Safety of next-day discharge following laparoscopic sleeve gastrectomy

Safety of next-day discharge following laparoscopic sleeve gastrectomy

Surgery for Obesity and Related Diseases 11 (2015) 525–529 Original article Safety of next-day discharge following laparoscopic sleeve gastrectomy A...

183KB Sizes 5 Downloads 36 Views

Surgery for Obesity and Related Diseases 11 (2015) 525–529

Original article

Safety of next-day discharge following laparoscopic sleeve gastrectomy Ahmad Elnahas, M.D.a, Allan Okrainec, M.D.C.M., M.H.P.E.a,b, Fayez A. Quereshy, M.D., M.B.A.a,b, Timothy D. Jackson, M.D., M.P.H.a,b,* a

Division of General Surgery, University Health Network, Toronto, Ontario, Canada b Department of Surgery, University of Toronto, Toronto, Ontario, Canada Received April 30, 2014; accepted August 22, 2014

Abstract

Background: The safety of next-day discharge after laparoscopic sleeve gastrectomy (SG) for the treatment of morbid obesity has not been well studied. The objective of this study was to determine if next-day discharge after laparoscopic SG was comparable to standard discharge (i.e., postoperative day [POD] 2) with respect to the rate of 30-day adverse events. Methods: A retrospective cohort analysis was performed. Patients were selected if they underwent a laparoscopic SG for morbid obesity between 2010 and 2012 and discharged on either POD 1 or 2. The primary outcome was the 30-day adverse event rate, which was a composite endpoint of complications, mortality, or reoperations. A multivariable logistic regression was performed to determine an adjusted odds ratio (OR) of 30-adverse events for next-day discharge. Results: There were 2982 (37.4%) and 4985 (62.6%) patients discharged on POD 1 and 2, respectively. Both groups were comparable with respect to clinical characteristics. The adjusted OR for 30-day adverse events with next-day discharge was .75 (P ¼ .08, 95% CI [.55–1.04]). Preoperative hypertension and dyspnea were significant predictors of adverse events for next-day discharge. Conclusion: Based on data from the ACS-NSQIP registry, laparoscopic SG patients discharged on POD 1 did not have a worse rate of 30-day adverse events compared to the POD 2 group. Appropriate perioperative evaluation may help surgeons implement next-day discharge for select patients after uncomplicated laparoscopic SG. (Surg Obes Relat Dis 2015;11:525–529.) r 2015 American Society for Metabolic and Bariatric Surgery. All rights reserved.

Keywords:

Morbid obesity; Laparoscopic sleeve gastrectomy; Next-day discharge

The laparoscopic sleeve gastrectomy (SG) continues to become an increasingly popular operation and now accounts for almost 28% of bariatric procedures worldwide [1]. The laparoscopic SG appears to be safe with a favorable risk profile compared with other available surgical options [2–4]. As well, the laparoscopic SG as a definitive operation has proven to be clinically effective in the treatment of morbid obesity [5–8]. * Correspondence: Dr. Timothy D. Jackson, M.D., M.P.H., University Health Network – Toronto Western Hospital, 399 Bathurst Street, Room 8 MP-322, Toronto, Ontario, M5 T 2 S8 Canada. E-mail: [email protected]

Within bariatric centers of excellence, very good clinical outcomes after laparoscopic SG can be achieved with relatively short hospital stays [9]. In fact, participating hospitals in the American College of Surgeons’ Bariatric Surgery Center Network reported mean hospital stays between 2 and 3 days for both laparoscopic Roux-en-Y gastric bypass and SG operations [2]. Furthermore, bariatric centers are increasingly implementing next-day discharge protocols for select patients in an effort to improve resource utilization [7,10]. The purpose of this study was to evaluate the safety of next-day discharge after laparoscopic SG by comparing the 30-day adverse event rate in patients discharged the

http://dx.doi.org/10.1016/j.soard.2014.08.013 1550-7289/r 2015 American Society for Metabolic and Bariatric Surgery. All rights reserved.

526

A. Elnahas et al. / Surgery for Obesity and Related Diseases 11 (2015) 525–529

next-day versus those discharged on postoperative day (POD) 2. Methods Data source A retrospective cohort analysis was performed using data from the American College of Surgeons’ National Surgical Quality Improvement Program (ACS-NSQIP) between 2010 and 2012. The ACS-NSQIP is a nationally validated, risk-adjusted database that uses well-defined variables to capture 30-day clinical outcomes on patients undergoing major operations [11–15]. The study protocol was approved by the Institutional Research Ethics Board. Patient selection Patients were selected from the ACS-NSQIP participant use data files using the current procedural terminology code 43775. Patients included in the study must have undergone a laparoscopic SG for the treatment of morbid obesity between 2010 and 2012 and discharged on either POD 1 or 2. Patients were excluded if they had prior surgery within 30 days, a relative contraindication to bariatric surgery, or any recorded complication/death during their principal admission. Statistical analysis Differences in baseline demographic characteristics, comorbidities, and outcomes were described. A univariate analysis was performed to compare patient characteristics across both groups. A Fisher’s exact test was used to compare categorical variables and a 2-tailed t test to compare continuous variables. An adverse event was defined as a composite outcome for any complication, mortality, or reoperation. Complications were defined as the following diagnoses: pneumonia; superficial and deep incisional surgical site infections; abdominal sepsis; bleeding transfusions; unplanned intubation; pulmonary embolism; deep venous thromboembolism; stroke; myocardial infarction; cardiac arrest; sepsis/septic shock; and urinary tract infections. A multivariable logistic regression analysis was performed to adjust for confounding and identify possible significant predictors of 30-day adverse events. Independent predictors were chosen a priori and included the following demographic and clinical variables: age; body mass index (BMI) Z 50 (i.e., super-obesity); male sex; positive smoking status; dependent functional status; operative time; preoperative hypertension; history of diabetes; preoperative dyspnea; history of bleeding disorder; and steroid use for chronic conditions. All statistical analyses were performed using SAS v9.3 software (Cary, NC).

Results A total of 7967 patients underwent a laparoscopic SG during the study period. There were 2982 (37.4%) and 4985 (62.6%) patients discharged on POD 1 and 2, respectively (Table 1). A comparison of patient demographic characteristics between groups revealed statistical differences with respect to the proportion of females (75.4% versus 77.4%; P ¼ .04), mean BMI (45.5 versus 46.5; P o .001), and mean operative minutes (89.6 versus 96.6; P o .001). Considering co-morbidities, only patients with chronic obstructive pulmonary disease (0.4% versus 1.3%; P o .001) and preoperative dyspnea (11.9% versus 15.3%; P o .001) were found to be statistically different with fewer patients in the next-day discharge group. With respect to study outcomes, 167 (2.1%) patients had at least 1 postoperative complication, 55 (0.7%) patients underwent a reoperation, and 2 (0.03%) patients died (Table 2). In total, there were 200 (2.5%) patients with recorded adverse events within 30 days of surgery. The adjusted OR for next-day discharge was .75 but did not reach statistical significance (P ¼ .08, 95% CI [.55– 1.04]). Preoperative dyspnea and a history of hypertension requiring medications were both found to be significant predictors for adverse events in patients discharged the next day (Table 3). A power analysis was also performed to determine the detectable effect size using an alpha set at .05 and a power of .80. The results showed that a 30% change would be needed to detect a significant difference across groups. Because the adverse event rate is already quite low in the study population, requiring a larger sample size to detect a smaller difference did not seem necessary from a clinical perspective.

Discussion This study found that patients with uncomplicated procedures and hospital stays discharged the next day did not have a significantly higher rate of 30-day adverse events compared to patients discharged on POD 2. However, preoperative hypertension and dyspnea were found to be significant predictors of adverse events in patients discharged the next day. There have been few previous studies addressing the safety and feasibility of next-day discharge after laparoscopic SG. A randomized clinical trial by Lemanu et al. [16] looked at the effect of an enhanced recovery protocol following laparoscopic SG and determined that it significantly reduced hospital stay and costs without compromising postoperative morbidity. Another study by Billing et al. [7] reviewed outcomes in 250 consecutive patients that received a laparoscopic SG at a single ambulatory surgical center. They concluded that outpatient laparoscopic SG operations could be performed safely in carefully selected patients. However, they also acknowledged that more

Next-day Discharge after Sleeve Gastrectomy / Surgery for Obesity and Related Diseases 11 (2015) 525–529

527

Table 1 Descriptive statistics of patient and operative characteristics

Mean age (yr) [SD] Sex Female (%) Male Mean BMI (kg/m2) [SD] Mean operative time (min) [SD] Smoker† Yes (%) No Bleeding disorders Yes (%) No Steroid use for chronic condition Yes (%) No Diabetes requiring medication Yes (%) No Hypertension requiring medication Yes (%) No Dyspnea‡ Yes (%) No History of severe COPD Yes (%) No Previous PCI Yes (%) No

POD 1 (n ¼ 2982)

POD 2 (n ¼ 4985)

Total (n ¼ 7967)

P value

43.4 [10.8]

43.5 [11.2]

N/A

.63

2245 (75.4) 733 45.5 [7.6] 89.6 [39.5]

3840 (77.4) 1120 46.5 [8.2] 96.6 [45.7]

6085 (76.7) 1853 N/A N/A

.04*

275 (9.2) 2707

521 (10.5) 4464

796 (10.0) 7171

.08

16 (.5) 2966

46 (.9) 4939

62 (.8) 7905

.07

25 (.8) 2957

60 (1.2) 4925

85 (1.1) 7882

.14

425 (15.1) 2390

775 (16.8) 3828

1200 (16.2) 6218

.05

1383 (46.4) 1599

2452 (49.2) 2533

3835 (48.1) 4132

.02*

354 (11.9) 2628

763 (15.3) 4222

1117 (14.0) 6850

o.001*

13 (.4) 2969

67 (1.3) 4918

80 (1.0) 7887

o.001*

9 (.9) 1047

29 (.9) 2074

38 (1.2) 3121

.23

o.001* o.001*

BMI ¼ body mass index; COPD ¼ chronic obstructive pulmonary disease; N/A ¼ not applicable; PCI ¼ percutaneous coronary intervention; POD ¼ postoperative day; SD ¼ standard deviation. * P o .05 was considered statistically significant. † Smoker defined as any patient who has smoked cigarettes within a year of surgical admission. ‡ Dyspnea diagnosis based on the clinician’s focused history and examination.

studies are needed to establish guidelines for patient selection and postoperative protocols. The question of safety for early discharge after laparoscopic SG can be addressed using the ACS-NSQIP registry, which captures short-term outcome data for quality improvement purposes. However, as with any retrospective analysis, cohort selection in this study has the potential to introduce bias. It is well known that prolonged length of stay can be associated with complications. Therefore, patients discharged on POD 2 in this study could have been more likely to experience adverse events. To minimize this bias, the analysis excluded all patients with any recorded complication or death before discharge. In other words, only adverse events occurring after discharge but within 30 days from surgery were regarded as positive outcomes for the analysis. The purpose of this study was not to predict which select patients were more suitable for next-day discharge, but question the practice of delaying discharge for well patients that underwent uncomplicated surgery because of standard protocols.

This study has several other important limitations. Firstly, hospital and surgeon experience with bariatric surgery could not be accounted for in this database, even though these factors are known to influence time to discharge [17]. Therefore, it may be difficult to extrapolate the results of this study to all hospitals that are currently performing bariatric surgery, which is a clear limitation of the NSQIP Table 2 Summary of 30-day adverse events based on discharge day

Postoperative complication Yes (%) No Reoperation Yes (%) No Mortality Yes (%) No POD ¼ postoperative day.

POD 1 (n ¼ 2982)

POD 2 (n ¼ 4985)

Total (n ¼ 7967)

53 (1.8) 2929

114 (2.3) 4871

167 (2.1) 7800

15 (.5) 2967

40 (.8) 4945

55 (.7) 7912

0 2982

2 (.04) 4983

2 (.03) 7965

528

A. Elnahas et al. / Surgery for Obesity and Related Diseases 11 (2015) 525–529

Table 3 Multivariable logistic regression analysis of 30-day adverse events Outcome

Predictors*

30-d adverse events

Next-day discharge Dyspnea Hypertension

Adjusted OR (95% CI) P value .75 (.55 – 1.04)

.08

1.80 (1.25 – 2.60) 1.42 (1.01 – 1.98)

.002 .04

CI ¼ confidence interval; OR ¼ odds ratio. Only key predictor and statistically significant (P o .05) predictors are included. *

database. However, the ACS-NSQIP is a nationally representative registry that includes a wide variety of participating institutions, ranging from small, rural hospitals to large urban academic centers. Furthermore, the effect of patient distance from hospital could not be evaluated using this database since there was no information on the proximity of patients after discharge. Although patients discharged early and living in remote areas are commonly advised to remain near the hospital for several days, the effect of this practice on patient safety or readmissions is not yet clear. The effect of some clinically relevant variables such as sleep apnea, which was not captured by the registry, could also not be evaluated. Patients with sleep apnea may require more monitoring after surgery and may not always be suitable for next-day discharge. Discharge planning for these patients should remain based on individual clinical assessment. Further research could attempt to incorporate these above potential confounders in the analysis. As well, given that this study did not evaluate readmissions, more research is needed to determine if patients sent home the next-day might be more likely to return to hospital. In the era of enhanced recovery programs and “fasttrack” surgery, surgeons are increasingly searching for suitable procedures to incorporate into these pathways. Patients undergoing laparoscopic SG may be good candidates for these models of care, because the operation and perioperative care can be easily standardized [18]. As well, the low complication rates and short operative times associated with laparoscopic SG can provide further incentive to adopt the procedure in an outpatient setting [9]. Nonetheless, the greatest barrier to the adoption of next-day discharge has been concern over missing early staple-line complications such as leaks or hemorrhage. Therefore, patient safety and quality must remain paramount to prevent delaying treatment for such complications. In this study, preoperative hypertension and dyspnea were found to be significant predictors of adverse risk, which suggests patients with cardiovascular and respiratory co-morbidities may not be appropriate for next-day discharge. Undoubtedly, the successful implementation of next-day discharge after uncomplicated laparoscopic SG in high-volume bariatric centers will be contingent on the proper selection of patients.

Conclusion In conclusion, laparoscopic SG patients that were discharged on POD 1 did not have a significantly higher rate of adverse events compared to patients discharged on POD 2. This finding provides a better understanding of the relationship between discharge timing and clinically relevant shortterm outcomes in a well patient population. The predictors of 30-day adverse events based on the analysis may also help bariatric surgeons further characterize this relationship. However, further research will be needed to better define the bariatric patient that may benefit most from next-day discharge.

Disclosures The authors have no commercial associations that might be a conflict of interest in relation to this article. The American College of Surgeons National Surgical Quality Improvement Program and the hospitals participating in the ACS-NSQIP are the source of the data used herein; they have not verified and are not responsible for the statistical validity of the data analysis or the conclusions derived by the authors.

References [1] Buchwald H, Oien DM. Metabolic/bariatric surgery worldwide 2011. Obes Surg 2013;23:427–436. [2] Hutter MM, Schirmer BD, Jones DB, et al. First report from the American College of Surgeons Bariatric Surgery Center Network: laparoscopic sleeve gastrectomy has morbidity and effectiveness positioned between the band and the bypass. Ann Surg 2011;254: 410–20. [3] Jackson TD, Hutter MM. Morbidity and effectiveness of laparoscopic sleeve gastrectomy, adjustable gastric band, and gastric bypass for morbid obesity. Adv Surg 2012;46:255–68. [4] Brethauer SA, Hammel JP, Schauer PR. Systematic review of sleeve gastrectomy as staging and primary bariatric procedure. Surg Obes Relat Dis 2009;5:469–75. [5] Chang SH, Stoll CR, Song J, Varela JE, Eagon CJ, Colditz GA. The effectiveness and risks of bariatric surgery: an updated systematic review and meta-analysis, 2003-2012. JAMA Surg 2014;149:275–87. [6] Strain GW, Saif T, Gagner M, Rossidis M, Dakin G, Pomp A. Crosssectional review of effects of laparoscopic sleeve gastrectomy at 1, 3, and 5 years. Surg Obes Relat Dis 2011;7:714–9. [7] Billing PS, Crouthamel MR, Oling S, Landerholm RW. Outpatient laparoscopic sleeve gastrectomy in a free-standing ambulatory surgery center: first 250 cases. Surg Obes Relat Dis 2014;10:101–5. [8] Karmali S, Schauer P, Birch D, Sharma AM, Sherman V. Laparoscopic sleeve gastrectomy: an innovative new tool in the battle against the obesity epidemic in Canada. Can J Surg 2010;53:126–32. [9] Bellanger DE, Greenway FL. Laparoscopic sleeve gastrectomy, 529 cases without a leak: short-term results and technical considerations. Obes Surg 2011;21:146–50. [10] Sasse KC, Ganser JH, Kozar MD, et al. Outpatient weight loss surgery: initiating a gastric bypass and gastric banding ambulatory weight loss surgery center. J Laparoendosc Adv Surg Tech A 2009;13:50–5.

Next-day Discharge after Sleeve Gastrectomy / Surgery for Obesity and Related Diseases 11 (2015) 525–529 [11] Khuri SF, Henderson WG, Daley J, et al. The patient safety in surgery study: background, study design, and patient populations. J Am Coll Surg 2007;204:1089–102. [12] Khuri SF, Daley J, Henderson W, et al. Risk adjustment of the postoperative mortality rate for the comparative assessment of the quality of surgical care: results of the National Veterans Affairs Surgical Risk Study. J Am Coll Surg 1997;185:315–27. [13] Daley J, Khuri SF, Henderson W, et al. Risk adjustment of the postoperative morbidity rate for the comparative assessment of the quality of surgical care: results of the National Veterans Affairs Surgical Risk Study. J Am Coll Surg 1997;185:328–40. [14] Daley J, Forbes MG, Young GJ, et al. Validating risk-adjusted surgical outcomes: site visit assessment of process and structure. National VA Surgical Risk Study. J Am Coll Surg 1997;185:341–51.

529

[15] Khuri SF, Henderson WG, Daley J, et al. Successful implementation of the Department of Veterans Affairs’ National Surgical Quality Improvement Program in the private sector: the patient safety in surgery study. Ann Surg 2008;248:329–36. [16] Lemanu DP, Singh PP, Berridge K, et al. Randomized clinical trial of enhanced recovery versus standard care after laparoscopic sleeve gastrectomy. Br J Surg 2013;100:482–9. [17] Courcoulas A, Schuchert M, Gatti G, Luketich J. The relationship of surgeon and hospital volume to outcome after gastric bypass surgery in Pennsylvania: a 3-year summary. Surgery 2003;134:613–21. [18] Lancaster RT, Hutter MM. Bands and bypasses: 30-day morbidity and mortality of bariatric surgical procedures as assessed by prospective, multicenter, risk-adjusted ACS-NSQIP data. Surg Endosc 2008;22:2554–63.