This study is the first to use data from the PHIS network to examine laparoscopic fundoplication and its association with quality and cost outcomes. A number of single-center retrospective studies have examined patient outcomes by type of pediatric fundoplication. For instance, Somme et al5
examined 55 infants who underwent fundoplication from 1996 through 2000 and found that the time to initiation of feeding postoperatively was shorter in the laparoscopic group. Mattioili et al4
examined a group of 66 children who underwent fundoplication from 1993 through 1997 and found a lower postoperative LOS in the laparoscopic group. Diaz et al3
examined 762 patients and found evidence that open fundoplication resulted in lower reoperation rates than the laparoscopic approach. These and similar studies2,17–19
have added to our knowledge, but all suffered from shortcomings of some kind, including the inherent bias in analyzing one's own work, the uncontrolled nature of the patient selection, and the lack of a standard set of outcome measures. In contrast, we used a large, multicenter dataset, attempted to control for case mix using multiple methods, and examined standard outcome measures.
We found that the laparoscopic approach is the most prevalent form of antireflux surgery in the population studied, but open fundoplication was more common among children who were less than 1 year old. In addition, we found that patients on whom the laparoscopic procedure was performed had fewer surgical complications and infections, shorter LOS, and lower cost of care than their counterparts who had open fundoplication, although their unadjusted per-day costs were higher. Multivariate regression analysis confirmed that the laparoscopic approach was associated with lower risks of surgical complication and infection as well as shorter LOS. In addition, the multivariate regression analysis showed that laparoscopic fundoplication was associated with lower total cost of care, but the strength of this association was substantially reduced when LOS, surgical complication, and infection were added to the estimating model, consistent with the hypothesis that these are important mediating factors.
It is known that children with neurologic impairment present an enormous challenge with regard to fundoplication. They suffer more reflux- and aspiration-related morbidity and have higher surgical complication rates from fundoplication.9,20,21
Our results were consistent with those of previous studies. Specifically, we found that neurologic impairment or complex chronic conditions increased the odds of infection and surgical complication. In addition, they showed that the laparoscopic approach was associated with fewer surgical complications for children with neurologic impairment.
We found substantial variation across hospitals in the use of the laparoscopic procedure. At the same time, most of the hospitals studied showed a consistent trend toward more procedures being performed laparoscopically. Publicly available data from Health Care Cost and Utilization Project show that in 2006 ~44% of all pediatric fundoplications in the United States were performed in the laparoscopic fashion.12
This is ~8 percentage points lower than what we found in the PHIS data. If we assume that the PHIS database is sentinel in nature, patients seen at general hospitals and children's units may see a rise in the percentage of fundoplications done laparoscopically.
Our physician-level data may have important training implications. We showed that there is a cadre of pediatric surgeons who do not utilize the laparoscopic approach and that the variation in the choice of procedure was associated with the individual surgeon. If the superiority of the laparoscopic technique is confirmed in prospective studies, this group of surgeons may benefit from additional training.
We sought to determine whether the introduction of the laparoscope technique resulted in an increase in the overall utilization of fundoplication. Early experience with adult laparoscopic cholecystectomy provides a cautionary tale: there was a 17% increase in total inpatient spending for gall bladder surgery because the threshold for performing the procedure was lowered.22
Our data are reassuring: laparoscopic fundoplication is associated with lower adjusted hospital costs, and yet the threshold for performing the procedure does not seem to have shifted.
Our data source does not include all pediatric fundoplications performed in the country, and this could limit its generalizability. Moreover, the PHIS database is based on administrative records, which have important limitations, including possible coding errors and the inability to randomize. Our sample excluded patients whose primary surgical procedure was not fundoplication, and, therefore, we cannot draw conclusions about these patients. Our analysis had a look-back period of 5 years, but not all hospitals contributed data during the look-back period; as a result, the history of previous fundoplication was underestimated. The PHIS database has no information on physician charges, which would impact the overall cost of the procedure, and it is possible that some pediatric surgeons moved from one participating hospital to another. Decisions about short gastric-vessel division, the tightness of the wrap, crural dissection and repair, and partial fundoplications could not be determined but may have impacted outcomes. Finally, we were unable to account for any procedures that were “converted” from a laparoscopic to open approach intraoperatively.