Journal of Pediatric Surgery xxx (2016) xxx–xxx
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Laparoscopic pyloromyotomy decreases postoperative length of stay in children with hypertrophic pyloric stenosis☆,☆☆ Justin B. Mahida a,b, Lindsey Asti b, Katherine J. Deans a,b, Peter C. Minneci a,b, Jonathan I. Groner a,⁎ a b
Department of Pediatric Surgery, Nationwide Children's Hospital, Columbus, OH Center for Surgical Outcomes Research, The Research Institute at Nationwide Children's Hospital, Columbus, OH
a r t i c l e
i n f o
Article history: Received 23 August 2015 Received in revised form 1 May 2016 Accepted 8 May 2016 Available online xxxx Key words: Pyloromyotomy Laparoscopic procedure Postoperative length of stay Pediatrics ACS NSQIP pediatric
a b s t r a c t Objective: To determine the impact of laparoscopic versus open pyloromyotomy on postoperative length of stay (LOS). Materials and methods: The 2013 National Surgical Quality Improvement Project Pediatric database was queried for all cases of pyloromyotomy performed on children b1 year old with congenital hypertrophic pyloric stenosis. Demographics, clinical, and perioperative characteristics for patients with and without a prolonged postoperative LOS, defined as N 1 day, were compared. Logistic regression modeling was performed to identify factors associated with a prolonged postoperative LOS. Results: Out of 1143 pyloromyotomy patients, 674 (59%) underwent a laparoscopic procedure. Patients undergoing open pyloromyotomy had a longer operative time (median 28 vs. 25 min, p b 0.001) but shorter duration of general anesthesia (median 72 vs. 78 min, p b 0.001). Patients undergoing open pyloromyotomy more frequently had a prolonged postoperative LOS (32% vs. 26%, p = 0.019). Factors independently associated with postoperative LOS N1 day included open pyloromyotomy (odds ratio, 95% confidence interval, p-value) (1.38, 1.03–1.84, p = 0.030), cardiac comorbidity (3.64, 1.45–9.14, p = 0.006), pulmonary comorbidity (3.47, 1.15–10.46, p = 0.027), lower weight (1.005 per 100 g decrease, 1.002–1.007, p b 0.001), longer preoperative LOS (1.35 per additional day, 1.13–1.62, p = 0.001), longer operative time (1.11 per additional 5 min, 1.05–1.17, p b 0.001), higher preoperative blood urea nitrogen (1.04 per additional mg/dl, 1.01–1.07, p = 0.012), and higher serum sodium (1.08 per additional mg/dl, 1.03–1.14, p = 0.004). Conclusions: Compared to laparoscopic pyloromyotomy, open pyloromyotomy is independently associated with a higher likelihood of a prolonged postoperative LOS. © 2016 Elsevier Inc. All rights reserved.
Hypertrophic pyloric stenosis affects 1.9 of every 1000 live births and pyloromyotomy is the standard of care for this condition [1,2]. The traditional approach for this procedure is a right upper quadrant transverse incision, although other “open” approaches, such as a
☆ Funding Support and Disclosures: This project is supported by intramural funding from the Department of Pediatric Surgery and the Center for Surgical Outcomes Research, The Research Institute at Nationwide Children's Hospital. 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. The authors have no other disclosures. The authors report no proprietary or commercial interest in any product mentioned or concept discussed in this article. ☆☆ Author contributions: JBM, and JIG contributed to study conception. All authors contributed to study design. JBM and LA performed data collection and analysis. JBM wrote the article. All authors provided critical review of the article. ⁎ Corresponding author at: Department of Pediatric Surgery, Nationwide Children's Hospital, 700 Children's Drive, Columbus, OH 43205. Tel.: +1 614 722 3919. E-mail address:
[email protected] (J.I. Groner).
periumbilical incision, have been described [3]. Although open pyloromyotomy is associated with a low complication risk, it results in scarring that has been associated with reports of worse body image and less satisfaction with scar cosmesis [4]. Laparoscopic pyloromyotomy has several potential advantages, including a shorter hospital stay, shorter postoperative recovery, less postoperative pain, lower complication rates, and improved cosmesis. However, these benefits as reported in published studies have been inconsistent [4–11]. Disadvantages, including higher likelihood of incomplete pyloromyotomy and perforation requiring reoperation, have been suggested by some studies [6,8] but have not been confirmed in randomized controlled trials [10,12]. The current study utilized prospectively collected, validated, and standardized data in the American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) Pediatric to perform a multi-institutional analysis to identify factors associated with a prolonged postoperative length of stay (LOS) in patients undergoing pyloromyotomy. Specifically, we wanted to assess if a laparoscopic
http://dx.doi.org/10.1016/j.jpedsurg.2016.05.006 0022-3468/© 2016 Elsevier Inc. All rights reserved.
Please cite this article as: Mahida JB, et al, Laparoscopic pyloromyotomy decreases postoperative length of stay in children with hypertrophic pyloric stenosis, J Pediatr Surg (2016), http://dx.doi.org/10.1016/j.jpedsurg.2016.05.006
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J.B. Mahida et al. / Journal of Pediatric Surgery xxx (2016) xxx–xxx
approach was associated with a decreased LOS or fewer postoperative complications.
1. Materials and methods The ACS NSQIP Pediatric is a multispecialty program that reports peer-reviewed, risk-adjusted 30-day postoperative outcomes for surgical cases performed on patients b18 years of age from participating institutions for the purpose of benchmarking and quality improvement. Dedicated surgical clinical reviewers at participating institutions collect more than 124 data elements (including information on demographics, preoperative and intraoperative variables, and postoperative occurrence and discharge variables) on patients selected by the ACS NSQIP 8-day cycle-based systematic sampling of 35 procedures per cycle [13–15]. All instances of pyloromyotomy performed on patients diagnosed with hypertrophic congenital pyloric stenosis based on the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD9-CM) code 750.5 with a primary Current Procedural Terminology (CPT) code of 43,520 in the 2013 ACS NSQIP Pediatric were included. For purposes of defining the minimally invasive nature of a case, the ACS NSQIP Pediatric categorizes all included cases into one of three options: minimally invasive technique only, minimally invasive and open technique, and open or not applicable [16]. Cases in which the surgical approach was coded as an open or not applicable procedure were included in the open pyloromyotomy cohort, and those for whom the surgical approach was coded as a minimally invasive procedure only were included in the laparoscopic pyloromyotomy cohort. Patients who were coded as having a minimally invasive and open procedure were defined as having undergone a laparoscopic procedure that was converted to an open approach. They were included in the laparoscopic pyloromyotomy cohort and included in all analyses comparing laparoscopic to open pyloromyotomy populations. Demographic, clinical, and 30-day outcome characteristics between patients who underwent an open versus a laparoscopic pyloromyotomy were compared and definitions for all NSQIP variables can be found elsewhere [16]. Patients with pulmonary risk factors were defined as any patient with a diagnosis of asthma, chronic lung disease, structural pulmonary disorder, cystic fibrosis, preoperative ventilator dependence, preoperative oxygen requirement, or a preoperative tracheostomy. Neurologic risk factors were defined as history of a cerebrovascular accident (CVA), tumor involving the central nervous system (CNS), seizure disorder, cerebral palsy, structural CNS abnormality, neuromuscular disorder, or intraventricular hemorrhage. Operation time was defined as the length of time between the initial surgical incision and closure of all surgical incisions. Total anesthesia time was defined as the length of time between initiation of induction of general anesthesia and handoff of the patient's care from the anesthesia provider to the postoperative care provider, inclusive of operation time. To separate operation time from total anesthesia time, postoperative anesthesia time, defined as the time between the end of surgery and handoff of the patient's care from the anesthesia provider to the postoperative care provider, was also compared. All complications were identified within 30 days of the operation, unless otherwise specified. Wound complications were defined as superficial surgical site infections (SSI), deep SSIs, organ or organ space SSIs, and wound disruption. Respiratory complications were defined as pneumonia, unplanned intubation, pulmonary embolism, and ventilator dependence N 48 h. Urinary tract complications included acute renal failure, progressive renal insufficiency, and urinary tract infection. Central nervous system complications included coma N 24 h, seizure, and nerve injury. Cardiovascular complications included cardiac arrest requiring cardiopulmonary resuscitation, CVA, and venous thromboembolism. Other complications included graft or prosthesis failure, postoperative systemic sepsis, unplanned reoperation, or death. Other outcomes included postoperative LOS,
unplanned readmission, and transfusion performed intraoperatively or within 72 h of surgery. Continuous variables were compared using Wilcoxon rank-sum tests and categorical variables were compared using Pearson chisquare tests or Fisher exact tests where appropriate for open versus laparoscopic pyloromyotomy. P-values b0.05 were considered statistically significant. A multivariable logistic regression model was fit to identify adjusted odds ratios (aOR) and 95% confidence intervals (CI) of preoperative factors predictive of a prolonged postoperative LOS, defined as a postoperative LOS N 1 day, which is consistent with prior studies [17,18]. Factors with p-value b0.20 in the univariable analysis were considered for inclusion in the backwards stepwise regression model. A pvalue b0.20 was chosen because less-stringent p-values used for univariable analysis may identify more important variables to include in the multivariable model [19,20]. The Hosmer–Lemeshow goodness of fit test was used to assess the adequacy of model fit to explain variation in the dataset with a p-value of b 0.05 required to accept our final model [19]. All analyses were performed using SAS 9.3 (Cary, NC). 2. Results Of 1143 patients with hypertrophic congenital pyloric stenosis who underwent pyloromyotomy, 674 (59%) were performed laparoscopically and 469 (41%) were open procedures. Thirty of the laparoscopic pyloromyotomies (4%) were converted to an open procedure. Table 1 shows demographics and preoperative characteristics for the two procedure type groups. Patients undergoing a laparoscopic procedure were more likely to identify as white, to weigh less, and to have a congenital malformation other than pyloric stenosis. Patients undergoing open surgery had longer operative times, but patients undergoing laparoscopic surgery had longer total anesthesia duration. Table 2 presents outcomes following surgery. Patients undergoing laparoscopic pyloromyotomy were less likely to have a postoperative LOS N 1 day. There were no differences in the number of patients experiencing a complication of any type between the two groups including the number of patients undergoing an unplanned related reoperation. On multivariable analysis (Table 3), the following factors were significantly associated with a postoperative LOS N 1 day (aOR, 95% CI): an open procedure (1.38, 1.03–1.84, p = 0.030), cardiac comorbidity (3.64, 1.45–9.14, p = 0.006), pulmonary comorbidity (3.47, 1.15–10.46, p = 0.027), lower weight (1.005 per 100 g decrease, 1.002–1.007, p b 0.001), longer preoperative LOS (1.35 per additional day, 1.13–1.62, p = 0.001), longer operative time (1.11 per additional 5 min, 1.05–1.17, p b 0.001), higher preoperative blood urea nitrogen (1.04 per additional mg/dl, 1.01–1.07, p = 0.012), and higher serum sodium (1.08 per additional mg/dl, 1.03–1.14, p = 0.004). 3. Discussion Compared to laparoscopic pyloromyotomy, open pyloromyotomy was independently associated with a higher likelihood of a postoperative LOS N1 day. Laparoscopic pyloromyotomy was not associated with an increased proportion of readmissions, need for initiation of supplemental nutrition, or other unintended consequences from the decreased postoperative LOS. These findings are consistent with previous studies comparing open and laparoscopic pyloromyotomy [6,10]. Patients undergoing laparoscopic pyloromyotomy were less likely in the current study to have a postoperative LOS N 1 day. This finding is consistent with previous studies noting a shorter postoperative LOS in patients undergoing laparoscopic pyloromyotomy [5,6]. One study notes that the reduced LOS is the main driver for a cost savings of 14% when comparing patients undergoing laparoscopic pyloromyotomy to patients undergoing open pyloromyotomy [5]. Tolerance of oral intake and postoperative pain control are the two main barriers to postoperative discharge for these patients. Previous studies demonstrate no difference in time to full feeding but reduced postoperative analgesic
Please cite this article as: Mahida JB, et al, Laparoscopic pyloromyotomy decreases postoperative length of stay in children with hypertrophic pyloric stenosis, J Pediatr Surg (2016), http://dx.doi.org/10.1016/j.jpedsurg.2016.05.006
J.B. Mahida et al. / Journal of Pediatric Surgery xxx (2016) xxx–xxx Table 1 Demographics and preoperative characteristics for patients with congenital hypertrophic pyloric stenosis who undergo laparoscopic versus open pyloromyotomy. Characteristic Patient demographics Age at surgery, days Neonate (NR: 215) Female Non-white race Prematurity (NR: 18) Weight, kg Comorbidities Weight loss N10%/failure to thrive Cardiac risk factors Pulmonary risk factors Neurologic risk factors Congenital malformation other than pyloric stenosis Hematologic disorder Developmental delay or impaired cognitive status Steroid use Need for nutritional support Hospital admission Transfer status From home, clinic, or outpatient clinic From emergency department Other Preoperative length of stay, days Admitted ≥1 day prior to date of surgery Preoperative serum sodium, mg/dL (NR: 55) Preoperative BUN, mg/dL (NR: 85) Preoperative creatinine, mg/dL (NR:88) Blood transfusions within 48 h before surgery ASA class ≥3 Surgery details Duration of time in the operating room, minutes Total anesthesia time, minutes Total operation time, minutes Conversion to open procedure
Open N = 469
Laparoscopic N = 674
P-value
35 (27–48) 133 (28) 66 (14) 131 (28) 33 (7) 4.0 (3.5–4.5)
34 (26–45) 181 (27) 104 (15) 152 (23) 45 (7)
0.625 0.666 0.526 0.038⁎ 0.817
19 (4) 14 (3) 9 (2) 1 (b0.5) 44 (9) 3 (1) 1 (b0.5) 1 (b0.5) 8 (2)
368 (78) 32 (7) 69 (15) 1 (0–1) 303 (65) 138 (137–140) 7 (5–10) 0.3 (0.3–0.4)
3.9 (3.5–4.4)
0.046⁎
30 (4) 17 (3) 15 (2) 3 (b0.5)
0.743 0.636 0.722 0.648
109 (16) 3 (0) 0 (0) 1 (b0.5) 12 (2)
480 (71) 59 (9) 135 (20) 1 (0–1) 466 (69)
0.001⁎ 0.694 0.410 1.000 0.925
0.022⁎ 0.279 0.108
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Table 2 30-day outcomes for patients with congenital hypertrophic pyloric stenosis who undergo laparoscopic versus open pyloromyotomy. Open N = 469
Outcome Postoperative LOS N1 day (NR: 2) Any postoperative complication Any incisional complication Superficial incisional SSI Deep incisional SSI Wound disruption Any respiratory complication Unplanned reintubation Ventilator dependence for N24 h Any urinary complication Urinary tract infection Any other complication Sepsis Initiated and discharged on supplemental nutrition Unplanned related reoperation Intraoperative or postoperative transfusion within 72 h Unplanned readmission
Laparoscopic P-value N = 674
150 (32) 173 (26) 15 (3) 17 (3) 7 (1) 4 (1) 5 (1) 2 (b0.5) 2 (b0.5) 0 (0) 1 (b0.5) 2 (b0.5) 4 (1) 6 (1) 2 (b0.5) 1 (b0.5) 2 (b0.5) 5 (1) 2 (b0.5) 1 (b0.5) 2 (b0.5) 1 (b0.5) 3 (1) 8 (1) 1 (b0.5) 1 (b0.5)
0.019⁎ 0.496 0.137 0.130 0.168 1.000 1.000 0.572 0.707 0.572 0.572 0.540 1.000
0 (0)
1 (b0.5)
3 (1)
6 (1)
0.744
3 (1)
2 (b0.5)
0.406
14 (3)
21 (3)
1.000
0.900
Results reported as frequencies (percent) for categorical variables and median (interquartile range) for continuous variables. LOS: length of stay. NR: number of patients for whom data is not reported. SSI: surgical site infection. There were no instances of the following complications: organ space SSI, pneumonia, pulmonary embolism, progressive renal insufficiency, acute renal failure, coma N24 h, seizure, nerve injury, intraventricular hemorrhage, cardiac arrest, cerebrovascular accident, venous thromboembolism, graft or prosthesis failure, or death. ⁎ Significant at p b 0.05.
139 (137–140) 0.388 8 (5–11)
0.181
0.3 (0.3–0.4)
0.651
2 (b0.5)
0 (0)
0.168
57 (12)
85 (13)
0.818
68 (58–78)
72 (60–85)
0.001⁎
72 (62–86) 28 (22–38) NA
78 (65–92) 25 (20–35) 30 (4)
b0.001⁎ b0.001⁎ NA
Results reported as frequencies (percent) for categorical variables and median (interquartile range) for continuous variables. NR: number of patients for whom data is not reported. BUN: blood urea nitrogen. ASA: American Society of Anesthesiologists. NA: not applicable. There were no instances of the following comorbidities: bleeding disorder or immune disease or immunosuppressant use. ⁎ Significant at p b 0.05.
requirements in patients undergoing laparoscopic pyloromyotomy may contribute to their shorter LOS [8,11]. The higher likelihood of having a LOS N1 day in with open pyloromyotomy in our study reflects a potentially important decrease in healthcare resource utilization with laparoscopic pyloromyotomy compared to open pyloromyotomy in clinical practice. We identified several preoperative risk factors associated with a postoperative LOS N1 day that have not been identified in previous studies. Elevated serum sodium and blood urea nitrogen are associated with a postoperative LOS N 1 day and may reflect suboptimal resuscitation of fluid losses prior to surgery. Cardiac and pulmonary risk factors and longer preoperative LOS were also associated with a postoperative LOS N1 day and may reflect greater comorbidity. Our findings are consistent with one previous study, noting that patients with lower weight and a longer preoperative LOS have an increased risk of prolonged hospitalization after pyloromyotomy [18]. Future analyses should account for these preoperative risk factors in reporting outcomes after open versus laparoscopic pyloromyotomy.
Patients undergoing laparoscopic pyloromyotomy had shorter operative times but longer times under general anesthesia. Previous prospective studies have disagreed as to whether laparoscopic operations are associated with shorter or longer operative or anesthesia times [4,6,8,10,11]. The current study, in comparison to these, presents multi-institutional data with standardized measures for operative time and anesthesia time. In addition, the current study indicates the importance of differentiating the two; longer operative time was associated with a prolonged postoperative LOS, but longer anesthesia time was not. Previous studies have reported concern that laparoscopic pyloromyotomy may be associated with an increased incidence of postoperative complications, such as incomplete pyloromyotomy and mucosal perforation, warranting reoperation and subsequently resulting in readmission or a prolonged postoperative LOS. One multicenter retrospective cohort study involving centers in the United States, United Kingdom, and Canada reported an increased risk of incomplete pyloromyotomy in patients undergoing laparoscopic pyloromyotomy [21]. In the current study, there is no difference in reoperation rates. Reoperation rates in the current study are consistent with previous randomized controlled trials [4,6,8]. Although the ACS NSQIP Pediatric does not report on the incidence of mucosal perforations that are repaired
Table 3 Adjusted odds ratios for independent predictors for a postoperative length of stay (LOS) N1 day.
Open surgery Lower weight, 100 g Cardiac risk factors Pulmonary risk factors Preoperative LOS, days Preoperative serum sodium, mg/dL Preoperative BUN, mg/dL Operation time, 5 min
aOR
95% CI
P-value
1.38 1.005 3.64 3.47 1.35 1.08 1.04 1.11
1.03–1.84 1.002–1.007 1.45–9.14 1.15–10.46 1.13–1.62 1.03–1.14 1.01–1.07 1.05–1.17
0.030 b0.001 0.006 0.027 0.001 0.004 0.012 b0.001
aOR: adjusted odds ratio; CI: confidence interval. BUN: blood urea nitrogen.
Please cite this article as: Mahida JB, et al, Laparoscopic pyloromyotomy decreases postoperative length of stay in children with hypertrophic pyloric stenosis, J Pediatr Surg (2016), http://dx.doi.org/10.1016/j.jpedsurg.2016.05.006
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J.B. Mahida et al. / Journal of Pediatric Surgery xxx (2016) xxx–xxx
intraoperatively, previous studies note that, when mucosal perforation occurs intraoperatively, it does not occur more frequently in laparoscopic pyloromyotomy [6]. There are several limitations to our study. Unlike previous studies, the current study does not report time from operation to feeding or why the feedings were initiated. Although the ACS NSQIP Pediatric does not provide data on feeding regimens or time from operation to feeding, previous studies indicate that feeding regimens do not impact postoperative LOS [22–24]. The ACS NSQIP Pediatric reports limited data on clinical factors that may have impacted the postoperative LOS, including postoperative complications and reoperations performed during the hospitalization. In addition, surgeon experience and institutional volume, two variables that influenced laparoscopic pyloromyotomy outcomes in other studies, were not available in the current study. Length of stay is also not reported in hours, which may have been more meaningful instead of LOS in days. It is also important to note that in some instances clinically significant relationships may be separate from statistically significant. Often this is evidenced by small but significant odds ratios. Finally, the sample size was too small to perform additional multivariable analyses of incisional complications or reoperation rates. Additional accrual of data into the ACS NSQIP Pediatric and participation by additional institutions will allow for future analysis with increased power to test these associations. 4. Conclusions Compared to open pyloromyotomy, laparoscopic pyloromyotomy is independently associated with lower odds of a postoperative LOS N 1 day. Other factors independently associated with a prolonged postoperative LOS in patients undergoing pyloromyotomy were lower weight, cardiac risk factors, pulmonary risk factors, longer preoperative LOS, elevated preoperative serum sodium, elevated preoperative blood urea nitrogen, and longer operative time. References [1] de Laffolie J, Turial S, Heckmann M, et al. Decline in infantile hypertrophic pyloric stenosis in Germany in 2000–2008. Pediatrics 2012;129:e901–6. [2] Wang J, Waller DK, Hwang LY, et al. Prevalence of infantile hypertrophic pyloric stenosis in Texas, 1999–2002. Birth Defects Res A Clin Mol Teratol 2008;82:763–7. [3] Lazar D, Naik B, Fitch ME, et al. Transumbilical pyloromyotomy with umbilicoplasty provides ease of access and excellent cosmetic results. J Pediatr Surg 2008;43:1408–10. [4] Siddiqui S, Heidel RE, Angel CA, et al. Pyloromyotomy: Randomized control trial of laparoscopic vs open technique. J Pediatr Surg 2012;47:93–8.
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Please cite this article as: Mahida JB, et al, Laparoscopic pyloromyotomy decreases postoperative length of stay in children with hypertrophic pyloric stenosis, J Pediatr Surg (2016), http://dx.doi.org/10.1016/j.jpedsurg.2016.05.006