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September 15, 2008

Long-term Antireflux Medication Use Following Pediatric Nissen Fundoplication

Author Affiliations

Author Affiliations: Division of Pediatric Surgery (Drs Lee, Sydorak, and Applebaum), Department of Surgery (Drs Lee, Sydorak, Hsu, Applebaum, and Haigh and Ms Chiu), Kaiser Permanente, Los Angeles Medical Center, Los Angeles, California.

Diana L. Farmer, MD, San Francisco, California: This is a retrospective cohort study using the Southern California Kaiser database to determine the use of antireflux medications after Nissen fundoplication in the pediatric population. The authors identified 342 patients under the age of 18 years who had Nissen fundoplication between the years of 1996 and 2005 (a total span of 10 years). The study showed that the overall incidence of antireflux medications significantly decreased after antireflux surgery. For example, the odds of prescribed antireflux medications decreased by 0.63 (P value of .002). However, approximately 75% of the patients were restarted on antireflux medications within the first year after the operation. When the cohort was stratified by neurological disorders, the authors found that the need for antireflux medications was unchanged for patients with neurological disorders, while there was a decrease in use for patients without neurological disorders.

The results of this study in conjunction with the recently published article in the Journal of Pediatric Surgery (where the same authors demonstrated that the incidence of subsequent hospitalization for pulmonary complications after Nissen fundoplication did not change) make me question what the benefits are of antireflux operation in children with neurological disorders.

Was the change in antireflux medications before or after the operation statistically significant or not in the strata of neurologically impaired and neurologically normal patients? In addition, I ask the authors if the use of antireflux medications after fundoplication is a time-dependent event? If so, the follow-up time for each patient becomes very important in the study, and a survival analysis may be the most appropriate statistical analysis. I suspect that the patients who were found not on antireflux medications after fundoplication may not have been followed up long enough.

Dr Applebaum: It was a great surprise for us to find such a high level of antireflux medication usage so soon after what we thought to be technically successful procedures, but in fact, in our neurologically normal children, a 60% incidence of return to medication is relatively close to the 50% incidence reported in some studies of adult patients.

As far as the statistical significance of our data, there was statistical significance for neurologically normal children. There was no significance for neurologically impaired children.

With regard to the use of antireflux medications being a time-dependent event, it probably is, but the large majority of patients going back on medications do so within a few months to a year of fundoplication, so a survival analysis likely would not change the results of the study.

I would like to briefly touch upon why kids might appear to have more problems than adults. Growth is likely an important predisposing factor in children that may lead to complete or partial disruption of wraps and a return to symptoms. In many neurologically devastated children, growth is markedly asymmetrical and is often accompanied by an increasing degree of scoliosis and respiratory compromise. Enlargement and shifting of tissues can result in a great deal of strain on sutures. In our practice it is not uncommon for even neurologically normal children to return every 7 or 8 years, usually following growth spurts with a relatively sudden return of symptoms.

The other major factor for a return of antireflux medications in children as well as in adults is a lack of diagnostic sophistication on the part of primary care physicians. Any abdominal or pulmonary symptom, be it related to proven acid reflux or not, can become an indication. Children with neurological disabilities may have additional nasopharyngeal reflux, and all may have dysmotility of 1 or more parts of the GI [gastrointestinal] tract.

While a fundoplication usually improves the overall sense of well-being, it will obviously fail to resolve symptoms related to these problems. The critical question, as was brought up of course, is will we continue to recommend fundoplications in children either with or without neurological symptoms? We have witnessed a dramatic decrease in referrals for this procedure in the past several years as medical therapy becomes more potent. Those who are eventually referred have the most incapacitating problems, and it is in these children that any significant decrease in symptomatology, even if less than complete or permanent, is greatly appreciated by patients and caregivers. A further refined and standardized preoperative workup may make complete resolution of symptoms more of a reality.

Arch Surg. 2008;143(9):873-876. doi:10.1001/archsurg.143.9.873

Hypothesis  Nissen fundoplication decreases the use of antireflux medications.

Design  Retrospective cohort study using discharge abstract data and pharmacy data.

Setting  Twelve regional Kaiser Permanente hospitals in southern California.

Patients  Three hundred forty-two patients underwent Nissen fundoplication.

Intervention  Nissen fundoplication.

Main Outcome Measure  Use of antireflux medications.

Results  The number of patients requiring antireflux medications decreased from 233 patients (68.1%) before Nissen fundoplication to 197 (57.6%) after Nissen fundoplication. Of the 233 patients, 176 (75.6%) were restarted on antireflux medications within 1 year after Nissen fundoplication. Use of antireflux medication decreased in neurologically healthy patients but was unchanged in neurologically impaired children.

Conclusions  Use of antireflux medication decreased after Nissen fundoplication. Neurologically healthy children showed the biggest decrease in antireflux medication use after Nissen fundoplication.