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Showing 1-9 of 9 trials
NCT07530159
This prospective observational study aims to evaluate the clinical outcomes and cost-effectiveness of retromuscular midline ventral hernia repair using open, laparoscopic and robotic approaches. Patients undergoing elective repair are included and followed to assess postoperative complications, length of hospital stay, recurrence and quality of life. In addition, a cost-effectiveness analysis will be performed from the perspective of the Spanish National Health System. The study is currently ongoing.
NCT07384962
Ventral hernia repair is one of the most commonly performed abdominal surgical procedures worldwide, increasingly carried out using minimally invasive techniques. In this setting, mesh reinforcement is standard practice, but the optimal anatomical plane for mesh placement remains debated. Intraperitoneal and extraperitoneal mesh positions may have different long-term consequences, particularly when patients undergo subsequent abdominal surgery. However, prospective data evaluating the impact of prior mesh position on reoperative risk and postoperative outcomes are limited. The ORION study is a prospective, multicentre, observational cohort study designed to evaluate the impact of prior minimally invasive ventral hernia repair with intraperitoneal versus extraperitoneal mesh placement on subsequent minimally invasive abdominal surgery. The primary objective is to compare the incidence of intraoperative visceral injury during adhesiolysis between the two mesh positions. Secondary objectives include the assessment of adhesion burden and severity, duration and extent of adhesiolysis, conversion to open surgery, and adhesion-related postoperative complications. In a predefined subgroup of patients undergoing surgery for ventral hernia recurrence, the study also evaluates short-term postoperative outcomes, including chronic post-surgical pain, neuropathic pain features, sensory disturbances, and analgesic use. By prospectively collecting standardized intraoperative and postoperative data across multiple centres, the ORION study aims to provide real-world evidence on the long-term surgical and functional implications of mesh positioning in minimally invasive ventral hernia repair.
NCT07071740
The aim of this clinical investigation is to confirm the perioperative and early postoperative safety and clinical performance (efficacy) of the Dexter Robotic System, in patients undergoing incisional or primary ventral hernia repair.
NCT07314398
Emergency hernia repairs are associated with significantly higher morbidity and mortality compared with elective hernia surgery. In Finland, approximately 500 emergency groin hernia repairs and 600 ventral hernia repairs are performed annually, but treatment practices vary widely, and high-quality evidence is lacking. This prospective multicenter cohort study will evaluate outcomes of emergency groin and ventral hernia repairs in Finland. About 600 patients will be recruited over two years and followed for five years postoperatively. The study will collect standardized data on patient demographics, comorbidities, surgical technique, intraoperative findings, postoperative course, and long-term follow-up. Quality of life will be assessed with RAND-36, AAS, and PROMIS questionnaires. The primary endpoint is hernia recurrence within two years after surgery. Secondary outcomes include 30- and 90-day complications, infection rates, readmissions, recovery time, and quality of life at 1, 2, and 5 years. The results will provide robust evidence to guide clinical practice, optimize surgical techniques, and refine urgency classification and surgeon competence requirements for emergency hernia repair.
NCT06462066
This pre-market, prospective, randomized, non-inferiority clinical study was designed to evaluate the safety and performance/effectiveness of Glutack-Glubran® Tiss 2 system compared to Glutack-Glubran® used for mesh fixation in laparoscopic and robotic hernia surgery to obtain the indication and upgrade the medical device Glubran® Tiss 2 to class IIb.Cyanoacrylate is the generic name of a group of fast-acting adhesives such as ethyl-2-cyanoacrylate, n-butyl cyanoacrylate, 2-octy1 cyanoacrylate sold under various trade names and blend. Cyanoacrylate is a liquid acrylate monomer that polymerizes exothermically in the presence of water, especially with hydroxide ions, joining the bonded surfaces in 4-5 s and reaching the final stage in 60-90 s . It bonds body tissue excellently and shows bacteriostatic effects . The film of glue is eliminated by hydrolytic breakdown, a process whose duration varies according to tissue type and quantity . In contrast to most cyanoacrylate glues used only for external applications as skin wound closure, Glubran® 2 is a modified n-butyl-cyanoacrylate (Glubran® 2 - N-Butyl 2 Cyanoaciylate \[NBCA\]+ Methacryloxysulfolane \[MS\]), class III medical device, CE-certified for both external and internal use . Glubran® 2 effectiveness in repairing hernias with less post-operative pain, less complications, less hernia recurrences and a greater cost-effectiveness is largely documented . Other cyanoacrylate-based glues are authorized to fix hernia meshes, i.e.: Histoacryl (pure NBCA; classified as class IIb medical device), Liquibond FIX8 (pure NBCA; classified as class III medical device) and Ifabond (n-hexyl-cyanoacrylate; classified as class III medical device). Others are authorized to be used for specific internal indication like Omnex (2-Octyl-CyanoAcrylate \[OCA\] + Butyl-Lactoyl-Cyanoacrylate), which is indicated for use in vascular reconstructions. Sometimes, abroad, also some cyanoacrylate-based glues are applied for internal uses even if not authorized . The present prospective and randomized study was aimed at comparing the effectiveness and safety of another cyanoacrylate-based glue called Glubran® Tiss 2 (NBCA + OCA), classified as class IIa surgical medical device, CE-marked (under the European Union \[EU\] Directive 93/42 EEC), being already authorized for use as atraumatic fixation system: Glubran® 2. Both medical devices have previously demonstrated to be well-tolerated and safe. Glubran® 2 and Glubran® Tiss 2 were to be applied by Glutack®, a CE-marked medical device system for glue application in the surgical field. Glutack® is the related Glubran® 2/ Glubran® Tiss 2 applicator device for laparoscopic mesh fixation procedures was fabricated to offer a precise and controlled delivery of Glubran® glues . Glubran® Tiss 2 fulfils the requirements of EU Medical Device Regulation (MDR) 2017/745 (confirmation letter received by the relative Notified Body). The composition of Glubran® Tiss 2 is obtained by mixing two different monomers of cyanoacrylate (NBCA + OCA); this gives the product a better elasticity, while maintaining high levels of tensile strength. In fact, international scientific literature has shown that the common NBCA is the cyanoacrylate molecule with the greatest tensile strength (34.27 N), low elasticity, while OCA has a lower resistance (11.27 N) but has good elastic properties. Glubran® Tiss 2 glue has a tensile strength of 27.34 N and thanks to the presence of OCA, also excellent elasticity . Among its characteristics, this formulation has haemostatic, sealing, bacteriostatic and adhesive properties. Polymerization begins 1-2 seconds after application and completes within 60 seconds. The polymerization reaction generates a temperature of approximately 45°C, which is lower than that of pure cyanoacrylates . Glubran® Tiss 2, indicated also for use in paediatrics, is a sterile, ready for use, blended cyanacrylate adhesive to be used on the skin and mucosal tissues, which is approved as class IIa medical device, effective even in patients anticoagulated and with congenital coagulopathies .
NCT03945357
This is a study to determine if the incidence of infection at the Surgical SitE is impacted if with Antibiotic Irrigation is used during Ventral Hernia Repair (RINSE Trial)
NCT04597840
Incisional hernia is one of the most common complications of abdominal surgery and carries a significant burden for both patients and the economic health service. However, no consensus for the surgical treatment of incisional hernia in contaminated field is currently available. The purpose of the COMpACT-BIO study is to investigate the clinical and economic benefit of the use of biosynthetic mesh in contaminated incisional hernia repair.
NCT02505204
Paravertebral block (PVB) combined with light intravenous sedation was associated with a short hospital stay, less post-operative nausea and vomiting and reduced analgesic consumption compared to general anesthesia for ventral hernia repair. Given the effectiveness of PVB in the ventral hernia repair, it would be beneficial to study the effect of PVB with versus without clonidine in elderly patients. Patients will be randomly allocated to one of 2 groups with 30 patients in each, using the sealed envelope technique. Group one will receive PVB with clonidine while group 2 will receive PVB with placebo.
NCT04132986
The potential value of biological and biosynthetic meshes is their ability to integrate and remodel the wall in a contaminated environment in complex surgical situations. However, postoperative morbidity and recurrence rate for biologic prostheses are high. The delay to evaluate biosynthetic prostheses is not enough at present, and the high cost of biological prostheses requires a parsimonious use of this type of material. The interest of absorbable biosynthetic prostheses remains to be demonstrated in terms of postoperative complications and long-term recurrence. Current studies have been done on groups with few subjects and in clean surgery. The primary purpose is to describe the number of complications of the operative site at 12 months, including infectious and noninfectious complications as hematoma and seroma type. The secondary purpose is to describe the number of recurrent ventral hernia at 12 months. The ventral hernia repair is a frequent operation of general surgery. Thanks to this descriptive work considering the new therapeutic offer with absorbable polymers, it would make possible to update the knowledge of the surgeons and to bring new elements of discussion in the surgical decision.