An incisional hernia (IH) is defined as a defect in the abdominal wall at the site of a previous surgical incision, detectable through physical examination and/or imaging techniques [1]. In laparoscopic procedures, this entity is further classified as a Trocar Site Incisional Hernia (TSIH) or Port Site Hernia (PSH), depending on the terminology used.

Every year, around 1,000 incisional hernias are operated on in Spain. Despite significant advancements in anesthetic techniques, postoperative care, surgical methods, suture quality, and antibiotic prophylaxis, complications related to abdominal wall closure remain prevalent. These complications include hematomas, surgical site infections, eviscerations, and incisional hernias (IH). They result in hospital readmissions, increased healthcare resource utilization, and higher associated costs. These events negatively affect surgical outcomes and diminish patients’ quality of life.

Numerous studies have advocated for the use of prophylactic mesh during abdominal wall closure in open surgery, demonstrating a reduction in the incidence of postoperative hernias [2]. However, the widespread adoption of laparoscopic surgery since its introduction in 1987 has not eliminated such complications. On the contrary, TSIH/PSH remains the most frequent postoperative complication associated with minimally invasive techniques [3, 4].

It is now recognized that a lack of medium- and long-term follow-up contributes to underdiagnosis of TSIH, particularly since many patients remain asymptomatic or do not seek medical care. Accurate diagnosis often requires a combination of thorough physical examination and imaging modalities such as ultrasound or CT scanning. Recent studies report a surprisingly high incidence of TSIH, ranging from 25.9% in procedures like laparoscopic cholecystectomy to 37.1% in more complex interventions such as laparoscopic colorectal surgery [4–6].

Established risk factors for TSIH include a body mass index (BMI) ≥30 kg/m², age ≥65 years, and enlargement of the umbilical trocar incision [5].

While not all cases of TSIH are diagnosed—largely due to inadequate follow-up—and not all require surgical intervention, the growing use of laparoscopic techniques has rendered trocar site hernias a significant healthcare concern. The most promising strategy to address this issue lies in preventive measures. Although consensus exists among experts on the importance of prevention, relatively few studies have specifically investigated prophylactic strategies. Previous research by our group examined the use of a prophylactic supra-aponeurotic mesh but failed to demonstrate sufficient efficacy in preventing TSIH(7).

Incisional hernia is one of the most frequent complications in open surgery, with a considerable rate of morbidity and mortality. Advances in anatomical knowledge and new technological devices have improved surgical techniques and devices aimed at preventing and treating incisional hernias in open surgery.

In recent decades, there has been a significant increase in laparoscopic surgery. Nowadays, laparoscopic access to the abdominal cavity is considered the gold standard for a large number of procedures. Initially, it was assumed that the laparoscopic approach would drastically reduce the incidence and/or severity of postoperative complications related to incisional hernias. However, it is now well recognized that TSIH are highly prevalent. The incidence of TSIH can exceed 30% in patient cohorts with risk factors who are followed up adequately [5]. Such a prevalent pathology—resulting directly from a surgical intervention—warrants special attention through the development of effective preventive measures.

Current guidelines recommend closing all trocar sites that are 10 mm or larger but there is not enough data on optimal closure technique or material [7]. Some researchers have also suggested the use of prophylactic mesh placement as a strategy to prevent TSIH; however, evidence in the literature remains limited [8–10]. There is a scarcity of comprehensive clinical guidelines or meta-analyses that strongly support these practices. Despite the inconclusive nature of the available data, the most recent joint review by the European Hernia Society and the American Hernia Society provided a “weak recommendation” for placing mesh in the preperitoneal space [7]. Previous investigations have yielded conflicting findings: while several studies from the past decade endorsed sublay mesh placement for hernia prevention [8–10], a more recent study assessing onlay mesh did not confirm its efficacy [11]. Based on these findings, and considering that current incisional hernia guidelines recommend sublay mesh placement [12], we hypothesize that positioning a reinforcing sublay mesh (as opposed to a supra-aponeurotic mesh) at the umbilical trocar site in patients with one or more risk factors could reduce the incidence of TSIH.

Finally, an equally important aspect in our current healthcare context is the rationalization of resources. In an effort to highlight the significance of incisional hernias (IH), increase their visibility, and secure funding for research, Poulose et al. published a study estimating the cost of IH repair: $3,873 for outpatient procedures and $15,899 for inpatient surgeries. The study further determined that each 1% reduction in recurrence rates translates into an annual savings of $32 million in procedural costs alone [13].

In our setting, the Catalan Health Service (Servei Català de la Salut, Catalonia, Spain) published in 2013 the official pricing of public health services, listing the cost of a “hernia surgical procedure, excluding inguinal or femoral hernias, in patients over 17 years old, without complications or comorbidities” at a level III reference hospital as €2,608.35 [14].

A cost–benefit analysis focused on reducing the incidence of TSIH represents a valuable avenue for future research.

The objective of our study is to evaluate the efficacy of prophylactic sublay mesh placement in reducing the incidence of TSIH without increasing morbidity. We hypothesize that sublay mesh placement, due to its morphological characteristics and optimal positioning, may be more effective in preventing TSIH.

Our study will provide Level I evidence (Oxford Centre or Evidence- Based Medicine), as it is designed as a prospective, multicenter, randomized controlled trial with 1:1 allocation and double-blinding of patients and principal investigators. Inclusion criteria have been selected to increase the likelihood that participants present the event of interest, as they must have one or more risk factors. Although this may initially appear to limit the generalizability of the results, these risk factors—such as obesity, diabetes mellitus, and advanced age—are highly prevalent in the general population.