LONG-TERM OUTCOME AND PERSPECTIVES OF LAPAROSCOPIC FUNDOPLICATION
B. Hugl and R. A. Hinder
Mayo Clinic, Jacksonville, FL, USA
Introduction
The ability to perform a fundoplication laparoscop- ically since 1991 has changed the surgical approach to patients with gastroesophageal reflux disease (GERD). Laparoscopic antireflux surgery remains an excellent option in patients with severe GERD.
Laparoscopic Nissen fundoplication offers less morbidity and mortality than the open procedure with at least the same short-term outcome and better results compared to medical therapy. The rate of con- version to an open procedure is now close to zero.
Appropriate preoperative investigation, patient selection and adequate discussion of risks are impor- tant in securing a good outcome and long-term patient satisfaction.
Some patients have continuing symptoms, but more than 90% of patients remain satisfied with their decision to undergo surgery. This excellent success rate is maintained for up to 20 years after open fundoplica- tion and indications are that this should be the same after the laparoscopic procedure [1], [2].
Long-term results of laparoscopic fundoplication will be discussed under various headings.
1. Overall satisfaction with surgery- quality of life
When a new procedure or technology is introduced the most important outcome measurements are mortality, morbidity, recurrence rate and long-term survival. However, from the patient’s point of view symptom relief, duration of convalescence, satisfaction, well-being and quality of life are of great importance.
Recently, a number of studies have evaluated the quality of life of patients with GERD-related symp- toms [3]. These have shown that quality of life in
GERD patients is significantly impaired when com- pared to that of healthy individuals [4]. Therefore, im- provement of quality of life is one of the major goals of GERD treatment. During recent years, laparoscopic antireflux surgery has shown itself to be effective at im- proving the long-term quality-of-life in the treatment of patients with GERD [5]–[7]. Several authors have used quality-of-life assessments to compare the results of different surgical treatments and medical versus sur- gical treatment, respectively. Antireflux surgery, open or laparoscopically performed, led to a significant im- provement of quality-of-life in a 5- to 8-year follow up [5], and even after laparoscopic redo fundoplication [8]–[10]. This applied to all domains including phys- ical functioning (how patients perceive their ability to perform physical tasks), role-physical (how patients perceive their ability to fulfill their life role physically), role-emotional (how patients perceive their ability to fulfill their life role emotionally), bodily pain (how pa- tients perceive their level of pain), vitality (how patients perceive their level of “energy”), mental health (how patients perceive their emotional and psychological well-being), social functioning (how patients perceive their ability to participate in social activities), and gen- eral health (how patients perceive their overall health and well-being). Kamolz et al [11] showed that pa- tients without Barrett esophagus undergoing laparo- scopic antireflux surgery achieve a better quality-of-life improvement than those with Barrett esophagus.
However, after surgery the Gastrointestinal Quality- of-Life Index of both groups was comparable to the mean value of the general population.
Nevertheless, some appropriately selected patients will not be satisfied with the result of antireflux surgery [5], [12]. This dissatisfaction may be due to failure of the fundoplication including misdiagnosis of esopha-
performed in 29 of 233 (12%) patients after laparo- scopic antireflux surgery. This was required in 6 pa- tients within the first week after surgery. Dysphagia resolved in 67% after dilation and in an additional 17% after reoperation [20]. Severe or persistent dysphagia, however occurs in 3% to 43% of patients after Nissen fundoplication [16], [17], [19], [21], [22] and is usually related to the tightness of the fundic wrap around the esophagus, fibrosis at the esophageal hiatus or hiatal herniation with or with- out migration of the wrap into the chest. Redo surgery to achieve hiatal closure with or without prosthetic material will frequently cure this problem [23]–[25].
Some feel that avoidance of dividing the short gastric vessels contributes to dysphagia with a rate of dysphagia of 4.7% compared to 2.6% when the short gastric vessels are taken down [26]. Others feel that this is only selectively required during the Nissen fundoplication and never needed during a partial fundoplication.
Inability to belch is an expected outcome after fundoplication and most patient learn to compensate.
Patients with an esophageal stricture prior to sur- gery usually have dysphagia. The need for dilation was found to be 252 dilations in 102 patients over 26 months prior to surgery and 29 dilations in 24 months after surgery [27].
3. Barrett esophagus
Barrett esophagus is associated with chronic gastro- esophageal reflux disease and represents the severest form of GERDwith malignant potential.
There is no well-defined therapy for patients with this disease. Barrett esophagus is unlikely to regress with medical or surgical therapy, and progression to cancer in not prevented by either [28]. Most studies show no difference in cancer risk after medical or surgical therapy for Barrett. Our own meta-analysis shows a cancer risk in Barrett of 1:294 patient years after anti-reflux surgery and 1:145 patient years during medical therapy [29].
Spechler et al [30] showed that 4 of 166 patients developed adenocarcinoma during long-term follow- up in a medically treated group and none of 82 pa- tients after fundoplication, however El-Serag and geal disorders, complications or side effects of surgery
or to symptoms of non-esophageal disease. There re- mains a percentage of patients who are dissatisfied with antireflux surgery without physiologically demonstra- ble reason. Vélanovich [13] recently showed that 68%
of dissatisfied patients had no physiological or ana- tomic problem with their surgery. The median scores of the 36-Item Short-Form Health Survey (SF-36) for dissatisfied patients with unexplained dissatisfaction were generally lower than those for patients with docu- mented surgical failure. Patients who were dissatisfied with surgery had statistically significantly worse me- dian preoperative scores in 6 domains (role-physical, role-emotional, bodily pain, mental health, social func- tioning, and general health) compared with patients who were satisfied with surgery and worse postopera- tive scores in all domains, statistically significant in 2 domains (role-emotional and vitality). Postoperative scores were statistically significantly better in all 8 do- mains for the satisfied group compared with the dissat- isfied group. Patients with lower preoperative quality of life are more likely to be dissatisfied despite successful antireflux surgery.
This is another reason why both physician and surgeon should be very sensitive to how GERDaf- fects each patient’s quality-of-life before making treatment recommendations.
2. Dysphagia
Transient dysphagia occurs in 40% to 70% of patients after Nissen fundoplication [14]–[16]. Dysphagia is reported by Anvari et al in up to 72% of patients after surgery with a mean dysphagia score of 4.3 4.8 decreasing to 2.6 3.8 (p 0.001) 6 months after surgery and remaining stable at 2 years (2.2 3.4) and 5 years (2.4 3.4) after surgery [17]. This may be secondary to postoperative edema at the gastro- esophageal junction or transient esophageal hypo- motility with most symptoms resolving in a few weeks [14], [17], [18]. Most of these patients have mild symptoms and postoperative dilatation was required in 3.5% of 2068 reported patients [19].
In our experience dilation shortly after fundopli- cation is safe and successful in most patients with dysphagia. Symptoms other than dysphagia were found not to respond well to dilation. Dilation was
Sonnenberg [31] reported that fundoplication did not protect patients, with either complicated or uncompli- cated esophagitis, against esophageal adenocarcinoma.
As it is hypothesized that adenocarcinoma devel- ops among a subset of patients who have acquired genomic instability in Barrett epithelium and takes up to 6 years for developing from low-grade dysplasia, the genetic alteration may have occurred before antireflux surgery was performed [32]. Thus, development of adenocarcinoma in the first few years after antireflux surgery may not represent progression of disease after surgery [33]. This is supported by the fact that a Mayo analysis showed that all cancers occurred within 3 years of the fundoplication. The development of Barrett esophagus is rare after an effective procedure [34]–[36]. This was also shown by Wetscher et al [37]
who found that progression to Barrett was frequently seen when patients were on medical therapy and that this was halted after surgery.
Bammer et al [29], in a review, showed that anti- reflux surgery seems to result in a lower incidence of new cancers and less progress in length or dysplasia.
They suggest that surgery may be superior to medi- cal therapy to prevent progression of Barrett esopha- gus and the development of carcinoma. Nevertheless, surveillance is required, irrespective of the treatment modality.
Patients with severe dysplasia on a biopsy specimen of the esophagus have a high incidence of coexisting carcinoma and are candidates for esophagectomy.
Surgical therapy for Barrett esophagus should be reserved for patients who are resistent to medical therapy or who develop complications of GERD.
4. Bowel dysfunction and diarrhea
Postoperative bowel dysfunction after laparoscopic antireflux surgery, particularly diarrhea, has not recei- ved wide recognition. Klaus et al [38] found that 35%
of patients had bowel dysfunction before surgery.
Swanstrom et al noted that as many as 66% who un- derwent antireflux surgery had pre-existing irritable bowel syndrome. In the series of Klaus et al [38] 43%
of patients undergoing laparoscopic antireflux surgery did not experience any bowel problems before or after surgery and, in 21% the same symptom was experi- enced before and after surgery. However, new-onset
bowel dysfunction occurred in 36% of the patients with 14% having new onset diarrhea.
Diarrhea is an uncommon complication after antireflux surgery but has been reported to be persis- tent in 8% of patients. The diarrhea seen is most commonly postprandial, resembling the dumping syndrome. The cause of the diarrhea is unclear and possible causes include an increased rate of gastric emptying, bacterial overgrowth or vagus nerve injury resulting in postvagotomy diarrhea.
5. Abdominal bloating
Temporary, mild bloating occurs in up to 100% of patients. The inability to belch and reduced fundic volume can predispose patients to the development of gasbloat after fundoplication. The habit of fre- quent swallowing of spit and aerophagy contribute to the problem. On the other hand, gastric emptying particularly of liquids has been shown to be acceler- ated after fundoplication. While in the majority this symptom improves after surgery, few patients devel- op severe symptoms of bloating after fundoplication.
The treatment can be frustrating, and includes avoidance of carbonated beverages, gas trapping medications and promotility agents.
6. Recurrence of GERD after surgery
In our experience, the cumulative failure rate of sur- gery is about 1% per year. Continuing symptoms such as abdominal bloating, excess flatus, nausea, diarrhea, dysphagia and chest pain are not uncommon after surgery and were frequently present before surgery.
Carlson et al [26] in a review of 41 papers reporting 9,433 procedures showed a reoperation rate of 2.77% (individual reoperation rate ranging from 0% to 15.4%). The most common indications for reoperation after a primary minimally invasive antireflux procedure were reflux (43%), followed by dysphagia (24%) and wrap herniation (18%).
We have found that only 0.7% of all patients re- quire revisional surgery and the remainder are easily controlled by medical therapy. In our experience of 46 patients requiring reoperation after previous fundopli- cation, the most common causes of failure were hiatal
8. Who should not have had surgery?
Patients who present with atypical symptoms (gastric, respiratory, chest pain) and with a normal LESpressure have a 56% failure rate after antireflux surgery [45].
The Nissen fundoplication will reliably replace the gastroesophageal junction into the abdomen and restore LES barrier function. Little benefit is likely to occur if the patient’s symptoms are not caused by a transient or permanent loss of this bar- rier. Thus, in large part the predictability of success following laparoscopic fundoplication is directly proportional to the degree of certainty that gas- troesophageal reflux is the underlying cause of the patient’s complaints. It is therefore important to identify patients less likely to benefit from antire- flux surgery and to avoid surgery in these cases.
The presence of an abnormal 24-hour pH score, typical primary symptoms, and a significant re- sponse to acid suppression therapy predicts a suc- cessful outcome after Nissen fundoplication [46].
Twenty-four-hour pH monitoring provides the strongest predictor, which is based more on the correct identification of the disease than on its se- verity. Campos et al [46] showed that excellent and good symptomatic outcome occurred in those who satisfied these criteria, and a fair or poor outcome occurred in those who did not. The most common pattern of failure seemed to be inadequate patient selection with atypical symptoms or a normal 24- hour pH study prior to surgery.
9. Delayed gastric perforation
Gastric perforation in a fundoplication is a rare event. Our series of 1600 laparoscopic fundoplica- tions resulted in six delayed gastric perforations at the fundoplication in 3 patients 13 to 84 months after fundoplication. All had been taking Cele- xobid. One possible cause of the full thickness ulceration could be the suture material or Teflon pledgets used to secure the fundoplication. An- other possibility is that entrapment of tablets caught in the folds of the fundoplication may have produced severe, local injury with transmural gastric perforation.
herniation (67%), fundoplication breakdown (43%), fundoplication slippage (20%), tight fundoplication (4%), misdiagnosed achalasia (4%), and displaced Angelchik prosthesis (4%). Twenty-two patients (48%) had more than 1 cause [39]. There was no mortality and a conversion rate to the open procedure of 20% after previous laparoscopy.
Antireflux reoperation with the open technique has a higher mortality than the initial procedure, with an average mortality of 2.8% and success rate of 79% [40]. Our 0% mortality attests to the safety of doing these procedures laparoscopically. The cause of most deaths is an unsuspected esophageal or gastric perforation with ensuing sepsis. The pres- ence of severe fibrosis makes dissection difficult and dangerous leading to a high conversion rate [41].
7. Need for further medical therapy
Patients with GERD are known to have associated functional bowel symptoms that will persist after antireflux surgery and generally cannot be expected to improve on antireflux medication given before or after surgery. In a recent study, 62% of patients were given antireflux medications after antireflux surgery and 32% of patients were using proton pump In- hibitors (PPI) [42]. Lord et al showed that 14% of patients who had undergone fundoplication were found to be using PPIs for abdominal and chest symptoms, but 79% of these were using the medica- tion for symptoms unrelated to gastroesophageal reflux [43]. Bammer et al found 39% of patients 2 years after laparoscopic antireflux surgery to be on acid suppressive or promotility agents. Eighty-four percent of these subjects reported a good surgical outcome despite continuing on medication [44].
This is an unexpectedly high need for antire- flux medication, but an evaluation of postopera- tive use of medication showed that the indication for proton pump inhibitors is often for vague, nonspecific symptoms. Only 6% had evidence of GERDrequiring therapy; therefore the high post- operative use of PPI is questionable. The appro- priateness of prescribing antireflux medications in patients with nonspecific symptoms after antire- flux surgery must be carefully considered by the prescribing physician.
10. Vagus nerve dysfunction
Mechanical changes in the cardia with lack of ac- commodation to liquids may be related to some symptoms such as bloating and diarrhea, but vagus nerve injury during the fundoplication has been pro- posed as an etiological factor.
DeVault et al found vagus nerve dysfunction in 30% of patients prior to antireflux surgery rising to 42% after surgery. But, most importantly, dysfunc- tion did not correlate with worsening or develop- ment of new symptoms in these patients [47].
In conclusion, laparoscopic Nissen fundoplica- tion is an excellent long-term treatment for selected patients with severe GERD with good success for several years. It provides an excellent alternative to patients requiring long-term medical therapy. There is a low morbidity and mortality similar to medical treatment, and it is cost-effective.
Side effects and complications can occur and pa- tients should be aware of this. Some patients have continuing symptoms and remain on therapy, but more than 90% of patients remain satisfied with their decision to undergo surgery.
Careful patient selection, preoperative evaluation, and correct choice of operation are necessary for successful surgical outcome and long-term results.
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