View clinical trials related to Internal Hernia.
Filter by:The use of synthetic mesh to repair infected defects of the abdominal wall remains controversial. This study aimed to evaluate the short-term outcomes of using PVDF mesh to treat infected abdominal wall defects in the elective setting.
Observational, Retrospective, Multi-center Clinical Study on the Safety of SAFIL® MESH in Patients Undergoing Reinforcement of Soft Tissues After Abdominal Wall Surgery or Other Fascial Defects
The general objective of the study is to confirm the medium/long-term safety and clinical performance of the CELLIS membrane used in abdominal wall reconstruction including, but not limited to, ventral hernia repair and stoma closure, and to identify emerging risks in comparison to the clinical data related to other types of fixation material. The present study will be a prospective multicentric non-randomized and noncontrolled trial involving 112 patients followed for 24 months. The study will be conducted in France in 3 investigational centres.
The objective of this study is to establish the extent to which mesh improves quality of life and surgical outcomes following hernia repair.
Surgical site infection (SSI) is the main complication of surgery. The prevention of superficial SSI by topical prophylaxis is controversial. Human studies on wound lavage with topical solutions (saline, antiseptics or antibiotics) are old and do not yield conclusive results. In experimental conditions there is evidence in favor of the efficiency wound lavage with saline and antibiotic solutions. Clinical studies are needed to demonstrate the safety and efficacy of antibiotic lavage. Objective. Study of the efficacy of topical antibiotic therapy in the prevention of SSI in patients undergoing abdominal surgery with different risk of infection. Method. Project comprising several randomized double-blind clinical trials with a common methodology. Procedures with varying degrees of contamination, as emergency abdominal surgery, cesareans and complex abdominal wall reconstructions will be studied. Follow-up will be 30 days after operation. Data will be collected anonymously and the relationships between the variables will be analyzed using Pearson's chi-square, survival analysis and analysis of risk factors as appropriate. The effect of topical antibiotic on hospital stay, resistance patterns in SSI, and antibiotic serum levels will be analyzed.
Patients who underwent ventral abdominal hernia repair with self adhering, atraumatic mesh in sublay position are examined for their recurrence rate
Large abdominal wall hernias are surgically challenging to repair and often associated with significant postoperative complications. Risk factors associated with surgical site complications, such as infection and wound dehiscence, include obesity, diabetes, and smoking. In these high risk patients, the placement of synthetic mesh increases the risk of mesh infection, enterocutaneous fistula formation, and mesh explantation. One of the larger studies of risk factors associated with mesh explantation demonstrated concomitant intra-abdominal procedures have a greater than 6-fold increased hazard of subsequent mesh explantation. As an alternative to synthetic meshes, bioprosthetic meshes derived from the decellularization and processing of allogeneic or xenogeneic tissue sources have been introduced that can often allow the surgeon to treat the surgical site occurrences and salvage the repair without required mesh explantation. Low rates of mesh infection and explantation have been reported for bioprosthetic meshes and are recommended in these complicated patients by the Ventral Hernia Working Group, based on the best available clinical evidence. Despite widespread use of bioprosthetic mesh, there continues to be concern for complications associated with their use (i.e. high seroma and recurrence rates, etc.). This has led to the modification of these matrices by several industry leaders (Acelity, Cook, Integra, etc.) to include a fenestrated platform to allow for fluid to flow through the matrix upon implantation while supporting regeneration in complex abdominal wall reconstruction. To our knowledge, there are no clinical studies prospectively evaluating the long term clinical outcomes for abdominal wall reconstruction procedures involving fenestrated macropourous biologic matrices.This macroporous technology allows for tissue revascularization and integration of the biologic graft and thus an expected improvement in overall outcome. Bioprosthetic fenestrated materials such as Surgimend MP® were developed to assist with earlier incorporation and vascularization of the biologic graft while providing reinforcement of hernia repair. However, there is an absence of high quality prospective data regarding the use of these materials in complicated abdominal wall reconstruction, and no comparative data exists. This study is a prospective, case series study evaluating the efficacy and performance of SurgiMend MP® during complex ventral hernia repairs. This case series involves a biologically derived hernia mesh under its cleared FDA indication for hernia repair. Efficacy will be determined by quantifying surgical complications, hernia recurrence, and cost effectiveness endpoints.
This study is designed to examine the effects on post operative pain after the use of a fixation device to secure a mesh in the abdomen to repair a hernia of the abdominal wall. The fixation devices to be used differ with one being made from titanium and is permanent and the other being made from an absorbable material. Both fixation devices are commonly used but two questions remain unanswered, does one cause more chronic pain and also what if any will be the effect on recurrence rates of the hernia. No trial has been undertaken to date which will not only examine the fixation device but in the setting where the hernia is closed first. The closure of the hernial defect by the keyhole technique is a relatively new and growing concept in the hernia world.
The purpose of this protocol is to determine the safety and efficacy of abdominal wall transplantation as a treatment for the reconstruction of abdominal wall defects. Abdominal wall transplantation may be performed alone or in combination with another transplant.
Introduction: Morbid obesity, defined as a body mass index (BMI) of over 40 kg/m2, is globally an imminent health threat. Conservative therapies do often not yield the desired result. Bariatric surgery includes several interventions that are performed on patients with morbid obesity, like gastric bypass surgery. The number of bariatric surgeries annually is estimated to be around 500,000 worldwide; about half of these are gastric bypass surgeries. In the Netherlands, the most common performed bariatric intervention is the Roux-en-Y gastric bypass (RYGB). An important long-term complication of this surgery is internal herniation, a condition in which a part of the GI tract is herniated through an opening in the mesentery made during RYGB surgery. Incidence of internal herniation is 1-5%. Conventional abdominal CT examination is often not conclusive about the presence of internal herniation. When internal herniation is clinically highly suspected after abdominal CT examination (but not necessarily confirmed), the patient is subjected to diagnostic laparoscopic surgery. Unfortunately, a negative abdominal CT scan does not exclude internal herniation in all patients. This pleads for the development or exploitation of alternative techniques that might aid in the diagnosis of complications after RYGB surgery. Since the anatomy of GI tract is altered when internal herniation is present, visualizing the mesenteric vasculature may aid in the diagnosis of this complication after RYGB surgery. This study aims to confirm the feasibility and superiority of diagnosing internal herniation using CT examination of the mesenteric arteries over conventional CT examination. Objectives: The primary objective is to determine whether abdominal arterial CT angiography is a feasible technique for diagnosing internal herniation after RYGB surgery. Secondary, it is examined whether arterial angiography of the mesentery is superior over conventional CT examination with oral and IV contrast in the venous phase. Study design: This study will be a prospective pilot study, in which the outcomes of both the conventional CT examination and abdominal angiogram are compared to the outcome of diagnostic laparoscopy as gold standard. Study population: Patients will be included who underwent laparoscopic RYGB surgery at least half a year earlier and have persisting abdominal pain. They should be highly suspected for internal herniation by their doctor, based on several characteristics. Main study parameters/endpoints: Primary study endpoints are the assessments of the arterial abdominal angiogram and mesenteric arterial mapping in relation to the outcome of the diagnostic laparoscopic surgery in 12 subjects. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In this pilot study, study subjects will receive an additional effective radiation dose of about 10 mSv. On average, an acute dose of 10 mSv leads to an additional risk of cancer of about 1 in 1750 (~1 in 2000 for males, ~1 in 1500 for females) for a 50-year old subject, based on the linear no threshold model. However, when the mesenteric artery mapping proves to be feasible and superior, many unnecessary diagnostic laparoscopic surgeries will be prevented (along with their complications and risks).