes significantly reduced the spread of outliers around our mean length of stay.
Key Words: Laparoscopic colorectal surgery; Process improvement; Enhanced recovery pathways; Health care utilization; Pain management. Diseases of the Colon & Rectum Volume 57: 2 (2014)
195
Diseases of the Colon & Rectum Volume 57: 2 (2014)
E
nhanced recovery pathways (ERPs), also called fasttrack pathways, were designed to standardize medical care, improve outcomes, and lower health care costs. The ERPs use care practices including laparoscopic technique, early mobilization, early liquids, and antiemetics for prophylaxis against postoperative ileus.1 ERPs have had a significant impact on safely reducing length of stay and optimizing short-term patient outcomes.2–9 The pathways have also had a beneficial impact on health care utilization.10 Over the past 10 years, our group has developed, implemented, and refined an ERP that integrates preoperative, perioperative, and postoperative patient information, preservation of GI function, avoidance of organ dysfunction, active pain control, and promotion of patient autonomy. The ERP benefits have evolved to a significantly shorter hospital length of stay (LOS) and lower complication and readmission rates, with no adverse effect on patient quality of life or pain scores.11–13 Despite these successes, internal review identified room for further improvement in short-term outcomes and subsequent hospital costs. Laparoscopic surgery using transversus abdominis plane (TAP) blocks for postoperative analgesia was reported to facilitate accelerated recovery after abdominal surgery: shorter postoperative LOS, earlier resumption of diet, and less opioid use.14,15 In early studies, we found a significantly shorter hospital LOS (p < 0.01) and lower postoperative narcotic use for TAP block patients in comparison with control laparoscopic colorectal surgery patients (p = 0.01). Thus, TAP blocks were added as an adjunct to potentially reduce postoperative analgesia, postoperative pain control, LOS, and health care expenditures. In addition, studies have shown that 4 g/day intravenous acetaminophen significantly reduces postoperative pain, nausea, vomiting, sedation, and opioid consumption as a component of the multimodal analgesia model.15–17 Given the efficacy with a stellar safety profile, we initiated 1000 mg intravenously every 6 hours or 4 g/day intravenous acetaminophen in our postoperative ERP.16,17 The goal of this study was to evaluate the LOS, health care costs, readmission, complication, and mortality rates after integrating TAP blocks and intravenous acetaminophen into our ERP. We hypothesized that the addition of TAP blocks and intravenous acetaminophen to this established ERP would improve patient outcomes and reduce resource use.
TAP block from September 2011 to September 2012. The TAP blocks and intravenous acetaminophen were initiated in September 2011. The elective laparoscopic colorectal procedures were matched to elective laparoscopic cases from the previous 12-month period without a TAP block or intravenous acetaminophen as part of the ERP by age (years), sex (male/female), BMI (kg/m2), procedure (based on Current Procedural Terminology codes (44204–44212, 45330, 45378, 45380, 45395, 45397, 45400, 45402, and 45499)), and diagnosis (based on the all-patient-refined diagnosis-related group (DRG) 221). In the United States, DRGs are a case classification system based on diagnosis and complexity; each DRG has a payment weight assigned to it, based on the average resources used to treat Medicare patients in that DRG.18 The all-patient-refined DRG includes both non-Medicare populations and severity-of-illness subclasses. The colorectal procedure was the primary procedure for the episode of care. Patients under 18 years of age, patients with incomplete medical records, patients with loop stoma closure, and cases performed through an endoscopic, anorectal, and transanal endoscopic microsurgery approach were excluded from the study. For the analysis, single-incision laparoscopic surgery (SILS) and converted laparoscopic cases were grouped with the laparoscopic cohort on an intention-to-treat basis. Additional demographic and clinical information was gathered from electronic medical records. Data fields evaluated included age, sex, BMI, ASA class, Charlson Comorbidity Index, Modified Frailty Index, diagnosis, procedure type, discharge disposition, postoperative complications, 30day mortality, direct hospital costs, total margin, and net revenue.
MATERIALS AND METHODS
TAP Block Protocol
After obtaining institutional review board approval, a retrospective review of a prospectively maintained, institutional review board-approved departmental database was performed to identify elective laparoscopic colorectal resections performed via an abdominal approach with a
Enhanced Recovery Pathway
All cases followed a standardized ERP and discharge criteria with the exception of the TAP block and intravenous acetaminophen. The key principles focus on anesthesia, analgesia, reduction of surgical stress, fluid management, minimally invasive surgery, nutrition, and ambulation. Specific pathway components including patient education, early ambulation, early diet progression, nasogastric tube avoidance or early removal, opioid-sparing pain control, and nursing care are standardized. Our ERP is demonstrated in Figure 1. The standardization of the ERP allows us to infer that differences in cost are due to postoperative outcomes.
The TAP block is performed at the conclusion of the procedure. Under direct laparoscopic vision, a Braun Stimuplex A insulated needle is passed through the skin at the level of the midaxillary line, midway between the iliac crest and the costal margin. The needle is advanced until 2 distinct “pops” are felt, indicating the desired position between the
196
KELLER ET AL: SPC TO EVALUATE CHANGES TO AN ERP
Dietary orders: DAY BEFORE SURGERY: • Boost or glucose drink evening before • Chewing gum, 1 stick x 60 minutes tid surgery • Clear liquids given as tolerated after surgery. • Bowel prep as directed • Voltaren 100 mg evening before surgery • Boost, 1 can twice daily po • Gabapentin three days preop • Soft diet on POD1 for laparoscopic and POD 2 for open cases • Oral antibiotics • Info sheet about expected end points Medication orders: • Baseline CRP, type and screen, WBC • Gabapentin 300 mg po tid for 72 hours if in hospital PREOPERATIVE HOLDING AREA: • Alvimopan 12 mg po bid while in hospital • Gabapentin 300 mg po 1-2 hours before or to a maximum of 7 days surgery • Toradol 15 mg iv q6h ATC for open and • Alvimopan 12mg po 1-2 hours before laparoscopic patients, except in those surgery with renal dysfunction, HTN, elderly, etc • Thromboprophylaxis: Heparin 5000 iu sc • Heparin 5000 IU sc tid, PAS stockings tid, PAS stockings. • Bisacodyl 10 mg twice daily po • Antibiotics at induction as needed • Use Vistaril 25 mg IM q6 hours prn • Heparin and PAS stockings (generally for first 24-48 hours), or Reglan • Steroid at induction as needed 10 mg iv q6h (generally after first 24-48 hours) as first-line treatments for nausea. POSTOPERATIVE HOLDING AREA: Ambien 5 mg or Restoril 15 mg po • • Morphine or dilaudid PCA for all qhs starting from POD1. patients, unless morphine bolus for • Hydrocortisone 50 mg iv tid for patients selected lap patients with hx of steroids within 6 months. • Prophylactic antibiotics are NOT routinely continued after surgery, except Oral analgesia: for specific therapeutic indications • Laparoscopic patients: POD 1: Hold (doses in OR only) morphine except for BTP. Start Tylenol 3, 1-2 q4-6 hours prn. NURSING FLOOR: General orders: • Open patients: POD 2: Hold morphine except for BTP. Start Percocet 5/325, 1-2 • CBC and BMP daily postop, at least nd q4-6 hours prn. (write for oral analgesia every 2 day to be given 30-60 minutes prior to • CRP on postoperative day 2 stopping PCA or epidural). Ambulate x5 in hallways q day • • Sit out of bed 4-6 hours per day • Remove Foley on POD1 for laparoscopic and POD 2 for open cases • Heplock iv fluids on POD1 for laparoscopic patients FIGURE 1. University Hospitals Case Medical Center Division of Colorectal Surgery Enhanced Recovery Pathway. CRP = C-reactive protein; WBC = white blood cell count; PAS = pneumatic antiembolism stockings; PCA = patient-controlled analgesia; lap = laparoscopic; OR = operating room; ATC = around the clock; HTN hypertension; CBC = complete blood cell count; BMP = basic metabolic panel; BTP = breakthrough pain; hx = history; postop = postoperative; POD = postoperative day; preop = preoperative; q = every; po = orally; iv = intravenous; bid = twice a day; q4-6 = every 4 to 6; q6h = every 6 hours; prn = as needed; IM = intramuscular; sc = subcutaneous; tid = three times a day.
internal oblique and transversus abdominis muscle. Then, 15 mL of 0.25% bupivacaine is injected; an intramuscular bulge is laparoscopically confirmed, which signifies that the anesthetic is being delivered into the plane. The procedure is performed at a second injection site on the same side and bilaterally.19 Acetaminophen Protocol
Starting on postoperative day 0, 1 g of intravenous acetaminophen (OFIRMEV, 1000 mg/100 mL) was administered every 6 hours. The administration was continued for at least 24 hours (4 g dose). At that point, if the patient was tolerating food by mouth, the intravenous acetaminophen
was transitioned to acetaminophen by mouth. The dose of 1 g every 6 hours was maintained until hospital discharge or 7 days postoperatively if the patient was not already discharged. Statistical Analysis
Statistical analysis was performed to compare the pre-TAP and TAP groups by using the Student paired t test; a 2-sided p value < 0.05 was considered statistically significant. Statistical process control was used to evaluate the impact of the TAP block and intravenous acetaminophen on outliers for LOS. An outlier was defined as any value outside of the (mean ± 1 SD).
197
Diseases of the Colon & Rectum Volume 57: 2 (2014)
3%
17%
Colon cancer
32%
Inflammatory bowel disease Diverticulitis Polyps
14%
Rectal cancer 14%
Other
20%
FIGURE 2. Indications for surgery.
RESULTS During the study period, 102 elective laparoscopic major colorectal procedures were performed with a TAP block and intravenous acetaminophen. Those cases were matched to 106 elective laparoscopic major cases without a TAP block or intravenous acetaminophen, leaving 208 cases included in the analysis. There was no difference in SILS or converted cases between groups in the matched analysis; each group had 2 converted cases and 1 SILS. The main indication for surgery was colon cancer (32%) (Fig. 2). The main operative procedure performed was a segmental colectomy (59%) (Fig. 3). The matched groups were similar in age, BMI, and comorbidities, as defined by ASA class, Modified Frailty Index, and Charlson Comorbidity Index (Table 1). Length of stay was significantly shorter once TAP and acetaminophen were introduced (p < 0.005), dropping from a mean 3.7 (median, 3 days) to a mean 2.6 days (median, 2 days). The most common postoperative complication in both groups was postoperative ileus/ small-bowel obstruction (44.4% postchange, 36.4% prechange). There were significantly more overall complications in the prechange group (p = 0.019). The rates of unplanned reoperation (3/22, 13.6% prechange vs 1/9, 11.1% postchange) were similar. There were no significant differences in readmissions or mortality. Direct costs were similar, but there was a $500 increase in total margin per case (p = 0.004) with the ERP changes (Table 2). With the use of statistical
7%
3% 3%
2% Operative procedure Segmental colectomy 26%
59%
Low anterior resection Abdominoperineal resection Total proctocolectomy Ileoanal anastomosis
FIGURE 3. Surgical procedures performed.
process control to examine the effect on outliers, where LOS was plotted against days since ERP change, there was noticeably less variation from the mean LOS (2.29 vs 1.90 days, p < 0.001) after the addition of TAP blocks and intravenous acetaminophen (Fig. 4).
DISCUSSION Continuous quality improvement is crucial for ensuring quality outcomes in colorectal surgery. Studies have shown that evaluating surgical outcomes has the power to reduce complications, mortality, and financial expenditure.20 In colorectal surgery, a surgical self-audit of colorectal cancer cases helped reduce adverse surgical events by half, with a
TABLE 1. Patient demographic data Elective lap abdominal cases
Postchange
Prechange
Count of cases Age, mean (SD) BMI, mean (SD) ASA class, n (%) II III IV Modified Frailty Index Charlson Comorbidity Score
102 60.65 (15.82) 29.60 (5.42)
106 60.07 (18.70) 29.12 (6.80)
37 (36.3) 58 (56.8) 7 (6.9) 1.58 2.55
41 (38.7) 60 (56.6) 5 (4.7) 1.40 2.74
p – 0.84 0.62 0.60
0.32 0.66
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KELLER ET AL: SPC TO EVALUATE CHANGES TO AN ERP
TABLE 2. Patient outcome data Elective lap abdominal cases
Postchange
Prechange
LOS, mean (SD) LOS, median (range) Operative time, min ICU stay required, n (%) Readmission, n (%) Unplanned reoperation, n (%) Postoperative complications, n (%) Postoperative ileus/small-bowel obstruction Superficial wound infection Anastomotic bleed Pneumonia/urinary tract infection Cardiac/pulmonary Anastomotic leak Thromboembolic Count of deaths (30-day) Average of hospital costs Average of total margin) Average of net revenue Average of cost per OR minute
2.58 (1.90) 2 (1–15) 181.93 (78.95) 2 (2.0) 3 (2.9) 1 (
Process Control to Measure Process Improvement in Colorectal Surgery: Modifications to an Established Enhanced Recovery Pathway Deborah S. Keller, M.S., M.D.1 • Jonah J. Stulberg, M.D., Ph.D., M.P.H.2 Justin K. Lawrence, M.D.1 • Conor P. Delaney, M.D., M.Ch., Ph.D., F.R.C.S.I.1 1 Division of Colorectal Surgery, Department of Surgery, University Hospitals-Case Medical Center, Cleveland, Ohio 2 Department of Surgery, University Hospitals-Case Medical Center, Cleveland, Ohio
BACKGROUND: After more than a decade of
improvement, our enhanced recovery pathway had patients who had undergone laparoscopic colectomy going home a mean 3.7 days postoperatively. We wondered if adding a transverse abdominus plane block and intravenous acetaminophen to an established pathway would improve outcomes and resource use. OBJECTIVE: The aim of this study was to evaluate the impact of modification of an enhanced recovery pathway on patient outcomes. DESIGN: This was a case-matched study. METHODS: After the addition of transverse abdominus
plane blocks and acetaminophen to the enhanced recovery pathway 12 months ago, review of a prospective database was performed. Patients were matched by procedure type, age, and sex. SETTINGS: This study was performed at a tertiary referral
center. PATIENTS: Patients undergoing elective major
laparoscopic colorectal surgery from 2010 to 2012 were included.
Financial Disclosure: None reported. Poster presentation at the meeting of The American Society of Colon and Rectal Surgeons, Phoenix, AZ, April 27 to May 1, 2013. Correspondence: Conor P. Delaney, M.D., M.Ch., Ph.D, F.R.C.S.I., Division of Colorectal Surgery, Department of Surgery, University Hospitals Case Medical Center, Case Western Reserve University, 11100 Euclid Ave, Cleveland, OH 44106–5047. E-mail: [email protected] Dis Colon Rectum 2014; 57: 194–200 DOI: 10.1097/DCR.0b013e3182a62c91 © The ASCRS 2014
194
MAIN OUTCOME MEASURES: The primary outcome measures were hospital length of stay, readmission rate, postoperative complications, and the cost of the hospital episode before and after the amendment of our enhanced recovery pathway. RESULTS: Two hundred eight elective major laparoscopic cases were evaluated. Both groups were similar in demographics and comorbidities. Length of stay was significantly shorter once transverse abdominus plane blocks and acetaminophen were introduced (p < 0.01), dropping from 3.7 to 2.6 days. There were significantly more complications in the prechange group (p = 0.02), but no significant differences in readmissions or mortality. Direct costs were similar, but there was a $500 increase in total margin per case (p = 0.004) with the pathway changes. With the use of statistical process control to examine the effect on outliers, there was significantly less variation in the mean length of stay (2.29 vs 1.90 days, p < 0.01) after the addition of transverse abdominus plane blocks and intravenous acetaminophen. LIMITATIONS: The single-surgeon, single-institution
design was a limitation of this study. CONCLUSIONS: The addition of a transverse abdominus plane block and acetaminophen significantly reduced length of stay more than that seen with a previously established pathway. Statistical process control demonstrated that our pathway changes significantly reduced the spread of outliers around our mean length of stay.
Key Words: Laparoscopic colorectal surgery; Process improvement; Enhanced recovery pathways; Health care utilization; Pain management. Diseases of the Colon & Rectum Volume 57: 2 (2014)
195
Diseases of the Colon & Rectum Volume 57: 2 (2014)
E
nhanced recovery pathways (ERPs), also called fasttrack pathways, were designed to standardize medical care, improve outcomes, and lower health care costs. The ERPs use care practices including laparoscopic technique, early mobilization, early liquids, and antiemetics for prophylaxis against postoperative ileus.1 ERPs have had a significant impact on safely reducing length of stay and optimizing short-term patient outcomes.2–9 The pathways have also had a beneficial impact on health care utilization.10 Over the past 10 years, our group has developed, implemented, and refined an ERP that integrates preoperative, perioperative, and postoperative patient information, preservation of GI function, avoidance of organ dysfunction, active pain control, and promotion of patient autonomy. The ERP benefits have evolved to a significantly shorter hospital length of stay (LOS) and lower complication and readmission rates, with no adverse effect on patient quality of life or pain scores.11–13 Despite these successes, internal review identified room for further improvement in short-term outcomes and subsequent hospital costs. Laparoscopic surgery using transversus abdominis plane (TAP) blocks for postoperative analgesia was reported to facilitate accelerated recovery after abdominal surgery: shorter postoperative LOS, earlier resumption of diet, and less opioid use.14,15 In early studies, we found a significantly shorter hospital LOS (p < 0.01) and lower postoperative narcotic use for TAP block patients in comparison with control laparoscopic colorectal surgery patients (p = 0.01). Thus, TAP blocks were added as an adjunct to potentially reduce postoperative analgesia, postoperative pain control, LOS, and health care expenditures. In addition, studies have shown that 4 g/day intravenous acetaminophen significantly reduces postoperative pain, nausea, vomiting, sedation, and opioid consumption as a component of the multimodal analgesia model.15–17 Given the efficacy with a stellar safety profile, we initiated 1000 mg intravenously every 6 hours or 4 g/day intravenous acetaminophen in our postoperative ERP.16,17 The goal of this study was to evaluate the LOS, health care costs, readmission, complication, and mortality rates after integrating TAP blocks and intravenous acetaminophen into our ERP. We hypothesized that the addition of TAP blocks and intravenous acetaminophen to this established ERP would improve patient outcomes and reduce resource use.
TAP block from September 2011 to September 2012. The TAP blocks and intravenous acetaminophen were initiated in September 2011. The elective laparoscopic colorectal procedures were matched to elective laparoscopic cases from the previous 12-month period without a TAP block or intravenous acetaminophen as part of the ERP by age (years), sex (male/female), BMI (kg/m2), procedure (based on Current Procedural Terminology codes (44204–44212, 45330, 45378, 45380, 45395, 45397, 45400, 45402, and 45499)), and diagnosis (based on the all-patient-refined diagnosis-related group (DRG) 221). In the United States, DRGs are a case classification system based on diagnosis and complexity; each DRG has a payment weight assigned to it, based on the average resources used to treat Medicare patients in that DRG.18 The all-patient-refined DRG includes both non-Medicare populations and severity-of-illness subclasses. The colorectal procedure was the primary procedure for the episode of care. Patients under 18 years of age, patients with incomplete medical records, patients with loop stoma closure, and cases performed through an endoscopic, anorectal, and transanal endoscopic microsurgery approach were excluded from the study. For the analysis, single-incision laparoscopic surgery (SILS) and converted laparoscopic cases were grouped with the laparoscopic cohort on an intention-to-treat basis. Additional demographic and clinical information was gathered from electronic medical records. Data fields evaluated included age, sex, BMI, ASA class, Charlson Comorbidity Index, Modified Frailty Index, diagnosis, procedure type, discharge disposition, postoperative complications, 30day mortality, direct hospital costs, total margin, and net revenue.
MATERIALS AND METHODS
TAP Block Protocol
After obtaining institutional review board approval, a retrospective review of a prospectively maintained, institutional review board-approved departmental database was performed to identify elective laparoscopic colorectal resections performed via an abdominal approach with a
Enhanced Recovery Pathway
All cases followed a standardized ERP and discharge criteria with the exception of the TAP block and intravenous acetaminophen. The key principles focus on anesthesia, analgesia, reduction of surgical stress, fluid management, minimally invasive surgery, nutrition, and ambulation. Specific pathway components including patient education, early ambulation, early diet progression, nasogastric tube avoidance or early removal, opioid-sparing pain control, and nursing care are standardized. Our ERP is demonstrated in Figure 1. The standardization of the ERP allows us to infer that differences in cost are due to postoperative outcomes.
The TAP block is performed at the conclusion of the procedure. Under direct laparoscopic vision, a Braun Stimuplex A insulated needle is passed through the skin at the level of the midaxillary line, midway between the iliac crest and the costal margin. The needle is advanced until 2 distinct “pops” are felt, indicating the desired position between the
196
KELLER ET AL: SPC TO EVALUATE CHANGES TO AN ERP
Dietary orders: DAY BEFORE SURGERY: • Boost or glucose drink evening before • Chewing gum, 1 stick x 60 minutes tid surgery • Clear liquids given as tolerated after surgery. • Bowel prep as directed • Voltaren 100 mg evening before surgery • Boost, 1 can twice daily po • Gabapentin three days preop • Soft diet on POD1 for laparoscopic and POD 2 for open cases • Oral antibiotics • Info sheet about expected end points Medication orders: • Baseline CRP, type and screen, WBC • Gabapentin 300 mg po tid for 72 hours if in hospital PREOPERATIVE HOLDING AREA: • Alvimopan 12 mg po bid while in hospital • Gabapentin 300 mg po 1-2 hours before or to a maximum of 7 days surgery • Toradol 15 mg iv q6h ATC for open and • Alvimopan 12mg po 1-2 hours before laparoscopic patients, except in those surgery with renal dysfunction, HTN, elderly, etc • Thromboprophylaxis: Heparin 5000 iu sc • Heparin 5000 IU sc tid, PAS stockings tid, PAS stockings. • Bisacodyl 10 mg twice daily po • Antibiotics at induction as needed • Use Vistaril 25 mg IM q6 hours prn • Heparin and PAS stockings (generally for first 24-48 hours), or Reglan • Steroid at induction as needed 10 mg iv q6h (generally after first 24-48 hours) as first-line treatments for nausea. POSTOPERATIVE HOLDING AREA: Ambien 5 mg or Restoril 15 mg po • • Morphine or dilaudid PCA for all qhs starting from POD1. patients, unless morphine bolus for • Hydrocortisone 50 mg iv tid for patients selected lap patients with hx of steroids within 6 months. • Prophylactic antibiotics are NOT routinely continued after surgery, except Oral analgesia: for specific therapeutic indications • Laparoscopic patients: POD 1: Hold (doses in OR only) morphine except for BTP. Start Tylenol 3, 1-2 q4-6 hours prn. NURSING FLOOR: General orders: • Open patients: POD 2: Hold morphine except for BTP. Start Percocet 5/325, 1-2 • CBC and BMP daily postop, at least nd q4-6 hours prn. (write for oral analgesia every 2 day to be given 30-60 minutes prior to • CRP on postoperative day 2 stopping PCA or epidural). Ambulate x5 in hallways q day • • Sit out of bed 4-6 hours per day • Remove Foley on POD1 for laparoscopic and POD 2 for open cases • Heplock iv fluids on POD1 for laparoscopic patients FIGURE 1. University Hospitals Case Medical Center Division of Colorectal Surgery Enhanced Recovery Pathway. CRP = C-reactive protein; WBC = white blood cell count; PAS = pneumatic antiembolism stockings; PCA = patient-controlled analgesia; lap = laparoscopic; OR = operating room; ATC = around the clock; HTN hypertension; CBC = complete blood cell count; BMP = basic metabolic panel; BTP = breakthrough pain; hx = history; postop = postoperative; POD = postoperative day; preop = preoperative; q = every; po = orally; iv = intravenous; bid = twice a day; q4-6 = every 4 to 6; q6h = every 6 hours; prn = as needed; IM = intramuscular; sc = subcutaneous; tid = three times a day.
internal oblique and transversus abdominis muscle. Then, 15 mL of 0.25% bupivacaine is injected; an intramuscular bulge is laparoscopically confirmed, which signifies that the anesthetic is being delivered into the plane. The procedure is performed at a second injection site on the same side and bilaterally.19 Acetaminophen Protocol
Starting on postoperative day 0, 1 g of intravenous acetaminophen (OFIRMEV, 1000 mg/100 mL) was administered every 6 hours. The administration was continued for at least 24 hours (4 g dose). At that point, if the patient was tolerating food by mouth, the intravenous acetaminophen
was transitioned to acetaminophen by mouth. The dose of 1 g every 6 hours was maintained until hospital discharge or 7 days postoperatively if the patient was not already discharged. Statistical Analysis
Statistical analysis was performed to compare the pre-TAP and TAP groups by using the Student paired t test; a 2-sided p value < 0.05 was considered statistically significant. Statistical process control was used to evaluate the impact of the TAP block and intravenous acetaminophen on outliers for LOS. An outlier was defined as any value outside of the (mean ± 1 SD).
197
Diseases of the Colon & Rectum Volume 57: 2 (2014)
3%
17%
Colon cancer
32%
Inflammatory bowel disease Diverticulitis Polyps
14%
Rectal cancer 14%
Other
20%
FIGURE 2. Indications for surgery.
RESULTS During the study period, 102 elective laparoscopic major colorectal procedures were performed with a TAP block and intravenous acetaminophen. Those cases were matched to 106 elective laparoscopic major cases without a TAP block or intravenous acetaminophen, leaving 208 cases included in the analysis. There was no difference in SILS or converted cases between groups in the matched analysis; each group had 2 converted cases and 1 SILS. The main indication for surgery was colon cancer (32%) (Fig. 2). The main operative procedure performed was a segmental colectomy (59%) (Fig. 3). The matched groups were similar in age, BMI, and comorbidities, as defined by ASA class, Modified Frailty Index, and Charlson Comorbidity Index (Table 1). Length of stay was significantly shorter once TAP and acetaminophen were introduced (p < 0.005), dropping from a mean 3.7 (median, 3 days) to a mean 2.6 days (median, 2 days). The most common postoperative complication in both groups was postoperative ileus/ small-bowel obstruction (44.4% postchange, 36.4% prechange). There were significantly more overall complications in the prechange group (p = 0.019). The rates of unplanned reoperation (3/22, 13.6% prechange vs 1/9, 11.1% postchange) were similar. There were no significant differences in readmissions or mortality. Direct costs were similar, but there was a $500 increase in total margin per case (p = 0.004) with the ERP changes (Table 2). With the use of statistical
7%
3% 3%
2% Operative procedure Segmental colectomy 26%
59%
Low anterior resection Abdominoperineal resection Total proctocolectomy Ileoanal anastomosis
FIGURE 3. Surgical procedures performed.
process control to examine the effect on outliers, where LOS was plotted against days since ERP change, there was noticeably less variation from the mean LOS (2.29 vs 1.90 days, p < 0.001) after the addition of TAP blocks and intravenous acetaminophen (Fig. 4).
DISCUSSION Continuous quality improvement is crucial for ensuring quality outcomes in colorectal surgery. Studies have shown that evaluating surgical outcomes has the power to reduce complications, mortality, and financial expenditure.20 In colorectal surgery, a surgical self-audit of colorectal cancer cases helped reduce adverse surgical events by half, with a
TABLE 1. Patient demographic data Elective lap abdominal cases
Postchange
Prechange
Count of cases Age, mean (SD) BMI, mean (SD) ASA class, n (%) II III IV Modified Frailty Index Charlson Comorbidity Score
102 60.65 (15.82) 29.60 (5.42)
106 60.07 (18.70) 29.12 (6.80)
37 (36.3) 58 (56.8) 7 (6.9) 1.58 2.55
41 (38.7) 60 (56.6) 5 (4.7) 1.40 2.74
p – 0.84 0.62 0.60
0.32 0.66
198
KELLER ET AL: SPC TO EVALUATE CHANGES TO AN ERP
TABLE 2. Patient outcome data Elective lap abdominal cases
Postchange
Prechange
LOS, mean (SD) LOS, median (range) Operative time, min ICU stay required, n (%) Readmission, n (%) Unplanned reoperation, n (%) Postoperative complications, n (%) Postoperative ileus/small-bowel obstruction Superficial wound infection Anastomotic bleed Pneumonia/urinary tract infection Cardiac/pulmonary Anastomotic leak Thromboembolic Count of deaths (30-day) Average of hospital costs Average of total margin) Average of net revenue Average of cost per OR minute
2.58 (1.90) 2 (1–15) 181.93 (78.95) 2 (2.0) 3 (2.9) 1 (
