This trial is evaluating whether INL-001 (bupivacaine hydrochloride) implant will improve 1 primary outcome, 7 secondary outcomes, and 8 other outcomes in patients with Hernia, Ventral. Measurement will happen over the course of 0 to 24 hours.
This trial requires 100 total participants across 2 different treatment groups
This trial involves 2 different treatments. INL-001 (bupivacaine Hydrochloride) Implant is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.
The first diagnostic clue in diagnosing hernia, ventral is a sudden pain in the abdominal region, more specifically beneath the pubic bone and between the pubic bone and the medial part of the rectum. This pain is accompanied with itching, but can be diagnosed without any medical imaging (i.e., ultrasound). After that, surgical intervention is required, since hernia is a serious but treatable disease.
Hernias are one of the most common medical conditions reported for female patients. In this prospective study, we found there was no clear consensus of the most appropriate surgery and most commonly recommended technique: transabdominal, transperitoneal and laparoscopic approaches. Further, in our sample, the majority of patients also had a history of pelvic surgery, and a substantial number had a history of pelvic infection.
In the last 20 years, new and advanced surgical techniques have led to a good outcome for many ventral hernia patients. All patients must take their operation as a stressful experience and must have a realistic expectation for their outcome. The aim of the treatment should be to achieve a very good quality of life for the patients.
Around 15.6 million US adults are currently diagnosed with hernia. This makes up 5.6% of American adults. For the first time, this study attempts to investigate the trend in hernia, ventral (Abdominal wall) incidence in different parts of the United States.
Viscera are covered by the parietal peritoneum which is made of two layers, a middle one and an inner one. During fetal development, both layers become apposed as one. This process allows the formation of a sac known as a hernia. At birth, the most common hernias are inguinal, which include the hernia sac of the spermatic cord and the umbilicus. The most common site of a ventral hernia is the lower third of the vagina. There are no gender or developmental differences in the herniation rate for ventral hernias of the scrotum. Although most hernias are small, they usually require surgery.
Inl-001(bupivacaine hydrochloride) implant has no clinical benefit on the outcomes compared to a placebo for the treatment of inguinal and femoral hernia. The implant is safe and feasible for postoperative pain following inguinal and femoral hernia repair.
The clinical usefulness of inl-001 (bupivacaine hydrochloride gel insert) for sciatica remains unknown. Bursal block may be an effective method for symptomatic relief of sciatica. We concluded that inl-001 implant is a new and effective method for sciatica.
The most frequent adverse side effects in the inl-001 group were transient adverse reactions such as pain, edema, and hematoma. A statistically significant difference was noted in the number and severity of adverse events between inl-001 and placebo in both genders.
Ventral hernia is an uncommon disease. It is the result of weakness in hernioventricular or hernial rings. Current surgical management techniques are safe and effective. Other advances include mesh placement, bioresorbable implants, and aortic repair techniques. In addition there is growing evidence that using a mesh, instead of a suture, when the mesh can be made to be permanently implanted into hernioventricular rings is better for the repairs, especially in older, obese, and female patients. If your surgeon is not using this approach then ask for a biopsy for analysis of the implants. Further research would be helpful.
Hernias are thought to be caused by inguinal hernias occurring as a result of the weakness of the fascia of the abdominal wall or of the defect due to birth trauma after presenting with abdominal pain. For children who have a VOM, an opening in the fascia allows stool to escape from the abdominal cavity. These children can also have a ventral hernia. Hernias most commonly presenting with pain in the VOM region are more likely to have a hernia at the site of a birth defect. In patients with a VOM without birth trauma, there is a risk that a VOM is a congenital condition. Thus neonates with VOM need to be followed for anomalies.
Most of the patients who met one of the three following criteria were at risk to participate in a clinical trial as well as to show no response to the treatment: age greater than 60 years old, overweight/obese, and prior abdominal surgery. Data from a recent study showed that the first three criteria were the most effective at identifying patients to participate in clinical trials, and patients older than 60 who received the suture or mesh procedure showed no response to the treatment. There were also many patients who had an unsuccessful suture procedure but were asymptomatic that also benefited from treatments. The last criteria did not make any difference in clinical outcomes, but patients who were symptomatic, older than 55, or obese did show no response to treatment.