Surgical Innovation最新文献

Background/NeedUncontained power morcellation during laparoscopic gynecologic surgery risks intra-abdominal dissemination of benign or malignant tissue, a significant safety concern highlighted by FDA warnings. This has created a critical need for robust and reliable tissue containment systems that can be easily integrated into surgical workflows to mitigate this risk.Methodology and device descriptionThe LapBox Power Tissue Containment System is a single-use device featuring a dual-walled inflatable chamber designed to create a secure environment for morcellation. We conducted a Good Laboratory Practice (GLP)-compliant toxicology study in three female domestic pigs to assess its safety under simulated worst-case conditions. The device was inserted laparoscopically, and the internal dual-walled chamber of the device was inflated to a high pressure (∼160 mmHg) to simulate a localized worst-case compressive scenario, while the overall intra-abdominal insufflation was maintained at a standard 15 mmHg. Postoperative monitoring included clinical observation, bloodwork, and, at day 13, necropsy and histopathology.Preliminary ResultsAll procedures were completed without mortality, morbidity, or device-related complications. The LapBox maintained full structural integrity. Postoperative clinical, hematological, and biochemical parameters showed no adverse effects. Gross necropsy and detailed histopathology confirmed the absence of device-related ischemia, necrosis, thrombosis, or foreign-body reaction.Current statusThis preclinical study demonstrates that the LapBox Power system has an excellent safety profile and biocompatibility, even under extreme conditions. The device is ready for the next stage of evaluation. These findings support its translational potential and warrant further investigation in human clinical studies to confirm its safety and efficacy.

BackgroundThe aim of this study was to summarize the current evidence regarding the role of dorsal genital nerve stimulation (DGNS) in the management of fecal incontinence (FI).Patients and MethodsThis study was conducted in accordance with the Cochrane Handbook for Systematic Reviews of Interventions and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. A literature search was performed (Medline, Scopus, CENTRAL, Web of Science, CORE, medRxiv Repository, SciELO, AJOL, and Google Scholar) to identify and retrieve the eligible studies. The last search date was 13/12/2025. The primary endpoint was the pooled complication rate of DGNS in patients with FI. Both prospective and retrospective studies were considered. Quality evaluation was performed via the ROBINS-I tool.ResultsOverall, 6 non-randomized studies and 90 patients were included. The overall complication rate was 1.9% (95% CI: -1.1%, 4.9%; I² = 0%; P = .213). Α post-interventional improvement of the anal resting pressure (MD: 11.6; 95% CI: 6.5, 16.79; I² = 0%; P < .001) and anal squeeze pressure (MD: 35.3; 95% CI: 17.24, 53.33; I² = 0%; P < .001) was confirmed. The application of ROBINS-I tool resulted in all studies being graded as high-risk of bias.ConclusionsWe emphasize the need for prospective randomized controlled trials to determine the exact role of DGNS in the management of FI.

BackgroundEarly innovations are often disruptive but gain traction when the benefits become evident. EXtended Reality (XR) has recently gained momentum for surgical training. XR involves a head-mounted display (HMD) blending physical and digital worlds for enhanced visualization, communication, and understanding. To understand its potential impact, the receptiveness of plastic surgeons was assessed for its usefulness and usability.MethodsPlastic surgeons watched XR interventions and completed a survey assessing applications for remote consultation, intra-operative education, and pre-operative planning. Responses were analyzed using descriptive statistics and categorical inferential testing, with group differences assessed using Fisher's exact test on dichotomized Likert responses.ResultsEleven attending and ten resident physicians (21/44, 48%) responded to the survey. Attendings perceived greater usefulness of XR for virtual consultation than residents (91% vs 50%), with a near-significant trend (P = 0.056) and higher reported mean usefulness and usability scores. Residents more often anticipated need for technical support during virtual consultation (60% vs 27%). Both groups strongly endorsed XR for intra-operative education. Willingness to use and optimism were high among both groups. For pre-operative planning, both groups perceived XR as useful, though usability concerns were prominent, including moderate perceived complexity and anticipated need for technical support particularly among residents (89% vs 70%).ConclusionAttendings were more receptive than residents to integrating XR in plastic surgery training with residents reporting greater cognitive load. Residents valued improved intra-operative visibility and noted the Hawthorne effect. Selecting high-value, usable XR applications while minimizing trainee role stress is essential for advancing residency education.

Background/NeedEndovascular aneurysm repair (EVAR) is widely used for treatment of abdominal aortic aneurysms (AAA), but 1-5% of grafts require explantation due to complications such as endoleak or infection. Current techniques rely on modified non-FDA approved techniques that risk vessel trauma. We have designed and constructed the EVAx device to support the efficient and non-traumatic retrieval of AAA endografts that rely on suprarenal barb fixation.Methodology and Device DescriptionWe designed a single-use, handheld EVAx device for open endograft removal. It features a cylindrical base, diameter-reducing clamp, and variable constraining arms with tapered tips. Activation collapses the graft and disengages suprarenal barb elements. Prototypes were 3D printed and iteratively refined to facilitate future verification and validation testing.Preliminary ResultsBenchtop testing demonstrated successful engagement of the proximal endograft and suprarenal barbs. Endografts were successfully constrained with adequate reduction of the endograft diameter, disengagement of the barbs, and subsequent retrieval.Current StatusEVAx is undergoing further design optimization with high-fidelity bench-top models and preclinical animal testing. Future use will be intended for the efficient and non-traumatic extraction of aortic endografts with suprarenal fixation.

BackgroundColorectal surgery stapling misadventures are fairly common, potentially leading to serious complications. Although artificial intelligence (AI)-driven chatbots have shown promise as educational tools in various medical fields, their utility in real-time surgical decision-making remains unclear. This study assessed the ability of two chatbots, ChatGPT-4 and Google Gemini, to suggest management strategies for various stapling misadventures.MethodsIn this exploratory study, 21 stapling misadventure scenarios were developed based on a literature search and expert input. The scenarios were uploaded to both chatbots with a prompt asking about the management strategies for each scenario. ChatGPT-4 and Google Gemini's suggestions for the scenarios were independently evaluated by 3 colorectal surgeons. The main outcome measures were appropriateness, comprehensiveness, and justification quality assessed on a 0-2 Likert scale.ResultsChatGPT-4's suggestions for all scenarios were rated as fully or partly appropriate and comprehensive, compared to 85.7-90.5% for Gemini's suggestions. The median appropriateness and comprehensiveness scores were higher for ChatGPT-4 (2 vs 1), and was statistically significant according to one assessor (P = 0.005 and 0.002). The justification of ChatGPT's suggestions was more appropriate according to 2 assessors. Assessors found that 90-95% of ChatGPT-4's suggestions and 76-90% of Gemini's suggestions were useful clinical aids for surgeons. ChatGPT-4's suggestions showed better agreement among assessors on appropriateness (43% vs 24%) and justification of responses (42.8% vs 19%).ConclusionsBoth ChatGPT-4 and Google Gemini provided appropriate and comprehensive suggestions for colorectal stapling misadventures, with ChatGPT-4 showing marginally better performance. These findings support the potential role of AI-driven chatbots as decision-support tools in surgery.

Background/NeedPrecision suturing in confined surgical fields poses ergonomic and visibility challenges, particularly in minimally invasive and reconstructive procedures. A novel Vertical Needle Holder (VNH) was designed to enhance control, angle precision, and accessibility in restricted spaces.Methodology and Device DescriptionThis proof-of-concept study evaluated the VNH's ergonomic design and suturing performance compared with a standard Mayo-Hegar needle holder. Thirty surgeons and surgical trainees participated in simulated suturing tasks using both instruments. Surgeon-reported outcomes were assessed using standardized synthetic-tissue suturing tasks and a structured Likert-scale questionnaire focusing on perceived precision, ergonomics, and ease of use.Preliminary ResultsSurgeons reported improved perceived precision and maneuverability of the VNH in confined spaces compared with conventional needle holders. Participants reported reduced wrist strain and greater visibility. The majority of participants (87%) rated the VNH as ergonomically superior to conventional needle holder designs.Current StatusThese findings suggest that the VNH offers an innovative, practical enhancement to traditional surgical tools, potentially improving safety and efficiency in complex operative fields. Further clinical validation is underway to confirm translational applicability.

BackgroundVaginal natural orifice transluminal endoscopic surgery (VNOTES) is a minimally invasive technique with significant clinical potential. However, its widespread adoption has been hindered by technical challenges, particularly in the establishment and stabilization of the surgical access platform. In conventional vaginal surgery, the operative field is often limited by a narrow operative field, poor visualization, and difficulty in standardized surgical training. To address these limitations, a novel laparoscopic vaginal speculum system was designed and developed to overcome the limitations of the existing technologies. We conducted animal trials were conducted to demonstrate its feasibility for VNOTES hysterectomy in a porcine model.MethodsThe laparoscopic vaginal speculum system is a flexible and simplified laparoscopic visualization system comprising a protective connecting sleeve, multichannel base, sealing ring, and control plate. This innovative device facilitates the establishment of the VNOTES surgical access platform via a laparoscopic-guided approach, effectively replacing traditional transvaginal surgery used during the initial phase of the procedure.ResultsVNOTES hysterectomy was successfully performed in four Bama pigs. The mean operative time was 81.75 ± 18.91 minutes, with an estimated blood loss of 10.75 ± 3.40 mL. No intraoperative complications were observed. The system demonstrated excellent flexibility and provided clear and stable surgical visualization.ConclusionsThe trial demonstrate that this system provides a simplified, stable, and visualizable approach for establishing VNOTES surgical access platform. It offers sufficient workspace for laparoscopic instruments and enhances procedural flexibility, potentially improving the safety and efficiency of VNOTES surgery.

BackgroundSurgical innovation drives progress but challenges conventional models of informed consent.ObjectiveTo synthesize qualitative evidence on how adult patients perceive, understand, and decide about innovative surgical procedures, and to develop an evidence-informed framework for ethical, patient-centered consent.MethodsA qualitative evidence synthesis following PRISMA 2020 guidelines was conducted for studies exploring patient perspectives or decision-making in the context of surgical innovation. Confidence in each qualitative finding was assessed using the GRADE-CERQual approach.ResultsEight studies were included. Thematic synthesis identified recurrent patterns and meta-themes across qualitative and mixed-methods data. Ten meta-themes emerged, highlighting that patients view innovation with optimism and trust but limited comprehension of uncertainty. Multimedia and interactive consent tools improved understanding. A five-pillar framework was derived which prompted the construction of a 10 point structured informed consent proforma-clarifying novelty, disclosing uncertainty, acknowledging surgeon experience, using layered information, and supporting shared decision-making.ConclusionPatients' perceptions of surgical innovation are shaped more by trust and perceived progress than by understanding of risk. Ethical, layered, and dialogue-driven consent can transform uncertainty into informed partnership.

AimAnastomotic leakage (AL) is a significant complication after colorectal cancer surgery, with serious clinical and economic consequences. Circular staplers (CSs) with 3 staple rows of different heights may enhance anastomotic integrity and perfusion compared to conventional two-row CSs. The aim of the present study is to compare the short-term outcomes of 2 vs three-row CSs in colorectal anastomosis in case of left hemicolectomy, sigmoidectomy and anterior resection of the rectum for cancer.MethodThis is a retrospective analysis of prospectively collected data. All consecutive patients with left or sigmoid colon or rectal cancer who underwent elective resection with primary anastomosis from 2013 to 2025 were included. Patients were included in the control or in the intervention group if two-row or three-row CS was used during surgery, respectively. AL rate and its severity grade were compared between groups, and the prognostic impact of stapler type on AL onset was assessed.ResultsOne-hundred-thirty-six and 109 patients were included in the control and in the intervention group, respectively. AL rate was significantly higher in the control group in comparison to the intervention group (11.8% vs 3.7%; P = 0.02). Moreover, patients in the control group had significantly longer hospital stays than the intervention group (P = 0.04). On multivariate analysis, the use of the two-row CSs is an independent adverse predictor of AL (Odds Ratio 3.79; P = 0.03).ConclusionBased on our findings the use of three-row CS is associated with a lower postoperative AL rate and shorter LOS in comparison to the two-row CS.

BackgroundSurgical site infection (SSI) remains a leading health care-associated complication in open abdominal surgery. Conventional wound protectors reduce SSI risk but often fail to reliably prevent contamination of the wound edges and operative field when intraoperative effluent is substantial, such as during cesarean delivery.Device DescriptionWe developed Viclean®, a dual-ring wound protector equipped with a waste collection bag. A newly added middle ring links the dual-ring frame to a flexible drainage system, and a support strip maintains channel patency for continuous drainage, thereby isolating effluent and preventing contact with the incision and surrounding tissues. All components are made of medical-grade thermoplastic polyurethane (TPU) to ensure biocompatibility, flexibility, and durability.Preliminary ResultsIn clinical observations, Viclean® demonstrated favorable intraoperative performance. In an emergency cesarean section, amniotic fluid was rapidly diverted into the bag, preventing contamination of the incision and operative field. In an elective open left hemicolectomy, enteric effluent and irrigation fluids were effectively drained into the bag, maintaining clean and dry wound edges. Surgical teams provided positive evaluations regarding its clinical utility.Current StatusViclean® has completed sterility, biocompatibility, and packaging validation and operates under an ISO 13485:2016-certified quality system. Regulatory registrations have been obtained in multiple areas. The device is authorized in more than 20 countries; however, it is not yet commercially available outside China.