Mesh-reinforced cruroplasty for type III-IV hiatus hernia repair: a single-center experience using the Patient-Tailored Algorithm

INTRODUCTION

The surgical management of hiatus hernia (HH) is complex and remains a widely discussed topic. Despite extensive literature on laparoscopic repair, there is still no consensus on many technical aspects, which limits the standardization and reproducibility of the procedure. This lack of consensus contributes to the wide range of reported HH recurrence rates after surgery, which vary from 1.2% to 66%^[1-7]. Such variability largely reflects heterogeneous definitions of HH recurrence, representing a major limitation when comparing studies, interpreting results, and evaluating different surgical techniques.

Over the years, several methods have been proposed to reinforce cruroplasty, including mesh placement, pledgets, gastropexy, relaxing incisions, ligamentum teres augmentation, and anterior cruroplasty^[8,9]. Among these, the use of mesh to reinforce cruroplasty and potentially reduce recurrence has generated considerable discussion, yet clear guidelines on indications for mesh reinforcement remain lacking. In this context, we previously proposed a Patient-Tailored Algorithm (PTA) based on four criteria (laparoscopic classification of HH, hiatus diastasis, pillars trophism, and recurrence) to guide the decision-making process for mesh-buttressed (MB) cruroplasty^[10-12].

The aim of this study was to evaluate the medium-term efficacy of PTA-guided MB cruroplasty compared to simple suture (SS) cruroplasty in laparoscopic repair of type III-IV HH.

METHODS

This single-center, retrospective observational study was approved by the local Institutional Review Board and conducted in accordance with the Declaration of Helsinki.

All HH cases treated laparoscopically at IRCCS Ospedale Galeazzi-Sant’Ambrogio were recorded in a prospectively maintained database. We screened patients from November 2019 to April 2023 to include adults (≥ 18 years) who underwent SS or MB cruroplasty with Toupet fundoplication. The inclusion criteria were: (a) adults (≥ 18 years); (b) diagnosis of type III or IV HH; (c) surgical indications according to the latest Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) guidelines^[13,14]; and (d) a minimum follow-up of 12 months. Exclusion criteria were: (a) previous gastric surgery preventing fundoplication; (b) patients deemed ineligible for surgery; and (c) follow-up < 12 months. The primary outcome was HH recurrence, defined as the reappearance of GERD symptoms combined with evidence of > 2 cm of stomach herniation above the diaphragm on follow-up upper gastrointestinal (UGI) endoscopy and/or swallow study^[15]. Secondary outcomes included recurrence-free probability, short-term postoperative complications, and quality of life assessment.

RESULTS

During the study period, 89 patients meeting the inclusion criteria underwent laparoscopic HH repair with Toupet fundoplication at our institution. During follow-up, three patients died from unrelated reasons and 12 patients were lost to follow-up. Thus, 74 patients were included in the final analysis [Figure 1]. All procedures were performed in a standardized manner by two surgeons (D.B. and A.A.).

Figure 1. Patient population. SS: Simple suture cruroplasty; MB: mesh-buttressed cruroplasty.

Among the 74 patients, 69% were female. The mean age was 65.9 years, and the mean preoperative BMI was 27.6 kg/m². The most common comorbidities were hypertension (51%), dyslipidemia (15%), and thyroid disease (10%). The main symptoms were heartburn (58%), regurgitation (39%), and epigastric pain (38%), while atypical symptoms were reported in a minority of patients [Table 1]. The mean HH size measured during UGI endoscopy was 6.5 cm, and esophagitis of any grade (according to the Los Angeles classification) was observed in about 14% of cases. HRM and pH-impedance testing were performed selectively as part of the diagnostic work-up.

The mean operative time was 126 min. According to the preoperative PTA score, 50% of patients with a score ≤ 5 underwent SS cruroplasty, while the remaining 50% received MB cruroplasty. The mean HSA was 6.2 cm². Concordance between HSA and PTA in indicating MB cruroplasty was 86%.

No intraoperative complications occurred, and no cases required conversion to open surgery. The 90-day postoperative complication rate was 5.4% (n = 4). Complications according to the Clavien-Dindo classification included: grade IIIa (pneumothorax, pleural effusion; n = 3) and grade IIIb (hydropneumothorax with pleural empyema; n = 1). No mortality (grade V) was observed.

The median follow-up was 38 months (range, 12-98). Compared to baseline, there was a significant reduction in postoperative PPI use (74% vs. 47%; P = 0.001) and significant improvements in quality of life, as measured by both GERD-HRQL (20 vs. 3; P = 0.004) and RSI (14 vs. 6; P = 0.008). Overall, seven patients (9.5%) were diagnosed with HH recurrence; none required redo surgery. No mesh-related complications were reported during follow-up.

Patients were stratified into SS and MB groups. Demographic, preoperative, intraoperative, and postoperative characteristics are reported in Table 2. Compared with SS cruroplasty, MB cruroplasty showed a trend toward lower HH recurrence (10.8% vs. 8.8%). Notably, both GERD-HRQL (2 vs. 7; P = 0.048) and RSI (3 vs. 10; P = 0.008) were significantly improved in the MB group compared with SS. Trends toward improved SF-36 scores and reduced PPI use were also observed with MB cruroplasty. Multivariate logistic regression, adjusting for relevant covariates, did not identify significant factors associated with HH recurrence [Table 3]. The recurrence-free probability for mesh vs. no mesh repair was as follows: at 12 months, 1.00 vs. 0.95; at 24 months, 0.94 vs. 0.95; at 36 months, 0.94 vs. 0.94; at 48 months, 0.86 vs. 0.91; and at 72 months, 0.86 vs. 0.83 [Figure 2].

Figure 2. Kaplan-Meier survival curve of patients treated with mesh (red line) vs. no mesh (blue line). The x-axis represents time in months, and the y-axis represents recurrence-free probability.

DISCUSSION

This study shows a promising effect of MB PTA-guided cruroplasty in patients with symptomatic type III-IV HH. Compared to SS cruroplasty, MB cruroplasty was associated with a trend toward lower medium-term HH recurrence and reduced PPI use, along with significant improvements in patient quality of life.

Laparoscopic posterior cruroplasty is a crucial step in HH repair. The choice of technique largely depends on the surgeon’s subjective assessment of crural weakness, as there is currently no standardized, objective method for crura repair. The use of mesh to reinforce diaphragmatic closure and reduce recurrence risk remains controversial due to the lack of clear guidelines. Conflicting evidence in the literature contributes to this uncertainty. Studies comparing MB cruroplasty with SS cruroplasty report heterogeneous outcomes, with some suggesting benefits in recurrence reduction and others showing no significant effect. For instance, a 2022 meta-analysis by Clapp et al., including 21 studies, reported a significantly lower recurrence rate in the bioabsorbable mesh group compared to the non-mesh group (8% vs. 18%, pooled P-value < 0.0001) with a median follow-up of 27 months^[26]. Similarly, Hanna et al. (2024) found that mesh placement during primary HH repair reduced early recurrences but did not affect late recurrences, complications, or postoperative symptoms^[27]. Conversely, Petric et al., in a meta-analysis of randomized control trials (RCTs) comparing sutured vs. mesh-augmented HH repair, found no significant differences in short-term recurrence (6-12 months, 10.1% mesh vs. 15.5% sutured, P-value = 0.22), long-term recurrence (3-5 years, 30.7% mesh vs. 31.3% sutured, P-value = 0.69), functional outcomes, or patient satisfaction^[28]. Latorre‐Rodríguez et al. similarly reported no difference in recurrence rates between absorbable mesh and suture repair (20.6% vs. 20.8%)^[29]. Another 2022 RCT meta-analysis also found comparable early [relative risk (RR) = 0.74, P-value = 0.46) and late (RR = 0.75, P-value = 0.48) recurrence rates regardless of mesh use. However, heterogeneous definitions of HH recurrence and inclusion of patients lost to follow-up limited these conclusions. By reanalyzing the same RCTs with a more uniform definition of recurrence (both anatomic and symptomatic), excluding patients lost to follow-up, and performing sensitivity analysis, Aiolfi et al. found a significant reduction in HH recurrence (RR = 0.35; P-value = 0.02), supporting mesh use for crural augmentation^[30]. Nevertheless, it remains essential to weigh the potential benefits against possible mesh-related complications. Absorbable meshes are preferred, as the inflammation associated with implantation promotes native tissue strengthening and scar formation without causing the serious complications seen with non-resorbable meshes, such as erosion, migration, adhesions, infection, strictures, dysphagia, or chest pain^[31-33].

As noted, there is no standardized method for posterior cruroplasty, and techniques vary according to surgeon experience, contributing to outcome heterogeneity. An early attempt at standardization was proposed by Granderath et al. (2007), who introduced the HSA calculation via a complex trigonometric formula^[21]. They recommended mesh placement when HSA exceeded 4 cm². To simplify decision-making, we developed the PTA, a tool based on easily assessable intraoperative features without complex computations. The PTA provides a simpler, reproducible, and direct method for guiding cruroplasty, demonstrating promising outcomes in improving quality of life and reducing HH recurrence^[23]. Compared to HSA, the PTA is more accessible intraoperatively, with a high concordance rate exceeding 85%, and accounts for factors such as HH recurrence risk and crural frailty, which HSA does not.

In our study, the overall recurrence rate was 9.5%, lower than many reported rates. However, the lack of a uniform definition of recurrence contributes to such variability and makes robust comparisons difficult^[9,34,35]. Surgeons at our center are part of a specialized referral unit for GERD surgery, which may also contribute to lower recurrence and complication rates. The use of Phasix-ST®, a biosynthetic absorbable mesh composed of P4HB with Sepra Technology (ST) coating, may further reduce complications. This mesh degrades over 12-18 months, acting as a scaffold to reinforce the hiatus^[12], while the ST coating - composed of sodium hyaluronate and carboxymethylcellulose - minimizes visceral adhesions. This type of mesh demonstrates a favorable short- and medium-term safety and efficacy profile, preventing early recurrences while avoiding long-term complications. In our study, a trend toward lower HH recurrence was observed for MB vs. SS cruroplasty (8.8% vs. 10.8%), although the difference did not reach statistical significance, likely due to the small number of recurrences. Multivariate analysis suggested a possible clinical trend (point estimation 0.78), but the 95%CI included the null value. Increasing age was linearly associated with HH prevalence, though statistical significance was limited by the sample size^[36,37]. Clinically, postoperative PPI use tended to be lower in the mesh group (37.8% vs. 56.8%, P-value = 0.16). MB cruroplasty was also associated with improved GERD-HRQL and RSI scores compared to SS, an important finding given that, according to the 2024 SAGES guidelines, HH repair primarily aims to improve quality of life^[13].

Limitations of this study include its retrospective design, which may introduce attrition and selection bias. Variable follow-up durations could underestimate recurrence rates. The limited number of patients and recurrences restricted robust multivariate analysis. Additionally, as a tertiary referral center study, generalizability may be limited. Prospective, multicenter studies with larger samples are required to validate these preliminary findings.

In conclusion, MB cruroplasty using a biosynthetic absorbable mesh appears safe and promising for reducing HH recurrence, improving quality of life, and potentially decreasing PPI use. Careful patient selection is essential to optimize outcomes. The PTA offers a practical, reproducible approach to standardize type III-IV cruroplasty, reducing reliance on subjective surgical judgment.