Two Decades of Experience with Laparoscopic Nissen Fundoplication in Infants and Children: A Critical Evaluation of Indications,Technique,and Results

Introduction

Gastroesophageal reflux disease (GERD) is one of the most common foregut disorder seen in infants and children in the United States. ¹ Fundoplication is considered in this group of patients for the treatment of GERD refractory to medical therapy or GERD resulting in recurrent aspiration, apnea episodes (sudden infant death syndrome or acute life-threatening events), reactive airway disease, neurologic impairment, failure to thrive, and esophagitis and stricture formation. ² Advances in laparoscopy have significantly changed the practice patterns for the treatment of GERD in pediatric surgery over the last two decades. Prior to the 1990s fundoplications were routinely performed through an open approach, requiring a longer hospital stay, and were associated with increased morbidity. Since its introduction in 1991, laparoscopic antireflux surgery has become a mainstay in the management algorithm for GERD by both physicians and surgeons.^3–8 However, it has been plagued by a series of reports describing significant morbidity and recurrences. In 2005 we reported on our experience with 1048 laparoscopic fundoplications over a 10-year period, ⁴ the largest series in children at that time. We showed that the procedure was not only safe and effective in the management of GERD in the pediatric population, but we recorded a recurrence rate of only 4%. The results included a significant decrease in morbidity and hospitalization compared with traditional open surgery. ⁴ There was also improved cosmesis and parent and patient satisfaction compared with the open approach. However, the study lacked significant long-term follow-up and outcomes. This report is meant as a follow-up to the initial article, with a much larger series, improved technique, and longer follow-ups.

Subjects and Methods

With Institutional Review Board approval the data of all patients undergoing fundoplication from 1992 to December 2012 were reviewed. Data were kept prospectively from the time of first encounter with each patient. Ages ranged from 5 days to 18 years, and weight ranged from 1.2 to 120 kg. The procedures were performed using a four- or five-port technique and with 5- or 3-mm instruments, depending on the size of the patient, as previously described. In total, 2008 fundoplications were performed by or under the direct supervision of a single surgeon. Patients were divided into groups based on age: <6 months, 6–12 months, 1–6 years, and >6 years. Data on indications, surgical demographics, postoperative course including any complications, and long-term follow-up were kept prospectively on each patient.

Indications for surgery included medically refractory reflux (n=1456), associated with failure to thrive (n=588), respiratory compromise (n=362), neurologic impairment and need for chronic gastrostomy tube feedings (n=210), and severe esophagitis and or stricture formation (n=156). Preoperative evaluation included upper gastrointestinal examination in 1989, 24-hour pH probe in 1420, and upper endoscopy with biopsy in 744.

Gastric emptying studies were done in 118 patients, and bronchoscopies with bronchial washings (checking for lipid-laden macrophages) were performed in 520. No patient was excluded based on size, medical condition, or history of previous surgery. One hundred five patients were ventilator-dependent at the time of surgery. Of the patients, 283 had had previous fundoplications: 84 patients had had previous open fundoplications (14 Thal, 67 Nissen, and 3 Toupet fundoplications) with a recurrence of their gastroesophageal reflux, and 199 patients had had previous laparoscopic fundoplications (3 Thal, 4 Toupet, and 192 Nissen fundoplications); 30 of these patients had had more than one previous fundoplication. Fifty-four patients already had gastrostomy tubes in place (10 placed open, 27 percutaneous, and 17 laparoscopic). All patients had failed a course of medical therapy except 10 patients with Pierre Robin syndrome who required feeding tubes during the first 2 weeks of life and whose upper gastrointestinal examination showed reflux to the thoracic inlet as well as malrotation in 2.

The patients for their initial fundoplication were further classified with regard to age at time of surgery (Table 1): 0–6 months, 619; 6–12 months, 141; 1–6 years, 426; and >6 years, 539. An additional 283 patients underwent redo fundoplications.

The patients undergoing a Nissen only procedure were started on clear liquids 2 hours postoperatively. If a gastrostomy tube or button is placed, then the tube is left to gravity overnight, and feeds are started on postoperative Day 1. In each case skin-to skin operative time, time that feeds were initiated, time to full feeds, hospital stay, and complications were monitored and recorded in a prospective manner.

Results

Average operative time dropped dramatically from 109 minutes for the first 30 cases compared with 35 minutes for the last 30. Of the 283 procedures that were redo fundoplications, 85 cases had had previous open surgery, and 198 cases had had laparoscopic surgery. Intraoperative and postoperative complication rates were 0.13% and 4.0%, respectively, in the primary group and 2.2% and 5.1%, respectively, in the redo group. There were no conversions to open surgery after the first 3 years of the study period, and all major complications occurred in the first 5 years of the study.

There were 42 postoperative complications (4.0%); these included a prolonged gastroparesis in 3 cases, significant dysphagia in 12 cases (0.67%), requiring re-admission for 24 hours in 5 cases, and outpatient esophageal dilatation in 8 others. Three of these patients required a revision of the Nissen fundoplication to a Toupet fundoplication because of persistent pain/dysphagia, which developed after the original fundoplication. One of these patients had significant neurologic impairment. One of the 3 later underwent a redo Nissen because of severe reflux symptoms. There were seven gastrostomy tube dislodgements, four during the first week. One resulted in feeds being given intraperitoneally, requiring laparoscopic exploration and revision. The others were replaced without incident. There were 24 gastrostomy-site infections requiring antibiotics. There were four trocar-site hernias with incarcerated omentum requiring re-exploration as an outpatient.

The most serious complications occurred in 3 patients undergoing redo fundoplication. There were two delayed perforations requiring re-exploration, and a third patient developed an incarcerated paraesophageal hernia after gagging and retching for 48 hours postoperatively. All of these occurred in the first 4 years of our experience. There was one postoperative death secondary to brainstem herniation from a ventriculoperitoneal shunt malfunction unrelated to the surgery.

The average hospital stay for those patients admitted for their fundoplication was 1.4 days (range, 1–4 days, excluding the 2 patients with delayed perforation) and was 1.1 days for patients undergoing a Nissen fundoplication only and 2.1 days for a Nissen/gastrostomy tube.

Follow-up has been from 3 months to 20.5 years. Follow-up has been by office visit or phone consultation at 1 week, 1 month, 6 months, and yearly intervals postoperatively. All patients were asked to contact the office immediately if any problem arose concerning their wrap. There are 93 patients who had recurrence of their reflux symptoms and had documented breakdown of their primary fundoplication or development of a hiatal hernia (4.6%). All of these were repaired successfully laparoscopically, with six secondary breakdowns. Five of these patients underwent a third repair laparoscopically and are intact at 4–16 years of follow-up. One of the patients with a second recurrence, and two others had open repairs by another surgeon and have since been lost to follow-up. Seven patients with wrap breakdowns also underwent a formal pyloroplasty for delayed gastric emptying. Five patients with breakdown underwent a Collis–Nissen procedure for an apparent short esophagus; all 5 of these patients had been born with esophageal atresia. Ten additional patients with apparently intact fundoplications on upper gastrointestinal examination and endoscopy are on proton pump inhibitors and pro-kinetic agents to help moderate gagging and retching associated with occasional emesis.

The most common complication in the redo group was a gastrotomy during mobilization. These were all treated by intracorporeal closure. Thirty-five patients had pyloroplasties or pyloromyotomies; the majority of these (n=26) were in the first 10 years of the study.

Average time to discharge post-fundoplication was 1.1 days for the primary group and was 1.6 days in the redo group. The overall wrap failure rate for primary fundoplications was 4.6% and was highest in the <6-month-old age group (5.2%). The failure rate in the redo group was 6.2%. The most common causes of wrap failure were hiatal hernia (46%) and slipped Nissen fundoplication (34%). A slipped Nissen fundoplication was seen more commonly in the last 5 years for patients referred from outside institutions.

Discussion

Laparoscopic Nissen fundoplication has changed the way GERD is managed in both adults and children. The first laparoscopic fundoplication was described in 1991 by Dallemagne et al., ³ followed 2 years later by Georgeson ⁹ and Lobe et al. ¹⁰ advocating this approach in children. Low morbidity of the procedure has led to wide acceptance for the surgical treatment by both physicians and patients, and laparoscopic Nissen fundoplication has become the standard of care for the treatment of GERD. ¹¹ We reported our largest series with 1048 laparoscopic fundoplications in the pediatric population in 2005 with no procedural mortality; clinical results were comparable to those of traditional open fundoplication with a recurrence rate of only 3.2% and with a significant decrease in morbidity and hospitalization. ⁴ Pulmonary benefits afforded by this minimally invasive approach potentially play even a greater role in neurologically impaired children, ex-premies, and intensive care population, among whom the complication rates are higher and the ability to avoid respiratory complications has an additional benefit. ¹² We have also shown the great benefit in the treatment of patients with reactive airway disease, in terms not only of treating their reflux, but more importantly in an improvement in the clinical manifestations of their asthma. The recurrence rate and the need for redo procedure in patients younger than a year of age are higher (6.4%), possibly because of immature tissues and differential growth. However, the growth and respiratory advantages of fundoplication in this population outweigh the minimal risk and morbidity associated with redo procedures. The laparoscopic approach also provides improved and magnified visualization, decreasing the chances of vagus nerve injury, which has been shown to decrease the incidence of bloating, dysphagia, and other symptoms associated with fundoplication postoperatively. Many of our older patients provided a history of stomach flu leading to severe retching prior to the recurrence of GERD-related symptoms, which has been shown previously an important contributor in early failures.

The key to a good outcome and a relatively low recurrence rate is secondary to technical considerations and the surgeon's experience. Key points include adequate creation of intraabdominal esophagus, limited hiatal dissection leaving the phrenoesophageal ligament, and creation of a tension-free and appropriate orientation and positioning of the wrap. Therefore the right crus must be clearly identified and dissected out so that the gastroesophageal junction is clearly identified and an adequate length of intraabdominal esophagus is confirmed. Dissection should not extend through the phrenoesophageal ligament and up into the hiatus as this increases the risk of secondary hiatal hernia formation. A failure to adequately identify the gastroesophageal junction and acquire a significant length of intraabdominal esophagus results in a wrap being performed too low. This complication has been presenting itself more commonly in the last 5 years in patients referred from outside institutions. The findings at the time of surgery are an intact wrap but one at or below the gastroesophageal junction. These wraps have proven to be incompetent.

A crural repair should be performed in all cases, to decrease the incidence of hiatal separation and hiatal hernia formation. If there is a large defect or a recurrent hernia, the repair should be reinforced with Teflon^® (Dupont, Wilmington, DE) pledgets. The upper short gastric vessels should be divided to allow for a tension-free wrap, and orientation of the wrap should be at 11 o'clock on the esophagus to prevent twisting or torsion of the esophagus. The wrap should be loose and short (2 cm or less). If these guidelines are followed, the morbidity of the procedure becomes minimal, and the advantages in most patients are significant.

It is clear that the laparoscopic Nissen fundoplication is an imperfect operation, but if an experienced laparoscopic surgeon performs the procedure, the procedure is safe and effective. It requires less than an hour of operative time and only an overnight hospital stay and has minimal morbidity. Although the recurrence rate is significant, the morbidity of that recurrence and a redo laparoscopic fundoplication is minimal in the majority of these cases and should not be considered as a reason to avoid fundoplication in appropriate patients.

Laparoscopic Nissen fundoplication is successful in more than 95% of cases; however, failure of fundoplication has been reported over time with failure rates ranging from 2% to 24% after open and from 3% to 19% after laparoscopic antireflux procedures. ¹³ Despite the popularity gained by the laparoscopic approach for the initial fundoplications, there has been a relatively slow acceptance and significant criticism for lapraoscopic Nissen fundoplication in children. We believe it is secondary to the advanced laparoscopic skills required for redo procedures secondary to adhesions and distortion of anatomical planes, which is even more significant when the initial procedure is an open fundoplication. Pacilli et al. ¹⁴ in 2007 reported a failure rate of 42% for redo procedures, in contrast to the 6% reported in our earlier series with 118 patients. ⁸ Our current series included more complex patients, with 13% with more than two prior fundoplications. Despite these challenges, we were still able to achieve a secondary failure rate of 6.3% with no increased complications and improved operative times than our previous series, which further highlights the concept of the learning curve. ⁸

The present study is focused on the results of laparoscopic redo fundoplication, trying to identify the mechanism of initial wrap failure. In our series, the pattern of anatomic failure was similar to that reported in the adult literature after open and laparoscopic procedures. ¹⁵ Hiatal hernia (including intrathoracic wrap migration and paraesophageal hernia) and wrap disruption were the leading causes for recurrence requiring redo surgery, followed closely by misplaced or malpositioned wraps, which was specially noticed during the last 3 years of the study and was only seen in laparoscopic Nissen fundoplications referred from outside hospitals. Lopez et al. ¹⁶ in 2008 advocate extensive dissection well above the diaphragm deep into the mediastinum and reported a secondary wrap failure rates of 20%. We strongly believe that recurrence in most cases is due to insufficient esophagus and fundus mobilization and inadequate hiatal closure but recommend the dissection to be focused around the crura and gastroesophageal junction and not extend into the mediastinum, which in our opinion increases the risk for recurrence. We also believe that the use of pledgets in cases of recurrent hiatal hernias is a key to reduce the secondary wrap failure rate. The recent increased incidence of slipped fundoplication suggests that there is failure to adequately identify and mobilize the gastroesophageal junction in laparoscopic cases. It may be a result of an attempt to minimize mediastinal and crural dissection, factors implicated in development of hiatal hernia and fundoplication recurrence in earlier series. What is optimal dissection is difficult to define but can slowly be understood and achieved with experience. We believe that exposure of hiatus and gastric anatomy and formation of an optimally positioned floppy wrap are the keys to success.

Another potential area of importance is the careful selection of these patients and identifying the need for additional preoperative evaluation and procedures when needed. ¹⁷ Delayed gastric emptying was identified in 16 patients in our series, and a simultaneous pyloroplasty was performed, which contributes to our low rate of secondary recurrences.

We emphasize that, although technically challenging, the laparoscopic approach for redo fundoplication does not result in increased morbidity and mortality in infants and children compared with the open procedure, offers the same advantages as the first laparoscopic procedure, is safe in the hands of an experienced laparoscopic surgeon, and should be considered as a primary approach. Although the learning curve for redo procedures is steep, the procedure can be performed effectively once these skills are mastered.