|Year : 2018 | Volume
| Issue : 2 | Page : 87-94
A collective review of biological versus synthetic mesh-reinforced cruroplasty during laparoscopic Nissen fundoplication
P S S Castelijns1, J E H Ponten1, M C G van de Poll2, SW Nienhuijs1, JF Smulders1
1 Department of Surgery, Catharina Hospital Eindhoven, 5623 EJ Eindhoven, The Netherlands
2 Department of Surgery and Intensive Care Medicine, MUMC+, 6229 HX Maastricht, The Netherlands
|Date of Submission||15-May-2017|
|Date of Acceptance||17-May-2017|
|Date of Web Publication||12-Mar-2018|
Dr. J F Smulders
Department of Surgery, Catharina Hospital Eindhoven, Michelangelolaan 2, 5623 EJ Eindhoven
Source of Support: None, Conflict of Interest: None
Background: Laparoscopic cruroplasty and fundoplication have become the gold standard in the treatment of hiatal hernia and gastro-oesophageal reflux disease (GERD). The use of a mesh-reinforcement of the cruroplasty has been proven effective; although, there is a lack of evidence considering which type of mesh is superior. The aim of this study was to compare recurrence rates after mesh reinforced cruroplasty using biological versus synthetic meshes.
Methods: We performed a systematic review of all clinical trials published between January 2004 and September 2015 describing the application of a mesh in the hiatal hernia repair during Nissen fundoplication for both GERD and hiatal hernia. The primary outcome was the recurrence rate, and secondary outcomes were complication rate, mortality and symptomatic outcome.
Results: We included 16 studies and extracted data regarding 1089 mesh operated patients of whom 385 received a biological mesh and 704 a synthetic mesh. The mean follow-up was 53.4 months. The recurrence rate in the synthetic mesh group was 6.8% compared to 16.1% in the biological mesh group (P < 0.05). The complication rate was 5.1% and 4.6% (P = 0.694), respectively, and there were 12 mesh-related complications. No mesh-related mortality was reported.
Conclusion: Mesh reinforcement of hiatal hernia repair seems safe in the short-term follow-up. The available literature suggests no clear advantage of biological over synthetic meshes. Regarding cost-efficiency and short-term results, the use of synthetic nonabsorbable meshes might be advocated.
Keywords: Biologic, cruroplasty, hiatal hernia, laparoscopy, mesh, Nissen fundoplication, synthetic
|How to cite this article:|
Castelijns P S, Ponten J E, van de Poll M C, Nienhuijs S W, Smulders J F. A collective review of biological versus synthetic mesh-reinforced cruroplasty during laparoscopic Nissen fundoplication. J Min Access Surg 2018;14:87-94
|How to cite this URL:|
Castelijns P S, Ponten J E, van de Poll M C, Nienhuijs S W, Smulders J F. A collective review of biological versus synthetic mesh-reinforced cruroplasty during laparoscopic Nissen fundoplication. J Min Access Surg [serial online] 2018 [cited 2018 May 24];14:87-94. Available from: http://www.journalofmas.com/text.asp?2018/14/2/87/214882
| ¤ Introduction|| |
In 1992, the first report on laparoscopic hiatal hernia repair was published, and over the subsequent years, the laparoscopic approach has become standard treatment., Hiatal herniation is a common disorder of the digestive tract, which is defined by a protrusion of the stomach into the thoracic cavity through a widening of the right crus of the diaphragm. Anatomically, hiatal hernias can be divided into four categories. Type I, a sliding hernia, means that the gastro-oesophageal junction migrates into the thorax. This is the most common type (95%) and it may predispose to gastro-oesophageal reflux., Type II, paraoesophageal hernia, is a defect of the diaphragm with herniation of the gastric fundus through the hiatus into the thorax. Type III is a mixed type of hernia with both aspects of a Type I and Type II hernia. Often more than 50% of the stomach is in the thorax. The most severe type of hernia is a Type IV, in which not only the stomach but also other viscera like colon or spleen herniate into the mediastinal sac. In this latter case, it is also called an “upside-down stomach.”
The possible life-threatening aspects of a hiatal hernia, such as obstruction, acute dilatation, perforation, or bleeding of the stomach mucosa, make it important to diagnose and repair the hiatal hernia. The use of mesh to repair a hiatal hernia had already started in the era of the open surgery. However, there is growing interest in the use of a mesh during laparoscopic surgery as well. According to the Society of American Gastrointestinal and Endoscopic Surgeons guidelines, the laparoscopic Nissen fundoplication and cruroplasty is the gold standard for both gastro-oesophageal reflux disease and hiatal hernia repair. Recent studies,, have suggested that reinforcement of the cruroplasty with a mesh results in a reduction in the recurrence rate. Several different meshes are available, broadly categorised into synthetic or biological material, various shapes or the fixation method. Both biological and synthetic meshes have been applied. The theoretical advantages of a biological mesh are less mesh-related complications such as erosion or migration of the mesh, infection of the mesh and development of fibrotic strictures. However, considering the considerably higher costs of biological meshes and a possible higher recurrence rate, these theoretical advantages should be supported by clinical evidence before the standard use of biological meshes for cruroplasty reinforcement can be advocated. Only one randomised clinical trial has been performed addressing the direct question whether biological meshes are indeed superior to synthetic meshes. However, this study only reports short-term follow-up. We systematically reviewed the outcomes of mesh reinforced cruroplasty, comparing biological and synthetic meshes. By including the “mesh-arms” of randomised controlled “mesh vs. non-mesh-trials,” we attempted to reduce selection bias.
We evaluated the recurrence rate in the different mesh groups as the primary outcome. Complications, mortality and the symptomatic success rate are seen as secondary outcomes.
| ¤ Methods|| |
PubMed database, including an e-link to related articles, Embase, and the clinical trial registry for the Cochrane Collaboration (CENTRAL) were searched for relevant studies reporting a mesh-based hiatal hernia repair and the outcome of recurrence of hiatal hernias.
The first search was performed in pubMed with the following terms: ((((((“Hernia, Hiatal”[Mesh]) OR hiatal hernia) OR hiatus)) and (((“Surgical Mesh”[Mesh]) OR mesh) OR mesh*)) and ((“Laparoscopy”[Mesh]) OR laparoscopic)) and ((((“Fundoplication”[Mesh]) OR nissen) OR toupet) OR fundoplication). When searching in Embase, the following search was used to identify the related articles: (hiatal hernia and laparoscopic and mesh and fundoplication).
In 2005, a large review described the results of laparoscopic versus open hiatal hernia repair up to 2004. Therefore, studies from January 1, 2004 to September 30, 2015 were selected. Two reviewers independently reviewed the articles (BC/JP). In case of discrepancy between the two reviewers, a third party (JFS) was consulted. Restrictions were: At least n = 15 and minimum follow-up of 12 months, primary repairs only. There were no limitations on language or study design. Selection was based on title and abstract, and when in doubt, full text.
All cohort studies, both retrospective and prospective, case-control studies and randomised controlled trial (RCT), which reported recurrence rates of mesh-based repair of hiatal hernia were selected, and studies with a level of evidence ≥3B were included in the study. Paediatric studies, reviews, meta-analyses, case reports and case-series were excluded from the study. The recurrence rate and mesh characteristics were obligatory to be included; the symptomatic outcome, however, was not an inclusion criteria. Only non-absorbable synthetic meshes are included in this study. A recurrence is defined as an objectified recurrence, if a hiatal hernia is seen on endoscopy or a Barium swallow examination. [Figure 1] gives an overview of the search strategy.
A preform was used to extract study design, number of mesh operated patients, the size and type of hernia, the primary indication for the repair, details of the procedure, information about the type, configuration and fixation of the mesh, length of follow-up, recurrence rate, all complications and symptomatic outcome.
Some studies described both non-mesh based repair and mesh-based repair. Since this is a systematic review of mesh-based hiatal repair, all above mentioned data regarding mesh-operated patients were extracted. Total recurrence, complications and symptomatic outcome were calculated for the patients that underwent a mesh-based hiatal hernia repair. Data regarding a fundoplication other than Nissen were not extracted. Mean follow-up was extracted or the given median was used as the mean. Patient groups, in which the same type of mesh was used, were pooled.
All data were analysed using SPSS for MacOs version 21.0 (SPSS Inc., Chicago, IL, USA). Values are expressed as mean ± standard deviation (SD).
All included studies were assessed regarding their methodological quality. The Jadad score was used to qualify the RCTs. In this score, the way of randomisation, the method of blinding and the amount of drop-outs lead to a minimum score of zero (a RCT of statistical inferior quality) and a maximum score of five (a RCT of statistical very good quality). To determine the methodological quality of the cohort studies and the case-control studies, the Newcastle-Ottawa assessment scale of the quality of non-randomised studies in meta-analysis was used. The minimal score used is zero (very poor statistical quality) and the maximum score for the case-control series is nine (excellent statistical quality).
Consequently, a level of evidence was assigned to each article according to the Oxford Centre of Evidence Based Medicine Levels of Evidence [Table 1]. A Jadad score <4 was graded as a level 2B evidence and a score of four or five was Level 1B. Cohort studies with a Newcastle-Ottawa Assessment score of <6 were graded a level of evidence of 4 and a score of >5 was graded Level 2B. All case-control studies are assigned a Level of 3B.
|Table 1: Grades of evidence according to the oxford centre for evidence-bases medicine levels of evidence|
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| ¤ Results|| |
Description of the studies
The used search strategy generated a total of 207 articles eligible for selection. All articles were selected on title and abstract, based on the inclusion and exclusion criteria. Seventy-four articles underwent critical appraisal of the full text. Eventually, 21 articles fulfilled the selection criteria and were selected for quality assessment [Figure 1].
Four of the studies are case-control series, and all of them had a level of evidence 3B. Four of them are RCTs, all of them with a level of evidence 1B and a mean Jadad score of 4.75 ± 0.4. The remaining 13 articles described cohort studies; eight of them had a level of evidence 2B and the remaining five studies had a level of evidence four and were, therefore, excluded from this review. Finally, 16 articles were included in this review [Table 2].,,,,,,,,,,,,,,,
In the 16 articles, a total of 2364 patients were included in the study. All patients that underwent a mesh-based hiatal hernia repair were extracted. This led to the inclusion of 1089 patients in total. A total of 385 patients received a biological mesh (35.4%) and 704 patients were operated on with a synthetic mesh (64.6%). The gender was not described in five studies (31.3%),,,,, and in the remaining studies the male:female ratio was 1:1.2. The weighted mean age of the population was 51.1 years and the weighted mean follow-up was 53.4 (range: 12–97.7) months. Four studies included all hernia sizes, seven studies included large hernias defined by a defect larger than 5 cm or migration of >50% of the stomach into the thorax. Three studies included only small defects defined by a hernia <5 cm or <50% of the stomach in the thorax. The remaining studies did not report their included hernia size.
Several types of mesh were used in the included studies. Most studies described only one specific type of mesh, but in three studies, multiple types of synthetic or biological meshes were used, and these studies are referred to as the multiple mesh group. Polypropylene (Prolene®; Ethicon) (synthetic mesh) and the Small Intestine Submucosa (SIS, 4-ply Surgisis; Cook Biotech Inc., Lafayette, IN) (biological mesh) are the most-used mesh types in this review – respectively, 540 (48.6%) and 125 (11.3%) patients. The methods of mesh fixation to the hiatus were suturing, stapeling and/or the use of glue. In nearly all studies, except for one, the mesh was used as a reinforcement of the primary closure. In that study, the mesh was used to create a tension-free repair.
An accurate analysis of the recurrence rate appeared to be complex, as a standardised definition for recurrence was lacking in most studies. Some studies reported the return of symptoms as a recurrence and others reported an anatomical hiatal hernia at follow-up as a recurrence. The anatomical recurrence data were extracted and the definition we used for a recurrence was a hiatal hernia >2 cm on barium swallow or on endoscopy. The anatomical recurrence rate in the biological mesh group was 16.1% compared with a recurrence of 6.8% in the synthetic mesh group (P< 0.05). In the biological group, two mesh types were used – a Human Acellular Dermal Matrix (HADM, Alloderm; LifeCell Corporation, Bridgewater, NJ, USA) and the SIS with an individual anatomical recurrence rate of 3.8% and 14.4%, respectively. In the synthetic mesh group the lowest individual recurrence rate was seen for the polypropylene mesh, 5.9%, and the highest recurrence rate was 7.1% for the polytetrafluoroethylene mesh.
There is no agreement between studies regarding which symptoms are classified as complications and which are not. Therefore, the reported complication rates were used, regardless of what the complications were. The most frequently reported complications were an intraoperative splenic lesion, post-operative dysphagia and a post-operative gasbloating syndrome [Table 3]a and [Table 3]b. Most complications appeared in the post-operative period, and 12 of the 1089 operated patients had a mesh-related complication. The most reported mesh-related complication was stenosis of the gastro-oesophageal junction. Only one mesh-related complication was in the biological mesh group compared with 11 events in the synthetic mesh group (P = 0.065). The overall complication rate was 5.1% in the synthetic mesh group and 4.6% in the biological mesh group (P = 0.694). The complication rates vary per type of mesh between 3.1% with a polypropylene mesh and 15.8% for the multiple synthetic group. In the biological group, the lowest complication rate was seen for the HADM mesh with 5.5%, where the upper limit was 8.7% for the SIS mesh.
All studies used a different criteria for a symptomatic successful outcome. Some authors used the complete remission of symptoms as a successful outcome; others were satisfied when patients suffered less severe post-operative symptoms when compared with their pre-operative symptoms. The successful outcome reported in the individual articles is analysed in this review, regardless of the criteria that were used. Six studies did not report symptomatic outcomes.,,,,, An overall symptomatic success rate of 85.5% was found in the biological mesh group, and a success rate of 94.6% in the synthetic mesh group. The highest success rate overall was in the Polypropylene group with 97.5% of the patients being relieved of their symptoms at a mean follow-up of 48.6 months. The lowest symptomatic success rate was found in the SIS group; 80.4% of these patients were relieved of their symptoms.
Mortality after laparoscopic fundoplication and hiatal hernia repair is low. No mesh-related mortality was reported in the included studies [Table 4].
| ¤ Discussion|| |
The aim of this study was to evaluate the recurrence rate in mesh repaired hiatal hernia. Recent studies have shown that a mesh-based hiatal hernia repair is superior to a non-mesh based repair.,, Until now, various recurrence rates have been reported for the use of synthetic meshes, varying between 0% and 44%, with a median recurrence rate of 7% in a large review by Draaisma et al.,, This spread may be caused by the difference in follow-up, since higher recurrence rates are found in studies with a longer follow-up. Another explanation for this wide spread is that different definitions for recurrence are available. One can define recurrence as the return of symptoms or as a radiological recurrence as well. If the latter one is used, recurrence rates up to 54% have been reported in patients that received a biological mesh-based repair. In 2006, Oelschlager et al. reported that a radiographic recurrence rate of 24% in patients in which the hiatal hernia was primarily closed compared with a recurrence rate of 9% in patients who received a biological mesh for a follow-up period of 6 months. However, when they describe the same cohort in 2011 and report the 5-year follow up, the recurrence rates are 59% and 54%, respectively. It seems that the advantage in recurrence rate of the biological mesh disappears when the follow-up becomes longer. Unfortunately, it is very difficult to draw strong conclusions based on published studies, since there are only five studies describing a biological mesh and most studies only report short-term results. Nevertheless, we found a significantly higher recurrence rate in the absorbable mesh group. This finding is supported by Watson et al.; however, there was no statistically significant difference in this study (P = 0.161). We believe that this result may be due to the small sample size, since the reported recurrence rates are 30.8% after biological absorbable mesh compared with 12.8 for the non-absorbable synthetic mesh. This study also reports a short-term follow-up of only 6 months.
The secondary outcomes of this review were the complication rate, mortality and the symptomatic success rate. There is a large heterogeneity among the studies regarding the different outcomes; nevertheless, the complication rates and symptomatic outcomes are pooled. Due to the large heterogeneity, it was not possible to apply an extensive statistical analysis on the data. If the complications are pooled, an overall complication rate of 4.9% is found [Table 5].
There is a large diversity in the reported complications. This can probably be explained by the fact that some studies describe a symptom as a complication, for example, dysphagia, where others report this as a common side effect of the procedure. Dysphagia is the main problem after antireflux surgery with an incidence of 3%–24% after Nissen fundoplication., Most complications are not related to the use of a mesh during the procedure, but there were 12 mesh-related complications. The mesh-related complication reported the most is a stenosis at the gastro-oesophageal junction. This is probably due to shrinkage of the mesh, which is more common in a synthetic mesh. The shrinkage rate can be up to 70% for a polypropylene mesh. Since the sample sizes of the individual series are rather small, there is a considerable risk of underreporting of complications due to publication bias.
Theoretically, a biological mesh could show lower mesh-related complication rates, since this type of mesh is made of collagen, which will be absorbed by the body over time. Furthermore, the biological material may still contain some growth factors, which may induce the remodelling faster. In this review there were no complications reported in the biological mesh-based hiatal hernia repairs. However, Stadlhuber et al. described in 2009 a series of 28 case reports describing mesh-related complications. Seven of these cases described mesh-related complications in biological meshes, including stenosis, fibrosis and even one case of erosion of the mesh into the oesophagus. There is only one mesh-related complication found in the included studies, which was described by Soricelli et al. This concerned a polypropylene mesh after a mean follow-up of 89 ± SD 29.8 months. The specific follow-up in this case is not reported and further details on this specific case are not reported either. Still, hiatal hernia repair with the use of a mesh seems to be a safe procedure since low mortality rates were reported.
The overall mortality rate was 0.29%, which is very low, and all deaths were due to non-mesh related causes [Table 4].
As demonstrated in [Table 2], the symptomatic outcome is reported in 10 studies and the overall success rate is 687/750 (91.6%). The most common method to measuring the symptomatic outcome is by a 0–4 point Likert scale,,,, Visick score,,, or by a yes/no scoring system.,, The definition for a successful symptomatic outcome used in this review is an improvement of the previously mentioned scores. Since there is a large heterogeneity in the symptomatic outcome, the only conclusion that can be made is that there is an increasing need for a standardised method to report the symptomatic outcome of hiatal hernia repair.
Another aspect that needs to be considered is the cost of the different mesh types. Unfortunately, the price of the meshes was not mentioned in any of the articles. However, there is one literature review done in 2011 by Shankaran et al. They evaluated the cost of different mesh types. The conclusion of this review is that the price of a synthetic mesh is between $0.20 and $1.00 per cm2. The biological mesh is available for a price between $8.00 and $26.00 per cm2. Therefore, one can conclude that the biological mesh is on average far more expensive than a synthetic mesh.
| ¤ Conclusion|| |
This is the first review that gives an overview of performed studies between 2004 and September 2015 describing hiatal hernia repair with the use of a mesh in Nissen fundoplication. Despite the large heterogeneity, some differences were found in recurrence, complications and symptomatic outcomes between a synthetic and a biological mesh. The use of a synthetic mesh showed a significant lower recurrence rate. Regarding the complication rate, there is no advantage of one mesh over the other; however, it seems that with the use of a synthetic mesh more mesh-related complications occur. For both synthetic and biological meshes, the mortality rate is very low. Mesh repair of a hiatal hernia seems safe in the short-term; however, more long-term studies are needed to analyse the mesh-related complications. Since the biological mesh is more expensive and does not show better results, a synthetic mesh seems a good choice to use for hiatal hernia repair.
In the synthetic mesh group, the polypropylene shows a very low recurrence rate and the lowest complication rate. This type of mesh might be superior to the other synthetic meshes. There is a lot of heterogeneity among the studies so far, and only a few studies report on a biological mesh. There is a need for more RCTs comparing synthetic meshes with biological meshes with a long-term follow up, and a standardised method to report the success ratio of the procedure, both symptomatic and anatomically.
This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]