Review for cost-effectiveness analysis of laparoscopic Intra-peritoneal Onlay Mesh for ventral hernia repair in Indian settings

Abstract

Background

Health Technology Assessment in India (HTAIn) carries evidence-based decision making in improving health care. This study was done to assess cost-effectiveness of the laparoscopic IPOM technique compared to open VHR from health system perspective of India.

Methods

A Meta-analysis of outcomes of both procedures was carried out whereas cost estimates were obtained from national health system costing database.

Results

A meta-analysis of Randomized Control Trials (RCTs) showed similar risk in hernia recurrence rates between laparoscopic IPOM and open technique (RR: 1.28 95% C.I: 0.81, 2.04) but with significantly less risk for wound infections (RR: 0.31 95% C.I: 0.18, 0.54). Estimated cost from National Health System Costing Database (NHSCD) per VHR was high for laparoscopic IPOM (INR 58,872) compared to open hernioplasty (INR 36,166) with estimated Incremental Cost-Effective Ratio of INR 5,023 per wound infection averted.

Conclusions

Laparoscopic IPOM was not clinically effective in hernia recurrence and less likely to be cost-effective

Supplementary Information

The online version contains supplementary material available at 10.1186/s12962-025-00638-4.

Key points

• Laparoscopic IPOM as compared to open surgery for ventral hernia significantly reduces risk for wound infection but not hernia recurrence.

• Simulated analysis suggested that laparoscopic IPOM is less likely to be cost-effective as compared to open surgery for ventral hernia.

Supplementary Information

The online version contains supplementary material available at 10.1186/s12962-025-00638-4.

Introduction

Ventral hernia is a common patient presentation with an overall incidence between 6 and 22%, common in females and elderly persons between 40 and 60 years of age [1, 2]. Worldwide, nearly 20 million people with ventral hernia undergo Ventral Hernia Repair (VHR) [3]. Evidence from USA showed significant increase in VHRs (611,000/year) with about an estimated annual cost of VHR to be USD10 billion [4]. The conventional treatment method involved either suturing the defect or placing synthetic mesh via an open surgical approach. This often resulted in high rate of infections and recurrence [5–7]. More recent approaches focus on using minimally invasive techniques such as laparoscopic repair, which is expected to be less invasive, with fewer wound complications, faster recovery and low rate of recurrence along with improved cosmesis. However, most commonly used technique used for ventral hernia repair is Intra-peritoneal Onlay Mesh (IPOM) as compared to alternative techniques such as eTEP, TAPP, etc. [8].

The laparoscopic IPOM VHR is recommended by the International Endohernia Society (IEHS) with pre-peritoneal/intra-peritoneal repairs for small to medium-sized ventral and incisional hernias (EHS classification W1 and W2) [9]. However, in a resource-limited healthcare system, evaluating the cost-effectiveness of such surgical interventions is crucial for optimizing resource allocation. We hypothesized that laparoscopic IPOM likely to be cost effective over conventional open hernioplasty for ventral hernia repair. With this background, this study systematically reviewed the clinical evidence on laparoscopic IPOM versus conventional open hernioplasty for VHR with its cost-effectiveness from a health system perspective in India.

Methods

For present study, population under study were adult patients with ventral hernia defects inclusive of incisional hernia, irrespective of size of the defect. The intervention was laparoscopic IPOM and open hernioplasty was comparator. Primary outcome was hernia recurrence and the secondary outcomes were wound infection, seroma, duration of surgery and length of hospital stay. The time horizon was taken as five years and RCTs published from 2005 to 2024 were included in analysis.

Assessing clinical effectiveness

First, clinical effectiveness of intervention (Laparoscopic IPOM) as compared to open hernioplasty, was established by conducting a systematic review and meta-analysis of Randomized Control Trials (RCTs). The review was performed following consultations of Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines as per predefined protocol [10] and was also registered on PROSPERO (CRD42024603106).

The clinical evidence of RCTs was searched from databases such as PubMed, Embase, Scopus, Web of Science, and Cochrane Central Register of Controlled Trials. The search strategies in PubMed were (‘Ventral Hernia’ [MeSH] OR ‘Abdominal Hernia’ [MeSH] OR “Hernia Ventral” OR “Hernia Abdominal” OR “Small Ventral Hernia” OR “Primary Ventral Hernia”), (“Intra peritoneal Onlay Mesh” OR “IPOM” OR “Intraperitoneal Mesh” OR “Mesh Repair”) OR (“Open Hernioplasty” OR “Open Hernia repair” OR “Open Surgery” OR “Open Mesh Repair”), (“Randomized Controlled Trial” OR “Clinical Trials” [MeSH]). This search strategy was modified and applied to other four databases.

Thereafter, included RCTs were assessed by JBI (Joanna Briggs Institute) critical appraisal tool for the assessment of risk of bias independently, by two reviewers [11]. The third reviewer was consulted in case of any discrepancy in the decision between the first two reviewers. Subsequently, data was extracted in Microsoft Excel. Risk Ratio (RR) was calculated for all the dichotomous outcomes with 95% confidence intervals (95%CI).

Dichotomous outcomes were wound infection, seroma, and hernia recurrence whereas mean difference was reported for continuous outcomes like duration of surgery (minutes) and length of hospital stay (days). The I² statistics were calculated to assess heterogeneity. An I² value < 25% was considered as minimal or no heterogeneity, between 25 and 50% as mild to moderate, within 50 to 75% as moderate to substantial and > 75% as substantial heterogeneous [12]. In current meta-analysis, random effect estimates are interpreted, however common effect model was also reported. Data was analyzed using R Studio (4.3.1) using the “meta” package.

Estimating unit cost and cost-effectiveness analysis

Second, unit cost was calculated using cost estimates from National Health System Central Database (NHSCD) for India. In database, cost data is given as average (mean and median) cost under general surgery for outpatient department (OPD), inpatient department (IPD), and operation theatre (OT) at the current, 80% and 100% capacity utilization of hospitals. The current study used mean cost for analysis for OPD, IPD, and OT at the tertiary level hospitals. Thereafter, total cost of each procedure was calculated (Table 1). District level hospitals were not considered for analysis as the cost for laparoscopic VHR was not available. The total cost was considered to be same for both primary and secondary outcomes of laparoscopic IPOM and open VHR.

Table 1.

Cost calculations for outpatient department (OPD), inpatient department (IPD), and operation theatre (OT)

Costs	Methods of Estimation (Probabilistic)
Inpatient department (IPD)
Laparoscopic IPOM	Mean cost x 2.65 days
Open Surgery	Mean cost x 4.39 days
Outpatient Department (OPD)
Laparoscopic IPOM	Mean cost x number of visits
Open Surgery	Mean cost x number of visits
Operation Theatre (OT)
Laparoscopic IPOM	Mean cost + Cost of Mesh + Cost of Tackers
Open Repair	Mean cost + Cost of Mesh
Total Cost	OPD Cost + IPD Cost + OT Cost

While estimating cost parameters for IPD, the length of hospital stays for both procedures was estimated from meta-analysis (Supplementary Figs. 1 and 2) and used to calculate total IPD cost (Table 1). Additionally, the market retail price for the mesh and tackers was added to the final cost for analysis. Probabilistic estimates for mean cost and pooled meta-analytic outcomes were calculated with the R studio package (4.3.1) with 10,000 simulations. Consecutively, mean incremental cost-effectiveness ratio (ICER) was calculated and compared to willingness to pay threshold (WTP) for India. It was considered as INR 2,14,000 using per capita income of India. ICER below the WTP threshold were considered cost-effective.

In addition to cost-effectiveness, budget impact analysis (BIA) for state of Himachal Pradesh was conducted to assess affordability. It involved assessing current spending on the standard of care and estimate change in spending after introducing laparoscopic IPOM. To have a better estimate at state-level, BIA parameters were selected from a study which was done at one of the state’s government hospitals [13]. It was calculated as number of ventral hernia patients per year means laparoscopic IPOM cost.

Results

The systematic literature review identified 4,334 articles. Following an initial screening, 48 articles were selected for further review. Of these, 19 were excluded for not specifying the type of laparoscopic technique, 11 randomized controlled trials (RCTs) lacked a reported randomization method, and 8 were not primary studies (Fig. 1). Ultimately, 10 RCTs were included and assessed for risk bias assessment (Supplementary Tables 1 & 2). The details of the studies are provided in supplementary Table 5.

Fig. 1.

PRISMA format for the studies reviewed for systematic review and meta-analysis for laparoscopic IPOM and open ventral hernia repair (VHR), 2005–2024

A total of 1204 patients were randomized in 10 studies, laparoscopic IPOM group (n = 600) and open hernioplasty group (n = 604) with a follow-up period of up to 5 years. The pain score assessment was done in seven studies and varied in terms of post-operative day of assessment. One of the studies reported VAS pain scores on day 1, day 2 and day 3 [13]. Another study reported pain scores at 1 month after the surgery [14]. Two studies mentioned pain scores at only Day 2 of surgery [15, 16]. One study observed chronic pain up to 12 months after procedure. Due to reported variability in post-surgery assessment, pain score was not considered for meta-analysis.

Clinical-effectiveness estimates

The major outcomes reported in included studies were length of hospital stay (n = 10), wound infections (n = 9), duration of surgery (n = 9), hernia recurrence (n = 8), seroma (n = 7), and post-operative pain scores (n = 7) (Supplementary Table 3). Analysis showed an insignificant risk (RR: 1.28; 95% CI: 0.81–2.04) for hernia recurrence laparoscopic IPOM and open VHR with a low level of heterogeneity (Fig. 2) [14–22], whereas, wound infection showed significantly lower risk (RR: 0.31; 95% CI:0.18–0.54) with low level of heterogeneity (Fig. 3) [17–20]. The pooled proportions of wound infection were used for ICER calculations. It was 0.02 for laparoscopic IPOM and 0.10 for open hernioplasty (Supplementary fig. 3 & 4). Insignificant risk was also observed for seroma (RR: 1.22; 95%CI:0.63–2.35) [13–18, 20–22]. Insignificant mean difference (MD) was observed for duration of surgery (MD: -12.30; 95%CI: -34.87-10.27) between both the procedures with high level of heterogeneity [13–16, 19–23]. Meta-analysis of least reported/observed complications was not done as they were reported one-two studies. They were mainly MESH infection, flap necrosis, urinary retention, adhesiolysis, neuralgia, bowel obstruction/paralytic ileus, caval thrombosis, pulmonary embolism, post-operative hemorrhage, hematoma, bulging, trochar herniation, blood loss, and mortality.

Fig. 2.

Risk of hernia recurrence in laparoscopic Intraperitoneal Onlay Mesh (Experimental) and Open Hernioplasty (control)

Fig. 3.

Risk of wound infection in laparoscopic Intraperitoneal Onlay Mesh (Experimental) and Open Hernioplasty (control)

Cost estimates

In present analysis, based on NHSCD data, cost per visit in OPD and IPD was assumed to be same for both procedures. Whereas, cost of operation theatre was different for both procedures (Supplementary Table 4). Total IPD Cost for both laparoscopic IPOM and open hernioplasty was calculated from mean days of length of hospital stay estimated from meta-analysis. The mean days estimated were 2.6 days for laparoscopic IPOM and 4.4 days for open hernioplasty (Supplementary Figs. 1 & 2). Cost of the mesh was estimated to be INR 4,000 and Tacker INR 20,000 at market price.

After simulations, the mean cost calculated for open hernioplasty at current capacity utilization was INR 36,166 and for laparoscopic IPOM was INR 58,872, which rose at 80.0% capacity (Laparoscopic IPOM: INR 95,044; Open: INR 55,110) and 100.0% capacity utilization (Laparoscopic IPOM: INR 83,061; Open: INR 47,324). As 10,000 simulations were used, laparoscopic IPOM was cost-effective in only 54.0% simulations (Fig. 4). As wound infection showed significant difference between procedures, ICER was calculated for this outcome. Simulated mean ICER was INR 5,023 per wound infection averted at current hospital capacity. However, only 36.0% of simulations were cost effective as compared to India’s WTP threshold). Annual cost for Himachal Pradesh was calculated using probabilistic estimates with total cost of INR 60,63,816 for laparoscopic IPOM and INR 37,25,098 for open VHR in tertiary hospitals.

Fig. 4.

Incremental Cost effectiveness planes for laparoscopic IPOM and open hernioplasty at current capacity utilization of hospitals. Each dot represents a simulation (n = 10,000). The vertical line indicates cost neutrality; the horizontal line indicates effectiveness neutrality. The Willingness to pay threshold (Red color line) is considered at INR 2,14,00 per capita income for India

Discussion

With technological advancements, health-system is aiming to provide better care with fewer complications at a better cost to patients. Current study was an attempt to understand whether laparoscopic intraperitoneal onlay mesh (IPOM) is effective as a treatment over conventional open hernioplasty. Assessment for clinical effectiveness revealed that there was no significant difference in hernia recurrence, as a primary outcome. Similar findings were reported in various studies where hernia recurrence rate was statistically insignificant in two groups, ranging from 6.0 to 23.0% for laparoscopic IPOM and from 3.0 to 16.0% for open VHR [16, 17, 20]. Similarly, the current study did not observe any significant difference in seroma formation and duration of surgery between the two groups. However, significant difference was only observed for wound infection which had lower risk in laparoscopic IPOM group compared to open hernioplasty. The findings are similar to other studies which reported lower rates of wound infection ranging from 1 to 33% [14, 17, 18] and a lower risk for wound infection (RR: 0.26; 95%CI: 0.15–0.46) in laparoscopic IPOM group [23].

Further, for cost effectiveness analysis, cost data was obtained from NHSCD for India. In current study, a simulated average cost of open hernioplasty at current capacity utilization is INR 36,166 and INR 58,872 for laparoscopic IPOM with an ICER of INR 5,023 per wound infection averted per patient. The unit costs estimated at 80 and 100% capacity utilization of hospitals were comparably high. Further, cost for management of various complications (during and after operation) was not given in database so the cost per complication was not carried out. Inferring this in Indian scenario, the difference is considerably high with high budget impact (case analysis for one state). There are no dedicated studies for comparison, describing the cost of the two procedures from Indian settings. However, worldwide literature does support current findings as laparoscopic IPOM being costlier over open hernioplasty for VHR [15]. Analyzing the results from the current study, intervention does not appear to be much effective clinically and seemed costly over conventional treatment. It may be due to additional costs which includes equipment (Laparoscope, Tackers, Mesh, etc.) used in IPOM procedure along with cost of training needs to be provided to healthcare professional to perform laparoscopic IPOM procedure. It is to be deduced from a micro-costing approach which was not used in the current study.

The current study encountered a few limitations as well. Since costs were derived from NHSCD whereas outcomes were obtained from RCT. It might not be true representative of clinical and cost comparisons as costs were derived only from Indian settings. Except one study, sample size in other studies was less expecting low power and increased variability. Further, analysis using different types of mesh could not be performed. Moreover, cost analysis was limited to tertiary care hospitals only limiting generalizability. Since laparoscopic IPOM was cost effective in about half of simulations, a full economic evaluation in selected hospitals using micro-costing approach is required for actual and generalizable results for cost-effective analysis.

Conclusion

Laparoscopic IPOM appears to be a costly as compared to conventional open hernioplasty for VHR. Further, the meta-analysis findings also did not observe any significant difference in the primary outcome for the study “hernia recurrence” between the experiment and control group. With no difference in the major primary outcome, laparoscopic IPOM just demonstrates lower risk of wound infections.

Electronic supplementary material

Below is the link to the electronic supplementary material.

Author contributions

CG and DK conceptualized the study, CG handled data and drafted the manuscript, and DK and KCS carried out data analysis and edited the manuscript.

Data availability

No datasets were generated or analysed during the current study.

Declarations

Competing interests

The authors declare no competing interests.