The abdominal pressure–volume (P–V) relationship during laparoscopic insufflation is curvilinear and subject to substantial inter-individual variability, yet clinical practice relies on universal pressure targets derived from population-level guidelines. The Smart Inline Compliance Module (SICM) is a novel inline retrofit device that acquires intra-abdominal pressure and insufflation gas flow through physically separated sensing circuits, reconstructs insufflated volume by numerical integration of the flow signal, and derives the abdominal P–V curve and its biomechanical parameters in real time. This study reports the first two-arm pilot technical evaluation of the SICM system. Arm A comprised an exploratory biomechanical phantom with three defined stiffness levels (Soft, Medium, Rigid) tested under Continuous and Stepwise insufflation protocols (30 curves). Arm B comprised three female feline cadavers assessed under the same dual-protocol design (18 curves). This study should be interpreted as an early-stage technical evaluation rather than as a definitive validation benchmark. Signal quality was consistently high across both arms (Curve Quality Index: 1.0000 in the phantom arm; 0.9974 ± 0.0009 in the cadaveric arm). Volume integration accuracy was confirmed against an independent offline reference (mean absolute percentage difference: 0.07%). The system extracted reproducible biomechanical parameters under the Continuous protocol: in the cadaveric arm, maximum compliance (Cmax) ranged from 116.8 to 191.4 mL/mmHg across subjects, with intra-session coefficients of variation below 16%; Knee Pressure (Pknee), defined as a working operational index of the compliance transition, was 3.33–4.17 mmHg with CV below 8%. The Rigid phantom and cadaveric datasets showed partial numerical overlap in selected shape-derived parameters, which was interpreted only as an internal consistency check and not as evidence of biomechanical equivalence. The Stepwise protocol exposed the current methodological limits of the parameter-extraction workflow and identified specific targets for the next development iteration. These results are interpreted exclusively within the scope of technical feasibility and preliminary biomechanical characterisation; clinical applicability and optimal pressure guidance require adequately powered in vivo studies.
Guadalupi et al. (Sat,) studied this question.