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Laparoscopic giant hiatal hernia repair with absorbable mesh
Massimiliano Ardu1, Damiano Bisogni1, Alessandro Bruscino1, Rosaria Tucci1, Massimo Falchini2, Andrea Valeri1, Paolo Prosperi1
1 Emergency Surgery Unit, DEA Department, Careggi University Hospital, Florence, Italy
2 Sperimental and Clinical Science Department “Mario Serio”, Florence University, Florence, Italy
|Date of Submission||16-Jan-2021|
|Date of Decision||04-Mar-2021|
|Date of Acceptance||27-Apr-2021|
|Date of Web Publication||16-Jul-2021|
Emergency Surgery Unit, Azienda Ospedaliero-Universitaria Careggi, Largo Brambilla 3 50134, Florence
Source of Support: None, Conflict of Interest: None
Background: The best operative approach to large hiatal hernias still remains controversial between suture cruroplasty and prosthetic hiatal herniorrhaphy. This study aims at analysing results from a single institution in Italy in terms of subjective and objective outcomes.
Methods: Retrospectively collected data of all patients that underwent laparoscopic hiatal hernia repair since 2011 were considered. Sixty-five patients were included overall; 17 of them fit the criteria of large hiatal hernia. Follow-up (FU) was assessed by visit, questionnaires and X-ray imaging.
Results: No major complications occurred in the post-operative course. No patient was lost during the FU period. Out of all the patients included, 13 agreed to have an X-ray with water-soluble contrast. The questionnaires showed a 76.5% rate of satisfaction (13 patients), and the recurrence rate demonstrated by radiology was 29.4% (five patients). There were no major mesh-related complications.
Conclusion: The best operative approach for large hiatal hernias remains far from standardised: There is a lack of evidence on the use of a mesh for this kind of surgery as well as substantial controversy over the definition of what a giant hiatal hernia is. Nevertheless, the results from this study and the main studies in the literature seem to be encouraging in improving giant hiatal hernia repair outcomes.
Keywords: Hiatal hernia, laparoscopy, upper gastrointestinal
|How to cite this URL:|
Ardu M, Bisogni D, Bruscino A, Tucci R, Falchini M, Valeri A, Prosperi P. Laparoscopic giant hiatal hernia repair with absorbable mesh. J Min Access Surg [Epub ahead of print] [cited 2021 Dec 9]. Available from: https://www.journalofmas.com/preprintarticle.asp?id=321685
| ¤ Introduction|| |
The laparoscopic treatment of hiatal hernia repair has become the current gold standard., There are some basic steps to be followed in the repair of hiatal hernia: Appropriate mobilisation of the oesophagus into the abdominal cavity, excision of the hernia sac, closure of the crural defect and the addition of a fundoplication in cases of a history of reflux symptoms.
A high percentage of recurrences in literature have emerged ensuing from direct suture repair; hence, mesh repair has often been cited as an alternative method for the reinforcement of the crural pillars. Both absorbable and non-absorbable meshes have been used for this purpose. The former is associated with a decreased short-term recurrence rate, but the radiologic recurrence rate in long-term follow-up (FU) appears equivalent to those of primary repair. Nevertheless, improvement of the subjective symptoms is reported in absorbable mesh series compared to non-absorbable or direct sutures series. Non-absorbable meshes, on the other hand, are associated with a higher rate of major complications such as migration in the stomach, subsequently requiring reoperation. Nonetheless, complications are reported also with biologic mesh.
The use of a mesh seems to be the preferable option for patients diagnosed with giant hiatal hernia. While often quoted in the literature, there remains significant controversy on the exact definition of the term 'giant hiatal hernia'. Some authors have proposed defining it as a type III or type IV hernia following the current anatomical classification; others, on the other hand, have suggested a classification based on dimensional criteria of either the herniated portion of the stomach or on the size of the anatomical defect at the level of the hiatus.,,
This article aims at presenting a case series on the surgical technique of repair of giant hiatal hernias using BIO-A® (W. L. Gore & Associates, Inc.) mesh concurrently evaluating both objective and subjective outcomes. The primary outcome is the relief of symptoms according to the patients' subjective satisfaction with their condition after surgery and the secondary outcome is the hernia recurrence as shown in the post-operative X-ray water-soluble contrast.
| ¤ Methods|| |
Patients operated on for hiatal hernia at Careggi University Hospital (Florence, IT) from January 2011 to January 2019 were selected from the electronic database and retrospectively analysed. Out of the total of 68 patients operated on in our Surgical Unit, 17 of them fit the criteria of giant hiatal hernia, defined as a hernia containing at least 50% of the stomach or a hernia with a hiatal defect larger than 8 cm, and for that reason, they were treated with mesh repair.
Every patient underwent a pre-operative assessment including medical history, physical examination, blood test analyses, electrocardiogram, upper gastrointestinal endoscopy, X-ray of chest and abdomen administering oral contrast (barium or water soluble, based on the radiologist personal preferences), oesophageal manometry and pH-impedance monitoring. In selected patients, particularly those for whom a large hernia was suspected, computed tomography (CT) scans of the chest and upper abdomen were performed.
During the 1st post-operative day, a water-soluble contrast swallow was performed in every patient in order to assess if there are any problems as the liquid passes into the oesophagus and the stomach. If the test result showed a regular transit, the patient was allowed to go on a soft diet and then discharged on the 2nd post-operative day if no other complications were suspected.
FU was assessed by contacting the patients who were asked to come for a visit. Questionnaires such as gastroesophageal reflux disease–health-related quality of life (GERD-HRQL) [Figure 1] and SF-36 were administered during the visit by the physicians, who also took it upon themselves to translate it from English into Italian.
During the visit, each patient was also asked to have an X-ray with water-soluble contrast in order to obtain an objective FU, and if consent was obtained, the examination was planned within a week.
Anatomic recurrence was defined when any sized portion of the stomach was identified above the diaphragm at X-ray imaging.
All the patients belonging to the study series were treated according to the protocols outlined to ensure compliance with provisions of the 1964 Helsinki Declaration and its later amendments. Written informed consent was obtained from all the patients for the publication of their clinical data. The research was supervised at all stages by our local Ethics Committee.
All the patients belonging to the series were operated by the same surgeon (AV) or by another surgeons mentored by AV. Five ports were used for the laparoscopic approach. The first one (10 mm) was placed on the mid-line through an open access, few centimetres above the umbilicus considering the habitus of the patient. One 10-mm port was placed in the epigastrium (mid-line or immediately on the left) to insert a retractor for the left lobe of the liver. One 5-mm port was placed in the right hypochondriac region for the operator's left hand, one 12 mm in the left hypochondriac region for the operator's right hand and another 5 mm in the left flank in order to retract the stomach. The position of the ports is shown in [Figure 2].
The magnitude of the hiatal defect is generally evaluated prior to surgery through a careful review of CT imaging, estimation of both the size of the hiatal defect and of the percentage of the stomach expected to be herniated. Therefore, the use of the mesh can often be predicted before surgery and then, confirmed or abandoned according to the surgeon's judgement during the surgical operation.
The first step in the procedure is the reduction of the herniated stomach and the dissection of the sac. A tape, like a Penrose drain, is placed around the distal oesophagus. Mobilisation of the intra-abdominal oesophagus is performed and the mediastinal dissection is facilitated by the suspension of the oesophagus on the tape. Attention is paid to preserve both branches of the vagus nerve. Likewise, a careful dissection of the lesser omentum is performed in order to identify and preserve, when it is present, an aberrant left hepatic artery arising from the left gastric artery (Hirtle artery). Direct cruroplasty is routinely performed closing the hiatus with interrupted sutures of 2-0 silk. Then, a BIO-A® (W. L. Gore & Associates, Inc.) mesh [Figure 3], in its U-shaped configuration, is placed posteriorly and fixed with non-resorbable sutures. Eventually, the mesh is fixed with fibrin glue. In cases where a history of reflux is present or demonstrated at the pre-operative assessment, an anti-reflux procedure is also performed under a Bougie 52fr guidance, preferably a Nissen procedure, alternatively Toupet or Lortat-Jacob procedure as appropriate.
| ¤ Results|| |
From January 2011 to 17 January 2019, laparoscopic giant hernia repairs with BIO-A® (W. L. Gore & Associates, Inc.) mesh were performed.
The personal and pathological features of the patients are summarised in [Table 1] all patients were females. The main symptom before the operation in the series was gastroesophageal reflux (GER).
There were two minor complications during the post-operative course (grade I/II according to Clavien–Dindo), while the water-soluble contrast swallow performed in the post-operative day 1 has been always normal regarding the transit of the contrast solution. Furthermore, no cases of pneumothorax were noticed even if during surgery, in two cases, pleura was opened and sutured.
[Table 2] displays the analysis of the data within the series relative to type of intervention. The mean operative time in the Nissen procedure group was longer than the others but not statistically significant. Five patients did not receive an anti-reflux procedure during the surgery, Four out of five did not have acid-reflux symptoms and the pH-impedance monitoring confirmed no acid-reflux and one had a previous Nissen procedure and still complained about GER symptoms. In this case, during radiodiagnostic examinations, a herniation of the wrap was found; therefore, it was decided during the surgery only to repair the herniation and not to dismantle the previous wrap, considering that it was still good for anti-reflux purposes. There were no conversions.
|Table 2: Analysis of the data within the series relative to type of fundoplication|
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No patients dropped out during the FU period. The mean FU was of 42.5 months. The patients' subjective outcomes were evaluated via questionnaires: 13 (76.5%) patients expressed satisfaction with their condition after surgery. Dissatisfaction and neutrality were expressed by 11.7% of patients (two patients, each).
Each of the two dissatisfied patients complained about the persistent heartburn with reflux symptoms giving the score of 3 out 5 for almost every question of the GERD-HRQL related to this kind of symptoms with a total score of 36 and 37. Interestingly, each of the two patients had anti-reflux procedure during the surgery because the pH-impedance monitoring demonstrated an acid reflux; unfortunately, this has not improved after the operation.
Out of the two neutral patients, one, with a nutcracker oesophagus demonstrated preoperatively, complained about persistent dysphagia with no improvement of the symptoms after surgery. [Figure 4] shows the results of the SF-36 questionnaire. The graph displays an elevated mean quality of life at the time of FU.
|Figure 4: Results of the SF-36. Physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH)|
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Thirteen patients agreed to have a water-soluble contrast swallow X-ray. The examination at issue was generally performed within 1/2 weeks from the FU visit; hence, the mean temporal distance from surgery approximately corresponds to the mean FU period time frame. In five (29.4%) of them, radiological recurrence was demonstrated. Three of the recurrences were described as a 'minimal herniation of the stomach above the diaphragm'; of the other two, one was a herniation of about 6 cm and one of 5 cm.
In answering the questionnaires, 3 of the 5 patients with demonstrated recurrences expressed satisfaction with their post-surgery condition, one was neutral about them and one was dissatisfied. Interestingly, the patient with the recurrence of 6 cm expressed satisfaction and the patient with the recurrence of 5 cm expressed neutrality.
Regarding the proton-pump inhibitor (PPI) use, eight patients were still under therapy, while 9 were off medications. There were no mesh-related complications.
| ¤ Discussion|| |
Patients' satisfaction was the primary outcome of this case series. Concerning the surgical approach to hiatal hernia, it appears evident that subjective outcomes might indeed be more relevant than objective ones. Patients' satisfaction with symptoms recurrence and improvements thereof seems to be higher with the use of re-absorbable mesh. These data should nonetheless be posited in correlation with the types of anatomical recurrence. The studied series displays a considerably high level of post-surgery satisfaction with respect to the patients' conditions prior to surgery, considering the limitation that no questionnaires were submitted to patients prior to surgery. Nonetheless, the results seem not to highlight any statistically relevant correlation between the type of recurrence and the level of satisfaction expressed by the patients. On the other hand, the use of PPI appears significant even in cases where GER was not the prevalent symptom.
The main randomised trials carried out on the topic,,, have failed to prove beyond contestation the superiority of the use of mesh, re-absorbable or non-absorbable, with respect to direct cruroplasty. While Oelschlager et al. published a study showing lower recurrence rates with re-absorbable mesh, the result was refuted in the long-term FU. The recurrence rate indeed rose to 44% without any statistically significant differences comparatively to other analysed cohorts. The recurrence rate in present series is 29.4%. While significantly lower, it must obviously be considered that the sample was much smaller and that only some of the patients contacted for FU accepted to undergo radiological analysis. On the other hand, the mean body mass index of our study population is relatively high, and this could indicate that the necessity of a crural reinforcement should be considered in overweight patients. Recent series by Tartaglia et al. has focused on the same topic stating the benefit regarding the use of BIO-A® mesh on recurrence rate (4.5%) at 36 months.
Recent meta-analysis by Zhang et al. corroborate the thesis of a lower recurrence rate in patients prosthetic use. On the other hand, the study also reported higher levels of dysphagia. Throughout the analysed period, we have chosen not to use non-absorbable mesh in light of the subsequent potential serious complications. Among others, there have been reports of mesh migration into gastric lumen, or into the oesophageal lumen even after years. Moreover, this kind of complications is often associated with a higher likelihood of having to perform a gastric or even oesophageal resection. The choice of using BIO-A® mesh is due to the characteristic of this mesh. The mesh is re-absorbable within 6 or 7 months leaving no permanent material behind in the body but favouring a fibrotic reaction that reinforces the hiatus.
Campos et al. recently published a meta-analysis concluding that there is no evidence to support routine mesh reinforcement in laparoscopic repair of giant hernias. FU was performed only until 6 months in this paper and the primary outcome was hernia recurrence. Nevertheless, as shown in our results, hernia recurrence did not necessarily correlate to subjective symptoms; with a higher percentage of satisfied patients compared to objective hernia recurrence.
It must be pointed out that further differences may arise from the mesh-positioning technique chosen. The mesh can indeed either be posteriorly positioned or it can completely surround the oesophagus. As explained above, our surgical approach consisted in the posterior positioning of the U-shaped mesh. There are several rationales underlying the decision to adopt this technique; the oesophagus is an organ characterised by an inherent motility for which the positioning of a mesh fully surrounding the organ could raise several issues, namely causing a stenosis of the lumen and a reduction in the overall motility. Both the situations could potentially lead to the occurrence of dysphagia, which would then be difficult to treat with an endoscopic approach. Furthermore, this type of configuration could potentially increase the risk of erosion and subsequent mesh migration.
There is still a lack of a standardised definition of giant hiatal hernia; the operational definition adopted in this work was a defect larger than 8 cm or presence of a herniated portion of the stomach in the upper chest > 50%. Some studies refer to giant hiatal hernia concerning hiatal defects of diameter wider than 5 cm. Other authors refer to giant hiatal hernia as a hernia extended to at least 30% of the stomach. The drafting of an uncontested definition of giant hiatal hernia would be instrumental in setting a threshold above which to use a mesh. This could also contribute to cutting costs by avoiding the use of unnecessary devices, also in light of the high rate of anatomical recurrence highlighted.
One last issue worth pointing out is that, in our clinical practice, anti-reflux procedures are not routinely executed. All patients were diagnosed with hiatal hernia undergo a pH-impedance monitoring and a manometric study whose results are used to determine whether to execute an anti-reflux procedure. The data gathered seem to support the value of this approach.
This study has several limitations: first, its retrospective nature with the FU interval not being established prior to surgery but rather left to the patient's discretion upon contact. Moreover, the overall incidence of hiatal hernias falling into the definition of 'giant hiatal hernia' constitutes a mere 25% of the cases the authors encountered in the period studied. Nonetheless, the data gathered from the study potentially define an initial pathway trajectory for surgical practice encouraging the use of a mesh.
Current scientific evidence seems unable to provide a definite answer to whether the use of a mesh is ultimately advantageous with respect to direct cruroplasty in the surgical treatment of hiatal hernias. The use of an absorbable mesh appears to be associated with a lower recurrence rate in the short term and with generally fewer complications compared to the use of a non-absorbable mesh.
Dr. Valeria Testori for polishing the English content of the manuscript.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4]
[Table 1], [Table 2]