Negative Pressure Incisional Wound Therapy for High-risk Ventral Hernia Repair
Ventral HerniaThe investigators are testing the ability of vacuum dressings to improve wound healing for patients having large hernias surgically repaired who are at risk of having wound complications. The trial will randomly be giving some patients having this surgery the vacuum dressing and some a standard dressing and observing how their wounds heal in hospital and at follow-up appointments.
Esophagogastric Junction Distensibility During Hiatal Hernia Repair
Esophagogastric Junction DistensibilityHiatal HerniaThe investigators aim to ascertain the effects of hiatal hernia repair and fundoplication on the distensibility of the esophagogastric junction (EGJ) as measured by FLIP topography/impedance planimetry. The investigators also aim to assess for any correlation between values of EGJ distensibility and GERD related quality of life (QOL) and dysphagia scores.
Short-term Effectiveness of Gabapentin Versus Placebo in Acute Lumbosacral Radiculalgia by Herniation...
Radiculopathy of Lumbosacral Spine Due to Disc DisorderThe study consists in evaluating the analgesic efficacy of Gabapentin versus Placebo in the short term (72h) acute lumbosacral radiculalgia due to disc herniation. In addition to the usual analgesic treatment, the patient will receive gabapentin or placebo. During the three days of treatment, an evaluation of the pain and the tolerance will be performed within the two groups: experimental and control.
TISSIUM™ Adhesive Hernia Repair System (TAHRS) Pilot Study
HerniaThe purpose of this study is to capture preliminary clinical safety and performance on the TAHRS
Comparison of Conservative Treatment and Graston and Cup Applications in Patients With Cervical...
Neck PainCervical Disc HerniationThe aim of the study is to examine the effects of graston and dry cupping techniques applied in addition to the conservative treatment program on neck awareness, grip strength, balance and sleep quality in patients with cervical disc herniation between the ages of 18-65.
Laparoscopic Primary Umbilical Hernia Repair With Routine Defect Closure Using Su2ura Approximation...
Primary Umbilical HerniaIntended Use The Su2ura™ Approximation Device is indicated for tissue approximation in endoscopic and open surgery for the placement of interrupted or running stitches in soft tissue such as hernia repair Objectives To assess the safety and efficacy of the Su2ura approximation device for the laparoscopic repair of primary umbilical hernia Number of Subjects 45 patients Number of Centers Two study centers in Israel and one in Slovenia. Study Duration 6 months Study Procedures Surgery will be performed under general anesthesia. Standard antibiotic prophylaxis will be administered at induction of anesthesia. A single surgeon, the PI, will perform the procedure. A surgical assistant will be selected by the PI from the surgical staff of the department. The procedure will involve placement of laparoscopic ports, reduction of the hernia sac, closure of the defect with the Su2ura approximation device and fixation of mesh with tacks over the closed defect. Study follow up visits: at post operation discharge, 14 days, 3 months, 6 months. Study follow up procedures: Also include SAE's and SADE's during follow up Quality of life questionnaire: patient-reported satisfaction and function will be assessed through the validated, hernia-specific European Hernia Society Quality of Life questionnaire (EuraHS-QoL) Clinical testing to determine hernia recurrence and clinical bulging Statistical analysis The sample size calculation based on the Exact Binomial distribution. The investigators will compute the 95% confidence intervals for a binomial probability, relying on the Clopper-Pearson (exact) method.
PMCF Study of LiquiBand FIX8® OHMF Device
Inguinal HerniaStudy to evaluate the safety and performance of LiquiBand FIX8® Open Hernia Mesh Fixation Device.
Improving Pain Control in Paraesophageal Hernia Repair: Intravenous Lidocaine Versus Placebo
HerniaParaesophagealWe aim to study the impact of perioperative IV lidocaine on postoperative pain control in patients undergoing paraesophageal hernia repair. This is in the context of an established ERAS protocol. We wish to study the effect of IV Lidocaine on postoperative short and long-term outcomes, including patients' length of stay postoperative mortality, morbidity, and quality of life. We will compare this to our standard pain management.
Efficacy of an Intraoperative Periradicular Application of Platelet Rich Fibrin (PRF) on the Intensity...
Neuropathic PainChronic Postsurgical PainThe prevalence of post-surgical lumbar neuropathic radiculopathy is approximately 30%. Poor response to the treatments recommended for neuropathic pain, namely antidepressants and/or gabapentinoids, requires the development of new techniques to prevent this chronic pain. Certain well-tolerated techniques, such as the administration of plasma enriched with platelets and fibrin (PRF), are increasingly used in regenerative medicine for their anti-inflammatory and analgesic properties. Thus, a periradicular intraoperative application of PRF may have an analgesic effect on the intensity of residual postsurgical neuropathic pain after disc herniation surgery.
Laparoscopic Inguinal and Femoral heRniA rePaIr Using Pre-shapeD 4DMESH® (4DLap)
Inguinal HerniaFemoral HerniaThe purpose of this study is to evaluate the safety and performance of the 4DMESH® used in (robot-assisted) laparoscopic inguinal and femoral hernia repair. The goal of the study will be achieved by assessing the prevalence of recurrences, pain, quality-of-life (QoL), return to daily activities and work and groin symptoms, and by reporting of peri- and postoperative complications in a prospectively maintained database.