|Year : 2016 | Volume
| Issue : 1 | Page : 1-4
Nissen fundoplication in severely ill infants: A STROBE compliant study
John Yoon1, Sathyaprasad Burjonrappa2
1 St. Joseph's Regional Medical Center, Patterson, NJ, USA
2 St. Joseph's Regional Medical Center, Patterson; Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, USA
|Date of Submission||09-Nov-2015|
|Date of Acceptance||05-Jan-2016|
|Date of Web Publication||1-Apr-2016|
Montefiore Medical Center, Albert Einstein College of Medicine, 335 Bainbridge Avenue, Bronx, NY 10467
Source of Support: None, Conflict of Interest: None
Aim: Anti-reflux surgery is offered to those who fail medical management for gastroesophageal reflux disease (GERD) in the pediatric population. A handful of studies show that those with neurologic impairment have benefited from these procedures; however, there are a few studies that document the indications and outcomes for infants < 6 months of age. Methods: A retrospective analysis of children < 6 months of age who underwent a Nissen fundoplication (NF) at St. Joseph's Regional Medical Center from December 2006 to June 2013 was performed. The following factors, such as surgical indications, comorbidities, hospital course data, weight gain, length of stay, and complications, were analyzed. Results: A total of 23 patients with the average age of 95.8 days were studied in this analysis. Presurgery, the average weight of these patients was 9.88 percentile (interquartile range: 5.85). A total of 65.2% patients were considered having failure to thrive (FTT) as they were under the 10th percentile and 78% patients had anatomic or genetic abnormalities. Nearly 47.8% patients underwent upper gastrointestinal studies that were positive for reflux. All patients had a concomitant gastrostomy tube (G-tube) placed during the NF. Diet was advanced on the average postoperative day of 2, and the patients tolerated the highest diet by the postoperative day of 6. Most patients saw a decrease in medications after the procedure. Moreover, 7 patients had complications related to the G-tube, with the main complication reported as leakage around the tube. There were two mortalities, both unrelated to the operation. Conclusion: Infants undergoing NF under the age of 6 months typically present with multiple comorbidities. NF in this population will not only lead to weight gain but also decrease in overall need for GERD-related medications. Early recognition of the failure of nasojejunal feeds will facilitate NF before significant FTT is present.
Keywords: Nissen fundoplication, failure to thrive, gastrostomy
|How to cite this article:|
Yoon J, Burjonrappa S. Nissen fundoplication in severely ill infants: A STROBE compliant study. Transl Surg 2016;1:1-4
| Introduction|| |
Gastroesophageal reflux disease (GERD) is a very common problem among infants. The severity of the disease may range from mild regurgitation of feeds to forceful ejection of the food that limits the caloric intake. Infants are naturally predisposed to GERD due to their underdeveloped gastroesophageal anatomy.,,
The conservative management of an infant with GERD includes nonpharmaceutical measures, and if not resolved, proton pump inhibitors and H2 antagonists were used. Most infantile reflux symptoms improve with age; however, for those who fail to recover with conservative treatment, anti-reflux surgery is recommended, with the Nissen fundoplication (NF) being the most commonly performed surgery. Other indications for NF include the presence of apneic of episodes, bronchopulmonary dysplasia, and documented esophagitis or esophageal strictures secondary to GERD.,,
Although poorly understood, children with neurologic impairment (NI) are predisposed to more GERD due to vagal nerve dysfunction and gastroesophageal dysmotility. Most patients with NI undergo NF concomitantly with surgically placed gastrostomy tubes (G-tubes) as the incidence of GERD is higher after placement of G-tubes alone.,, Many studies document the positive outcomes of NF in young children, with a low rate of morbidity and mortality. In this study, we analyzed benefits and limitations of NF in children < 6 months of age and analyzed the outcomes of this procedure. We postulate that NF is a safe and effective way to manage GERD in infants < 6 months of age with or without NI.
| Methods|| |
We conducted a retrospective analysis of 23 children, with 11 males and 12 females, < 6 months of age who underwent NF at St. Joseph's Regional Medical Center facility from December 2006 to June 2013 with the institutional review board approval. STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) protocol was used in data collection, analysis, and reporting. The procedure was performed by a board certified pediatric surgeon. While the majority of the study subjects were inpatients in the Neonatal Intensive Care Unit (NICU), a few outpatient admissions were from long-term care facilities. GERD was defined as the regurgitation of gastric content or feeds through the oropharynx or esophagus. All patients undergoing the procedure had documentation of these events. Tube feeding rates were recorded in the medical charts for patients in the NICU. If the babies were unable to tolerate a given volume of diet for more than 3 days along with the presence of GERD, they were considered to have poor feeding. All patients underwent medical management of their GERD before surgery. Ultimately, it was a joint decision among medical team members (pediatrician, neonatologist, gastroenterologist, and surgeon) to perform NF based on the infants' hospital course. Preoperative evaluation using upper gastrointestinal (UGI) series was performed at the discretion of the surgeon.
All procedures were performed by laparotomy. NF was the procedure performed by all surgeons. A bougie was not used during the performance of the fundoplication. A greater curvature Stamm gastrostomy was performed on all infants. Tube feeding commenced early and was provided in a continuous fashion for 6 weeks before bolus feeds were initiated. Infants were discharged once tolerating goal feeds on the pump. The majority of infants were discharged to a long-term care facility. The obtained inpatient data include weight at birth, pre- and post-surgery, postoperative day when a patient tolerated full feeds, supplemental tests, number of GERD-related medication pre- and post-surgery, postoperative stay, and type of comorbidities. Weights were percentile according to the Center for Disease Control to compare the changes among the babies. Preoperative weight was measured the day of surgery, and postoperative weight was considered the weight on the last day of hospital admission. Failure to thrive (FTT) was considered weight ≤ the 10th percentile.
In addition to severe GERD, 78% infants had anatomic and genetic abnormalities, and 65% infants are FTT. All 23 patients were clinically diagnosed with GERD. A total of 11 patients underwent a fluoroscopic UGI to confirm reflux. Remaining 12 patients had significant clinical reflux and were scheduled for surgery without a UGI series at the discretion of the provider.
Statistical tests were conducted using the Chi-square tests to evaluate for a significance of differences in categorical data, such as pre- and post-surgical respiratory and GERD medications use and the Student's t-test to study differences in continuous variables, such as weight percentile and length of stay (SPSS Software, IBM, USA).
| Results|| |
All patients who underwent NF and placement of gastrostomy food tubes (NFGT) were analyzed [Table 1]. There were 11 males and 12 females with the average age of 95 days during the operation in this study (interquartile range [IQR]: 102.5; standard deviation [SD]: 56.9). Average hospital stay presurgery was 31 days (IQR: 26.5; SD: 21) and postsurgery was 17 days (IQR: 14; SD: 15). Infants had significant comorbidities including neurological, cardiovascular, genetic and anatomic, and respiratory anomalies in addition to the FTT. The most common comorbidities were neurologic (56.5%) and genetic/anatomic anomalies (78.3%). In addition, each baby had an average of two different classes of comorbidities. While all parameters show improvement in the early phase after NFGT, there is a significant decrease in the need for GERD medications.
The average weight of the babies before the surgery was 4.2 kg (IQR: 1.4; SD: 1.17) which equated to 9.88 percentile (IQR: 34 5.85; SD: 23.6). Postoperatively, the weight at discharge was 4.7 kg (IQR: 1.901; SD: 1.4) and an average of 12.49 percentile (IQR: 36 5.78; SD: 28.6) (P = 0.74; not significant). Average length of stay was 17 days after the procedure. A total of 3 patients had negative weight gain at the time of their discharge to another acute care facility. It was anticipated that their weight would be monitored at that facility.
Among the 23 patients, 18 had documented preoperative medical management of GERD and 5 patients who were transferred for surgical anti-reflux treatment did not have any documented medical GERD therapy but had significant preexisting FTT. Almost 21% of patients were taking Prevacid (lansoprazole, Takeda Pharmaceuticals, Osaka, Japan), 74% of patients were taking Pepcid (famotidine, Merck Inc, Kenilworth, NJ, USA), 39% patients were taking Reglan (metoclopramide, Baxter Inc, Deerfield, IL, USA), 8% patients were taking Maalox (aluminum hydroxide, Novartis Inc, East Hanover, NJ, USA), and 8% of patients were taking Sucralfate (carafate, Aptalis Pharma, Bridgewater, NJ, USA). Review of total GERD-related medication intakes disclosed an average of 1.82 medication types preoperatively and 0.782 medication types postoperatively, a statistically significant reduction (P = 0.0011). Among the 18 patients who were taking medications, only two patients were discharged with continued GERD medications. Among the 5 patients with respiratory issues treated by albuterol preoperatively, only 1 patient remained on albuterol at discharge. What is more, 4 patients required simultaneous tracheostomy for the management of airway and breathing issues.
Feeds were initiated on average days of 2 (IQR: 1; SD: 0.65) after surgery. By the 6th day postsurgery, all infants babies were tolerating their highest recorded of feeds.
All patients undergoing NF had concurrent placement of a gastric feeding tube. Totally, 7 patients had complications related to the feeding tube, but no re-operations were needed for these patients. Moreover, 3 patients had G-tube site infections, 3 patients had clogging of the G-tube, and 1 patient had a dislodged G-tube. No revisions of the NF were required. There were 2 patients died during the hospital course, secondary to their comorbidities, and unrelated to the operation. Moreover, one death occurred from respiratory complications and sepsis due to severe congenital malformations, and the second patient expired from a protein-losing enteropathy.
| Discussion|| |
NF has been a successful surgical option for GERD in the pediatric population.,,,, With the procedure, there are lower incidence of oropharyngeal reflux, shorter hospital stay, and improvement of respiratory issues. In most cases of GERD, infants improve by 18 months of age with conservative management. Subjecting infants to an early invasive procedure is viewed as controversial. On the other hand, delaying intervention before significant FTT may lead to complications as a result of malnutrition and adverse respiratory events. The debate between the use of nasojejunal feeding tubes (NJFT) and NFGT is ongoing in the pediatric literature. We observed that many of these infants in the NICU with NJFT lose a significant amount of weight related to tube complications and have significant FTT and respiratory issues before referral for NF.
In our study, the most prevalent indication for surgery was FTT. On average, the starting weight before surgery was below the 10th percentile for age, and more than half of these babies were below 1th percentile. Low weight profile and inability to tolerate an oral diet made them excellent candidates for NFGT as these babies had inconsistently fed through either a nasogastric or nasoduodenal tube before surgery. The significant level of FTT noted in our study suggests that there is a lack of diagnosis to consider early surgical intervention in a patient population that usually has significant comorbidities. Further studies are needed to determine the cause of FTT in GJFT fed infants. It is possible that FTT is related to NJFT-associated complications or ongoing NJFT due to the interference of lower esophageal sphincter function as a result of an indwelling catheter. Careful patient selection is critical to providing successful outcomes as well as optimizing surgical timing to prevent the adverse effects of malnutrition at a critical growth phase. Our study confirms earlier studies that have shown the need for concurrent NF and G-tube placement as a protective measure against life-threatening malnutrition.,,,
Another subgroup that should be considered for early NFGT intervention is those infants with multiple comorbidities. On average, infants in this study had two comorbidities: NI and congenital malformations. The babies who underwent NFGT were critically ill babies with extended stays in the NICU. NFGT was performed in these babies as a salvage effort to improve their weight profile. Healthy babies are prone to GERD secondary to their underdeveloped anatomy,, but other congenital abnormalities are also associated with anatomic changes that further exacerbate GERD. FTT, NI, and the presence of congenital malformations associated with reflux were indications for surgical intervention in our population. Comorbidities were classified by systems as gastrointestinal, neurologic, respiratory, congenital, and birth history. Given that prior studies have shown the benefits of NF in the premature population and those with NI,,, we suggest that infants with multiple comorbidities should also be considered for early NFGT. Decreased dependency on GERD-related medications after NFGT was seen in our babies to a statistically significant degree. Surgically recreating the lower esophageal sphincter decreases the amount of gastroesophageal reflux and vomiting episodes, thereby decreasing the need for GERD-related medications. Although a postoperative UGI series was not uniformly performed to document decreased reflux, the reduction in GERD-related medications noted in our study suggests the efficacy of this operation. Our results achieved statistical significance (P < 0.0011) which is consistent with other papers that show decreased use of anti-reflux medications after NF.
Studies also show the strong correlation of respiratory events in those with GERD and the improvement of those symptoms once GERD is controlled. In this series, only 20% of babies were dependent on asthma-related medications after surgery (P = 0.18). Among the babies who had respiratory comorbidities, 4 babies required tracheostomy before discharge. We propose that early intervention with NFGT, before significant FTT, may alleviate respiratory issues in these critically ill infants. It should also be borne in mind that these infants have greater metabolic requirements due to their critical illness. Early institution of effective feeding through NFGT may prevent the vicious cycle of events precipitated by malnutrition.
In an attempt to provide objective data to show the benefits of NFGT, we used inpatient documentation that was consistently available for all study patients. The babies in our study were tolerant to early initiation of tube feeds. Diets were resumed on the 2nd postoperative day, and within a week after surgery, all babies tolerated feeds at a greater volume compared to preoperative feeding rates. These results are similar to those reported by Rothenberg., Their results showed that even a limited period of NFGT feeding improved weight gain from an average of 9.8% to 12.8% after surgery. Since observation was limited to the period of inpatient status, our data suggest that effective nutrition through NGFT can quickly reverse GERD-associated FTT in infancy. An anabolic phase appears to start approximately a week after surgery, as evidenced by the three babies who were discharged in < 1 week with a negative weight gain, likely the result of expected postoperative catabolism. The benefits from early NF and G-tube placement are apparent in our study.
The complications associated with the operation were also relatively mild. All were related to the G-tube and were managed without readmission. There are no complications from the wrap compared to other studies, especially those with younger babies and with NI. Although not proven, it was suspected that the two mortalities noted in this study could be indirectly attributed to significant malnutrition. This occurred despite the use of NJFT in the NICU before surgical intervention.
Study limitations include the inability to analyze long-term objective data as follow-up was performed at the respective rehabilitation institutions. Given that all procedures were performed by laparotomy, the results of a laparoscopic approach and the theoretical impact of a smaller catabolic imprint could not be studied.
In conclusion, babies undergoing NF < 6 months of age are frequently severely malnourished and are unable to sufficiently control their GERD by conservative measures, medications, and NJFT. Many also have multiple comorbidities that exacerbate GERD and have increased baseline metabolic requirements. It is important to recognize critically ill NICU infants that fail to respond to conservative GERD management measures, such as NJFT and anti-reflux medications, before significant FTT occurs. Consideration of early NFGT, with its associated minimal morbidity, may improve outcomes by avoiding severe malnutrition. The NFGT procedure establishes definitive treatment of reflux and decreases the GERD-related medication burden of these patients. This operation is performed with a few complications and may be a life-altering procedure that potentially allows these babies to gain sufficient nutrition with multi-system benefits.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Solana García MJ, López-Herce Cid J, Sánchez Sánchez C. Gastroesophageal reflux in critically ill children: A review. ISRN Gastroenterol
Vandenplas Y, Rudolph CD, Di Lorenzo C, Hassall E, Liptak G, Mazur L, Sondheimer J, Staiano A, Thomson M, Veereman-Wauters G, Wenzl TG; North American Society for Pediatric Gastroenterology Hepatology and Nutrition, European Society for Pediatric Gastroenterology Hepatology and Nutrition. Pediatric gastroesophageal reflux clinical practice guidelines: Joint recommendations of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN) and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN). J Pediatr Gastroenterol Nutr
Pacilli M, Chowdhury MM, Pierro A. The surgical treatment of gastro-esophageal reflux in neonates and infants. Semin Pediatr Surg
Lightdale JR, Gremse DA; Section on Gastroenterology, Hepatology, and Nutrition. Gastroesophageal reflux: Management guidance for the pediatrician. Pediatrics
Rothenberg SS. Two decades of experience with laparoscopic Nissen fundoplication in infants and children: A critical evaluation of indications, technique, and results. J Laparoendosc Adv Surg Tech A
Wales PW, Diamond IR, Dutta S, Muraca S, Chait P, Connolly B, Langer JC. Fundoplication and gastrostomy versus image-guided gastrojejunal tube for enteral feeding in neurologically impaired children with gastroesophageal reflux. J Pediatr Surg
Burd RS, Price MR, Whalen TV. The role of protective antireflux procedures in neurologically impaired children: A decision analysis. J Pediatr Surg
Berezin S, Schwarz SM, Halata MS, Newman LJ. Gastroesophageal reflux secondary to gastrostomy tube placement. Am J Dis Child
Stringel G, Delgado M, Guertin L, Cook JD, Maravilla A, Worthen H. Gastrostomy and Nissen fundoplication in neurologically impaired children. J Pediatr Surg
Fonkalsrud EW, Bustorff-Silva J, Perez CA, Quintero R, Martin L, Atkinson JB. Antireflux surgery in children under 3 months of age. J Pediatr Surg
Rothenberg SS. The first decade's experience with laparoscopic Nissen fundoplication in infants and children. J Pediatr Surg
PLOS Medicine Editors. Observational studies: Getting clear about transparency. PLoS Med
Mauritz FA, van Herwaarden-Lindeboom MY, Stomp W, Zwaveling S, Fischer K, Houwen RH, Siersema PD, van der Zee DC. The effects and efficacy of antireflux surgery in children with gastroesophageal reflux disease: A systematic review. J Gastrointest Surg
Tovar JA, Luis AL, Encinas JL, Burgos L, Pederiva F, Martinez L, Olivares P. Pediatric surgeons and gastroesophageal reflux. J Pediatr Surg
Gilger MA, Yeh C, Chiang J, Dietrich C, Brandt ML, El-Serag HB. Outcomes of surgical fundoplication in children. Clin Gastroenterol Hepatol
King M, Barnhart DC, O'Gorman M, Downey EC, Jackson D, Mundorff M, Holubkov R, Feola P, Srivastava R. Effect of gastrojejunal feedings on visits and costs in children with neurologic impairment. J Pediatr Gastroenterol Nutr
Lee SL. Short- and long-term antireflux and asthma medication use in children after Nissen fundoplication. Perm J