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Ann Thorac Surg 2002;74:1019-1025
© 2002 The Society of Thoracic Surgeons

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Original article: general thoracic

Excellent quality of life after Nissen fundoplication depends on successful elimination of reflux symptoms and not the invasiveness of the surgical approach

^a Department of Surgery, University of Southern California, Los Angeles, California, USA
^b Department of Cardiothoracic Surgery, University of Southern California, Los Angeles, California, USA

* Address reprint requests to Dr Steven DeMeester, Norris Comprehensive Cancer Center, 1441 Eastlake Ave, Suite 7418, Los Angeles, CA90033-0804, USA.
e-mail: sdemeester{at}surgery.usc.edu

Presented at the Thirty-eighth Annual Meeting of The Society of Thoracic Surgeons, Fort Lauderdale, FL, Jan 28–30, 2002.

	Abstract

Top Abstract Introduction Patients and methods Results Comment Discussion References

 
BACKGROUND: Quality of life, poor in patients with reflux disease, improves significantly after an antireflux operation. The aim of this study was to determine the relative importance of the operative approach used for a fundoplication, as well as the successful elimination of reflux symptoms on long-term quality of life in patients with gastroesophageal reflux disease.

METHODS: A questionnaire, including the medical outcome study short-form health survey (SF-36), was completed by 105 patients who had undergone either a laparoscopic Nissen fundoplication (n = 72) or a transthoracic Nissen fundoplication (n = 33); median follow-up was 25 and 31 months, respectively. Patients were classified as completely or incompletely relieved of reflux symptoms based on the frequency of reflux symptoms and the use of acid-suppression medication.

RESULTS: Patients selected for transthoracic Nissen fundoplication had significantly worse preoperative gastroesophageal reflux disease based on the presence of a large hiatal hernia, Barrett’s esophagus, or stricture. Long-term quality of life was similar for the two approaches, but was significantly decreased in patients with recurrent reflux symptoms. Compared with laparoscopic Nissen fundoplication patients, transthoracic Nissen fundoplication patients were less likely to use acid-suppression medication and tended to be more satisfied with their operation.

CONCLUSIONS: Long-term quality of life was independent of the invasiveness of the procedure, but significantly dependent on successful elimination of reflux symptoms and the necessity for acid suppression medication. Patients who underwent a transthoracic Nissen fundoplication, despite having more advanced disease preoperatively, tended to have less reflux symptoms and less long-term acid-suppression medication usage after their procedure. These findings support the continued use of a transthoracic antireflux procedure in patients with advanced gastroesophageal reflux disease.

	Introduction

Top Abstract Introduction Patients and methods Results Comment Discussion References

 
Gastroesophageal reflux disease (GERD) is a common disorder in the United States. Manifestations of the disease range from occasional episodes of heartburn and regurgitation to the more serious complications of stricture and Barrett’s esophagus. Most patients manage their symptoms with a combination of dietary and lifestyle modifications and over-the-counter or prescription medications. However, reflux disease impacts their quality of life (QOL). It has been shown that compared with the normal population, patients with reflux disease have a substantial decrement in QOL, such that the QOL in patients with reflux disease is similar to that in patients with chronic congestive heart failure [1]. Antireflux operations abolish reflux, and success rates in excess of 90% have been reported for both relief of symptoms and elimination of reflux on 24-hour pH monitoring [2, 3]. By abolishing reflux, removing the need for restrictions on diet and lifestyle, and ending the necessity for acid-suppressing medications, antireflux operations significantly improve QOL.

Since the introduction of laparoscopic antireflux procedures many patients have opted for an operation to treat their reflux disease. However, the failure rate of an antireflux procedure increases in patients with advanced reflux disease, particularly those with large hiatal hernias, strictures, or long-segment Barrett’s esophagus [4, 5]. Frequently failures, including recurrent hiatal hernia, breakdown of the fundoplication, or both, are caused by unappreciated esophageal shortening with excessive tension on the repair, or the presence of a wide hiatus with attenuated crura. Although a transthoracic antireflux operation provides the optimal approach to mobilize the esophagus, reduce tension on the repair, reconstruct the hiatus, and minimize the likelihood of failure in patients with advanced reflux disease, it is also a substantially more invasive procedure than a laparoscopic fundoplication. Furthermore, open procedures have been associated with a longer hospital stay, more patient discomfort, and a longer interval before fully returning to activities and work than laparoscopic procedures. Given these disadvantages some surgeons opt for a laparoscopic approach in all patients regardless of the severity of the disease or the presence of risk factors for failure of the fundoplication.

Previous studies have evaluated QOL after an antireflux operation. However, the impact of the surgical approach and the invasiveness of the procedure on QOL have not been assessed, nor have the consequences of recurrent reflux symptoms after a fundoplication on QOL been reported. We hypothesized that the short-term drawbacks of a transthoracic approach to an antireflux operation would become less important with time after the operation, and that the most important determinant of long-term QOL for a patient after an antireflux operation would be the continued relief of reflux symptoms. Our aim was to determine the relative importance of the operative approach for fundoplication, as well as successful elimination of reflux symptoms on long-term QOL in patients with reflux disease.

	Patients and methods

Top Abstract Introduction Patients and methods Results Comment Discussion References

 
Patient selection
To address the question of QOL related to outcome after laparoscopic or transthoracic antireflux operations, and to minimize the impact of comorbidities, only patients that had undergone a primary and uncomplicated Nissen fundoplication were considered for this study. From 1992 until 1999 we performed 298 laparoscopic Nissen fundoplications and 50 transthoracic Nissen fundoplications as a first-time, uncomplicated procedure at the University of Southern California University Hospital. Because laparoscopic Nissen procedures were far more common, a randomly selected group of 100 laparoscopic Nissen fundoplication patients were asked to complete the study questionnaire. All 50 transthoracic Nissen fundoplication patients were asked to participate.

Questionnaires were mailed to the patients, and those that failed to respond within 4 weeks had the survey mailed to them again. Failure to respond to the second mailing prompted an attempt to contact the patient by telephone; patients who were successfully contacted completed the questionnaire on the telephone with a physician other than the operating surgeon.

Operations
The diagnosis and severity of reflux disease was confirmed and evaluated in each patient by clinical history, video esophagram, upper gastrointestinal endoscopy, stationary esophageal manometry, and ambulatory 24-hour esophageal pH monitoring. Selection of the operative approach was at the discretion of the primary surgeon based on their assessment of the disease severity in each patient. Factors that encouraged selection of a transthoracic approach included the presence of a 5 cm or larger hiatal hernia that failed to reduce in the upright position, an esophageal stricture, or long-segment Barrett’s esophagus. Any one of these factors, or a combination thereof, indicated the potential for a short esophagus, and a transthoracic antireflux operation was chosen as the preferred approach. The absence of these factors suggested earlier disease, and these patients were offered a laparoscopic antireflux operation.

Laparoscopic Nissen procedures were performed as previously described [6]. All patients were admitted to the hospital after the procedure and discharged after an oral diet and comfort were established, usually within 48 to 72 hours. The technique used for the transthoracic Nissen procedures has also been previously described [7]. Epidural analgesia was used for postoperative pain relief for 5 to 7 days. Patients were discharged after their chest drains were removed and after diet and oral pain medication were tolerated.

Outcome measures
The medical outcome study short-form health survey (SF-36) is an established and validated generic health-related quality of life instrument [8]. The SF-36 uses a series of questions distributed among 8 health concepts to assess a patient’s general health status. The results are typically summarized as physical and mental health component scores, with higher scores reflecting a better QOL. Since the SF-36 is a generic measure of health and not specific for reflux disease or postoperative recovery, patients were also given a questionnaire that inquired about the presence and frequency of dysphagia, reflux symptoms, antireflux medication usage, the duration of wound pain, postoperative analgesia medication usage, the length of time before returning to full household or work activities, and the degree to which the individual was satisfied with their operation.

Adequacy of the fundoplication was assessed on the basis of symptoms. Patients were considered to have recurrent or incompletely controlled gastroesophageal reflux disease if they responded affirmatively on the questionnaire to the presence of heartburn or regurgitation more frequently than once a week, or to the use of medications for reflux.

Statistical analysis
Values are expressed as mean and standard deviation unless otherwise stated. Statistical analyses were performed using the SPSS 10.0 software (SPSS Inc, Chicago, IL). The Mann-Whitney U test was used to compare the QOL data, and the Fischer’s exact test was used to compare proportions between groups. Statistical significance was set at p 0.05.

	Results

Top Abstract Introduction Patients and methods Results Comment Discussion References

 
From the randomly selected group of 100 laparoscopic Nissen patients, ultimately 72 (72%) completed the questionnaire. This was similar to the 66% response rate from the transthoracic patients (33 of 50). There was no statistically significant difference in sex distribution, age at operation, or median length of follow-up between groups (Table 1). As would be expected based on our selection criteria, the severity of gastroesophageal reflux disease based on the presence of a stricture, Barrett’s esophagus, or large hiatal hernia was significantly greater in those patients that underwent a transthoracic procedure (Table 2). However, despite starting out with more severe disease, patients that underwent a transthoracic Nissen had SF-36 scores that were nearly identical to the laparoscopic Nissen patients at a median postoperative follow-up of 31 and 25 months, respectively (Table 3 and Fig 1). Furthermore, detailed questioning revealed that more laparoscopic patients (29%) had symptoms of heartburn or regurgitation or were using acid-suppression medication than transthoracic patients (9%), although the difference did not reach statistical significance (Table 4). There was no significant difference in the incidence of dysphagia between groups (data not shown).

View larger version (21K): [in this window] [in a new window]   Fig 1. Polar graph showing the health concept scores from the Medical Outcome Study Short-Form 36 Health Survey. There is no significant difference in postoperative quality of life between patients who underwent either a laparoscopic or a transthoracic Nissen fundoplication at a median follow-up of 25 and 31 months, respectively. Reported normal values for the United States (US) are shown for comparison.

View larger version (13K): [in this window] [in a new window]   Fig 2. Responses to the question about residual pain in the incision site by each of the patients after either laparoscopic or transthoracic Nissen fundoplication. There was no difference between the groups beyond 4 years. Interestingly, up to 3 years after laparoscopic Nissen procedures, some patients complained of pain most of the time. Clearly individual perceptions about residual pain vary widely, and residual pain is not an exclusive feature of a transthoracic operation.

Whereas the long-term QOL based on SF-36 scores was similar for both groups, a significantly decreased QOL was present in patients with persistent or recurrent reflux symptoms after an antireflux operation (Fig 3). The reduced QOL was particularly evident in the general health, vitality, and mental health component scores (Table 5).

View larger version (18K): [in this window] [in a new window]   Fig 3. Polar graph showing the health concept scores from the Medical Outcome Study Short-Form 36 Health Survey and questionnaire divided into those patients free of reflux symptoms and those patients who had persistent or recurrent reflux symptoms or who had resumed taking acid suppression medication postoperatively. Those free of symptoms and medications scored higher in each of the eight major health categories.

	Comment

Top Abstract Introduction Patients and methods Results Comment Discussion References

The major finding of this study was that long-term quality of life after a Nissen fundoplication was independent of the invasiveness of the approach used for the procedure. As would be expected, patients that underwent a transthoracic Nissen had significantly greater discomfort early after the procedure, used more pain medication postoperatively, and had delayed return to work and full activities. However, the late postoperative SF-36 total scores, as well as the component scores for bodily pain and physical functioning, were not significantly different for the two approaches, and both restored QOL back to or above established normal values for the United States.

A second major finding was that long-term quality of life was significantly decreased in patients with incompletely controlled or recurrent reflux symptoms after a Nissen fundoplication compared with patients relieved of their symptoms by the antireflux procedure. Importantly, good long-term QOL after antireflux operations did not correlate with the preoperative severity of reflux disease. Uniformly, patients selected for a transthoracic Nissen had more advanced disease, yet relief of their reflux symptoms yielded a similar QOL to that found in patients with earlier disease treated with a laparoscopic Nissen. Therefore, the key to restoring QOL to normal values in patients with reflux disease is to successfully eliminate the reflux symptoms that prompted them to undergo an antireflux operation in the first place. Consequently, long-term success of the fundoplication, and not factors such as the size and location of the incision, should be the primary focus of surgeons treating patients with reflux disease.

With this concept in mind it is interesting to note that despite the increased severity of preoperative reflux disease in the transthoracic group, a higher percentage of the laparoscopic patients reported symptoms of heartburn or regurgitation or were using acid-suppression medication at late follow-up. Clearly the transthoracic Nissen is an excellent operation, and it is our opinion that the incidence of recurrent symptoms would be further increased if patients with advanced disease were routinely selected for a laparoscopic approach. Support for this concept comes from studies using objective methods to detect recurrence after antireflux operations in patients with large preoperative hiatal hernias or Barrett’s esophagus. These patients have complicated reflux disease, and the surgical failure rate is higher in these patients, particularly when a laparoscopic approach is selected [13–15].

One of the continuing controversies in esophageal surgery is the existence and frequency of encountering a shortened esophagus. It has been our experience that chronic, severe reflux can produce injury to the longitudinal esophageal muscle layer, which results in scarring, contracture, and a shortened esophagus. A definitive diagnosis of a shortened esophagus can only be made intraoperatively by the inability to reduce the gastroesophageal junction below the diaphragm without excessive tension. However, preoperative indicators that suggest the possibility of a short esophagus include the presence of a large, nonreducible hiatal hernia, Barrett’s esophagus, or an esophageal stricture. These are all hallmarks of advanced disease, and patients with one or more of these abnormalities are at increased risk for a short esophagus. Furthermore, large hiatal hernias are commonly associated with a widened hiatus and attenuated crura making secure closure difficult. Consequently, we recommend a transthoracic antireflux operation in these patients in order to maximally mobilize the esophagus, reduce tension on the repair, securely approximate the crura, and minimize the likelihood of recurrence or failure. An alternative would be a laparoscopic approach with liberal use of a Collis gastroplasty; however, reports detailing problems with the use of a Collis gastroplasty in patients with complicated reflux disease should encourage a cautious rather than a cavalier attitude toward the use of an esophageal lengthening procedure [16, 17].

Overall we found that more than 90% of patients were pleased with the outcome of their operation, and would choose to have the procedure again, even given what they now know about the operation and recovery. This was true whether the patient had a laparoscopic or a transthoracic fundoplication, and is an indication of the significant impact reflux disease had on their QOL, as well as the improvement they experienced after the antireflux operation. The finding that so many patients would choose to undergo a transthoracic procedure again, if necessary, gives testimony to the fallacy of the concept that the disadvantages of this approach outweigh any potential benefits, particularly in light of the finding that these patients tended to be less likely to have recurrent symptoms or need acid-suppression medication despite more severe preoperative reflux disease.

One limitation of our study is that we did not assess QOL preoperatively. However, the decrement in QOL associated with chronic reflux disease has been well documented in the literature, and our goal was to address the question of long-term QOL in relation to the invasiveness of the surgical approach and the successful relief of reflux symptoms. Because both groups had documented reflux disease and underwent a primary uncomplicated Nissen fundoplication, we believe that QOL comparisons between the two groups are valid. Another potential criticism of this study concerns the severity of reflux in the two groups. It is possible that because the patients selected for a transthoracic procedure had more severe disease initially, they may have then had more intense symptoms, been willing to tolerate more invasive treatment, and remained less critical of the final results than laparoscopic Nissen patients. Whereas this potential bias exists, the fact remains that the goals of an antireflux operation are to abolish reflux and restore an excellent QOL in patients with reflux disease, and a transthoracic approach accomplishes these goals remarkably well. Last, we recognize that determining whether there is a recurrent hiatal hernia or a failed fundoplication requires radiographic, endoscopic, and physiologic evaluation, and we know full well that symptoms may be present that are unrelated to reflux or failure of the fundoplication. However, it is symptoms that drive most patients to undergo an operation, and it is relief of their symptoms that leads to the improvement in QOL. Consequently, because the aim of this investigation was to determine QOL and symptoms in patients after either a laparoscopic or transthoracic antireflux operation, no attempt was made to document whether the fundoplication had failed or not. Instead, an objective comparison of the long-term success of these two procedures needs to be the focus of future investigations, particularly because we have now demonstrated that a transthoracic antireflux operation remains a viable option from a QOL standpoint.

In conclusion, long-term QOL in patients treated with either a laparoscopic or transthoracic Nissen fundoplication is independent of the invasiveness of the surgical approach used for the procedure, but depends significantly on the successful elimination of reflux symptoms and the necessity for daily acid-suppression medication. In light of these findings, more emphasis should be placed on the achievement of a good long-term outcome, and less emphasis on the surgical approach in patients with reflux disease.

	Discussion

Top Abstract Introduction Patients and methods Results Comment Discussion References

 
DR DONALD E. LOW (Seattle, WA): Dr Streets, I enjoyed your presentation. More importantly, I think it is an important addition to the evolution of our decision profile in people with gastroesophageal reflux disease (GERD) and other significant related problems.

Like you, for years I have been using a different approach depending on the presentation of individual patients. You have nicely shown that long-term follow-up is an extremely important component to our decision profile as to how we should be approaching these patients. Unlike you, I do not go transthoracically. I use a transabdominal Hill procedure that firmly anchors these same types of patients and provides a more reliable long-term outcome. The literature is now filled with laparoscopic reports of feasibility but very little long-term follow-up data.

You have nicely reaffirmed that quality of life is the most important long-term issue. Were you able to look at any objective assessments of these people? In addition to quality of life, we have also noticed that people with stricture and Barrett’s are at increased risk for anatomic as well as symptomatic recurrence in the long term. You have strictures and Barrett’s in both populations, were you able to document a decrease in anatomic recurrence in the patients you’ve done transthoracically?

DR STREETS: Thank you for your question. We did not apply any objective postoperative assessments to our subjects. Other investigators have already shown that long segment Barrett’s esophagus, large hiatal hernia, and esophageal stricture are risk factors for the early breakdown of the wrap. We simply concentrated on the postoperative quality of life and symptoms using a mailed questionnaire.

DR HIRAN C. FERNANDO (Pittsburgh, PA): Ideally a minimally-invasive operation should be able to achieve what you have achieved with an open operation, so in the long term the results should be the same between the two procedures. How about early on, did you look at quality of life, say, at 1 month or 6 weeks or even at 3 months and compare the two groups?

DR STREETS: We did not consider any patients less than 3 months after their operation, thus allowing them to recover from the procedure itself. However, when we divided the follow-up into less than 1 year, between 1 and 4 years, and greater than 4 years, there was no significant difference in quality of life between those that had a laparoscopic or transthoracic procedure. This certainly holds true for 3 months.

DR JEAN-MARIE COLLARD (Brussels, Belgium): I congratulate you on this excellent article on the long-term outcome of the laparoscopic and transthoracic Nissen fundoplication. Although the difference is not significant in your article, there is a trend for a higher proportion of patients who require antacids many years after laparoscopic fundoplication as compared with the conventional approach, and this is in accordance with an article we published in The Annals of Surgery in 1994 in which we already showed at that time that there was little difference between the transabdominal approach and the laparoscopic approach for this kind of patient. With a 24% rate of patients who require medication in the long term, do you think that we should stop with the laparoscopic fundoplication or not? This is an important question.

DR STREETS: I agree that it is an important question, but I think that the answer requires consideration of several things.

First, we are not proposing that all antireflux procedures be done transthoracically. To do so would take antireflux surgery back 20 years and it would be restricted only to those with the most severe disease. Laparoscopic antireflux surgery is a great contribution, but it is best in patients with early disease. Thus patient selection is important, and encouragement of the medical community to move in the direction of antireflux surgery before patients develop strictures or Barrett’s is also important.

Second, in regards to postoperative medication use, it is important to understand why patients are taking the medications. A number of recent articles have shown that many patients are being prescribed antacid medications inappropriately after antireflux surgery. Unfortunately, we did not ask "Which particular symptom resulted in your primary care physician prescribing you antacid medication?" in our questionnaire. We simply asked our patients if they were or were not taking over-the-counter or prescription antacid medication. However, we have studied a group of patients taking acid-suppression medication after antireflux surgery and found that in most cases their 24-hour pH test was normal, and therefore the symptom for which they were taking the medicine was not likely to be secondary to reflux. Again, I would like to conclude by stating that this article does not discourage the performance of a laparoscopic Nissen fundoplication, but it does emphasize the need to select those patients that will do well.

	References

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This Article Abstract Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Personal Folders Download to citation manager Author home page(s): Steven R. DeMeester Tom R. DeMeester Jeffrey A. Hagen Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Streets, C. G. Articles by Bremner, C. G. Search for Related Content PubMed PubMed Citation Articles by Streets, C. G. Articles by Bremner, C. G. Related Collections Esophagus - other