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Hernia clinical trials

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NCT ID: NCT03607838 Completed - Clinical trials for Lumbar Disc Herniation

SI-6603 (Condoliase) Study for Lumbar Disc Herniation (Discovery 6603 Study)

Start date: May 30, 2018
Phase: Phase 3
Study type: Interventional

This study is to evaluate the effectiveness of a single-dose intervertebral disc injection of SI-6603 in subjects with lumbar disc herniation (LDH)

NCT ID: NCT03591146 Completed - Inguinal Hernia Clinical Trials

Phase I/II Dose-escalation Study to Evaluate Safety, PK and Efficacy of TLC590 for Postsurgical Pain Management

Start date: July 31, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Phase I/II, randomized, double-blind, comparator-controlled, dose-escalation study to assess the safety, PK, and efficacy of single postsurgical application of TLC590 compared with Naropin®

NCT ID: NCT03576222 Completed - Incisional Hernia Clinical Trials

Preventive PICO on Surgical Wounds After Large Incisional Hernia Repair

PICO
Start date: May 1, 2017
Phase: N/A
Study type: Interventional

To determine the efficacy on decreasing the rate of surgical wound complications in patients undergoing repair of large incisional hernias, after the prophylactic application of a single-use negative pressure therapy dressing (PICO), versus a conventional dressing.

NCT ID: NCT03575377 Completed - Hernia Clinical Trials

Opioid Use, Storage, and Disposal Among Pediatric Patients After Surgery

Start date: June 7, 2018
Phase: N/A
Study type: Interventional

Opioids are an important component of post-operative pain management among children, but are often prescribed in excess and rarely disposed of appropriately. The lack of prompt and proper opioid disposal after recovery from surgery is contributing to the opioid crisis in Ohio by placing children at risk of accidental ingestion of opioids remaining in the home and allowing for unused opioids to be diverted for non-medical use. The investigators propose to reduce the burden of the opioid crisis in Ohio by testing a strategy to increase proper opioid disposal by families of children undergoing outpatient surgery. The investigators will test the impact of a novel opioid disposal mechanism, the Deterra® drug deactivation system, after pediatric surgical operations. This system deactivates pills, liquids, or patches, allowing for their disposal in the home garbage. The investigators propose to evaluate the effectiveness of providing Deterra® bags to families of children having surgery on their disposal of excess opioids. The investigators will perform a randomized controlled trial (RCT) to test the effectiveness of Deterra® to improve opioid disposal among families of children having outpatient surgery at Nationwide Children's Hospital.

NCT ID: NCT03566784 Completed - Inguinal Hernia Clinical Trials

Electrocoagulation Employment During TAPP Inguinal Hernia Repair

Start date: June 1, 2018
Phase:
Study type: Observational

Laparoscopic TAPP (transabdominal preperitoneal) hernia repair presents a minimally invasive surgical procedure, which tends to be a gold standard in a wide range of inguinal hernia operations. Postoperative neuralgia is a troublesome complication following TAPP, which occurs in 0.2-7% of patients. The most common cause of nerve injury is an inappropriate use of electrocoagulation or dangerous tissue dissection during TAPP. However, the association between electrocoagulation employment during TAPP and postoperative neuralgia has not been investigated properly until now. The aim of the project is to compare postoperative pain (postoperative neuralgia) in patients undergoing TAPP inguinal hernia repair with/without the use of electrocoagulation.

NCT ID: NCT03566433 Completed - Inguinal Hernia Clinical Trials

Postoperative Pain After Endoscopic TEP vs. Lichtenstein Hernioplasty in Inguinal Hernia Repair

Start date: November 1, 2017
Phase: N/A
Study type: Interventional

Immediate pain reaction and return to work after TEP or Lichtenstein hernia repair have not been studied. In this multicenter trial the patients are allocated to surgery using TEP (n=50) or Lichtenstein (n=50) technique. Pain and return to work are recorded postoperatively up to one month. Immediate and late complications are also analyzed.

NCT ID: NCT03564535 Active, not recruiting - Inguinal Hernia Clinical Trials

Comparison of Self Fixating Mesh to Mesh Fixation With Metallic Tacks in Laparoscopic Inguinal Hernia Repair

SELFITAC
Start date: April 18, 2018
Phase: N/A
Study type: Interventional

This study compares the use of self-fixating mesh to mesh fixation with tackers in the management of inguinal hernia by laparoscopic method. Half of the participants in the study will be treated using self-fixating mesh, while the other half will be treated using conventional mesh fixed with tackers.

NCT ID: NCT03563092 Completed - Clinical trials for Inguinal Hernia Without Obstruction or Gangrene

Closed Suction Drain vs no Drain on Symptomatic Seroma Formation After Laparoscopic Inguinal Hernia Repair

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

The current study aims to determine whether a use of closed suction drain following laparoscopic inguinal hernia surgery performed for an inguinoscrotal variety can decrease the incidence of symptomatic seroma formation requiring interventions and thus, prevent postoperative morbidity.

NCT ID: NCT03561727 Recruiting - Incisional Hernia Clinical Trials

Risk Factors for Development of Incisional Hernia in Transverse Incisions

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

RESEARCH PROJECT OBJECTIVES The aim of this planned study is to evaluate factors, with particular reference to surgical technique of abdominal closure, accumulation of advanced glycation end products, and collagen content in the transversalis fascia, that are associated with the development of incisional hernias after transverse epigastric incisions in patients operated due to malignant tumors. RESEARCH PROJECT METHODOLOGY: The study is designed as prospective and is planned to include 392 patients undergoing abdominal surgery due to malignant tumors of the alimentary system performed through transverse incisions in the epigastrium. Primary end-point of the study is defined as the occurrence of burst abdomen during immediate postoperative period or incisional hernia over 2 year postoperative follow-up. Assessment of the association between the type of surgical technique and development of hernia will be based on comparison of mass (1 layer) continuous suture and layered (2 layers) continuous suture using slowly absorbable material and applying suture to wound length ratio of more than 4. Type of the utilized surgical technique will be based on randomization. The method of abdominal closure will remain unknown for patients and investigators assessing the presence of incisional hernias. Assessment of overall collagen content and type I to type III ratio will be performed by obtaining a fragment of tissue during operation, preparation of formalin-fixed and paraffin embedded blocks, cutting of 4-micrometer thick sections, staining with picrosirius red and immunohistochemical procedures. Images will be analyzed with dedicated computer software. Accumulation of advanced glycation end products will be evaluated indirectly by measuring skin autofluorescence utilizing a method based on the use of photodiodes. Postoperative follow-up will include the period of postoperative hospitalization and two additional control visits at 1 and 2 years after the operation. Assessment of the presence of incisional hernia will comprise clinical examination, ultrasonographical study, and analysis of images from other available radiological studies. Irrespective of the primary end-point, additional analyses will be performed concerning associations between evaluated factors and occurrence of burst abdomen and the impact of incisional hernia on patients quality of life using the EORTC QLQ C-30 questionnaires. Statistical analyses will, among other, include Kaplan-Meier method, log-rank test, Cox proportional hazards regression and logistic regression

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.