Laparoscopic paraesophageal hernia repair with absorbable mesh: a systematic review

Introduction

Hiatus hernia (HH) is a heterogeneous anatomic/clinical entity wherein abdominal viscera, most commonly the stomach, are dislocated across the esophageal hiatus. The current classification recognizes four types of HH. Type I (sliding HH) is associated with hiatal widening, laxity of the phrenoesophageal membrane and upward migration of the cardia. These are the most common HH type and are often associated with gastroesophageal reflux disease (GERD). Paraesophageal hernias (PEH) are less common types and approximately account for 5–15% of HH (1,2). Type II hernia consist in an upward herniation of the gastric fundus with a normally located gastroesophageal junction. Type III hernia has elements of both type I and II hernias with herniation of both fundus and displacement of the gastroesophageal junction above the diaphragm. Type IV HH is characterized by larger hiatal defects with upward migration of the stomach and other intra-abdominal organs or omentum. Although these hernias may be associated with GERD their clinical significance lies in the potential for mechanical complications, pulmonary impairment, and chronic bleeding (3).

Proper management and surgical indication of PEH is debated. Laparoscopic repair is the standard of care for symptomatic patients. Surgery is also recommended in asymptomatic patients with type III–IV hernia because the potential to develop related complications (4). Hernia recurrence is a puzzling problem with a reported incidence up to 60% (5-8). Since the first laparoscopic crural mesh reinforcement, different prosthetic materials have been proposed to bolster the hiatus in attempt to minimize recurrence (9). The ideal mesh material should be able to reinforce the hiatus and reduce crural tension without causing visceral erosion or dysphagia. While the use of non-absorbable mesh has been reported to be promising in term of recurrence minimization, recent studies questioned their safety profile because concerns of mesh-related complications (i.e., infection, migration, stenosis, esophageal/gastric erosion) (10-15). Opposite, absorbable mesh seems associated with mitigated related complications and similar short/medium-term hernia recurrence (16). Interestingly, a recent assessment by the Society of American Gastrointestinal Endoscopic Surgeons (SAGES) revealed that the majority of surgeon treating PEH preferred the use of absorbable mesh (17). Absorbable mesh can be both synthetic or biological with different technical/engineering characteristics, scaffold structure and resorption time (18,19). Nowadays, literature data reporting outcomes for absorbable mesh reinforced cruroplasty are sparse and puzzled.

Hence, the aim of this systematic review was to summarize current knowledge on laparoscopic PEH repair with absorbable mesh crural reinforcement. We present the following article in accordance with the PRISMA reporting checklist (available at https://vats.amegroups.com/article/view/10.21037/vats-22-27/rc) (20,21).

Methods

The present systematic review was not registered. Ethical approval was not required. PubMed (1949–present), MEDLINE (1946–present), EMBASE (1947–present), Scopus (2004–present), Google Scholar (2004–present), and ClinicalTrials.gov (2000–present) were executed (22,23). The last date of search was the May 31st, 2022. A combination of the following MeSH terms (Medical Subject Headings) was adopted (“hiatus hernia” (tiab), OR “hiatal hernia” (tiab)) AND (“mesh” (tiab), OR “reinforcement” (tiab)) AND (“hiatoplasty” (tiab), OR “cruroplasty” (tiab)) AND (“recurrence” (tiab), OR “reoperation” (tiab)) AND (“absorbable” (tiab), OR “resorbable” (tiab)) AND (“synthetic” (tiab), OR “biologic” (tiab)). Five authors (AA, AS, FL, AL, and CO) independently conducted the literature search and separately evaluated suitable titles, abstracts and cited references contained in every article. In case of disagreement among authors, a sixth senior author (GC) clarified discrepancies.

Eligibility criteria

Inclusion criteria: (I) cohort studies and randomized controlled trials (RCTs) reporting outcomes for elective laparoscopic PEH repair with cruroplasty and absorbable mesh reinforcement in adult patients (≥18 year old); (II) English written; (III) when two or more papers were published by the same institution or study group, articles with the longest follow-up or the largest sample; (IV) in case of duplicate studies with accumulating numbers of patients only the most complete reports were included. Exclusion criteria: (I) not English-written; (II) studies with follow-up shorter than 12 months; (III) articles with less than 10 patients per study arm; (IV) articles reporting data for open or non-absorbable mesh reinforced cruroplasty.

Data extraction

The following data were retrieved: authors, country, year of publication, design of the study, number of included patients, gender, age, body mass index (BMI), American Society of Anesthesiologists (ASA) physical status, comorbidities, surgical indication, type of surgical procedure, type of mesh (synthetic vs. biologic), follow-up and outcomes. All data were independently processed by five authors (AA, AS, FL, AL, and CO) and matched at the end of the revising process. A sixth author (DB) determined disagreements.

Quality assessment

Three authors (AE, VP, MC) judged the methodological quality of included studies with the ROBINS-I tool (24). Confounding bias, selection bias, classification bias, intervention bias, missing data bias, outcomes measurement bias, and reporting bias were pondered. Each domain was evaluated with one of the following: “yes”, “probably yes”, “probably no”, or “no”. The categories of judgement for each study are low, moderate, serious, and critical risk of bias. Incongruities were clarified.

Results

The PRISMA flow chart is reported in Figure 1. Overall, 1,065 publications were identified. After duplicates removal, 892 titles were screened, and 127 studies were found possibly relevant for full-text assessment. After full text evaluation, 39 studies (3,103 patients) meet the inclusion/exclusion criteria and were included in the systematic review (Table 1). Notably, 26 studies were of retrospective design, 10 were prospective while 3 were RCTs. The quality of included studies is summarized in Table S1.

Figure 1 The PRISMA diagram. PRISMA, Preferred Reporting Items for Systematic Reviews and Meta-Analyses.

The patient population ranged from 10 to 399 patients. The age ranged from 18 to 93 years old, 62.8% were females and the preoperative BMI ranged from 20 to 59 kg/m². Hernia sac dissection and excision was reported in all studies. Posterior cruroplasty was performed in all included studies while anterior cruroplasty was reported in four studies. The most commonly reported mesh configuration was U-shape (83.7%), followed by circumferential (8.1%), keyhole (5.4%) and starburst (2.8%). Different methods for mesh fixation (sutures vs. fibrin glue vs. absorbable tacks) were adopted depending on operating surgeon preference and experience. Nissen (75.1%) and Toupet (21.1%) fundoplication were commonly performed while gastropexy was reported in two studies. The operative time ranged from 36 to 510 minutes.

The overall postoperative complication rate was 2.5%. Inadvertent intraoperative iatrogenic esophageal/gastric perforation related to viscera manipulation was reported in six patients (0.19%). Postoperative pulmonary complication rate was 1.83%; pneumonia, pneumothorax and pulmonary embolism were the most commonly reported complications. Postoperative cardiac complications occurred in 0.92% of patients and atrial fibrillation was commonly reported. Postoperative in-hospital mortality was 0.22%. Postoperative follow-up ranged from 12 to 166 months. Mesh-related complication rate was 0.06% with two patients reporting esophageal stricture related to dense visceral fibrosis (1 synthetic and 1 biologic mesh). No full-thickness erosions were reported. Hernia recurrence according to different definitions (Table S2) was diagnosed in 393 patients (12.7%) while re-do surgery for recurrence was required in 1.9% of patients. Postoperative dysphagia occurred in 158 patients (5.1%).

Discussion

The use of mesh to reinforce the hiatus is highly discussed with two recently published meta-analyses reporting no significant differences for simple suture cruroplasty versus cruroplasty reinforced with mesh (64,65). Nevertheless, some limitations and significant heterogeneity limit the validity and robustness of such studies. First, the definition of hernia recurrence, inclusion criteria, and surgical indications were heterogeneous. Second, surgeon experience, mesh materials, shape and crural fixation further contributed to inter-study heterogeneity. Finally, the follow-up was limited (up to 42 months). Therefore, a definitive and robust evidence-based indication is still to be defined. Our study group recently described a “patient-tailored algorithm” based on four measurable parameters (type of HH, hiatus diastasis, pillar tropism and recurrence) to decide if it is necessary to place or not a mesh to bolster the crural repair during laparoscopic PEH repair (66,67). This algorithm has been shown to be possibly valuable to assure procedure reproducibility, standardization, and uniformly interpret outcomes in a field where the decision to place or not the mesh is left to the operating surgeon “feeling of a weak crura” and experience. Nowadays, there is still a lack of consensus regarding the best mesh material for crural buttressing after repair. Given the potential for tissue ingrowth rather than encapsulation, absorbable meshes (synthetic and biologic) are generally preferred over non-absorbable meshes (68). Advantages include reduced perivisceral inflammation and consequent tissue fibrosis with minimization of related complications such as esophageal and gastric erosion, mesh migration, and visceral stenosis (13-15). Three absorbable synthetic meshes are currently available for laparoscopic PEH repair: Bio-A^® (Gore Medical, Newark, DE, USA), Phasix^® (Bard, Warwick, RI, USA) and Vicryl^® (Ethicon, Somerville, NJ, USA).

The Bio-A^® is an absorbable synthetic mesh made of 67% polyglycolic acid and 33% trimethylene carbonate (69). Specifically, the mesh acts as a scaffold for the network of cells related to the inflammatory response. During prosthesis absorption (up to 6 months), these cells progressively migrate into the interstice of the mesh with consequent synthesis of new collagen and connective tissue that gradually replace the mesh. Nowadays, there are a few published studies reporting outcomes with Bio-A^®. Specifically, Massullo et al. reported their retrospective experience with 11 patients operated for PEH and managed with Nissen or Toupet fundoplication. Short-term outcomes (13-month follow-up) were encouraging with 9% recurrence rate and no reported mesh-related complications (25). Similarly, Powell et al. in their retrospective series described promising short-term outcomes (12 months) and no mesh-related complications (26). Similarly, Iossa et al. reported their medium-term results (42-month follow-up) on 120 patients with Bio-A^®. Postoperative recurrence rate was 6.2% (33). Asti et al. described their retrospective experience with 100 patients operated for PEH with laparoscopic Toupet fundoplication. No mesh-related complications were observed, and the medium-term (30-month follow-up) recurrence rate was 9% (30). Olson et al. in their single-center experience, reported data for 399 patients. All patients underwent Nissen, Toupet or Dor fundoplication. Results in term of postoperative recurrence, need for reoperation and complications were assessed at 45-month follow-up. Overall, 7.9% of patients underwent reoperation while 16% of patients had symptom recurrence (32). Tartaglia et al. described outcomes for 44 patients with HH treated with laparoscopic fundoplication (Nissen and Toupet) and Bio-A^®. Radiologic recurrence rate was 4.5% with no need for reoperation nor mesh related complications at 3-year follow-up (34). Interestingly, in all included studies a rectangular 7×10 cm Bio-A^®, shaped into a “U” configuration, was placed over the closed hiatus, and fixed with absorbable tacks, fibrin glue or stitches depending on operating surgeon preference.

The Phasix^® mesh is made of poly-4-hydroxybutyrate (P4HB), a naturally derived polymer. The P4HB degrades through both hydrolysis and a hydrolytic enzymatic digestive process in about 12–18 months (35). As described for the Bio-A^®, the Phasix^® mesh is progressively resorbed and gradually replaced with connective tissue synthetized by patient fibroblast that migrates into mesh interstices in the early phase. The first report describing outcomes for the Phasix^® mesh was published by Abdelmoaty et al. in 2020. The authors reported their experience with 50 patients. Mean length of hospital stay was 2.8 days with no major morbidity nor mortality. On the 1-year follow-up, hernia recurrence rate was 8% with no need for reoperation nor mesh infection/erosion (35). Panici Tonucci et al. described their retrospective experience with 73 patients with PEH and Toupet fundoplication. Results were reported at 17 months median follow-up. Postoperative hernia recurrence rate was 3.2% with no mesh-related complications or need for reoperation (36). Similarly, a study from our study group reported the experience with 68 patients with laparoscopic PEH repair and Toupet fundoplication. The median follow-up time was 26 months (range, 1–52 months). Hernia recurrence rate was 8.8%. The recurrence-free probability at 34 and 60 months was 0.89 (95% CI: 0.807–0.988) and 0.86 (95% CI: 0.76–0.97), respectively. During follow-up, hernia recurrence was predominantly observed between 21 and 36 months. No mesh-related complications were detected. None of the patients required surgical revision and all were managed with proton pump inhibitors (PPI). Patient-related quality of life, measured with both the GERD-HRQL and SF-36 was significantly improved compared to baseline (37). As described for Bio-A^®, most of the studies reported a U-shape mesh configuration fixed, over the closed hiatus, with different methods. Finally, a recent report by Konstantinidis et al. described the use of Phasix-ST^® in 40 patients that underwent robotic PEH repair and Nissen fundoplication. Over a median follow-up of 21 months no recurrences nor mesh related complications were observed (70).

Polyglactin 910 mesh (Vycril^®) is another absorbable mesh with a degradation time ranging from 6 to 8 weeks. Zehetner et al. published their experience with polyglactin mesh placed in 35 patients with PEH (38). At 1-year follow-up, recurrence rate was 9.5% with no mesh-related complications. Similarly, Parsak et al. published a randomized trial comparing crural reinforcement with polypropylene vs. Vycril^® including 150 patients (75 polypropylene vs. 75 polyglactin) (39). Postoperative morbidity was similar for both groups, with no mesh-related complications. At 36-month mean follow-up the overall recurrence rate was 7.5%.

Biologic mesh was developed and introduced as alternative and substitute to non-absorbable synthetic mesh. They support hiatal repair during the early phase thus providing a temporary collagen matrix for native tissue ingrowth. Different types of biologic mesh have been produced. They are generally constituted by collagen matrix derived from human acellular cadaveric dermis, porcine small intestine submucosa, porcine dermal collagen, or bovine pericardium. A mild inflammatory response and neovascularization have been reported for biologic grafts (71,72). The theatre of biologic meshes is particularly heterogeneous therefore give an exhaustive overview is challenging. Surgisis^® (Cook Medical, Bloomington, IN, USA), AlloDerm^® (Allergan PLC, Dublin, Ireland) and Strattice^® (Allergan PLC) are commonly used. Oelschlager et al. published in 2006 a trial comparing suture alone vs. Surgisis^® reinforced cruroplasty for PEH. Overall, 108 patients with symptomatic PEH were included. At 6-month follow-up, there was a significantly reduced incidence of hernia recurrence in favor of Surgisis^® (24% vs. 9%) (73). However, the medium-term follow-up analysis (58-month) showed no differences between the two groups in terms of hernia recurrence (59% vs. 54%) (52). Watson et al. compared outcomes between patients undergoing PEH repair by either synthetic (n=42) or biologic (n=41) mesh vs. patients with no mesh reinforcement (n=43). No significant differences were found at 6-month follow-up in term of hernia recurrence (21.8% vs. 23.1%; P=NS) (54). Lee et al. retrospectively reviewed their experience with AlloDerm^® mesh (52 patients). At 16-month follow-up the recurrence rate was 3.8% with no mesh-related complications. Another recent experience from the same group consisted of a retrospective review of 35 patients treated with crural repair and Strattice^® mesh. In the short-term follow-up (12-month) the recurrence rate was 14% (42,43). Finally, Lidor et al. described their experience with the Veritas mesh (Baxter International, IL, USA). At 12-month follow-up the postoperative recurrence rate was 27% with no mesh-related complications (60).

Intra and postoperative complications have been described. In the present study, intraoperative esophageal/gastric perforation was reported in six patients. This complication may be attributable to intraoperative difficulties in hernia reduction and visceral manipulation. Furthermore, operating surgeon inexperience, learning curve, improper traction of the gastric fundus/esophagogastric junction, and thermal injury may cause full thickness perforation (74). In case the perforation is immediately recognized, primary repair with interrupted sutures is advisable (75). The overall postoperative complication rate was 2.5% with pneumonia and pneumothorax commonly reported. Pneumonia may occur in patients with preoperative lung comorbidities or poor lung function therefore, a prompt postoperative pulmonary rehabilitation should be pursued (76). Pneumothorax generally occur because of inadvertent pleural injury during hernia sac dissection and excision. Surgeons should be aware of this potential complication while preventive trans-hiatal chest tube has been described in case of pleural injury (77,78). Mesh-related complications and postoperative dysphagia were reported in 0.06% and 5.1% of patients, respectively. The limited inflammatory response and minimized perivisceral fibrosis typical of all absorbable synthetic and biologic mesh may explain these findings.

Notably, there was a significant heterogeneity including indications for PEH repair, different types/sizes of HH, mesh configuration and shape (i.e., U-shape vs. keyhole vs. starburst, etc.), mesh position, diverse methods for mesh fixation and different type of fundoplication (i.e., Nissen vs. Toupet vs. Dor). In addition, some studies reported data for esophageal lengthening procedure (Collis gastroplasty) and/or diaphragmatic relaxing incisions. Finally, the definition of hernia recurrence (i.e., anatomical or radiological recurrence vs. >2 cm intrathoracic stomach in association with recurrent symptoms) and duration of follow-up were different among studies. Therefore, this significant interstudy heterogeneity limits the robustness of any conclusions. Hence, a definitive indication on the best mesh absorbable mesh for crural reinforcement during laparoscopic PEH repair is still to be defined.

Conclusions

Laparoscopic PEH repair with crural buttressing using absorbable mesh (synthetic or biological) is gaining acceptance within the surgical community. Both synthetic and biologic mesh are safe and effective in the short- and medium-term with acceptable postoperative complications, minimized mesh-related complications and acceptable recurrence rates. The safety and efficacy profile in the long-run mandates future well-designed studies. Focused trials are necessary to appraise the best absorbable mesh for crural buttressing thus possibly defining a treatment algorithm to guide surgeons in the choice of the most appropriate mesh material.

Acknowledgments

Funding: None.

Footnote

Reporting Checklist: The authors have completed the PRISMA reporting checklist. Available at https://vats.amegroups.com/article/view/10.21037/vats-22-27/rc

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://vats.amegroups.com/article/view/10.21037/vats-22-27/coif). AA serves as an unpaid editorial board member of Video-Assisted Thoracic Surgery from June 2022 to May 2024. The other authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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