The Laparoscopic Nissen fundoplication is a unique operation in the realm of General Surgery- in that the indication for operation is based on the patient’s subjective assessment of symptoms, the fundamental aspect of the operation includes an element of surgeon artistry, and the results are largely subjective. Outcomes are therefore highly dependent on patient expectations, and it is difficult to extrapolate the results of a given surgeon’s technique to a population served by many surgeons using the same technique.
Laparoscopic fundoplication is indicated for the treatment of objectively documented, relatively severe gastroesophageal reflux disease (GERD).
The 2008 American Gastroenterological Association medical position statement on gastroesophageal reflux disease notes antireflux surgery is a consideration in chronic (long-term) management of GERD. A selection of specific recommendations include:
- Grade A: strongly recommended: 1) When antireflux surgery and PPI therapy are judged to offer similar efficacy, PPI therapy should be recommended as initial therapy; 2) When a patient with esophageal GERD syndrome is responsive to, but intolerant of, acid suppressive therapy, antireflux surgery should be recommended as an alternative therapy.
- Grade B: recommended with fair evidence: Patient with esophageal GERD syndrome with persistent troublesome symptoms, especially troublesome regurgitation, despite PPI therapy should be considered for antireflux surgery.
- Grade C: balance of benefits and harms are too close to justify a recommendation: Patients with extraesophageal GERD syndrome
- Grade D: recommended against: Patients with esophageal GERD syndrome with or without tissue damage who are symptomatically controlled on medical therapy
The 2010 SAGES Guidelines for Surgical Treatment of GERD note that when the diagnosis of reflux is objectively confirmed, surgical therapy should be considered in individuals who:
- Have failed medical management (inadequate symptom control, severe regurgiations not controlled with acid suppression, or medication side effects)
- Opt for surgery despite successful medical management
- Have complications of GERD including erosive esophagitis, stricture, and/or Barrett’s esophagus
- Have extraesophageal manifestations such as asthma, hoarseness, cough, chest pain, and/or aspiration
In considering the diagnostic approach to patients there are several goals:
- Establishing that GERD is the etiology behind the patient’s symptoms
- Estimating the risk of progressive disease
- Evaluating esophageal body function
- Evaluating gastric emptying function in patients suspected of having delayed gastric emptying. These include select patients with complaints of epigastric pain, persistent nausea and vomiting, frequent bloating, loss of appetite, and for those who require reparative antireflux surgery (possible vagal nerve abnormalities).
Esophageal function testing (esophageal manometry and 24 hour pH monitoring) has been based on the same technology for decades. Recently, however, several technical improvements have transformed the field of esophageal diagnostic testing. Prolonged (up to 48 hours) monitoring of the esophageal pH is now possible with the wireless pH capsule monitoring and more detailed pressure topography of the esophagus has been achieved by the recent development of the high- resolution manometry.
Esophageal manometry and ambulatory pH monitoring were developed in the 70s. With time, the relevance of these techniques in clinical practice became evident. Johnston et al. in 1993 showed how esophageal manometry changed the management of 20% of patients with non-cardiac chest pain and GERD and of 60% of those with dysphagia. Eckardt reported in 1999 that the introduction of pH monitoring in their clinical practice changed management in 42-66%of the patients. Since that time, many studies have enhanced our understanding of the utility of this diagnostic modality in the management of patients with GERD and primary esophageal motility disorders. For instance, investigators at UCSF studied with esophageal function tests 822 consecutive patients who had a clinical diagnosis of GERD based on symptoms and endoscopic finding. They showed that only 70% of them had abnormal reflux on pH monitoring. Symptoms such as heartburn and regurgitation were also no more frequent in patients who had genuine reflux than in those who did not. Thus, symptomatic evaluation could not distinguish between the two groups. In addition, endoscopy could not confirm a diagnosis of GERD based on symptoms, because the esophageal mucosa was normal in about half of patients with GERD. In addition, there is a significant interobserver variation between endoscopists, particularly for low-grade esophagitis. The findings of the esophageal function tests are therefore important to achieve an objective diagnosis and to avoid the prescription of inappropriate acid suppression medications or the performance of an antireflux operation.
Ambulatory pH monitoring also establishes a temporal correlation between symptoms and episodes of reflux. Such a correlation is particularly important when atypical symptoms of 5gastroesophageal reflux disease, such as cough, are present, as it identifies patients most likely to benefit from anti-reflux surgery. For instance, Patti et al. have showed that following laparoscopic fundoplication, typical symptoms resolved in 90% of patients, and respiratory symptoms resolved in 83% of patients when a strong temporal correlation between cough and reflux was found on pH monitoring. Moreover, ambulatory pH monitoring allows stratifying patients with GERD on the basis of its severity. Specifically, pH monitoring identifies a subgroup of patients characterized by a worse reflux profile because of more acid reflux in the distal and proximal esophagus, and slower acid clearance. These patients more frequently develop Barrett’s metaplasia and thus might benefit from early antireflux surgery. Lastly, ambulatory pH monitoring provides baseline data that may prove useful postoperatively if symptoms persist or recur postoperatively. For instance, when a patient has heartburn postoperatively it is assumed that the fundoplication has failed and acid reducing medications are prescribed. However, when ambulatory pH monitoring is performed, it shows that about two-thirds of patients who are taking acid-reducing medications postoperatively have a normal reflux status.
This technology has also improved our ability of predicting the outcome of laparoscopic antireflux surgery. In a multivariate analysis, Campos et al. showed that an abnormal ambulatory pH monitoring (together with a good response to acid suppression therapy and the presence of typical symptoms such as heartburn), was important in predicting a successful outcome of laparoscopic antireflux surgery (16). The findings of this work influenced the practice of gastroenterologist and surgeons, for almost 10 years. This work, however, left some questions unanswered. It was not clear how to treat patients who still experienced typical or atypical symptoms while receiving medical therapy. Specifically it was not clear if another disease was responsible or if a non-acid form of reflux was causing the symptoms. The breakthrough came with the development of esophageal impedance, which detects the flow of liquids and gas through hollow viscera, such as the esophagus. When used in combination with esophageal pH monitoring, this technique is able to detect both the transit of the refluxate and its pH throughout the esophagus.
In 2004, Tamhankar et al. showed that in normal subjects, medical therapy did not affect the number of reflux episodes or their duration, but it just changed the pH of the refluxate, being weakly acidic or non acidic. This and other studies partially explained why patients could experience symptoms while treated with acid suppressing medications. Mainie and Castell have shown that patients with persistent symptoms on acid suppressive therapy can be successfully treated surgically when multichannel intraluminal impedance and pH monitoring shows a positive association between symptoms and reflux, regardless of its pH. This observation was true for both typical and atypical symptoms of reflux.. For instance, Mainie and Castell have shown that in patients with persistent cough despite twice-daily proton pump inhibitor laparoscopic antireflux surgery is effective in improving atypical symptoms when a correlation between reflux and symptoms equal or superior to 50%, is present.
The implications of these investigations are important, because they seem to finally validate the theory that it is the presence of reflux, regardless of it pH that causes GERD. Two corollaries follow: a) impedance pH monitoring should be performed in patients with persistent symptoms while on medical therapy and b) the surgical reestablishment of the esophageal competence as a barrier to the reflux can determine good outcomes.
The rapid evolution of the technology behind the esophageal function testing has also introduced over the last years in the clinical practice two other diagnostic tools: the wireless pH capsule monitoring and the high-resolution manometry. They had less impact that multichannel intraluminal impedance and pH monitoring in further improving our understanding of foregut diseases, but advances in technology and future research studies will clarify their role in clinical practice.
The wireless pH capsule monitoring was developed to avoid the fastidious pH monitoring wire that remained in the esophagus across the nostril for 24 hours. This technique, which involves the endoscopic placement of the capsule to the esophageal mucosa, has important advantages: it has no connecting wire to the recorder and it is able to record up to 48 hours of data. However, the system has several limitations: it records only the pH in the distal esophagus, it can cause chest pain or discomfort that in some case has warranted early endoscopic removal, and it can detach early (<24 hours) from the esophagus (22). When this happens and by falling into the stomach, the capsule will record an acidic pH, thus creating a false positive study. In addition, the wireless capsule is placed transorally by endoscopy. This has the potential to create false positive or false negatives, depending on whether the capsule is placed to close or too far from the gastroesophageal junction.
High-resolution manometry provides detailed pressure topography of the esophagus. This allows a better identification than conventional manometry of segments of compartmentalized esophageal pressurization and better discrimination of conditions such as distal esophageal spasm, nutcracker esophagus, and vigorous achalasia.
The SAGES Guidelines for Surgical Treatment of GERD note that although there is no consensus regarding which studies should be obtained before surgery, the following studies may provide useful information:
- Esophagogastroduodenoscopy (EGD) – Noted as “likely the one study that all patients should have preoperatively,” as it allows for visualization of the esophageal mucosa for GERD related pathological changes and offers the potential for mucosal biopsies if needed.
- pH monitoring – this may be important in patients with significant esophageal or extraesophageal symptoms when the diagnosis of GERD cannot be confirmed on EGD
- Esophageal mannometry – Although there is no support in the literature for mandatory preoperative mannometry, this is frequently performed prior to surgery. Not only does it allow for an evaluation of esophageal body function, but it may identify conditions that might contraindicate antireflux surgery (e.g. Achalasia).
- Barium swallow/Upper GI – This is used for preoperative delineation of the anatomy. It is of particular benefit in helping to identify the presence and size of a hiatal hernia.
The AGA recommends:
- Endoscopy with biopsy for patients with esophageal GERD syndrome with troublesome dysphagia.
- Endoscopy to evaluate patients with a suspected esophageal GERD syndrome who have not responded to an empirical trial of twice-daily PPI therapy.
- Manometry is considered to evaluate patients with suspected esophageal GERD syndrome who have not responded to twice-daily PPI therapy and have normal findings on endoscopy. This may serve to localize the lower esophageal sphincter for potential pH monitoring, evaluate peristaltic function, and to diagnose subtle presentations of major motor disorders.
- Ambulatory impedance-pH, catheter pH, or wireless pH monitoring while off PPIs for 7 days should be used to evaluate patients with suspected esophageal GERD syndrome who have not responded to PPIs, have normal findings on endoscopy, and have no major abnormality on manometry.
There is not sufficient evidence to definitively support additional forms of pre-operative evaluation in the setting of extraesophageal symptoms. Some have advocated several pH and esophageal function studies to help confirm the present of gastric or duodenal fluid in the upper esophagus to aid in decision making regarding these atypical symptoms.
Laparoscopic 360 degree fundoplication (Nissen)
Laparoscopic 180 degree fundoplication (Toupet)
Laparoscopic Anterior fundoplication
Endoluminal therapies for GERD
Based on the large randomized, prospective trials of open and laparoscopic fundoplication versus medical therapy, it can be stated that patients who are responders to medical therapy at the time of enrollment have similar rates of therapy failure over time in either the surgical or medical arms. This rate of symptomatic failure increases slowly over time from 10% at 3 years (LOTUS) and 12% at 5 years (Anvari et al) to 19% at 7 years (Mehta et al) and to 21% at 10 years (Kelly et al). In the medicine versus surgery trials, the most relevant result to the gastroenterologist is the increased number of surgical patients that are strongly unhappy due to bloating and flatulence. However, due to the higher highs, and lower lows in the surgical arms, mean quality of life scores are equal in surgical versus medical arms. Due to the perceived overall equivalency of medical and surgical therapies in medication responders, the number of patients referred for antireflux surgery has been and will remain on the decline from its peak in 1999-2000.
Use of a bougie has become a fundamental tenet of antireflux surgery, and the single randomized trial by an American high-volume center confirmed this, with the rate of severe postoperative dysphagia reduced by half in the bougie group (although without reduction in the need for postoperative dilation and with one bougie perforation) versus no bougie. The seminal report by DeMeester showing a rate of dysphagia inversely proportional to the size of bougie should still be considered applicable today. Generally following Nissen fundoplication, 75% of patients who present with dysphagia preoperatively will have resolution of symptoms, and approximately 5% of patients will have new-onset dysphagia, resulting in a total rate of severe short-term post-operative dysphagia of approximately 16%. In patients with preoperative dysmotility, the rate of post-operative severe dysphagia is not reduced when a partial fundoplication is used (Fibbe et al). Up to 40% of all patients will have some solid dysphagia at one month, so a diet of gradually increasing solidity and complexity is reassuring to most patients.
During the first several years after introduction of the laparoscopic technique, review of all antireflux operations performed in Finland revealed a nearly three-fold increase in 14near-fatal complications of the laparoscopic Nissen fundoplication over the open approach, although the mortality rate was unchanged. The majority of these events are perforations (occurring in approximately 1%), and are undiagnosed at operation. Splenic injury and hemorrhage requiring splenectomy has occurred in 0.9% over several time periods. An American population-based study determined a volume-outcome effect, with a 0% mortality rate for surgeons performing more than 10 operations per year, and a 1.3% mortality rate for surgeons performing an average on one operation per year. A German surgeon survey also reported a volume effect, with low volume hospitals (< 10 operations per year) having triple the complication rate as higher volume centers.
There is a clinically important risk of anatomic fundoplication failure (including wrap herniation) in the initial 6 months after operation. Early studies without routine crural closure reported roughly double the rate of early anatomical failure. The rate of failure has been found to increase with size of the hiatal hernia, from 1.5 – 3% up to and over 20% 6-month radiological recurrence rate in large sliding hiatal and paraesophageal hernias. A higher anatomical failure rate is found in patients with Barrett’s esophagus. Denmark reported a 5% reoperation rate countrywide over an eight-year period. Patient education and prevention of retching may greatly impact this early failure rate, and biomaterial mesh placement to buttress the crural repair remains highly controversial as a means to prevent recurrent herniation (hiatal-mesh associated dysphagia may offset the reduced re-herniation risk). For patients who underwent laparoscopic Nissen fundoplication with crural closure between 1992 and 1995, the 10-year reoperation rate is 10-11%. Whether that is true of patients operated in 2009- with heavier patients and more recurrent and large hiatal hernias- remains to be seen.
Patients expected to fail
Defining failure as reoperation, severe symptoms, or dissatisfaction with initial operation, the Emory group identified 25% of patients considered to have failed antireflux surgery at 11 years. Analysis of these patients identified patients with atypical symptoms, BMI > 35, and no response to medication as those at particularly high risk for late failure. Patients with predominant airway symptoms (laryngopharyngeal reflux) and no response to medication are extremely poor candidates for antireflux surgery. Other groups that have been identified as having predisposition to postoperative dissatisfaction include: patients with active psychological disease, those with hypochondriacal tendencies or filling criteria for irritable bowel disorder, and patients with high resting LES pressure. In these patients a partial fundoplication may be more strongly considered.
This material was obtained from the 2009 SAGES Annual meeting Post-graduate course “Foregut – Combined” syllabus. Special acknowledgement is owed to Drs. S.P. Bowers and Marco Patti for materials provided in completing this submission.
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