Background: Intra-abdominal pressure during laparoscopic insufflation with pressurized carbon dioxide (CO₂) gas is strongly influenced by mechanical ventilation. Resulting pressure fluctuations can destabilize the surgical workspace and potentially cause harm associated with high insufflation pressures. To address this, a novel CO₂ insufflator was developed using a radial fan and a gas reservoir to generate and maintain continuously stable insufflation pressures (radial fan-based insufflator, RFBI). This first-in-human study evaluated its safety and feasibility during laparoscopic surgery. Methods: Adults undergoing elective intraperitoneal laparoscopic procedures were included. All procedures were performed using the RFBI and an 11 mm study trocar. Primary outcomes were safety, defined as the absence of serious or harmful adverse device effects (SADEs or ADEs), and feasibility, defined as completing the procedure without switching to a conventional insufflator. Secondary outcomes included pressure stability at the device outlet and documentation of observed events affecting pressure stability (e.g., trocar insertion/repositioning, leaks, suction, etc.). Results: Twelve patients were enrolled, having a total RFBI insufflation time of 35.9 h in seven different laparoscopic procedures. No SADEs occurred. One ADE occurred while inserting a 5 mm instrument into the 11 mm study trocar that resulted in high air leakage, causing temporary loss of surgical workspace but no harm. All procedures were completed without the need to switch to a conventional insufflator. Pressure remained stable at both target pressures of 10 mmHg (median 10.0 mmHg, interquartile range (IQR) 0.12) and 14 mmHg (median 14.0 mmHg, IQR 0.15). The RFBI rapidly re-established the target pressure after observed events affecting stability, without manual intervention or procedural delay. Conclusion: This first-in-human study demonstrates that RFBI technology is safe, feasible, and capable of maintaining stable insufflation pressures across varied adult laparoscopic procedures. Radial fan-based insufflation effectively compensated for pressure fluctuations from ventilation and surgical events, warranting further evaluation of clinical benefits.

Background: Establishing a pneumoperitoneum for laparoscopy is common surgical practice, with the goal to create an optimal surgical workspace within the abdominal cavity while minimizing insufflation pressure. Individualized strategies, based on neuromuscular blockade (NMB), pre-stretching routines, and personalized intra-abdominal pressure (IAP) to enhance surgical conditions are strategies to improve surgical workspace. However, the specific impact of each factor remains uncertain. This study explores the effects and side-effects of modifying intra-abdominal volume (IAV) through moderate and complete NMB in a porcine laparoscopy model. Methods: Thirty female Landrace pigs were randomly assigned to groups with complete NMB, regular NMB and a control group. Varying IAP levels were applied, and IAV was measured using CT scans. The study evaluated the maximum attainable IAV (V_max), the pressure at which the cavity opens (p₀), and the ease of expansion (λ_exp). Cardiorespiratory parameters, including peak inspiratory pressure (PIP), mean arterial pressure (MAP), heart rate (HR), and cardiac output (CO), were continuously recorded to evaluate side-effects. Results: There were no significant weight differences between NMB groups (median 21.1 kg). Observed volumes ranged from 0 to 4.7 L, with a mean V_max of 3.82 L, mean p₀ of 1.23 mmHg, and mean λ_exp of 0.13 hPa⁻¹. NMB depth did not significantly affect these parameters. HR was significantly increased in the complete NMB group, while PIP, MAP, and CO remained unaffected. Repeated insufflation positively impacted V_max; ease of opening; and expanding the cavity. Conclusion: In this porcine model, the depth of NMB does not alter abdominal mechanics or increase the surgical workspace. Cardiorespiratory changes are more related to insufflation pressure and frequency rather than NMB depth. Future studies should compensate for the positive effect of repeated insufflation on abdominal mechanics and surgical conditions.

Objective: To develop a realistic simulation model for laparotomy-assisted fetoscopic spina bifida aperta (SBa) surgery, to be used for training purposes and preoperative planning. Methods: The predefined general requirement was a realistic model of an exteriorized uterus, allowing all neurosurgical steps of the intervention. The uterus was modelled using ultrasound and MRI images of a 25 weeks’ gravid uterus, consisting of flexible polyurethane foam coated with pigmented silicone. The fetal model, contained an opening on the dorsal side for a customizable spinal insert with all the aspects of a SBa, including a cele, placode, and myofascial and skin layer. The model was assessed in a series of validation experiments. Results: Production costs are low, uterus and fetus are reusable. Placental localization and the level and size of the spinal defect are adjustable, enabling case-specific adaptations. All aspects of the simulator were scored close to realistic or higher for both appearance and functional capacities. Conclusions: This innovative model provides an excellent training opportunity for centers that are starting a fetoscopic SBa repair program. It is the first simulation model with adjustable spinal defect and placental localisation. Further objective validation is required, but the potential for using this model in preoperative planning is promising.

Background: Abdominal compliance describes the ease of expansion of the abdominal cavity. Several studies highlighted the importance of monitoring abdominal compliance (C_ab) during the creation of laparoscopic workspace to individualize the insufflation pressure. The lack of validated clinical monitoring tools for abdominal compliance prevents accurate tailoring of insufflation pressure. Oscillometry, also known as the forced oscillation technique (FOT), is currently used to measure respiratory mechanics and has the potential to be adapted for monitoring abdominal compliance. This study aimed to define, develop and evaluate a novel approach which can monitor abdominal compliance during laparoscopy using endoscopic oscillometry. Materials and methods: Endoscopic oscillometry was evaluated in a porcine model for laparoscopy. A custom-built insufflator was developed for applying an oscillatory pressure signal superimposed onto a mean intra-abdominal pressure. This insufflator was used to measure the abdominal compliance at insufflation pressures ranging from 5 to 20 hPa (3.75 to 15 mmHg). The measurements were compared to the static abdominal compliance, which was measured simultaneously with computed tomography imaging. Results: Endoscopic oscillometry recordings and CT images were obtained in 10 subjects, resulting in 76 measurement pairs for analysis. The measured dynamic C_ab ranged between 0.0216 and 0.261 L/hPa while the static C_ab based on the CT imaging ranged between 0.0318 and 0.364 L/hPa. The correlation showed a polynomial relation and the adjusted R-squared was 97.1%. Conclusions: Endoscopic oscillometry can be used to monitor changes in abdominal compliance during laparoscopic surgery, which was demonstrated in this study with a comparison with CT imaging in a porcine laparoscopy model. Use of this technology to personalize the insufflation pressure could reduce the risk of applying excessive pressure and limit the drawbacks of insufflation.