Antireflux Surgery Outcomes in Pediatric Gastroesophageal Reflux Disease

Diego M. Diaz, M.D., M.Sc.; Troy E. Gibbons, M.D.; Kurt Heiss, M.D.; Mark L. Wulkan, M.D.; Richard R. Ricketts, M.D.; Benjamin D. Gold, M.D.


Am J Gastroenterol. 2005;100(8):1844-1852. 

In This Article

Materials and Methods

We conducted a retrospective, follow up study of patients undergoing Nissen fundoplication for any indication at Children's Healthcare of Atlanta at Egleston Children's Hospital. Included in the study were 473 patients with ages ranging from newborns to 60 months. The subjects whose data were evaluated underwent Nissen fundoplication during the period of January 1, 1997 to December 31, 2002. At our institution five pediatric surgeons perform fundoplication. Exclusion criteria for data analysis were incomplete preoperative data (n = 3), acute conversion from LNF to ONF (n = 4), and children with underlying congenital anatomic anomalies of the esophagus (n = 10). Data from the hospital course and long-term surgical outcomes were retrieved from hospital charts and electronic medical records on 456 patients who underwent LNF or ONF. Demographic patient data collected on this cohort included age in months, gender, and underlying diagnoses. Hospital course data included complications such as acute intraoperative bleeding, acute respiratory problem (pneumonia, atelectasis, and bronchospasm), infection (peritonitis, surgical wound, or blood infection), and prolonged ileus (more than 48 h). The length of hospital stay (LOS) was defined as number of days from the day of operation until discharge. Included in the analysis were patients who had prolonged hospitalization for reasons unrelated to the fundoplication procedure. In such cases, hospitalization related to fundoplication was considered to be complete at the time of surgical clearance for discharge. Long-term surgical outcome was the need or lack thereof for reoperation. Mean follow-up time was 36.2 months (SD: 10.9). Outcome data on children who expired during the follow-up period (n = 9) were also included in the analysis; information collected included events occurring up until the time of death.

GERD was defined as the signs, symptoms, or complications occurring due to passage of gastric contents into the esophagus and/or oropharynx.[1] Indications for surgery included persistent GERD-related symptoms, complications from GERD not resolved from medical therapy, and surgeon clinical decision. Patients were referred for surgery from both inpatient and/or outpatient pediatricians and pediatric subspecialists. Data on the type of preoperative evaluation were not available for all patients, and some were referred based on the clinical decision of the referring physician. For postoperative risk factor assessment, the diagnoses included in the analysis were those previously reported in the literature as potential risk factors for reoperation.[2–4,17,22–27] These clinical diagnoses included prematurity, categorized as infants born at less than or equal to 29 gestational wk, and infants born between 30 and 36 gestational wk (gestational age at birth as determined by neonatology records); neurological impairment (cerebral palsy, seizure disorder, and spasticity); chronic respiratory conditions (bronchopulmonary dysplasia, persistent asthma, recurrent pneumonia, need for oxygen supplementation, and ventilator dependant patients); and cardiac disease (complex heart defects and other cardiac conditions that required medical or surgical management). Age at initial operation was categorized in three distinct strata; less than 15 months, 6–11 months, and 12–60 months. The study was approved and Health Insurance Portability and Accountability Act (HIPAA) authorization granted by the institutional review board at Emory University and Children's Healthcare of Atlanta.

All statistical analyses were performed using the SAS 8 software package (SAS Institute, Cary, NC). All reported p values were two-sided, those <0.05 were considered as significant. Data were analyzed using univariate logistic regression, then a multiple logistic regression model was used to assess the association between the type of initial procedure and the risk of reoperation, while adjusting for the possible confounding effects of age at initial operation, and patient comorbidities that were related to this risk in previous studies. Reoperation was the primary outcome variable. Odds ratios and 95% confidence intervals (CI) were estimated for the effect of independent variables on reoperation; these measures of association were estimated before and after adjustment by using the logistic regression procedure (LOGISTIC and GENMOD). Independent variables were those considered risk factors or potential confounding factors for reoperation a priori. These variables were included in the final model, and thus plausibility due to their potential biologic significance in influencing outcomes of operation.

The independent variables were type of initial procedure (LNF vs ONF), age category at initial operation, history of prematurity, gender, cardiac disease, chronic respiratory conditions, neurological impairment, and history of reflux alone. These variables were analyzed by univariate logistic regression, and then included in the multivariate logistic regression model; statistical significance of covariates was determined by Wald's χ2. Goodness-of-fit of the resulting model was evaluated by means of the Hosmer-Lemeshow test, by systematic exploration for possible interaction effects, and by evaluation of the contributions of individual subjects to the quantitative Results. Furthermore, multiple logistic regression analysis was used to create a model to predict the probabilities of reoperation for LNF and ONF utilizing the independent variables studied. Survival analysis was performed by the Kaplan-Meier method to estimate reoperation rates for LNF and ONF, with comparisons based on the two-sided log-rank test. p < 0.05 was considered significant. Tests of statistical significance (p values) and 95% CI for the odds ratio and comparison of proportions were calculated by the χ2 test or Fisher's exact test, as appropriate. Because of their non-Gaussian frequency distribution, continuous data (LOS and age at initial operation) are presented as medians and ranges and evaluated by nonparametric statistics using the Wilcoxon rank-sum test.


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