Active clinical trials for "Incisional Hernia"

The aim of this study is to ascertain if the use of PDS plus® reduces the number of wound infections and incisional hernia after midline and transverse laparotomy comparing to polyglactin suture.

Mesh repair for open incisional hernia repair with fibrin sealant or with drainage

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.

The aim of this study was to perform a randomised clinical trial comparing the use of closed-suction tubular drains and progressive tension sutures in individuals with large incisional hernias subjected to onlay mesh repair to evaluate the occurrence of seroma and surgical wound infection after surgery.

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 aim of the present study is to analyse feasibility, safety and Incisional Hernia rate using a prophylactic sub lay non-absorbable mesh [Parietex Progrip (Medtronic) ] in order to prevent Incisional Hernia following midline emergent laparotomy in clean and clean-contaminated wounds.

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.

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.

The purpose of this study is to determine whether a technique using very small stitches when closing a midline incision can reduce the risk for wound complications such as incisional hernia, infection or dehiscence.

This will be a single blinded, registry based, non-inferiority, randomized control trial comparing transfacial sutures for mesh fixation to no mesh fixation in open retromuscular repairs. The primary outcome of interest is recurrence measured one year postoperatively as per standard of care at Cleveland Clinic Center for Abdominal Core Health. Hence, recurrence will be measured using either physical examination, CT scan, or the Ventral Hernia Recurrence Inventory (VHRI). Study population will include all adult patients (18 years or older) undergoing elective open ventral hernia repair of a clean (Wound class I) defect, where the midline fascia can be approximated and mesh will be placed in the retromuscular position. Only a midline approach to hernia repair and hernia widths equal to or less than 20cm measured intraoperatively will be included