Introduction
Laparoscopic fundoplication (LF) is recommended as an adjunct to the surgical treatment of symptomatic large hiatal hernias with paraesophageal involvement (PEH) [
1‐
3]. However, there are a number of undesirable fundoplication-related side effects, such as gas bloating and dysphagia, which occur in up to 58 % of patients [
4,
5]. Due to the presence of persistent side effects in about 20 % of patients, it is necessary to investigate whether PEH could be surgically treated without an additional fundoplication [
6,
7]. An investigation of a simple laparoscopic mesh-augmented hiatoplasty without an additional fundoplication (LMAH) could answer this question.
Whether an adequate anti-reflux effect of LMAH can be achieved will depend on the reconstruction of the hiatus and the durable fixation of the esophagogastric junction below the diaphragm by mesh reinforcement, thereby lengthening the abdominal part of the esophagus. The latter is an important criterion for ensuring an adequate function of the lower esophageal sphincter [
8].
The major problem associated with simple hiatoplasties in combination with some type of cardiopexy is that, while they provide a good anti-reflux effect in up to 90 % of cases, they have reflux recurrence rates of 60 % in the long term [
9‐
11]. Styger et al. [
3] have also shown that after repair of PEH without fundoplication, there was a new onset of gastroesophageal reflux in 32 % of patients. Consequently, cardiopexy procedures have been rejected in favor of fundoplication. However, all of these data originated from the time before mesh augmentation at the hiatus was used to prevent recurrences of hiatal hernias and the consequent gastroesophageal reflux. Therefore, recurrences after LMAH may be prevented by mesh augmentation even without additional fundoplication.
The aim of the present retrospective cohort study was to evaluate the feasibility, safety and efficiency of LMAH in terms of reflux control, side effects and recurrences after the treatment of PEH.
Discussion
This study was planned to evaluate the feasibility, safety and efficiency of LMAH as a method to treat PEH without an additional fundoplication. In our study, the procedure could be performed at a reasonable time of 104 min on average. One (2 %) patient who had a gastric perforation without the need for conversion experienced complications during the surgical treatment. In our patient series, postoperative morbidity was observed in 7 % of patients and no postoperative mortality occurred. After an average of 72 months, 90 % of patients no longer had a PEH and two-thirds of patients were free of reflux symptoms. This is in line with the results of another prospective cohort study that was recently published by the last author. In that study, conducted at the cantonal hospital of St. Gallen/Switzerland, a significant decrease of reflux symptoms was shown 1 year postoperatively, with a recurrence rate of 9 % [
14]. Thus, LMAH appears to be feasible and safe and to have an anti-reflux effect, even without fundoplication.
Based on the past and present experiences, it appears that an anti-reflux procedure during PEH repair is necessary to prevent hernia recurrence and postoperative gastroesophageal reflux. Allison [
18] reviewed 421 of his own patients following hiatal hernia repair by hiatoplasty without fundoplication. Twenty-two years later, hiatal hernias or the presence of reflux were radiologically confirmed in 49 % after sliding hiatal hernia repair, and in 33 % after PEH repair. Styger et al. [
3] reported a new occurrence of reflux in 32 % of patients after a repair of PEH without fundoplication, an observation which was also confirmed by other authors [
19,
20]. On the other hand, in a non-randomized comparative study, Williamson et al. [
7] presented a nearly identical reflux rate of 19 % without and 16 % with fundoplication. However, in both studies, the presence of a selection bias cannot be ruled out. The uncertainty regarding the need for a fundoplication in the repair of PEH is also illustrated by the fact that different patient groups, despite consistent fundoplication, have had postoperative reflux rates of 8–15 % [
21‐
24]. In addition, in contrast to other patient groups, in which the fundoplication was only performed in patients with proven reflux, postoperative reflux was observed in 2–10 % of patients [
25‐
29].
However, all of the publications mentioned above date to the time before mesh patches were available for reinforcement at the hiatus. In our opinion, the option of mesh augmentation at the hiatus, which has been proven to reduce the recurrence of hiatal hernias, justifies a re-evaluation of the need for a fundoplication during PEH repair [
23,
30,
31]. Allison [
18] reported a steady increase in recurrences in the years following simple hiatoplasties. In contrast, upon evaluating 306 patients following LMAH for GERD and sliding hiatal hernias, we observed no increase in the treatment failure after the first year [
32]. The overall rate of anatomical hernia recurrence was 10 % in the present study. Recurrence rates of up to 42 % were seen with simple, primary suture repair of the hiatus in the previous studies [
1,
31,
33]. Therefore, we feel that consistent mesh application is the best way to prevent recurrences after PEH repair, and that the procedure can be successful in the majority of cases, even without fundoplication.
Notably, the anti-reflux effect of LMAH does not appear to be as good as that of LF. In our study, one-third of the patients showed a failure of the treatment according to the definition provided by Lundell et al. [
16], and two of these patients decided to undergo a reoperation due to reflux symptoms. When a reoperation is demanded because of persistent or new-onset GERD, we propose that fundoplication should be added to LMAH as a second-step procedure, as was done in the two patients who underwent reoperations in our cohort. Thus, a combination of LMAH and fundoplication seems to be the best option for the surgical treatment of PEH in terms of prevention of anatomical recurrence and postoperative reflux. However, the question remains whether the results are better with an additional fundoplication in terms of side effects and quality of life. This issue can only be resolved by future randomized controlled trials.
In our study, about 80 % of the patients were satisfied with their results, and almost 90 % reported that their condition had improved or normalized. About 80 % of the patients would undergo this operation again, and referred to the outcome of LMAH as good as or better than before the surgery. Regarding the side effects of LMAH, a significant decrease in gas bloating after surgery was noted. Only 8 % of patients were not able to vomit after surgery, and 4 % of patients reported that they could not belch. In studies with the main focus on side effects in the long-term follow-up after fundoplication, rates of gas bloating of 34 and 60 %, and rates of the inability to belch of 29 and 74 % were reported [
4,
6,
34]. Similarly, more than 20 % of the patients were found to be unable to belch in the study reported by Lundell et al. [
16]. Therefore, it can be assumed that LMAH has less negative effects, such as gas bloating, in comparison to LF. Regarding dysphagia, we found that 8 % of patients had serious complaints in our series without fundoplication. This value is not surprising, since dysphagia is a common problem associated with all forms of hiatoplasty, which is generally performed in combination with a fundoplication. In agreement with this, Granderath et al. [
35] stated that dysphagia is more a problem of the narrowing of the hiatus than of the fundoplication itself. Consequently, it cannot be expected that the problem of dysphagia will be completely resolved by LMAH, but it could possibly be reduced by using calibration tubes larger than the 32 Fr tubes used in the present study.
LMAH implies that there is consistent mesh application at the hiatus. Therefore, one important factor to consider is mesh-related complications, such as erosions, migrations and stenoses. In our study, only one (2 %) patient experienced a relevant mesh-related complication, which was a stenosis of the esophagus that could be endoscopically dilated. Stadlhuber et al. [
36] published a case series identifying 28 patients with mesh-related complications after hiatal repair. However, the true rate of mesh-related complications is unknown. Pooling all Medline-listed patient series from 1997 until 2009 with at least one mesh-related complication (
n = 2392), 22 mesh-related complications were reported [
32,
33,
37‐
42]. This correlates to a mesh-related complication rate of 0.9 %. In accordance with this finding, Targarona et al. [
43] considered mesh reinforcement at the hiatus to be a safe procedure.
In summary, LMAH is a feasible and safe method to treat PEH. It seems that a durable anatomical reconstruction and a certain anti-reflux effect can also be achieved without fundoplication, with the benefit of fewer side effects. However, the procedure also has some drawbacks, such as the persistence or new onset of reflux and the risk of dysphagia. It is currently not possible to draw a final conclusion as to whether a fundoplication during PEH repair is necessary or not. Nevertheless, the present results warrant a randomized controlled trial evaluating the need for a fundoplication during mesh-augmented PEH repair in terms of reflux control, patient satisfaction and quality of life.