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Hernia clinical trials

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NCT ID: NCT04150796 Completed - Ventral Hernia Clinical Trials

Comparing eTEP and Laparoscopic Intraperitoneal Onlay Mesh (IPOM) for Ventral Hernias

Start date: November 4, 2019
Phase: N/A
Study type: Interventional

Ventral hernias can be repaired using a variety of techniques, with smaller defects often being amenable to minimally invasive surgical (MIS) approaches. For many years, the standard of care MIS approach to ventral hernias has been the laparoscopic intraperitoneal onlay mesh (IPOM) approach, in which a large piece of mesh is placed inside of the abdomen and fixed to the inner abdominal wall using a combination of sutures and/or mechanical tacks. For selected patients, the IPOM approach has demonstrated benefits over open repair, including decreased postoperative length of stay and decreased incidence of surgical site infection. However, concern regarding long-term outcomes of placing mesh inside the abdomen have spurred the search for alternate approaches to MIS ventral hernia repair. This includes the enhanced-view totally extraperitoneal (eTEP) approach, in which the retromuscular plane is accessed and developed so a large piece of mesh may be implanted outside of the abdominal cavity. The theoretical benefits of this approach are that patients may experience reduced pain because mechanical mesh fixation is not required (as compared to traditional IPOM approaches in which mesh is fixed to the inner abdominal wall) and that mesh is kept outside of the abdominal cavity and away from the viscera, allowing use of less expensive, uncoated mesh and theoretically reducing risk for long-term mesh related complications. While popularity of eTEP has grown, literature published regarding this approach has been mostly retrospective, consists of relatively small series of patients, and suffers from selection bias. For the one prospective study of eTEP published by Radu, et al, there was no comparator arm. The investigators will conduct a registry-based randomized controlled trial comparing MIS approaches for repair of small to medium-sized ventral hernias, specifically eTEP versus IPOM. This will occur through the Americas Hernia Society Quality Collaborative (AHSQC). Our hypotheses are multiple: 1) Patients with ventral hernias undergoing eTEP will experience a 30% decrease in pain scores by postoperative day 1 compared to patients undergoing IPOM; 2) eTEP will be associated with higher median direct costs per case versus IPOM; 3) eTEP will be associated with equivalent 1-year hernia recurrence rates versus IPOM; 4) eTEP will be associated with significantly increased intraoperative surgeon workload compared to IPOM.

NCT ID: NCT04149847 Not yet recruiting - Quality of Life Clinical Trials

Comparing the Quality of Life After Nylon Darn Repair of Inguinal Hernia to Polypropylene Mesh Repair

Start date: November 1, 2019
Phase: N/A
Study type: Interventional

Inguinal hernia repair may be done by the nylon darn, polypropylene mesh and other methods. Polypropylene mesh is established in the literature as the standard of care for inguinal hernia repair. It is however expensive and not readily available in our community hospitals. Nylon darn repair is widely used in our hospitals. We think that the quality of life following nylon darn repair and polypropylene mesh repair is similar. In order to find out, we are recruiting 79 patients to undergo nylon darn repair for their inguinal hernia and another 79 patients to undergo polypropylene mesh repair for their inguinal hernia repair. We are doing research to compare the quality of life after nylon darn repair of inguinal hernia to polypropylene mesh repair in patients aged 18 years to 80 years who come to St. Luke Hospital for their first-ever inguinal hernia repair.

NCT ID: NCT04145908 Completed - Incisional Hernia Clinical Trials

Non Absorbable Mesh Reinforcement of Midline Incision Closure in High Risk Patients, Onlay Versus Preperitoneal Position, a Comparative Clinical Trial

Start date: July 2016
Phase: N/A
Study type: Interventional

comparison between onlay and preperitoneal augmentation of mid line closure in high risk patients

NCT ID: NCT04143776 Withdrawn - Acute Kidney Injury Clinical Trials

Renal- and Pulmonary Function in Relation to Abdominal Hypertension After Abdominal Reconstruction

REPARE
Start date: June 1, 2020
Phase:
Study type: Observational

An incisional hernia is technically challenging to operate and is the most frequent long-term complication after open surgery, resulting in impaired quality of life and reduced physical ability. Large hernias contain large amounts of abdominal volume, which similarly are missing from the abdominal cavity. Due to adaptations of the abdominal wall muscles and decreased space in the abdominal cavity, abdominal wall reconstruction lead to increased tension and thereby increased intraabdominal pressure. Reduced renal and lung function after surgery is one of the leading causes of prolonged hospitalization, increased costs and mortality. Elevated intraabdominal pressure is a known risk factor for kidney injury, but relationships between hernia surgery, increased intraabdominal pressure, renal and lung function are still unclear. Therefore, in patients undergoing surgery for incisional hernia, we will investigate the extent and consequences of elevated intraabdominal pressure, as well as its relation to renal injury and reduced lung function. We will also investigate the relationship between hernia dimensions and the development of increased intraabdominal pressure, as well as identifying patients at particular risk of developing elevated intraabdominal pressure. From April 2020 to October 2021, we will include 100 patients at Bispebjerg Hospital, Denmark, diagnosed with medium to giant incisional hernia, who will undergo scheduled surgery. Patients are followed from before to 30 days after surgery. They will be examined with CT scans before and after surgery. Blood tests, pulmonary function tests and measurement intraabdominal pressure will be performed before and until 3 days after surgery. Thirty days after surgery, lung function tests and blood tests are repeated at a final examination at the out-patient clinic. During follow-up, differences in hospital stay, complications, reoperations, and mortality will be investigated. Participation in the project is not associated with any side effects and risks. The study is expected great scientific gain, as the results can help identify particularly vulnerable patients in need of extended observation and treatment. The results obtained by the project are sought to be published in relevant scientific journals and conferences. The project is expected to extend over a 3-year period, which will include commissioning, data collection, analytical processing, dissemination of results and conduction of PhD thesis.

NCT ID: NCT04137172 Completed - Hernia Clinical Trials

Short Term Outcomes of Laparoscopic Intraperitoneal Onlay Mesh With Facial Repair(IPOM-plus) for Ventral Hernia.

Start date: October 3, 2016
Phase: N/A
Study type: Interventional

entral hernias are a major cause of functional impairment, abdominal pain, and bowel obstruction. The overall incidence of primary ventral hernia is estimated to be between 4 and 5 % in the literature, and ventral incisional hernia rates vary from 35 to 60 % within 5 years after laparotomy . After laparoscopy, this rate is estimated to decline from 0.5 to 15 % even after two decades, LVHR or open repair (OVHR) is still a matter of debate because of concerns about seroma formation, recurrence rate, and the intraperitoneal mesh position. . The laparoscopic technique for repairing ventral and incisional hernias is now well established. However, several issues related to LVHR, such as the high recurrence rate of hernias with large fascial defects and in extremely obese patients, are yet to be resolved. Additional problems include seroma formation. To solve these problems, laparoscopic fascial defect closure with IPOM reinforcement (IPOM-Plus) has been introduced in the past decade, and a few studies have reported satisfactory outcomes. Although detailed techniques for fascial defect closure and handling of the mesh have been published, standardized techniques are yet to be established.

NCT ID: NCT04134455 Completed - Hernia Incisional Clinical Trials

The Mesh-RTL Project, for Prevention of Incisional Hernia

RTL
Start date: January 20, 2022
Phase: N/A
Study type: Interventional

Introduction: By definition, the laparotomy is a surgical incision into the abdomen cavity performed to examine the abdominal and retroperitoneal organs. The evisceration/eventration and the hernia are considered the most frequent complication of the midline laparotomy with a high morbidity and mortality related. Conditions that will require a second intervention, in Mexico represent the seventh cause of elective surgery and fourth cause of emergency procedures. The objective of this study is to determine if the incidence of post-incisional hernia in patients with high risk after a midline laparotomy are similar between the closure of the abdominal wall with the RTL technique and the supraaponeurotic mesh closure reinforcement. Material and Methods: Clinical trial comparing the use of mesh against the RTL technique for post-incisional hernia prophylaxis. Two groups, triple blind Analysis will be carried out with intent to treat and not inferiority with 95% confidence intervals

NCT ID: NCT04132986 Recruiting - Clinical trials for Ventral Hernia Repair

Study of Absorbable Biosynthetic Meshes in Contaminated Ventral Hernia Repair

Start date: April 1, 2019
Phase:
Study type: Observational

The potential value of biological and biosynthetic meshes is their ability to integrate and remodel the wall in a contaminated environment in complex surgical situations. However, postoperative morbidity and recurrence rate for biologic prostheses are high. The delay to evaluate biosynthetic prostheses is not enough at present, and the high cost of biological prostheses requires a parsimonious use of this type of material. The interest of absorbable biosynthetic prostheses remains to be demonstrated in terms of postoperative complications and long-term recurrence. Current studies have been done on groups with few subjects and in clean surgery. The primary purpose is to describe the number of complications of the operative site at 12 months, including infectious and noninfectious complications as hematoma and seroma type. The secondary purpose is to describe the number of recurrent ventral hernia at 12 months. The ventral hernia repair is a frequent operation of general surgery. Thanks to this descriptive work considering the new therapeutic offer with absorbable polymers, it would make possible to update the knowledge of the surgeons and to bring new elements of discussion in the surgical decision.

NCT ID: NCT04131985 Completed - Postoperative Pain Clinical Trials

Analgesic Efficacy of Erector Spinae Plane Block for Laparoscopic Inguinal Hernia Repair

Start date: October 16, 2019
Phase: N/A
Study type: Interventional

Postoperative analgesia management in inguinal hernia surgery is difficult because of the content of the surgical procedure. A multimodal approach to postoperative analgesia has recently been proposed. For this reason, various methods are used.Regional blocks, pharmacological treatments are among these methods. Among the regional blocks, ilioinguinal and hypogastric blocks are used more safely and with increasing frequency, especially with the introduction of ultrasonography in the clinic.Forero et al. firstly, erector spinae block which was used for the first time in the treatment of thoracic neuropathic pain has been widely used especially in laparoscopic abdominal surgery and it has taken its place in the literature. It is performed at T4-5 level in breast and thoracic surgery and T7 level in abdominal surgery. In this block, local anesthesia between the erector spina muscle and the transverse protrusion of the vertebra was used to create analgesia in the anterior abdominal wall. In this study, we planned to investigate degree of postoperative pain, sensory block levels, analgesic consumption, propofol-remifentanyle consumption and side effects of patients undergoing inguinal hernia surgery under general anesthesia with erector spinae block.

NCT ID: NCT04131348 Completed - Clinical trials for Component Separation

Botulinum Toxin to Avoid Component Separation in Midline Large Hernias

BTCS01
Start date: December 1, 2016
Phase: N/A
Study type: Interventional

Introduction. The goal of our study was to compare results in patients with large midline incisional hernia (LMIH) using only anterior compònent separation (CST) versus preoperative botulinum toxin (BT) and following Rives repair (RSR). Material and methods. From to December 2016 to December 2018, a prospective comparative study was performed in 80 consecutive patients with LMIH and hernia transverse diameter between 12-18 cms at our tertiary center. Two groups were prospectively analyzed: patients underwent open CST (component separation group or CSG) and patients with preoperative BT administration and following open RSR (botulinum toxin group or BTG).

NCT ID: NCT04119466 Completed - Clinical trials for Degenerative Disc Disease

Stabilizing Training in Degenerative Disc Disease

Start date: September 1, 2019
Phase: N/A
Study type: Interventional

This study evaluates efficacy of stabilizing training of deep core muscles in the lumbar spine in degenerative disc disease subjects, considering the progression level of degenerative disc disease: protrusion or extrusion.