View clinical trials related to Incisional Hernia.
Filter by:Background: Development of an incisional hernia is one of the most frequent complications of midline laparotomies requiring reoperation. This paper presents the rationale, design, and study protocol for a randomized controlled trial, the aim of which was to evaluate the efficacy and safety of prophylactically placing a bioabsorbable synthetic mesh for reinforcement of a midline fascial closure. Methods: The PREBIOUS trial (PREventive midline laparotomy closure with a BIOabsorbable mesh) is a multicenter randomized controlled trial in which adult patients undergoing elective or urgent open abdominal operations through a midline laparotomy incision are assigned to one of two groups based on the laparotomy closure procedure: an intervention group in which a continuous polydioxanone (PDS) suture is reinforced with a commercially available GORE® BIO-A® Tissue Reinforcement prosthesis (W. L. Gore & Associates, Flagstaff, Arizona, USA), or a control group with continuous PDS suture only. Both groups are followed over 6 months. Outcomes: The primary outcome is the appearance of incisional hernias assessed by physical examination at clinical visits and radiologically (CT scan) performed at the end of follow-up. Secondary outcomes are the rate of complications, mainly infection, hematoma, burst abdomen, pain, and reoperation. The PREBIOUS trial has the potential to demonstrate that suture plus prosthetic mesh insertion for routine midline laparotomy closure is effective in preventing incisional hernias after open abdominal surgery, to avoid the effects on those affected, such as poor cosmesis, social embarrassment, or impaired quality of life, and to save costs potentially associated with incisional hernia surgical repair.
The aim of this Observational Registry Study is to assess the short- and long-term clinical outcomes following the use of Symbotex™ Composite Mesh in primary and incisional abdominal wall hernia surgeries by open or laparoscopic approach, according to the Instruction for use (IFU).
"Nanotechnologies applied to General Surgery and Emergency Surgery: The Buckypaper as a new fixing method for prosthetic materials in the treatment of abdominal wall hernias, diaphragmatic hernias, diaphragmatic rupture, incisional hernia and abdominal wall disaster in laparotomy procedure and laparoscopic procedures". Experimentation on breed pig Lantrace ANIMAL MODEL.
The purpose of this study is to evaluate the efficacy of the Cook Biodesign mesh for the repair of complex ventral incisional hernias. Using materials to reinforce tissue defects is indicated as standard of care for this type of surgery. The Cook Biodesign mesh is currently FDA-approved for implantation to reinforce soft tissues where weakness exists, but the investigators would like to collect additional follow-up information to continue to assess the durability of the repair after placement of the hernia mesh. This follow-up would include the collection of information about complications such as infections and seromas (collections of fluid around the surgery site), as well as hernia recurrence and quality of life questionnaires. Patients who qualify to take part in this study have been diagnosed with a ventral incisional hernia and will have been scheduled for a surgical hernia repair. This surgery will be an "open" surgical procedure and reinforcing your tissue with material is indicated for this type of hernia repair.
Despite of technological advances in surgery, incisional hernia and bowel obstruction remain frequent surgical complications. To date, the relationship between these two types of surgery and the occurrence of incisional hernia remains unclear. This is an observational study to evaluate outcomes of incisional hernia with respect to the incision site and adhesion-related bowel obstruction after open and laparoscopic colorectal surgery.
Incisional hernias are one of the most frequent complications in abdominal surgery. Laparoscopic repair is widely used but even not standardized. Existing data from different study designs show no representative data resulting in a lack of comparability and evidence. Therefore the standardization of operative techique has been proposed by the LIPOM-study group and will be assessed in a prospective manner.
Incisional hernias occur in nearly 20% of all laparotomy incisions accounting for almost 400,000 ventral hernia repairs annually in the United States. There is an even higher incidence of incisional hernia recurrence after prior repair if the patient is obese. Each subsequent hernia repair leads to increased morbidity and durability. It is not infrequent that many surgeons will advise overweight or obese patients to lose substantial weight prior to complex incisional hernia repair. However, it is quite difficult for any individual to lose more than 8 pounds a month in a safe, rapid, and sustainable fashion. This is based on losing 2 lbs. per week utilizing diet and exercise alone. Many patients with incisional hernia are physically debilitated that they cannot engage in any substantial physical activity to lose weight. Traditional laparoscopic bariatric surgery (i.e. Roux-en-Y gastric bypass (RYGB) and SG), while feasible, is a technically challenging endeavor since prior abdominal surgeries increase the amount of intra-abdominal adhesions. Furthermore, there is still a subset of patients who are not candidates for laparoscopic weight loss surgery because of inability to tolerate pneumoperitoneum due to underlying physiologic dysfunction. - Novel minimally invasive endoscopic technique may help obese patients with an incisional hernia lose weight in a safe and rapid fashion. Early case reports and small case series on gastric bypass revision utilizing such endoscopic technique have shown promise in efficacious weight loss. There have been reports of achieving nearly 20-25% excess weight loss. Abu Dayyeh and colleagues have also demonstrated that endoscopic gastric plication as a primary weight loss procedure is feasible, but their reported follow-up was only 3 months.8 Brethauer, et al. from Cleveland Clinic performed transoral gastric volume reduction for weight management in 18 patients (TRIM TRIAL). They utilized the Restore Suturing System (Restore device) and reported a mean decrease in BMI of -4.0 ± 3.5 kg/m2. Mean excess weight loss was 27.7% ± 21.9% with no reports of adverse events.9 There have also been reports of not only weight loss but improved insulin sensitivity and secretion.10 Laparoscopic gastric greater curvature plication afforded a mean 50.7% excess weight loss at 12 months.11 The intent of this study is not to demonstrate endoscopic suturing to be a primary option for weight-loss surgery. Preliminary reports have shown such procedure is technically feasible but not durable and the effects of the procedure varied widely among the study participants.12 The investigators view this technology as a bridge for morbidly obese patients, who will need subsequent surgery for another surgical disease, to improve their body habitus and decrease their postoperative morbidity and mortality. The aims of the investigators study are: - Feasibility of endoscopic gastric sleeve plication - Define the technical aspects of endoscopic suturing for sleeve plication - Provide long-term follow-up for both weight loss and resolution of their co-morbidities - Time from the endoscopic procedure to their incisional hernia repair - Photographic evidence of the stomach after endoscopic plication during the incisional hernia repair There are several advantages for the proposed study. First it avoids entering the intra-abdominal cavity. Second, the procedure is performed solely with sutures obviating the need for stapling which may increase the risk of gastric leak from the staple line.13 Lastly, it avoids placing endoscopic intra-luminal devices such as intragastric balloons or duodenal-jejunal sleeves. Limiting factor of such devices is a high rate of premature device withdrawal due to intolerance. Furthermore, their effects are short-lived as most devices will need to be removed by 12 weeks and they only offer a mean 23.6% excess weight loss.13, 14 The implications of this study can be far-reaching. Once efficacy is demonstrated where enough weight loss is achieved that patients can safely and quickly undergo their incisional hernia surgery, the investigators can then conduct a retrospective case-control cross-matched study to further delineate its true benefit. If there is a true benefit, then a randomized control study can be employed in the future.
Background: Laparoscopic repair of ventral hernias has gained popularity, since many studies and a recent meta-analysis have reported encouraging results and recurrence rates similar to open repair. The choice of the mesh and fixation methods is of paramount importance during laparoscopic approach, and nowadays, lightweight macropore meshes specifically designed for laparoscopic approach represent the first choice in several studies, due to the biomechanical properties and the optimal integration into the abdominal wall. No data with statistical relevance exist on the choice of fixation methods. Primary end point of the present Italian multicentric prospective randomized trial is to evaluate the safety and effectiveness of two different tacks to fix the lightweight polypropylene mesh (Physiomesh™) during laparoscopic incisional hernia repair: metallic spiral tacks (Protack™) vs absorbable "U" shaped tacks (Securestrap™) Design of the Study: 200 patients with ventral hernia will be randomized into two groups: Group A patients will be submitted to laparoscopic repair by Physiomesh fixed by Protack; Group B patients will be submitted to laparoscopic repair by Physiomesh fixed by Securestrap. Blind randomization will be guaranteed by an on-line software with specific key access for every surgical unit participating in the study. Patients demographics and characteristics, preoperative studies, intraoperative and postoperative results and complications, as well as scheduled follow-up will be recorded and uploaded to the database. Data represented by continuous variables will be expressed as arithmetic mean +/- standard deviation. Other data will be expressed as geometric mean +/- 95% confidence interval. Data representing low incidence events will be expressed as number and percentage of occurrence for each group. Statistical significance for all analyses will be indicated by a p value of 0.05 or less.
Collect data on safety, performance, and effectiveness of Phasix Mesh in subject requiring primary ventral and incisional hernias.
Principles= Prevention of incision hernias by primary closure of mid line laparotomies with the best-evidenced suture techniques. Background: Surgical practice of abdominal wall closure continues to rely largely on tradition rather than high-quality level I evidence. Incisional hernia after laparotomy for treatment of abdominal aortic aneurysm (AAA) has a high incidence. At this moment the best results in a prospective randomised clinical trial considering incision hernia rates and wound infections, have been reported by the surgeons from the Sundsvall clinic in Sweden. Their technique using a suture to wound length ratio of at least 4/1 and using many small stitches will be described in the protocol as the "Principles Technique". We want to explore if these results can indeed prevent incision hernias significantly if implemented with training and tutoring. Methodology:Vascular surgeons,who are not using the principles yet, but show an interest to learn the Principles, will be asked to monitor a cohort of AAA patients using their current sutures and surgical techniques. Some of the vascular surgeons will undergo training and if wanted, proctoring during the first procedures using the Principles. A cohort of 120 AAA patients will be closed according to the Principles and monitored. The results of these 120 patients will be compared to the control group consisting of patients closed with the conventional technique by non--‐trained surgeons. Primary endpoint:The incidence of incision hernias at 12 months will be determined by clinical examination. Data management and ownership: The data will be collected on a paper form and will be introduced is a database (SPSS Statistics, IBM) from which statistical analysis will be made.