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There are multiple techniques available to repair hiatal hernias. However, recurrence rates are fairly high. Mesh augmentation of the hiatal repair reduces the rate of recurrence, but is still highly controversial despite its frequent use. The aim of the present study was to evaluate clinical results of the minimally invasive mesh-augmented hiatal reconstruction using a new alloplastic 3D mesh (DynaMesh®-DELTA).
Methods
Between January 2019 and December 2022, 320 patients underwent 3D mesh-augmented hiatoplasty at Vivantes Urban Hospital, Berlin, Germany. 133 patients completed follow-up and were subsequently included in this study. Information regarding patient characteristics as well as peri- and postoperative complications were obtained from the electronic patient charts. Patients were followed-up by scheduled visits and questionnaires.
Results
24 (17.1%) out of the 133 patients had complications. One patient had an early recurrence and required redo surgery during the initial stay. Only 3 (2.2%) patients had grade III complications and underwent invasive treatment under general anesthesia. Overall mortality was 0%. During follow-up, 72.7% of the patients reported to be relatively asymptomatic. However, 23 (17.4%) patients had recurrent hiatal hernias and relevant symptoms. 12 (9.1%) of the patients underwent reoperation.
Conclusions
Patients undergoing mesh-augmented hiatal hernia repair showed low postoperative morbidity and recurrence rates. The majority of the patients had significantly improved GERD-associated symptoms. Given the fact that GERD symptom control may be multifactorial, the present technical approach to hiatal hernia repair should be investigated in more detail in the future.
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Introduction
Minimally invasive anti-reflux surgery offers a safe and sustainable treatment option in patients with symptomatic gastroesophageal reflux disease (GERD) [1‐4]. Several studies showed good long-term results [5, 6]. The majority of GERD patients undergoing surgery present with a corresponding hiatal hernia [7]. These patients show a significant recurrence risk associated with conventional hiatal hernia repair [8‐11]. In order to reduce the risk of recurrence, mesh augmentation of the hiatal repair became more popular [12]. Reinforcement of the hiatoplasty with a mesh has been shown to reduce the rate of recurrence significantly [13]. Mesh augmentation seems to be predominantly effective in patients with large hiatal hernias [14, 15].
There are multiple types of mesh available to augment the hernia repair. The various types comprise absorbable and non-absorbable meshes [16‐18]. However, it has been reported that mesh implantation at hiatus can lead to serious short-term and long-term complications, such as mesh migration, stenosis, mesh erosion and severe fibrosis, which subsequently leads to severe persistent symptoms such as dysphagia and pain [19‐21].
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We aimed to investigate the clinical results of laparoscopic mesh-augmented hiatal reconstruction using a new 3D alloplastic material (DynaMesh®-DELTA). In the present study, we present data of a 3-year follow-up of 133 patients with chronic GERD and a hiatal hernia exceeding 2 cm in axial length who underwent minimally invasive anti-reflux surgery.
Methods
Study design
We identified all consecutive patients that underwent mesh-augmented hiatal hernia repair at our institution between January 2019 and December 2022. Relevant data extracted from a prospective database as well as retrospective data from the electronic patient charts were analyzed. Patients were followed-up by scheduled routine visits and questionnaires. According to the study protocol, questionnaires are sent by mail at four different follow-up time points ranging from 1 to 15 years. Here, we report the results of the first follow-up time point. According to standard practice, exclusion criteria for surgical treatment were: age ≤ 15 years, suspected achalasia or malignant disease, co-morbidity that does not permit a surgical intervention, and uncertainty about the correct diagnosis. There were no study-related exclusion criteria. All surgeries were elective.
Preoperative examination
All patients underwent routine preoperative work-up as displayed below in order to confirm indications for surgical hiatal hernia repair, including:
• endoscopy (hiatus hernia, cardiac insufficiency, organ displacement)
• histology (esophagitis, Barrett's metaplasia)
• pH-metry (De Meester score > 14.7)
• barium swallow (gastroesophageal reflux)
• MRI/CT (organ relocation)
• manometry (insufficiency of the lower esophageal sphincter)
DynaMesh®-DELTA
The DynaMesh®-DELTA mesh implant is warp-knitted using colored and uncolored polyvinylidene fluoride (PVDF) monofilaments. PVDF is a non-absorbable, long-term stable polymer. The product has a central nose-piece and a base area (mesh wing) that is aligned longitudinally and orthogonally to it. The mesh wings are tapered at one end (pointing away from the esophagus) in the direction of the nose-piece. The black colored filaments contain a small proportion of triiron tetraoxide that is incorporated into the polymer matrix. The color scheme provides better intraoperative visibility and device alignment. Moreover, triiron tetraoxide enables the device to be visualized on magnetic resonance imaging (MRI).
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Surgical technique
The surgical procedure to close the hiatal hernia was performed laparoscopically as previously described [22]. The main steps consist of mobilization of the esophagus, anatomical reduction of prolapsed organ parts, anatomically correct restoration of the esophago-hiatal unit and closure of the hiatus by dorsal hiatoplasty using single sutures in extracorporeal technique. An alloplastic mesh implant (DynaMesh®-DELTA, FEG Textiltechnik mbH, Aachen, Germany) was inserted into the hiatus in order to increase the fusion stability of the hiatus (Fig. 1). The mesh implant was fixed solely with sutures (0-Prolene 0.9 m, CT-2 Plus; PROLENE™, Ethicon® Endo-Surgery Inc., USA). A fundoplication was not performed.
Fig. 1
Left: 3D-structure of the DynaMesh®-DELTA surgical implant. Right: The nose-piece of the implant is placed between the crura, with the wings positioned in the mediastinal compartment
All patients were followed-up perioperatively in hospital after the surgery and after discharge by scheduled routine visits and questionnaires (patient-reported outcome). Outcome was measured by peri- and postoperative morbidity and cure. Postoperative complications were graded according to the Clavien-Dindo classification [23]. Postoperative failure was measured as hernia recurrence and/or recurrence or de novo occurrence of GERD symptoms (reflux, dysphagia, regurgitation, chest pain). GERD symptoms were evaluated by asking patients about the presence of symptoms before surgery, presence of symptoms in the last 4 weeks, if current sympoms were bothersome, and if current symptoms were improved by surgery. Moreover, patients were asked about the satisfaction with the surgical result.
Ethical approval and statistical analysis
The ethics committee of Ärztekammer Berlin granted approval for the study. Data was collected retrospectively in an observational, non-interventional study design. In the present study we utilized available clinical data that were acquired from the electronic patient chart or obtained via questionnaires. All patients gave their written consent for a continued follow-up and for a scientific evaluation of the data in anonymous fashion. The data analysis was supported by a statistical expert. The data were analyzed and graphical output was generated using Excel 2013 (Microsoft Corp., Redmond, WA, USA) and XLSTAT version 2021.3.1 (Addinsoft, New York, USA). As this is not a hypothesis-based study, formal case number planning was not applicable.
Results
Patient demographics
Between January 2019 and December 2022, 320 patients underwent mesh-augmented hiatoplasty at Vivantes Urban Hospital, Berlin, Germany. 133 patients completed follow-up and were subsequently included in this study. The majority of the patients was diagnosed with type III hiatal hernia (97,7%) and most of the hiatal hernias were larger than 5.5.cm in diameter. All patients underwent elective minimal-invasive hernia repair. Twenty-one percent of patients had previously undergone surgical treatment for hiatal hernias and were redos. All patients received a mesh augmentation with DynaMesh®-DELTA of the hiatus as described above. Details of the patient characteristics and symptoms profile are listed in Table 1.
Table 1
Patient characteristics
Total number of patients
133
median age and interquartile range [years]
53.2 (range: 18–86)
median BMI
25.6 (range: 14–43)
f:m [%]
42.9: 57.1
Symptoms
heartburn
115 (87.1)
dysphagia
35 (26.5)
regurgitation
89 (67.4)
chest pain
77 (58.3)
secondary hiatoplasty [%]
21.1
hiatal hernia type
type I (sliding) [%]
0.8
type II (paraesophageal) [%]
type III (mixed types I and II) [%]
type IV (up-side-down stomach; giant paraesophageal) [%]
0
97.7
1.5
median hernia size, diameter [cm]
- > 5 cm [n (%)]
- ≤ 5 cm [n (%)]
5.8 (range: 1–10)
90 (64.7%)
39 (28.1%)
Minimally invasive approach n (%)
133 (100)
Peri- and postoperative outcome
One patient experienced in-hospital recurrence and required redo surgery. Overall, 24 (17.1%) patients had complications. Amongst them, 14 patients developed esophagitis (10%). Most of the recorded complications required either no treatment (grade I) or were managed by medical treatment only (grade II). In total, 3 (2.2%) patients had grade III complications and underwent invasive treatment under general anesthesia. Overall mortality was 0%. Details are given in Table 2.
Table 2
Perioperative in hospital complications
Peri- and post operative complications
N = 133
%
Total
24
17.1
perforation or leak
1
0.8
pulmonary
1
0.8
stenosis
2
1.5
dysphagia
2
1.5
recurrence
1
0.8
wound infection
1
0.8
esophagitis
14
10.5
erosion
1
0.8
Intestinal paralysis
1
0.8
Clavien Dindo grade n (%)
Grade I
7
5.2
Grade II
13
9.8
Grade IIIa
0
0
Grade IIIb
3
2.2
Grade IV
0
0
Grade V
0
0
Mortality
0
0
Patient-reported outcome on follow-up
The median follow-up was 36.2 months (range 4–64 months). Patient-reported outcomes are presented in Table 3. The majority of the patients reported having a good clinical outcome after surgery: 72.7% responded ‘yes’ to the question of whether they were satisfied with the surgical results. However, 23 (17.4%) patients had recurrent self-reported or clinically documented hiatal hernias and 12 (9.1%) patients underwent reoperation due to recurrent hernia or persistent GERD symptoms. At the time of follow-up, between 6.8 and 15.9% of patients reported GERD symptoms that were bothersome and did not improve with surgery.
Table 3
Follow-up
n
%
recurrence of hiatal hernia1
23
17.4
reoperation due to recurrent hernia or persistent severe GERD symptoms1
12
9.1
Are you satisfied with the surgical result?2
yes
96
72.7
no
30
22.7
n/a
6
4.5
heartburn3
21
15.9
dysphagia3
21
15.9
regurgitation3
9
6.8
chest pain3
11
8.3
1 self-reported or clinically documented
2 self-reported
3 self-reported: symptoms were present after surgery, symptoms were bothersome, no improvement of symptoms
Table 4 provides a detailed analysis of GERD symptoms before and after surgery. Improvements in GERD symptoms were most frequently reported for heartburn (68.2%), followed by improvements in regurgitation (56.8%) and chest pain (47.7%). These symptoms were also the ones most frequently reported before surgery (58.3–87.1%). In contrast, overall levels of dysphagia were comparatively low before surgery (26.5%) and did not change much after surgery (28.8%), with an equal proportion of patients reporting improvements (25.8%) and no improvements (24.2%). In this specific subgroup of patients, we observed patients with de novo dysphagia which lead to the overall no change in dysphagia symtoms.
Table 4
Comparison of pre-operative and post-operative symptoms
symptoms prior to surgery [n/N, (%)]
Persistent symptoms after surgery [n/N, (%)]
Severe symptoms after surgery? [n/N, (%)]
symptoms improved after surgery [n/N, (%)]
heartburn
yes
115/132 (87.1%)
65/132 (49.2%)
45/132 (34.1%)
90/132 (68.2%)
no
14/132 (10.6%)
62/132 (47.0%)
33/132 (25.0%)
25/132 (18.9%)
n/a
3/132 (2.3%)
3/132 (2.3%)
40/132 (30.3%)
15/132 (11.4%)
dysphagia
yes
35/132 (26.5%)
38/132 (28.8%)
30/132 (27.7%)
34/132 (25.8%)
no
95/132 (72%)
91/132 (68.9%)
33/132 (25%)
32/132 (24.2%)
n/a
2/132 (1.5%)
3/132 (2.3%)
69/132 (52.3%)
66/132 (50%)
regurgitation
yes
89/132 (67.4%)
34/132 (25.8%)
22/132 (16.7%)
75/132 (56.8%)
no
42/132 (31.8%)
97/132 (73.5%)
37/132 (28%)
17/132 (12.9%)
n/a
1/132 (0.8%)
1/132 (0.8%)
73/132 (55.3%)
40/132 (30.3%)
chest pain
yes
77/132 (58.3%)
34/132 (25.8%)
25/132 (18.9%)
63/132 (47.7%)
no
55/132 (41.7%)
96/132 (72.7%)
38/132 (28.8%)
25/132 (18.9%)
n/a
0/132 (0%)
1/132 (0.8%)
68/132 (51.5%)
44/132 (33.3%)
Possible determinants of surgical outcome
We explored whether the patient satisfaction was influenced by the following factors: length of the follow-up, patient age, patient BMI and hernia size. We found no significant differences between satisfied and dissatisfied patient with regard to any of these factors (Mann–Whitney test, Table 5). The distribution of follow-up times for satisfied and dissatified patients is shown in Fig. 2. Furthermore, we found that the surgical outcome tended to be better in patients with larger hernias (5.5–10 cm) compared to patients with smaller hernias (1–5 cm in diameter), but these differences did not reach statisticial significance (Fisher-Boschloo test; Fig. 3, Table 6, Table 7). However, there was a trend towards lower recurrence rates in patiens with larger hernias (p = 0.06).
Table 5
Effect of different factors on patient satisfaction
satisfied (n = 96)
dissatisfied (n = 30)
p value (Mann–Whitney test)
mean FU [months]
35.0
37.4
p > 0.05
mean age [years]
53.8
51.6
p > 0.05
mean BMI
25.9
25.1
p > 0.05
mean hernia size [cm]
5.9
5.6
p > 0.05
Fig. 2
Histogram of follow-up times for satisfied (a) and dissatisfied (b) patients
Statistical comparison of surgical outcomes as a function of hernia size (see also Fig. 2)
small hernia (1–5 cm)
large hernia (5.5—10 cm)
n (%)
N
n (%)
N
p-value (Fisher Boschloo)
satisfied—no
11 (28.2)
39
17 (19.1)
89
0.2501
recurrence
10 (25.6)
39
11 (12.4)
89
0.0606
recurrence with reoperation
5 (12.8)
39
7 (7.9)
89
0.4596
Table 7
Statistical comparison of surgical outcomes as a function of hernia size (see Figure X)
small hernia (1–5 cm)
large hernia (5.5 - 10 cm)
n (%)
N
n (%)
N
p-value (Fisher Boschloo)
satisfied - no
11 (28.2)
39
17 (19.1)
89
0.2501
recurrence
10 (25.6)
39
11 (12.4)
89
0.0606
recurrence with reoperation
5 (12.8)
39
7 (7.9)
89
0.4596
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In addition, we wanted to evaluate how GERD symptoms changed after the surgery in satisfied and dissatisfied patients (Fig. 4). We noticed that satisfied patients more frequently reported improved symptoms after surgery, while dissatisfied patients experienced less improvements in their symptoms. It was noteworthy that dissatisfied patients seemed to be especially affected by de novo dysphagia after surgery.
Fig. 4
Comparison of GERD symptoms before and after surgery in satisfied and dissatisfied patients
In the present study, laparoscopic hiatal reconstruction with a non-absorbable synthetic mesh was associated with a favorable surgical outcome 3 years post-operatively and an acceptable safety profile. About three-quarters of patients reported satisfaction with the surgical results and most complications were minor without requiring surgical interventions. Heartburn, regurgitation and chest pain as the most commonly reported GERD symptoms improved after surgery, while dysphagia as the least frequently reported symptom also showed the lowest improvement rate. Our analyses further suggest that patient satisfaction was especially high in patients that experienced symptom improvements.
The clinical manifestations of hiatal hernias vary and are impacted by the type and size of the hernia. In the present study, 97% of the patients had type III hiatal hernias, which are a combination of types I and II and account for more than 90% of para-esophageal hernias in general. In addition to the para-esophageal hiatal hernia, the gastroesophageal junction is not fixed but displaced above the diaphragm [24]. GERD symptoms are more common in Type III hiatal hernias, and the size of the hernia can impact symptom severity [25]. 64.7% of patients in our study population had large hiatal hernias (> 5 cm). It has been shown that hernia size is a negative predictor of the severity of symptoms such as esophagitis [26].
Typical symptoms of GERD consist of heartburn, esophageal chest pain and regurgitation. Heartburn and regurgitation are the most classical symptoms of GERD [25]. In the present study, approximately 87% of the GERD patients had heartburn and 67% had regurgitation as major symptoms when evaluated preoperatively. Patients with heartburn have shown reduced work productivity and significant impairments in health-related quality of life [27].
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The occurrence of the GERD symptom regurgitation varies and is inconsistent across clinical studies [28]. In our cohort, 67.4% of patients suffered from regurgitation preoperatively. In patients with daily regurgitation, lower esophageal sphincter pressure is frequently impaired. It has been described that many of these patients have associated gastroparesis and esophagitis making this symptom more difficult to address [29].
The GERD symptom dysphagia, which has been present in 27% of our patients prior to surgery, is considered a more worrisome symptom. It can be caused by severe inflammation or ulceration. However, in the era of proton pump inhibitors, ulcers have become quite uncommon. But in a small subset of patients it can still be the first symptom of Barrett’s esophagus or esophageal cancer. Hence, in patients with symptoms of dysphagia, a gastroscopy is highly recommended [29, 30].
The symptom chest pain was present in more than half of the GERD patients preoperatively in our study. Chest pain can be indistinguishable from ischemic cardiac pain, which has to be investigated ifthere is any uncertainty about the underlying cause [28].
In the present study, 68% of patients reported an improvement of heartburn symptoms and 57% reported improved regurgitation symptoms at the 3-year follow-up. It has been shown in many studies that surgery can significantly improve GERD symptoms such as heartburn. Reports have shown that persistent relief of heartburn and regurgitation is achieved in 80% to 90% of patients in long-term follow-up. It is most effective in the subgroup of GERD patients who are refractory to proton pump inhibitor treatment [31, 32].
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In this investigation, the proportion of GERD patients with dysphagia remained around 28% prior and after surgery. De novo dysphagia contributed to this finding. This is in line with previous reports that showed nearly one in four patients had persistent postoperative dysphagia. This finding was independent of the type of surgery [33, 34]. Patients with persistent postoperative dysphagia are more likely to be dissatisfied with the clinical result of the procedure [35] which was concordant with our findings (data not shown). There are certain risk factors associated with postoperative dysphagia. Patients with preoperative dysphagia and delayed esophageal transit on preoperative contrast study were significantly more likely to have persistent dysphagia after surgery. This study underlines the need for standardization of the preoperative contrast swallow assessment of esophageal function in this specific subgroup of patients in order to predict a possibly unfavorable postoperative outcome [36].
With respect to safety, the present results showed 17.1% patients with complications. However, only 2.2% had Clavien Dindo grade III, which is comparable to 1.5% described in a meta-analysis were 10 large studies of mesh augmentation have been pooled [18]. Mortality was very low, which has been expected and supported by many series [22, 37‐39]. Only one patient had an early recurrence in the present study, which is less than expected when compared to the literature where recurrence rate of 2.6% in patients with mesh augmentation have been described [18].
A meta-analysis of large studies showed lower recurrence rates in favor of mesh augmentation [18]. When patients were grouped in small (less than 5 cm), large to very large (more than 5 cm), and very large hiatal hernias (more than 8 cm), mesh augmentation was more effective in each group compared to suturing only [18].
We observed a higher recurrence rate in small hernias after mesh augmentation. At first sight, this finding is counterintuitive since large hernias have beeen associated with a greater risk of recurrence [40]. A possible explanation of this finding is the choice of the cutoff between small (≤ 5 cm) and large hernias (> 5 cm). In the present patient population, 65% of patients had hernias larger than 5 cm, 26% had hernias of 5 cm, and only 9% had hernias smaller than 5 cm. It is conceivable that the present distribution and relatively small sample size could have biased our findings.
In conclusion, our data suggests that mesh augmentation is feasible and safe and is a valuable option for hiatal hernia repair. However, the limitations of 3-year follow-up suggest that data should be interpreted cautiously. Further evaluation of the long-term data is required to draw more reliable conclusions.
Declarations
Regulation (EU) 2017/745, data protection laws (DSGVO 2016/679) and international standards (ISO 14155:2020) were adhered to and followed. The study was conducted in accordance with the ethical principles of the Declaration of Helsinki.
Informed consent
All patients were informed about the purpose, duration and course of the observational study. All patients gave their written consent for a follow-up by means of a questionnaire and for a scientific evaluation of the data in pseudonymized form.
Dislosures
The authors have no conflicts of interest or financial ties to disclose.
Open Access This article is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License, which permits any non-commercial use, sharing, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if you modified the licensed material. You do not have permission under this licence to share adapted material derived from this article or parts of it. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc-nd/4.0/.
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Ist eine Speichelgangsblockade und die damit verbundene Sialadenitis nicht durch Steine bedingt, wird oftmals versucht, die Symptomatik zu lindern, indem man den Gang mechanisch weitet. Ein aktuelles Review kann den Eingriff als chancenreiches Verfahren bestätigen und deckt gleichzeitig Schwächen auf.
Mehr als eine Million Menschen in Deutschland leiden unter Hallux valgus – eine Fehlstellung des Großzehs, die je nach Schweregrad und Symptomen behandelt wird. Welche neuen Empfehlungen die aktualisierte S2e-Leitlinie bietet, erklärt der Orthopäde Prof. Sebastian Baumbach im MedTalk Leitlinie KOMPAKT der Zeitschrift Orthopädie und Unfallchirurgie.
Ein chirurgischer Eingriff kann für Patienten mit primärem Hyperparathyreoidismus gegenüber dem konservativen Management metabolisch von Vorteil sein. Denn wie eine Studie zeigt, senkt die Operation das Diabetesrisiko.
