View clinical trials related to Hernia, Ventral.
Filter by: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 .
The study is aimed to clinically assess the AnovoTM Surgical System in ventral hernia procedures. Extensive preclinical testing of the system's integrity and safety has been performed to assure adequate safety for this trial.
The purpose of RECOVER is to evaluate the performance and safety of Transorb™ self-gripping resorbable mesh in high-risk subjects (at least one risk factor impairing wound healing) when used for reinforcement of abdominal wall soft tissues in procedures involving open extraperitoneal ventral hernia repair, in clean (US); and clean and clean-contaminated (Europe) surgical fields (Centers for Disease Control and Prevention (CDC) Classification I and II. Data from this study will primarily be used to support market approval and European post-market clinical follow-up needs. Secondarily, data will be used for product marketing, future product development, and to support market release and maintenance in global geographies.
This study compares short term outcomes of patients undergoing a hernia repair with heavy weight mesh vs medium weight mesh in clean-contaminated and contaminated cases.
This study investigates on the effect of two different operative techniques to treat abdominal wall hernias. The goal of this clinical trial is to learn if the eTEP (Extended totally extraperitoneal repair) technique leads to a better outcome than the IPOM (Intraperitoneal onlay mesh) technique. The main questions it aims to answer are: - pain after the operation - rate of complications - rate of recurrence and reoperations - quality of life. Participants will: Either be operated using the eTEP or the IPOM technique. Be followed up either in person or via email / phone call at day 1, day 7, day 14, 6 weeks, 6 months, 1, 3 and 5 years after the surgery to asses the above-stated main and some more outcomes.
This study investigates on the effect of two different operative techniques to treat large abdominal wall defects. The goal of this clinical trial is to learn if the minimally-invasive, robotically-assisted ventral hernia repair (RVHR) leads to a better outcome than the open ventral hernia repair (OVHR). The main questions it aims to answer are: length of stay after the operation rate of complications rate of recurrence and reoperations quality of life. Participants will: Either be operated using the RVHR or OVHR will be followed up either in person or via email / phone call at day 7, day 30, 6 months, 1, 3 and 5 years after the surgery to asses the above-stated main and some more outcomes.
- Assess short term outcome of posterior component separation technique(PCS) including the regain of the physiological function of the abdominal wall. - Detect most common post operative complications related to AWR techniques in a 6 months duration after operation.
1. Review the surgical outcome of different techniques using extraperitoneal ventral hernia repair regarding postoperative pain. wound infection ,hospital stay , recurrence ,mesh migration and mesh induced visceral complications. 2. Reviewing advantages and drawbacks of each surgical technique regarding feasibility ,cost effectiveness and technical difficulties
Incisional hernia related to the umbilical trocar site is probably the most frequent complication after laparoscopic surgical procedures. However, this is an underestimated sequelae of laparoscopic surgery which may involve an important morbidity and an increase in healthcare costs. The incidence of incisional trocar site hernia ranges from 20 to 35% of patients after laparoscopic surgery depending on the different investigations. Prophylactic meshes have been tried in an attempt to reduce the incidence of this complication in obese patients. In that sense, suture-meshes can be an alternative to conventional meshes to improve the incidence of incisional hernias. INDURATE TRIAL aims to test if suture-mesh is capable of reducing the incidence of incisional hernia in patients with risk factors for the development of this frequent complication when compared with conventional monofilament sutures.
The goal of this randomized controlled trial is to teach patients to safely and effectively self-remove drains at home in adults (aged 18 and older) following a ventral hernia repair (VHR). Researchers will compare the group of subjects self-removing the drain at home to a control group of standard of care drain removal during a clinic visit by a provider to see if subjects are able to safely self-remove the drain at home.