Endoscopic and histological evaluations of a newly designed inguinal hernia mesh implant: Experimental studies on porcine animal model and human cadaver.

PURPOSE: Conventional prostheses used for inguinal hernia repair are static and passive. This feasibility-study shows the features of a new 3D tension-free prosthesis in an experimental model. METHODS: This study was divided into two-phases: 1) aimed to test the physics intrinsic features and the anatomical adaptability of a new 3D designed mesh, and 2) aimed to evaluate the inflammatory reaction associated with different materials used. On phase-1 implantations were performed in pigs. During the first trial phase, the prostheses were also implanted on human cadavers. On phase-2, implantation was carried out on large swine. Follow-up was of 60-days, after which the animals were anaesthetized for laparoscopic assessment, and for sample collection of mesh implantation site for histological analysis. RESULTS: All animals showed good 3D mesh tolerance, and the follow-up period was uneventful. The laparoscopy showed no inflammatory lesions on the internal surface of the peritoneum. Macroscopic observation of implantation site revealed some local fibrosis and reorganization of tissue, no signs of infection, and no changes on original implant positioning. Histological analysis on phase-1 showed in most sample segments the deferent duct maintaining its central position and surrounded by vascular and nervous structures. On phase-2 differences in inflammatory lesion score could be found between subjects. CONCLUSIONS: This new 3D mesh can be placed appropriately and from this preliminary animal study no untoward complications were noted over a 60 day period.

Comparison of single access devices during cut and suturing tasks on simulator.

BACKGROUND: Published comparisons of the different available laparoendoscopic single-site surgery (LESS) devices focused on its economic cost and technical aspects. With this study, we aimed to objectively compare the use of three different LESS access devices in controlled experimental tasks. MATERIALS AND METHODS: Twenty subjects participated in simulator trials. A cut and an intracorporeal suturing task were carried out. Three single access devices (SILS: SILS(TM) Port, GPN. GelPOINT Advanced Access Platform, and XCN: XCONE) were used according to a randomized nine-session schedule. Completion time was registered and performance objectively assessed with task-specific rating scales. Two blinded expert raters worked over video recordings of the hands-on sessions. RESULTS: Participants showed improvement with all devices on total cut completion times and significantly for SILS (P = 0.017). The GPN decreased its adapted Global Rating Scale score (P = 0.002) from the first (W1) to the last week (W9). On the suture task, XCN constituted the device with longer completion times compared with SILS (P < 0.001) and to GPN (P < 0.001). There was significant improvement in times from W1 to W9 with XCN (P < 0.001), SILS (P = 0.003), and GPN (P < 0.001). On average summative score, we observed significant improvement in performance with all devices from W1 to W9 (SILS: P = 0.003; GPN: P = 0.001; and XCN: P < 0.001). CONCLUSIONS: Although we advise surgeons to focus on the specific procedures and patient characteristics to select the most adequate access device to maintain procedural safety standards, single-use devices appear to confer an easier adaptation to LESS surgery.

Application of a motion capture data glove for hand and wrist ergonomic analysis during laparoscopy.

OBJECTIVES: This study aims to analyze the surgeons' hand spatial configuration during the use of two different instrument handles for laparoscopy, by obtaining information from the data glove CyberGlove®, and establishing existing risk levels for wrist disorders. MATERIAL AND METHODS: Fifty surgeons participated in this study and were distributed into three groups (novices, intermediate and experts). Each subject carried out suturing and dissection tasks on a physical simulator, using axial-handled or ring-handled instruments, respectively. Hand and wrist positions were registered by the CyberGlove® and a modified RULA method was applied to establish appropriate risk levels for wrist disorders. RESULTS: We found statistically significant differences in seven of the eleven glove sensors when comparing both tasks. RULA method showed that all subjects, with the exception of the experts using an axial-handled instrument, assume a prejudicial wrist posture during the practice of suturing and dissection tasks on the simulator. CONCLUSIONS: Data glove CyberGlove® allows for the distinction between two laparoscopic exercises performed with different instruments. Also, laparoscopic intracorporeal suturing when performed with an axial-handled needle holder entails a more ergonomic posture for the wrist joint. Previous minimally invasive surgical experience is a positive influencing factor on the surgeons' wrist postures during laparoscopy.

Performance analysis on physical simulator of four different instrument setups in laparo-endoscopic single-site (LESS) surgery.

BACKGROUND: Over the past decades, minimally invasive surgery has undergone continuous development due to the demand for scarless results, with laparo-endoscopic single-site (LESS) surgery constituting one of today's most favored alternatives. In this study, we aim to assess the relative technical difficulty and performance benefits of dynamic articulating and pre-bent instruments, either combined with conventional laparoscopic tools or not, during the completion of two basic tasks hands-on simulator. METHODS: A total of 20 surgeons were included and performed two basic simulator tasks-coordination and cutting-carried out using four different combinations of LESS-designed and straight conventional laparoscopy instruments. Assessment took place before and after the completion of a 14-week training program. Performance data were objectively analyzed over video recordings with an adapted global rating scale (a-GRS) for performance evaluation, combined with a registry of total trial completion time. RESULTS: In the coordination task, the worst performance scores (p < 0.001) and longest completion times (p < 0.001 on first assessment and p < 0.01 on last assessment) were obtained with the two dynamic articulating tip instruments. On the cut trials, no significant differences between the different setups were found in a-GRS scores. The two dynamic articulating tip instruments also constituted the most time-demanding setup on both assessment trials (p < 0.05). The use of two dynamic articulating tip instruments showed significant improvement with training in all measured parameters except for performance in the cut task, in which the increase in a-GRS score was not significant. CONCLUSIONS: We conclude that the least adequate instrument set for initiation in LESS surgery is the one that combines two dynamic articulating tip instruments, as this has consistently obtained the worst results in all trials. Further data on more complex tasks and on a complete learning and skills-acquisition program must be obtained to confirm these findings.