Active clinical trials for "Hernia"

The 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.

The purpose of this research study is to see if the FETO surgery and FETO release (surgery to remove the device) works and is safe for babies with severe right or left Congenital Diaphragmatic Hernia (CDH). CDH is a condition in which a hole in the baby's diaphragm allows the abdominal organs to move into the chest and limit lung growth. The goal of the FETO device is to block the airway with a balloon-type device, allowing fluid to build up and help the unborn baby's lungs grow. Bigger lungs may improve the baby's quality of life.

Inguinal (groin) hernias are common and occur when an internal part of the body pushes through a weakness in the surrounding tissue wall of the groin. They are more likely to occur in men and affect people's quality of life by causing pain that is worse after any strenuous activity. If untreated they can cause serious problems such as strangulation when too much bowel comes through the weakness and becomes squeezed with the risk of losing blood supply requiring emergency surgery. To prevent such complications, elective surgery for symptomatic inguinal hernias is undertaken either in the conventional open method which involves a cut in the groin, or the keyhole surgery, when the surgery is undertaken via three small incisions in the abdomen (instead of a single, larger groin incision), a thin tube containing a light source and a camera (laparoscope) is inserted through one of these incisions, so the surgeon can see inside the abdomen. Special surgical instruments are inserted through the other incisions, so the surgeon can pull or push the hernia back into place and a piece of mesh is then stapled or glued to secure it to the weakened area in the abdomen wall. Securing the mesh with staple has been associated with increased post-operative pain and analgesia requirement; whereas not doing so has been thought to increase the chances of recurrence- more so in large sized weakness. A newer mesh appears to offer benefit over conventional meshes as it grips the tissues around the weakness without requiring staples or glue to fix it in place, and has shown to cause lesser post-operative pain and recurrence. This study is going to compare the newer self-gripping mesh with the conventional mesh requiring fixation to see which is best for patients undergoing keyhole repair to fix inguinal hernias.

This investigation will be a double-armed, randomized prospective study designed to compare open (Lichtenstein Technique) versus laparoscopic (TAPP) repair of primary unilateral inguinal hernia. Chronic pain, restriction of activities and esthetical outcome will be evaluated preoperatively and postoperatively, at 1, 4 and 12 months, using the European Registry for Abdominal Wall Hernias Quality of Life score (EuraHS-QoL score).

The goal of this clinical trial is to establish safety and tolerability of STA363 injected into a herniated intervertebral disc in patients with sciatica due to disc herniation. The main questions the trial aims to answer are: Is the treatment safe and tolerable? Does the volume of the disc and the herniation decrease? Is sciatica reduced? Participants will be given an injection into the herniated disc of either placebo or STA363 (one dose). Researchers will compare safety, tolerability, effects on disc and herniation volume and on symptoms between the group of patients injected with placebo and the group injected with STA363.

The purpose of this study is to make the proof of concept and to evaluate the safety of fetoscopic endoluminal tracheal occlusion (FETO) using Smart-TO device in fetuses with congenital diaphragmatic hernia and moderate to severe pulmonary hypoplasia

Study includes 5 visits: Screening, Baseline/Surgery, and 14 days, 3 months, 12months Follow-Ups post-surgery. The actual point of enrollment for each subject is considered the day of surgery. Total study duration is up to 12 months post-surgery. Surgery will be performed under general anesthesia. Standard antibiotic prophylaxis will be administered 30 min prior to skin incision. 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 in an IPOM fashion. Based on surgeon consideration, primary umbilical hernia defects under 2 cm will be repaired with or without mesh. Study follow-up visits will take place 14 days, 3 months and 12 months post-surgery.

Isolated CDH is a rare disease (1/3500) and displays a wide range of severity and outcome. Despite attempts to standardize the management of this disease at birth and during the first months of life, the mortality varies from 20 to 50% according to different hospitals in France and abroad. Several studies already showed the benefice of late cord clamping at birth on biological and physiological adaptation of newborns to life. Previous works also suggest a possible benefit of this procedure for babies with CDH. This multicenter randomized clinical study aims to investigate the efficacy of intact cord resuscitation compared to immediate cord clamping on cardiorespiratory adaptation at birth in full term newborn infants with isolated CDH.

In this clinical trial, equivalence is evaluated by exploratory comparison of changes in X-Ray lesions with test group (Cerazem Master V6) and control group (physical therapy) in patients with intervertebral disc herniation and degenerative stenosis.

The aim of this study is to compare laparoscopic -assisted, ultrasound-guided transversus abdominis plane block and laparoscopic intraperitoneal instillation of local anesthetic in pediatrics undergoing inguinal hernia repair.