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Hernia clinical trials

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NCT ID: NCT03541941 Completed - Clinical trials for Analgesia, Postoperative

Exparel vs. Bupivacaine Hydrochloride vs. Placebo for Hernia Repair

Start date: July 3, 2018
Phase: Phase 4
Study type: Interventional

Patients usually experience some level of pain after their hernia repair. To control pain after the operation, surgeons have many options. One of them is to make some injections of pain blocker medications into the nerves that are responsible for the sensations the abdominal wall.This procedure is called TAP block (transversus abdominis place block). These medications are called local anesthetics, and there is a variety of medications that can be used. One of such medications is called Exparel® (Liposomal Bupivacaine). Exparel® has the potential benefit of lasting more hours than regular anesthetics. Although this drug is being used with increasing frequency, the investigators do not have good quality studies investigating the benefits of using this medication during a hernia repair, especially when compared to other types of local anesthetics (Bupivacaine Hydrochloride) or when compared to not injecting this medication at all. This study aim to investigate if Exparel®, when injected in the nerves of the abdominal wall during hernia repair can: (1) reduce the dose of additional opioid medications (morphine and similar) needed to achieve good pain control and (2) result in lower pain scores. The hypothesis is that Exparel® will result in a 30% decrease in the total requirements for opioid medications during the first 72 hours after surgery. Patients will be randomized to receive either Exparel®+Bupivacaine Hydrochloride, Bupivacaine Hydrochloride or Placebo (normal saline) during the operation through a TAP block. All patients will receive a patient controlled analgesia device after the operation, where patients can simply push a button every time they feel pain and the device will administer a dose of opioid medications. The investigators of the study will record the necessary amount of opioids used by the patients to achieve good pain control and also record pain scores several times during hospital stay.

NCT ID: NCT03526341 Completed - Inguinal Hernia Clinical Trials

Post Market Clinical Follow Up Study for ReliaTack™ Articulating Reloadable Fixation Device With Deep Purchase Tacks

RAFDT
Start date: April 25, 2018
Phase:
Study type: Observational

A post-market clinical follow-up study for ReliaTack™ articulating reloadable fixation device with deep purchase tacks

NCT ID: NCT03520907 Completed - Postoperative Pain Clinical Trials

The Comparison of the Transversalis Fascia Plane Block With Ilioinguinal/Iliohypogastric Nerve Block

Start date: April 26, 2018
Phase: N/A
Study type: Interventional

This study compares the transversalis fascia plane block with the ilioinguinal/iliohypogastric nerve block in children undergoing hernia repair surgery. Half of participants will receive the transversalis fascia plane block, while the other will receive the ilioinguinal/iliohypogastric nerve block.

NCT ID: NCT03505918 Completed - Surgery Clinical Trials

Supervised Physical Therapy Versus Unsupervised Home Exercise After Surgery for Lumbar Disc Herniation

Start date: October 1, 2015
Phase: N/A
Study type: Interventional

This is a randomized controlled trial evaluation effect of postoperative rehabilitation after surgery for lumbar disc herniation. The primary aim of this study is to evaluate the effect of unsupervised home exercises compared to supervised physical rehabilitation. Secondary aims of this study are to determine if there is a difference in cost-effectiveness in patients undergoing supervised physical rehabilitation in patients after surgery for lumbar disc herniation compared to unsupervised home exercises.

NCT ID: NCT03495557 Completed - Incisional Hernia Clinical Trials

Prevalence of Port Site Hernia After Mesh Placement in Laparoscopic Cholecystectomy.

PSHERNIA
Start date: January 1, 2018
Phase: Phase 4
Study type: Interventional

A prophylactic mesh fixation after fascial closure in umbilical trocar after cholecystectomy may prevent the trocar site hernia incidence. Especially in patients who present certain risk factors.

NCT ID: NCT03495154 Completed - Ventral Hernia Clinical Trials

Post Market Study of Parietene™ DS Composite Mesh in Ventral Hernia Repair

PPDS
Start date: June 21, 2018
Phase: N/A
Study type: Interventional

A multi-center post-market single arm prospective study of Parietene™ DS Composite Mesh in subjects undergoing ventral hernia repair to confirm its clinical safety and performance in the short (1, 3 months), mid (12 months) and long term (24 months)

NCT ID: NCT03490266 Completed - Hernia, Ventral Clinical Trials

Robotic Versus Laparoscopic Ventral Hernia Repair

Start date: April 3, 2018
Phase: N/A
Study type: Interventional

Ventral hernias are a common disease and one half of all individuals are born with or will acquire a ventral hernia in their lifetime. Repair of ventral hernias may be associated with significant morbidity, including surgical site infection, hernia recurrence and reoperation. Minimally invasive ventral hernia repair decreases rates of surgical site infection and hospital length of stay, without affecting recurrence, however the laparoscopic approach to ventral hernia repair accounts for only about 1/3 of all total hernia repairs performed in the US. Recent large database studies have suggested that robotic ventral hernia repair may be associated with decreased hospital length of stay. However, this study is affected by common biases of database studies and randomized controlled trials are needed to assess the true impact of robotics for ventral hernia repair.

NCT ID: NCT03458845 Completed - Sarcopenia Clinical Trials

Prevalence of Sarcopenia and Undernutrition in Patients With Cirrhosis and Abdominal Hernia

Start date: May 30, 2018
Phase:
Study type: Observational

The study evaluates whether sarcopenia influences the prevalence of abdominal hernias in patients with cirrhosis.

NCT ID: NCT03450811 Completed - Inguinal Hernia Clinical Trials

Effect of Inguinal Hernia Repair on Uroflowmetric Parameteres

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

Post operative acute urinary retension or voiding dysfunction are complications after inguinal hernia repair and they cause a great deal of discomfort and stress to patients. Furthermore, they can also increase hospital costs by increasing hospital stay, and by growing the need for outpatient appointments after an elective surgical procedure. Some studies recommend prophylactic alpha blockers to minimizing these adverse effects. Investigators aimed to determine the changes of uroflowmetric values for male patients following elective inguinal hernia repair.

NCT ID: NCT03450473 Completed - Hernia, Ventral Clinical Trials

A Prospective Case Series Evaluating Surgimend Mp® In Patients Undergoing Complex Abdominal Hernia Repair

Start date: January 3, 2018
Phase: N/A
Study type: Interventional

Large abdominal wall hernias are surgically challenging to repair and often associated with significant postoperative complications. Risk factors associated with surgical site complications, such as infection and wound dehiscence, include obesity, diabetes, and smoking. In these high risk patients, the placement of synthetic mesh increases the risk of mesh infection, enterocutaneous fistula formation, and mesh explantation. One of the larger studies of risk factors associated with mesh explantation demonstrated concomitant intra-abdominal procedures have a greater than 6-fold increased hazard of subsequent mesh explantation. As an alternative to synthetic meshes, bioprosthetic meshes derived from the decellularization and processing of allogeneic or xenogeneic tissue sources have been introduced that can often allow the surgeon to treat the surgical site occurrences and salvage the repair without required mesh explantation. Low rates of mesh infection and explantation have been reported for bioprosthetic meshes and are recommended in these complicated patients by the Ventral Hernia Working Group, based on the best available clinical evidence. Despite widespread use of bioprosthetic mesh, there continues to be concern for complications associated with their use (i.e. high seroma and recurrence rates, etc.). This has led to the modification of these matrices by several industry leaders (Acelity, Cook, Integra, etc.) to include a fenestrated platform to allow for fluid to flow through the matrix upon implantation while supporting regeneration in complex abdominal wall reconstruction. To our knowledge, there are no clinical studies prospectively evaluating the long term clinical outcomes for abdominal wall reconstruction procedures involving fenestrated macropourous biologic matrices.This macroporous technology allows for tissue revascularization and integration of the biologic graft and thus an expected improvement in overall outcome. Bioprosthetic fenestrated materials such as Surgimend MP® were developed to assist with earlier incorporation and vascularization of the biologic graft while providing reinforcement of hernia repair. However, there is an absence of high quality prospective data regarding the use of these materials in complicated abdominal wall reconstruction, and no comparative data exists. This study is a prospective, case series study evaluating the efficacy and performance of SurgiMend MP® during complex ventral hernia repairs. This case series involves a biologically derived hernia mesh under its cleared FDA indication for hernia repair. Efficacy will be determined by quantifying surgical complications, hernia recurrence, and cost effectiveness endpoints.