A literature-based cost-effectiveness analysis of device-assisted suturing versus needle-driven suturing during laparotomy closure

Minimally invasive techniques have become standard for many abdominal procedures, but open-access laparotomy remains common, and sometimes essential, especially in complex tumor debulking procedures, trauma and emergency surgery and child delivery through cesarean Section. [1]. Laparotomy is associated with a high risk for abdominal wall complications such as wound infection (17–29% [2]) wound dehiscence (2,2–5,6% [3]) and incisional hernia formation (21%-31,8% [4]).

One fourth of patients undergoing incisional hernia repair will need a re-recurrence hernia repair and the risk of persistent pain after repair is 9–19% at one year follow-up [5, 6]. Patients with incisional hernia have reduced quality of life, suffer from impaired physical function including limitations to exercise and sex life [7]. The annual US cost for incisional hernia repair alone increased from $3.2 billion 2006 to a staggering $7,3 billion in 2011 and the individual and societal burden of abdominal wall complications is heavy, making identification and implementation of preventive measures a priority [8, 9].

Other abdominal wall complications occur because of impaired wound healing. How well a wound will heal is affected not only by patient factors such as comorbidities and wound contamination, but also surgeon attentive factors such as tissue handling and suturing tension [10]. The risk of such complications including wound dehiscence, wound infection and incisional hernia formation are reduced when a slowly resorbable suture is used, and the suture line is continuous with a suture-length-to-wound-length ratio (SL/WL ratio) of at least 4 and is deployed with small-bites [2, 11‐13].

The abdominal wall is typically closed in two layers – the fascial layer and the skin – when the intra-abdominal part of the operation is finalized. The size of a bite is the distance from the wound’s edge to the point of entry of the needle [14]. Small-bites avoid incorporation of fatty tissue and muscle into the bite. In clinical trials this is achieved by instructing the surgeon and using a smaller suture-needle that restricts bite size [11, 13]. Large-bites have a bite size > 10 mm and a step interval of 10 mm. For large-bites, a larger suture needle is used that incorporates more tissue. The length of the suture deployed in the wound should be measured and divided with the length of the wound to calculate the SL/WLratio which should be at least 4. In practice, small-bites implies fascial bites of five to eight millimeters and interval steps of five milimeters. The effectiveness of the small-bites technique has been assessed in several clinical trials, both in elective and emergency settings, and small-bites is now recommended by the Joint European and American Hernia Societies guidelines from 2022 and the World Society of Emergency Surgery guidelines from 2023 [15, 16].

Even though the clinical benefit of small-bites has been recognized in guidelines since 2015, uptake of the practice by surgeons remains uncommon. In a questionnaire-based Dutch study from 2019, less than one quarter of the responders practiced fascial bites with steps < 5 mm and only 35% preferred a suture-length to wound length ratio of 4:1 [17]. In a survey from 2019 where respondents included members of Americas Hernia Society, European Hernia Society and the International Hernia Collaboration, 19% stated they did not practice small-bites because it doesn’t apply to the patient population, 24% stated they were not familiar with the technique, and 13% stated the procedure takes too long [18]. Thus any developments that allow for the quicker and more efficient implementation of the small-bites technique could facilitate and improve uptake.

To facilitate implementation of the small-bites technique a suturing device, SutureTOOL (Suturion, Lund, Sweden) has been developed for swift and standardized laparotomy closure [19]. The device was developed by the second author (GB) in collaboration with Lund University, Lund Sweden. The device is a sterile, single use, handheld, mechanical laparotomy closure device with a double pointed needle. The suture needle has a centrally attached 130 cm long polydioxanone 2/0 suture thread. SutureTOOL has a guide that facilitates small-bites stitch placement – a 5–8 mm bites size and a 5 mm step interval. SutureTOOL and device suturing is explained in Fig. 1. Small-bites are enabled by a guide that indicates the measurements of small bites and facilitates correct stitch placement. Suture time, defined as the duration from the first stitch to the final stitch in the aponeurosis, is generally longer for small-bites suturing compared to large-bites suturing. However, the SutureTOOL has been shown to reduce suture time while ensuring small-bites suturing [19, 20]. It has been evaluated in pre-clinical studies where a SL/WL ratio of 4 was achieved in 95–98% of patients and in a recently completed first-in-man clinical trial where a SL/WL of 4 was achieved in 100% of patients.

To our knowledge there are two previous publications assessing the health economic cost-effectiveness of small-bites. Millbourn et al. [21] included data from a Swedish randomized clinical trial (2001–2006) comparing postoperative complications after laparotomy closure with small-bites and large-bites on patients undergoing laparotomy for colorectal cancer. The health economic analysis was performed from a societal perspective, included direct and indirect costs, and found a cost reduction of 2,415 SEK in patients that had a midline incision with small-bites, approximately $230 in 2013. Gokani et al. [22] performed a cost-utility analysis to compare outcomes after small-bites and large-bites technique for laparotomy closure and the change in quality-adjusted life years (QALYs) with the UK public health provider National Health Service (NHS) perspective rather than a societal perspective. The study assessed the cost implications of adopting small-bites as standard practice and the impact of small-bites as standard practice on QALY measures. The analysis of the added operation time (4,6 min) cost for small-bites suturing (£92 per patient) deemed small-bites to be cost-effective provided a decrease in absolute wound infection rates by more than 15%, or absolute incisional hernia rates by more than 3.4%. While SutureTOOL facilitates small-bite laparotomy closure, the additional equipment comes with a cost and changes how the procedure is performed. The cost-effectiveness of the SutureTOOL, accounting for these changes, has not yet been explored to inform procurement decisions.

The aim of the study was to compare the economic and clinical outcomes of two laparotomy closure techniques performed on patients undergoing open abdominal surgical procedures: needle-driver suturing (manual suturing) as standard care and device-assisted suturing (SutureTOOL).

This study indicates that from a healthcare perspective device-assisted suturing, with the SutureTOOL, is cost-effective as compared to manual needle-driver suturing. The results indicate that using the SutureTOOL for laparotomy closures can reduce operation theatre time, thereby improving operational efficiency and lowering costs associated with theatre use. Additionally, the intervention led to a reduction in complication rates, highlighting its potential to enhance patient safety and reduce healthcare expenses. Through ensuring the use of small bites, the use of the SutureTOOL reduced the risk of sharps injuries to surgical providers, mitigating related costs, and lowered the incidence of surgical complications such as wound infections, wound dehiscence, and incisional hernia, positively impacting patient recovery and healthcare resource utilization. Finally, the analysis indicates that the SutureTOOL improves survival. In contexts where at least half of patients are operated on with large bites, for every thousand patients operated on with the SutureTOOL, an estimated three lives are saved, along with the acquisition of nine quality-adjusted life years (QALYs). The results indicate substantial cost-saving potential across multiple countries. SutureTOOL is estimated to reduce costs associated with laparotomy closure by 42% in the US, 33% in Sweden, 27% in the UK, and 24% in France. Direct costs (operating theatre costs) associated with laparotomy closure are notably reduced, because of reductions in operating time, in all countries except France where the cost of the device is higher than estimated operating theatre costs. Savings grow further when considering the impact of avoided complications, and further still when including avoided incisional hernias beyond the first year. In Sweden, total savings increase substantially when incisional hernias occurring in the second and third years are included. In all country contexts, cost savings from incisional hernias are substantially reduced because 65% of patients are estimated to not need re-operation, and savings would be higher in contexts with higher re-operation rates. Additionally, costs of complications associated with incisional hernia were not included to avoid double counting, as these costs were included with incidents of wound infection and dehiscence.

The unit cost of wound infection emerges as the highest among considered surgical complications across all studied countries, except France where it is the second highest after incisional hernia. Notably, the unit cost of incisional hernia exceeds that of wound dehiscence in Sweden and France, while the reverse is true in the US and UK. This variation in cost distribution leads to slight differences in overall net savings across different countries. These nuanced differences underscore the well-established importance of contextually valid event rates and unit-cost data if the analysis is to effectively inform decision making [48].

Key model drivers included the percentage of procedures performed using small-bites, wound infection rates, dehiscence rates, and incisional hernia rates. These parameters significantly influence the model’s results and warrant careful consideration in clinical decision-making. These key parameters may change as model inputs are tailored to other countries or provider settings. Regardless, these inputs reflect critical aspects of surgical practice and technique and underscore the importance of adopting evidence-based approaches to laparotomy closure.

This study was performed under a set of methodological limitations. Variations in healthcare practices and costs between countries and providers will affect results, and large variations could lead to changes in key model drivers. In France for example, the authors’ clinical contacts indicated that the per-minute operating room cost is too low, however the most relevant literature available indicated a cost of 10.78 Euros [36]. It is crucial that decision makers carefully consider their own clinical context and adjust the analytical approach accordingly. The analysis assumed that 50% of wound closures are performed with small-bites, which was a key model driver. The sensitivity analysis (Fig. 7) suggests that an increase in the percentage of small-bites in provider settings is associated with less cost-effectiveness when implementing the suture tool. A Dutch study reported that only 24% of clinicians perform interval steps of 5 mm or less [17]. If this rate reflects international practice, our analysis indicates our results are conservative, particularly with respect to savings associated with avoided surgical complications. No other studies were found that reported small-bites rates. Clinical settings with higher proportions of small-bites will see less savings in terms of avoided complications and more gains associated with time savings. The opposite would be true when large-bites are the dominant practice, and, importantly, these changes in savings are sensitive to variation across clinical contexts with respect to surgical complication rates and suture time. The time improvements associated with the use of SutureTOOL will also vary across contexts depending on surgical methods, the experience of clinicians, and unit costs of resources. Another key assumption included the limited time horizon and subsequent exclusion of long-term complications. As a result, the actual survival benefits could exceed the reported values, further emphasizing the potential positive impact on patient outcomes when the SutureTOOL is adopted for use. Finally, at the core of this analysis is the SutureTOOL’s ability to effectively produce SL/WL of at least 4 with small-bites suturing, reduce suture time and protect users from sharps injury. Sharps injuries often occur at the end of long and sometimes strenuous procedures, and the risk increases with 22% per hour as an operation proceeds [49]. Suturing is the most common intraoperative task where sharps injury occurs and laparotomy closure at the end of the operation where risk of injury is high [50‐52]. Thus, laparotomy closure is responsible for the majority of glove punctures [52]. One feature of the SutureTOOL is that the needle track does not interfere with the user’s fingers. Glove puncture assessment has been an endpoint in SutureTOOL studies, and no punctures were recorded among 45 laparotomy closures [19].

Evidence indicates that the SutureTOOL ensures a SL/WL of at least 4 and can help surgeons adhere to guidelines for laparotomy closure and thus have the potential of reducing abdominal-wall complication rates and operating time. Prior to procuring the SutureTOOL, providers should be careful to ensure that these effects carry over into their clinical operations, and to consider the financial impact of operating time reductions according to their own per-minute operating theater costs. The SutureTOOL has been evaluated in two pre-clinical trials and one pre-market clinical trial. Within these study contexts, participants received minimal training with the SutureTOOL system. Performance could possibly be further enhanced when the practice is well-established in a broader clinical setting [19, 20]. These findings provide valuable insights into the potential benefits of adopting the SutureTOOL in clinical practice, supporting its integration as a valuable medical technology for enhancing surgical outcomes and patient care.

The results of this cost-effectiveness analysis suggest that the SutureTOOL is a cost-effective intervention largely due to the substantial savings generated through reduced operation time and abdominal wall-related complications. Hospitals considering this analysis as a basis for decision making should be careful to test the device within their clinical context to ensure (1) that reductions in operation time are replicable within their clinical context, and (2) that the device consistently delivers a SL/WL ratio of at least 4 with small-bites sutures for laparotomy closure among their providers. Consistent achievement of a SL/WL ratio of at least 4 with small-bites has been shown to reduce complication rates, and the costs savings of avoided events together with those of reductions in operating room time can improve the quality of care for patients undergoing laparotomy closure.