43 Clinical Trials for Various Conditions
The proposed project aims to evaluate the safety of DuraMesh™ suture for laparotomy closure in an emergent setting, while also providing preliminary efficacy data with regard to incisional hernia prevention. Conventional techniques for laparotomy closure in the setting of an emergency laparotomy or delayed abdominal closure suffer from a lack of durability, with incisional hernia rates of 30-34% reported. While prophylactic planar mesh placement has emerged as a cost-effective strategy to prevent hernia formation in the clean, elective laparotomy setting, higher rates of surgical site complications and increased technical complexity preclude its use in the emergency or contaminated setting. Utilized exactly like conventional suture without any change in surgical closure technique, DuraMesh™ provides the durability of planar mesh reinforcement without the marked increase in foreign material or added surgical complexity. As a result, DuraMesh™ is the only hernia prevention strategy that can be forward-deployed in support of the injured warfighter. While this study is specifically targeted to a gap in the care of the injured warfighter, the potential benefits extend well beyond the military applications. With over 2 million laparotomies performed annually in the United States, and approximately 20% of these resulting in an incisional hernia, the need for an alternative abdominal wall closure strategy is equally dire in the civilian setting. This clinical trial represents an opportunity to drive the needed paradigm shift towards prevention, rather than costly management of incisional hernias. The investigators anticipate this work will rapidly lead to further research, including providing the preliminary data necessary to launch a multi-center randomized controlled trial to assess the clinical efficacy of DuraMesh™ for hernia prevention in both the emergent and elective operative settings.
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.
The SYN 20-01 Study is a non-interventional, prospective, multicenter, multicohort, international, post-market clinical investigation looking into the assessment of GORE® SYNECOR Biomaterial in focused patient populations and in long-term application. Patients with ventral / incisional hernia amenable to hernia mesh repair will be enrolled into two cohorts (US and EU cohort) and followed-up over the period of 60 months.
Comparing the use of Stratafix Symmetric™ sutures to standard laparotomy closure sutures.
The goal of this randomized controlled trial is to compare the difference in quality of life at one year postoperatively for patients undergoing incisional hernia repair with mesh versus suture repair using modern techniques. The main question it aims to answer are: • Determine if primary suture repair is non-inferior to mesh repair for incisional hernias 2-6cm with respect to quality of life using the HerQLes summary score at one year postoperatively.
This clinical trial compares two different kinds of surgical closing techniques, short stitch suture or traditional suture, in patients who are having liver tumor surgery. This study may help researchers learn if one technique can lower the chances of developing a hole in the wall of the abdomen (an abdominal hernia) at the incision site better than the other.
Currently, no standard of care exists to prevent incisional hernias (IH). This study will compare how frequently IH develop in standard abdominal closures vs. abdominal closures with dHACM added. By adding dHACM to the standard closure, we think we can reduce the formation of IH. If patients decide to participate in this study, they will be randomly assigned to one of two study arms, Arm A or Arm B. They will have a 50% chance of being assigned to either arm. The assignment will be made by computer program and is completely random. Patients are not informed of which arm they are assigned. Arm A (Treatment Arm): dHACM Patients enrolled in this arm will have a thin sheet of dHACM placed as an overlay over the length of the closed incisions. dHACM is Dehydrated Human Amniotic-Chorion Membrane. It is a FDA-registered healing adjunct that has been applied in a broad range of diseases including wounds, plantar fasciitis and burns. Arm B (Control Arm) Patients enrolled in this arm will have standard fascial closure. Data collection will be performed at routine follow-up outpatient clinic visits with the primary surgeon to assess for IH related symptoms. At 6 months after surgery, patients will see a surgeon who is blinded to the randomization. This surgeon will perform a painless handheld ultrasound examination of the incision site.
The objective of this study is to collect additional data on safety, performance and effectiveness of Phasix™ ST in subjects receiving laparoscopic ventral or incisional hernia repair at high risk for surgical site occurrence (SSO).
The goal of this study is to evaluate the impact of Customizable in the management of extensive closed surgical incisions for Subjects undergoing abdominal surgery for incisional hernia repair and/or functional panniculectomy as compared to SOC dressing, and to significantly reduce the SSC rate experienced by Subjects receiving Customizable vs. SOC surgical incision dressing.
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 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.
Collect data on safety, performance, and effectiveness of Phasix Mesh in subject requiring primary ventral and incisional hernias.
Single-arm study of Phasix Mesh in High Risk patients looking at SSI and recurrence rates.
The objective of this study is to collect efficacy, safety and utility data with Phasix™ Mesh in ventral and incisional repair procedures by evaluating the following: 1. Hernia recurrence rate of ventral and incisional hernias post repair with Phasix™ Mesh for up to 12 months post surgery. 2. Perioperative, short-term and long-term procedural and/or device related complications. 3. Abdominal Wall Function and mobility.
Prospective, multicenter, observational study to evaluate performance of GORE® BIO-A® Tissue Reinforcement when used to reinforce midline fascial closure in single-staged open complex ventral incisional hernia repair.
The purpose of this study is to describe the outcomes of laparoscopic incisional hernia repair surgery and to record the outcomes of patients after surgery.
This study is being conducted to gain a better understanding of the quality of life for patients with a diagnosis of primary and recurrent incisional hernias and 1) who decline to have surgery to repair the hernia or 2) patients who cannot have surgery because their health will not allow them or 3O if surgery to repair the hernia is completed. A comparison will be made between those who receive surgery and those who do not.
The purpose of this research is to compare open ventral incisional hernia repair to the laparoscopic repair with respect to complications, recurrence, pain, return to normal activities of daily living, and return to work.
Diverting ileostomy is frequently utilized to protect high-risk anastomoses, though it is not shown to reduce the leak rate it may reduce the severe consequences of an anastomotic leak. Ileostomy will be reversed with restoration of continuity in majority of patients. Stoma site incisional hernias after ileostomy closure are complex hernias that can be associated with abdominal pain, discomfort, and a diminished quality of life. Duramesh™ non-absorbable polypropylene suture is a hollow core, microporous, cylindrical suture made off in polypropylene filaments that are loosely braided and bonded to each other with heat and pressure. The Aim of this study is to evaluate Duramesh™ suture vs standard closure on rates of hernia formation after ileostomy closure.
Prospective cohort study of patients with midline ventral incisional hernia with a range of hernia morphology who plan to undergo open retromuscular VHR. Study groups: Study groups are selected across a range of morphology and based on factors known or suspected to affect the ability to achieve fascial closure. Control groups: The study plans to enlist 5 volunteers with no incisional hernia or prior laparotomy to establish internal baseline SWE values and interrater reliability. The study will also plan to recruit 5 patients undergoing primary laparotomy in order to correlate SWE findings with closure tension.
The purpose of this study is to measure the changes in tension after each release in a standard posterior component separation during abdominal wall reconstruction.
The purpose of this study is to assess the incidence of hernia recurrence with the use of biologic and prosthetic mesh in ventral hernia repair.
Quantitative radiographic imaging holds promise as a novel and innovative strategy to assess ventral hernia patients. Assessing abdominal wall changes surrounding ventral hernia using shear wave velocity values measured with ultrasound will identify features of the abdominal wall that differ between healthy volunteers and subjects scheduled to have ventral hernia repair. Through the use of ultrasound including shear wave velocity measurements, the abdominal wall of 25 subjects scheduled to have ventral hernia repair will be compared to those of 35 healthy volunteers. The ultrasound measurements will elucidate if ventral hernia affects abdominal wall elasticity and effect surgical outcomes.
The hypothesis for this study is complex incisional hernia repair using the separation of components technique reinforced with retrorectus placement of Gentrix™ Surgical Matrix will lead to fewer incisional hernia recurrences and fewer wound complications compared to the same incisional hernia repair techniques reinforced with other prosthetic or biologically-derived mesh.
This study aims to prospectively explore the use of XenMatrix™ AB Surgical Graft for ventral or incisional midline hernia repair in patients across all wound classes ("All Comers") through 24 months post repair.
The purpose of this study is to measure abdominal wall strength both preoperatively and postoperatively in patients undergoing ventral/incisional hernia repairs. The investigators hypothesize that abdominal wall strength is improved in hernia repairs that reapproximate the rectus musculature to the midline. Abdominal wall strength measurements would be obtained utilizing various abdominal strength testing.
This is a multi-center, observational study of incisional/ventral hernia repair with NG-TSM laparoscopically. The study is not randomized and has a single treatment design assessing NG-TSM intra-operatively, its ease of use and handling characteristics.
This is a prospective cohort study. Patients have an incisional or parastomal hernia with \>20 cm fascial defect on pre-operative imaging who will undergo an anticipated open bilateral transversus abdominis release with retromuscular synthetic mesh will have their abdominal wall tension measured using a tension scale and their intra-abdominal pressure measured using a urinary catheter containing pressure sensors. The investigators aim to quantify the changes, as well as explore and describe the physiologic shifts that may be associated with these changes.
The goal of this observational study is to quantitatively measure the change in tension of the abdominal wall over time in subjects with open abdomens using a tensiometer.