By Rakita, Steven; Villadolid, Desiree; Thomas, Ashley; Bloomston, Mark; Et al
Nissen fundoplication is applied for patients with gastroesophageal reflux disease (GERD), usually because of symptoms of esophageal injury. When presenting symptoms are extraesophageal, there is less enthusiasm for operative control of reflux because of concerns of etiology and efficacy. This study was undertaken to evaluate the efficacy of laparoscopic Nissen fundoplication in palliating extraesophageal symptoms of GERD. Patients were asked to score their symptoms before and after laparoscopic Nissen fundoplication on a Likert scale (0 = never/none to 5 = always/ every time I eat). A total of 322 patients with extraesophageal symptoms (asthma, cough, gas/bloat, chest pain, and odynophagia) of 4 to 5 were identified and analyzed. After fundoplication, all extraesophageal symptom scores improved (P
GASTROESOPHAGEAL REFLUX DISEASE (GERD) is a common condition in Western society, occurring intermittently in over 40 per cent of the population. Furthermore, 20 per cent of the population is troubled with symptoms on a weekly basis. An evaluation of hospital employees in the United States demonstrated that 7 per cent experienced daily heartburn.1 The efficacy of laparoscopic Nissen fundoplication in alleviating symptoms with high patient satisfaction and improved quality of life is well documented.2-5
A considerable proportion of patients with GERD present with atypical symptoms, such as respiratory or otolaryngological symptoms. The etiology has been thought to be from regurgitation, resultant laryngopharyngeal acid exposure, and microaspiration or perhaps because of a vagally mediated reflex. Remarkably, studies have demonstrated acid reflux is present in 50 per cent to 80 per cent of asthmatic patients, 10 per cent to 20 per cent of patients with chronic cough, up to 80 per cent of patients with intractable hoarseness, and 25 per cent to 50 per cent of patients with globus sensation.6 Often, these patients have no conventional symptoms of GERD, such as heartburn and regurgitation, and they may lack endoscopic evidence of esophagitis, although they can ultimately develop Barrett’s esophagus, though less often than patients with classic GERD. Laryngoscopy may demonstrate laryngeal inflammation, but even this may be absent. The best method of diagnosis for this subset of patients is a dual-channel pH monitoring to determine the occurrence of acid exposure in the proximal and distal esophagus.7, 8 However, some have argued that proximal esophageal monitoring adds little, stating that patients are rarely misdiagnosed with normal distal probe findings and citing inaccuracies inherent in measurement of proximal esophageal acid reflux.9
Symptoms of GERD occur in nearly three-quarters of patients with asthma. Additionally, pathologic GERD has been found to occur in a similar proportion of patients with asthma, independent of classic GERD symptoms, when studied with esophageal pH testing.10
Laryngopharyngeal reflux (LPR) may manifest as head and neck symptoms, such as laryngitis, pharyngitis, sinusitis and/or middle ear disease, hoarseness, and globus sensation. Heartburn can be an uncommon symptom. Furthermore, esophagitis may be uncommon because esophageal motility often remains normal in these patients, and therefore, acid exposure time is minimal because of rapid clearance of refluxed acid. Although esophagitis may be rare, the fragile laryngeal epithelium is easily damaged with even brief periods of exposure to very small amounts of reflux.7, 11 Conversely, many have indicated that LPR is frequently associated with subtle esophageal dysmotility, such as upper esophageal sphincter dysfunction or a generalized nonspecific motility disorder.12 Roughly 40 per cent to 50 per cent of all patients presenting with laryngeal and voice disorders have been found to have abnormal pH studies, prompting the diagnosis of LPR.13
Chest pain of noncardiac etiology is most commonly because of reflux. Similar to other extraesophageal symptoms, approximately 50 per cent to 60 per cent of patients have been found to have refluxinduced pain when studied by endoscopy or 24-hour pH monitoring.14
The majority of patients with extraesophageal symptoms are likely managed by their gastroenterologist or otolaryngologist with proton pump inhibitor (PPI) therapy alone. Because of practical concerns of cost, availability, and patient comfort, many gastroenterologists commonly use a trial of antisecretory therapy as a diagnostic tool. However, alleviation of symptoms does not necessarily imply cessation of esophageal acid exposure, lack of nonacidic or bile reflux, or interruption of the progression to Barrett’s esophagus and ultimately dysplasia. A recent study examined patients with good control of classic GERD symptoms on PPI therapy. Abnormal acid reflux was detected in 45 per cent on ambulatory pH study. Abnormal bile reflux was detected in 60 per cent with Bilitec monitoring, including 55 per cent of patients with normal studies of acid reflux.15
The debate continues whether patients with extraesophageal symptoms of GERD should be treated any differently than those with conventional presentations of GERD. Although they are candidates for antireflux surgery, it is unknown if they will enjoy the same encouraging outcomes as those with classic symptoms of GERD. The indication for fundoplication are similar to those for classic GERD symptoms: persistent symptoms despite maximal medical therapy, complications of continued severe reflux such as Barrett’s esophagus, recurrent aspiration pneumonia, or leukoplakia and laryngeal carcinoma, and the choice of surgery over the need for lifelong medications.
This study was undertaken to determine the efficacy of laparoscopic Nissen fundoplication in palliating extraesophageal symptoms of GERD. Our hypothesis in undertaking this study was that patients with extraesophageal symptoms of GERD would benefit from antireflux surgery similar to patients with classic GERD, experiencing significant improvements in their symptoms and quality of life, and exhibiting significant satisfaction with their outcomes.
Materials and Methods
From a prospectively maintained database of 813 patients that have undergone laparoscopic Nissen fundoplication from 1991 to 2004, patients with extraesophageal symptoms of GERD were identified. Symptoms were scored by patients on a Likert scale (0 = never/none to 5 = every time I eat/always) before and after fundoplication. Patients with preoperative scores of 4 to 5 for extraesophageal symptoms of reflux (asthma, cough, gas/bloat, chest pain, and odynophagia) were identified and changes after fundoplication were noted. Asthmatics were identified if they had symptoms consistent with asthma and had been cared for by a physician because of their asthma. Gas/bloat symptoms included a host of subjective patient symptoms, including postprandial abdominal distention, crampy abdominal discomfort, excessive eructation, and flatulence. Medication requirement was also documented before and after fundoplication pertaining to all symptoms.
Before fundoplication, most patients underwent esophageal manometry and 24-hour pH monitoring. pH monitoring was not undertaken if the predominant presenting symptoms were obstructive (i.e., dysphagia) because of a large hiatal hernia or paraesophageal hernia, which was the case in approximately 10 per cent to 15 per cent of the patients. All patients with manometric dysmotility were further studied with barium-laden food boluses and esophagogram in the prone and 15 degree Trendelenburg position, as has been our practice. Manometry was occasionally supplanted by esophagogram as previously described.16 Esophageal peristalsis was observed first by swallowing a single large bolus of barium thinned with water to a 20 per cent suspension and then with swallowing of barium-laden food boluses. Patients were challenged with first a mechanical soft bolus (marshmallow) and then a solid bolus (bagel). All patients who underwent laparoscopic Nissen fundoplication had normal motility on manometry studies or exhibited adequate clearance of food boluses on esophagogram with two or fewer stripping motions. All patients with GERD symptoms undergoing ambulatory 24-hour pH testing had Demeester scores greater than 14.72.
Our technique of fundoplication has been previously described.3 Briefly, fundoplication was undertaken with five trocars, four 10 mm and one 5 mm. A Hasson cannula was placed in the umbilicus using a cut-down te\chnique and pneumoperitoneum was established. A fan retractor was placed through a trocar along the right anterior axillary line just caudad to the costal margin and was used to retract the left lobe of the liver to expose the gastroesophageal junction. A third trocar was placed near the xyphoid process, just to the left of midline and just below the liver edge. This trocar served as the videoscopic port for the remainder of the procedure. Two operating ports, a 10-mm trocar in the right midclavicular line at the level of the videoscopic port and a 5-mm trocar in the left midclavicular line just below the costal margin, were then placed.
The gastrohepatic omentum was opened in a stellate fashion and the dissection was carried to the right crus using the Ultrasonic Shears(TM) (US Surgical Corporation, Tyco Healthcare, Norwalk, CT). The phrenoesophageal membranes were divided and the esophagus was mobilized from its attachments to the right crus. The short gastric vessels were divided in all patients and the gastric fundus was widely mobilized. The esophagus was completely mobilized from the esophageal hiatus and the dissection continued into the mediastinum for further mobilization, assuring 6 to 8 cm of intra-abdominal esophagus. All of the hiatal hernia was completely reduced. The gastroesophageal fat pad was routinely excised. The sac of the hiatal hernia was routinely excised. The crura were approximated with braided polyester sutures to adequately close the hiatal defect. A floppy 2.5- to 3.0-cm fundoplication was constructed over a 54-60 French bougie using three sutures. The first two sutures incorporated esophagus above the gastroesophageal junction to prevent slippage and to ensure that the fundoplication was above the gastroesophageal junction. The wrap was then secured to the right crus, also incorporating esophagus, to prevent twisting and to minimize tension, which might cause the wrap to come undone. All port sites were closed with nonabsorbale monofilament suture under videoscopic guidance and skin was approximated with absorbable sutures and steristrips.
A liquid diet was started after fundoplication, once patients were awake and alert. Patients were usually discharged home the next day on a liquid diet. They were instructed to slowly advance their diet at home to mechanical soft foods over roughly 2 weeks.
Patients were seen in the clinic within the first 1 to 3 weeks after discharge. They were then seen in clinic as needed in the later postoperative period and followed annually thereafter. At the time of each contact, patients were asked to score their postoperative symptoms. Patients were also asked to grade their overall outcomes as excellent (complete or near complete resolution of symptoms), good (greatly improved symptoms), fair (slightly improved symptoms), or poor (no improvement or worsening of symptoms) relative to before fundoplication. They were also asked to declare if they would again have the operation if necessary after having been through the experience.
Median and mean (SD) symptom scores from before and after fundoplication were calculated for comparison. Dietary and sleeping habit modifications before and after fundoplication were compared. Statistical analysis was undertaken using paired Student’s t test, Wilcoxon matched-pairs test, and χ^sup 2^ analysis, when appropriate. Significance was accepted with 95 per cent confidence. Data are presented as median, mean SD, when appropriate. Of the 813 patients who underwent laparoscopic Nissen fundoplication, 322 patients with severe extraesophageal symptoms were identified and their outcomes analyzed. A subset of 25 patients with isolated extraesophageal symptoms who lacked conventional GERD symptoms, scoring a 0 or 1 for heartburn and regurgitation, were also evaluated.
Results
The patients were 47 per cent male and 53 per cent female. The median age was 52 years, with a mean of 52 15.5 years. Patients have been followed prospectively and data have been entered into our gastroesophageal reflux disease registry. Follow-up was 39 months, with a mean of 50 83.8 months.
Among the 813 patients undergoing laparoscopic Nissen fundoplication, the median length of stay was 1 day, and the mean was 2.7 3.45 days. Major complications were uncommon. Uncomplicated CO2 pneumothoraces occurred in 13 patients. Pneumonia occurred in three patients. Two patients developed small bowel obstruction. Gastrotomy occurred in eight patients and esophagotomy in one. Four of these patients required reoperation, as well as one patient for an enterotomy and another for postoperative bleeding. Cardiac arrest occurred in two patients, and there was one death from postoperative sepsis. Varying degrees of dysphagia were a common complaint, but were usually mild and almost uniformly limited and brief.
One hundred thirty-five patients presented with severe asthma. For these patients, mean symptom scores decreased from 4.7 to 1.7 after fundoplication, with 83 per cent reporting excellent or good outcomes (Table 1). Of the 132 patients with severe cough, only 69 per cent reported excellent or good outcomes, despite a reduction of mean postoperative symptom score 4.3 to 2.0 (Table 1). Still, 81 per cent stated they would still have the operation, after knowing what the process was like and being aware of their outcome. Median symptom scores similarly decreased with fundoplication (Fig. 1).
TABLE 1. Mean SD of Extraesophageal Symptom Scores before and after Fundoplication and Stated Patient Outcomes
Among patients with predominant preoperative symptoms of severe gas/bloat, chest pain, and/or odynophagia, mean and median postoperative scores were significantly reduced (Table 1 and Fig. 1). Excellent or good outcomes were reported to 79 per cent, 81 per cent, and 82 per cent, respectively (Table 1).
Modification of dietary habits diminished from 82 per cent to 50 per cent after fundoplication. Likewise, modification of sleeping habits decreased dramatically from 70 per cent to 28 per cent (Fig. 2).
Poor results were seen in 7 per cent, 11 per cent, 6 per cent, and 8 per cent of patients with predominant symptoms of asthma, gas/ bloat, chest pain, and odynophagia, respectively. Notably, among those with preoperative predominant symptoms of cough, 14 per cent described their outcome as poor. However, all had significant reductions in each of their respective predominant symptom scores after fundoplication (P
Poor outcomes were reported in 11 per cent of all patients after fundoplication. In these patients, analysis demonstrated a significant decrease in symptoms after fundoplication for dysphagia, heartburn, and regurgitation, as well as asthma, cough, gas/bloat, chest pain, and odynophagia (P
FIG. 1. Median extraesophageal symptom scores before and after fundoplication. *P
FIG. 2. Patient modification of dietary and sleeping habits before and after fundoplication. *P
Conversely, 49 per cent of patients reported excellent outcomes, denoting complete or near complete resolution of symptoms. Excellent or good outcomes were reported in 78 per cent of patients.
A subset of 25 patients was identified as having severe extraesophageal symptoms (preoperative symptom scores of 4 or 5) and a lack of classic GERD symptoms (preoperative scores of O or 1 for heartburn and regurgitation). Seventy per cent of these “atypical” patients reported excellent or good outcomes and 80 per cent stated they would undergo the operation again, having been through the experience. Only three patients (12%) described their outcome as poor.
Discussion
Herein, we report the results of laparoscopic Nissen fundoplication on a large and unique group of patients with long- term follow-up. Patients were generally middle-aged. The gender distribution between men and women was nearly equal. The patients focused upon in this report who underwent fundoplication had severe GERD and severe atypical symptoms before fundoplication. This report documents the beneficial impact of fundoplication on patients with GERD and asthma, cough, gas/bloat, chest pain, and odynophagia.
All patients had statistical improvement in their mean atypical symptom scores. Likewise, there was significant reduction in the proportion of patients who continued dietary or sleeping habit modification after fundoplication. Patients presenting with significant gas/bloat had the highest mean score postoperatively, which was likely a consequence of the usual aerophagia occurring with GERD and after fundoplication. It is generally believed that fundoplication causes bloating to be worse postoperatively, yet our patients experienced an improvement after surgery. Those with predominant symptoms of cough had relatively higher postoperative scores than seen with other atypical symptoms. Their outcomes may be attributed to numerous other causes of cough that are not refluxrelated and thus were not resolved with fundoplication. It is important that attention be paid to correlation of all extraesophageal symptoms with pH studies and initial response to PPI therapy, to maximize favorable outcomes. Despite this, all atypical symptoms improved significantly after fundoplication.
Subjective outcomes approached, but did not achieve, the results seen with patients with classic GERD symptoms. A great proportion of patients described their outcome as excellent or good, denoting complete or near complete resolution of symptoms. Few patients felt their outcomes were poor. Approximately 9 of 10 patients would still have had the surgery \again after experiencing it firsthand, and felt it was worthwhile.
It is not fully understood why some patients described their symptoms as poor, despite significant reduction in symptoms, for classic and atypical symptoms. Many patients were upset with issues unrelated to the surgery or their clinical outcomes, i.e., inconvenience, difficulty with insurance companies, miscommunication with the surgical team, etc. There were very few patients who had persistent symptoms despite adequate fundoplication. Patients with unsatisfactory outcomes were not routinely willing to be studied with pH monitoring, particularly if they had resolution of other reflux symptoms. Many atypical symptoms may have a nonreflux induced etiology and therefore are unable to be improved upon with fundoplication.
Patients with true atypical symptoms, that is, patients presenting only with extraesophageal symptoms and lack of classic GERD complaints, had results similar to those presenting with both. Nearly three in four reported their outcome as excellent or good and four in five would undergo the operation again, if necessary.
As we have collected a large database of patients and followed them for an extended period of time, we have been able to determine the time frame and slope relating to improvement of symptoms after fundoplication. Extraesophageal symptoms, as with classic GERD symptoms, improve almost immediately after the operation. Likewise, the results are durable and in the vast majority, long-term outcome approximates early outcome. Those who do not have early improvement are unlikely to achieve excellent results, although nearly all have some degree of improvement.
The efficacy of antireflux surgery in alleviating extraesophageal symptoms has, to date, not been established, and there remains a lack of consensus in the surgical literature. There have been reports of fair to good results after open fundoplication for asthma.17 More recently, small retrospective reports have identified improvements in respiratory symptoms in 58 per cent to 83 per cent.18-20 Surgical intervention has been seen to result in more marked improvement in comparison with medical therapy. The cause and frequency of failures in comparison with the excellent results seen in alleviating classic GERD symptoms have not been identified. It has been thought that esophageal dysmotility may be a factor in continued respiratory symptoms after fundoplication, failing to clear the esophagus or, worse yet, propelling food and saliva to the larynx/pharynx. However, this has not been documented nor does it seem likely. It is generally agreed that patients who initially respond to PPI therapy have the best results with operative intervention, and that although symptoms improve, pulmonary function is usually unaltered.
Laryngeal symptoms have been seen to similarly improve after fundoplication in 78 per cent to 86 per cent.18, 21 Failure to relieve symptoms occurs because of irreversible laryngeal structural damage. As with respiratory symptoms, the patients with the best outcomes after surgery were those who responded to PPI therapy.
Chest pain is reportedly relieved with antireflux surgery in 85 per cent to 96 per cent of patients. Patients who had greater than 40 per cent correlation of chest pain with acid reflux on pH study had the best outcomes as their symptoms were more clearly associated with esophageal acid exposure.22
In this study of a large group of patients with GERD, we have documented relief of extraesophageal symptoms in the majority of patients. This was seen in those who had extraesophageal symptoms in addition to more common classic GERD symptoms, and in patients who had “atypical” extraesophageal symptoms alone.
In summary, laparoscopic Nissen fundoplication is an effective method for palliating classic symptoms of GERD such as heartburn or regurgitation, and for “atypical” extraesophageal symptoms of reflux as well. Outcomes after fundoplication for extraesophageal symptoms, although not quite as favorable as those seen in patients with classic symptoms of GERD, are encouraging.
Extraesophageal symptoms of reflux are well palliated by laparoscopic Nissen fundoplication, and its application for such symptoms that are not amenable to or fail nonoperative therapy is encouraged.
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STEVEN RAKITA, M.D., DESIREE VILLADOLID, B.S., ASHLEY THOMAS, MARK BLOOMSTON, M.D., MICHAEL ALBRINK, M.D., STEVEN GOLDIN, M.D., ALEXANDER ROSEMURGY, M.D.
From the Department of Surgery, University of South Florida College of Medicine, Tampa, Florida
Presented at Southeastern Surgical Congress, 2005 Annual Scientific Meeting, February 11-15, 2005, New Orleans, LA.
Address corresponding and reprint requests to Steven Rakita, MD, Department of Surgery, James A. Haley VA Hospital, 13000 Bruce B. Downs Blvd., Tampa, FL 33612.
Copyright The Southeastern Surgical Congress Mar 2006
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