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Hernia clinical trials

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NCT ID: NCT03034213 Terminated - Clinical trials for Ventral Incisional Hernia

Gentrix™ Versus Biological or Prosthetic Mesh

Start date: October 6, 2017
Phase: N/A
Study type: Interventional

The hypothesis for this study is complex incisional hernia repair using the separation of components technique reinforced with retrorectus placement of Gentrix™ Surgical Matrix will lead to fewer incisional hernia recurrences and fewer wound complications compared to the same incisional hernia repair techniques reinforced with other prosthetic or biologically-derived mesh.

NCT ID: NCT02953769 Terminated - Ventral Hernia Clinical Trials

Prevena Incision Management System Wound Care

Start date: March 29, 2017
Phase:
Study type: Observational

Comparison of ventral hernia repair using standard wound care versus Prevena.

NCT ID: NCT02929589 Terminated - Pain Clinical Trials

Ibuprofen to Decrease Opioid Use and Post-operative Pain Following Unilateral Inguinal Herniorrhaphy

Start date: July 5, 2018
Phase: Phase 3
Study type: Interventional

This is a prospective, randomized, double-blinded, and placebo-controlled trial comparing oxycodone/acetaminophen prescribed with or without ibuprofen for pain control following open unilateral inguinal hernia repair, with allowed exception of any currently prescribed opioid (codeine, hydrocodone, hydromorphone, morphine, methadone, oxymorphone, transdermal fentanyl), which can be continued. The patients will not be allowed to continue any over-the-counter pain medications, such as ibuprofen, naproxen, or acetaminophen containing medications, that were not prescribed by the investigators during this study. Patients not receiving Ibuprofen will be given a placebo pill composed of corn starch. The placebo pill will be formulated into the same shape, size and color as the ibuprofen capsule. Neither the investigators nor the research subjects will know if the subject is receiving a placebo versus Ibuprofen. The subjects will complete pain level and medication diaries, and will be followed for 2 months after their surgery. The research aims to discover the appropriate amount of opioid medication to prescribe to patients undergoing an elective open inguinal hernia repair, and reduce the total opioid dose needed by utilizing ibuprofen in combination. The investigators expect that the subjects who take ibuprofen will use less oxycodone/acetaminophen, and have comparable or lower mean pain levels. This could contribute to reducing the surplus opioids prescribed by physicians after surgery, which can lead to opioid use disorders. This particular procedure is common in men, and the findings have the potential to decrease the symptoms and pain of Active Duty members and DoD beneficiaries who undergo an inguinal hernia repair, and are at risk for prescription drug abuse or dependence.

NCT ID: NCT02770703 Terminated - Clinical trials for Unilateral Simple Inguinal Hernia

Mesh Position and Outcomes Following Inguinal Hernia Repair Using an MRI Visible Hernia Mesh

Start date: April 2016
Phase: N/A
Study type: Interventional

Inguinal hernia repair can be considered as one of the most frequent surgeries in general surgery worldwide. Surgical hernia repair procedures can generally be divided into minimally invasive (TEP, TAPP) and open techniques (e.g. Lichtenstein) and are equivalent with some advantages and disadvantages. The posterior wall of the inguinal channel is usually reinforced by a synthetic mesh, while non-mesh based surgeries have been steadily abandoned. Two of the most frequent complications following hernia surgery are hernia recurrence and chronic groin pain. Latter can occur in up to 10%. Both represent a considerable socio-economic impact. While different surgical hernia procedures and mesh fixation techniques have been evaluated as influential factors, the impact of mesh position and mesh deformation on hernia recurrence and chronic groin pain is unknown. This may be even more important, since endoscopic and laparoscopic hernia surgery procedures (TEP, TAPP) carry the risk of suboptimal mesh positioning, due to the final steps at the end of the surgery, where the mesh position is not under direct visual control. Until now direct mesh visualization was impossible. A recent development of MRI visible meshes (DynaMesh® visible) provides the opportunity to evaluate mesh position and deformation after hernia surgery. In case of suspicious clinical hernia recurrence or postoperative chronic groin pain the mesh position can now directly be identified with Magnetic Resonance (MR) imaging preventing unnecessary explorative surgery. In this study the investigators plan to perform MRI scans to assess mesh position and deformation 90 days postoperatively and correlate it with the clinical status and pain score (VAS) of the patient. In order to allow for an optimal comparison of the post-operative mesh position in relation to the operative technique, patients will be randomized to minimally invasive (TEP, TAPP) and open techniques (e.g. Lichtenstein). To the investigators knowledge this is the first study investigating the impact of the three most common surgical hernia procedures on postoperative mesh position and deformation and its correlation to the clinical findings focussing on hernia recurrence and chronic groin pain.

NCT ID: NCT02708303 Terminated - Clinical trials for Gastroesophageal Reflux

Mayo Clinic Foregut Surgery Report Card Questionnaire

Start date: March 17, 2016
Phase:
Study type: Observational

The Mayo Clinic Foregut Surgery Report Card Questionnaire has been created in order to have a consistent evaluation tool for patients undergoing foregut surgery in order to standardize and validate outcome measures.

NCT ID: NCT02489175 Terminated - Parastomal Hernia Clinical Trials

Stomaplasty Ring (KoringTM) for Prevention of Parastomal Hernia

StoKo
Start date: July 2015
Phase: N/A
Study type: Interventional

Parastomal hernia (PSH) is one of the most frequent stoma complications with a high impact on patients' quality of life. Half of the stomas created each year are permanent and up to 50% of the patients will develop a PSH. PSH rates depend on the type of ostomy, ileo- or colostomy. End colostomy carries the highest risk for PSH (48%). PSH lead to recurrent pain, poor fitting appliance with leakage and therefore, skin irritation, and can also be complicated by strangulation or occlusion. The literature reports that 30% of patients with a PSH will require surgery. There are many different surgical procedures to repair PSH: primary fascia repair, relocation of the stoma or repair with various type of mesh. Despite the efforts done to improve the techniques, the incidence of recurrent PSH is up to 70% dependent of the used technique. Therefore, the idea of implanting a mesh at the time of initial stoma formation has lately been advocated. A new device, the KoringKM, which is a stomaplasty ring made of propylene, flexible and non-absorbable, was created. This study will try to prove that incorporation of the new stomaplasty ring at the time of stoma creation will diminish long-term PSH rate. This hypothesis will improve patient's quality of life and reduce costs associated with PSH. All patients requiring a permanent ostomy (ileostomy or colostomy) for a malignant disease and fulfilling the inclusion criteria are eligible to participate in the trial. The patients will be randomized 24 to 48 hours prior to surgery after given written informed consent. The implantation of the Koring will be perfomed by experienced surgeons (expertise based, best team approach) who have already implanted the Koring (e.g. participated in the observational study) and/or have reviewed the video documentation. The surgeon will fill out the first form with the data of the patient and of the surgical procedure. The surgical wound will be daily examined. A second form will be fill out during the 30 post-operative days visit. The patients will be asked to inform the surgeon and/or investigator if any side event or suspicion of infection occurs after hospital discharge. The next follow-up visits will be at one and two years including a clinical examination and an abdominal CT. At this moment, the 3rd and 4th forms will be documented. All data will be anonymised and included in an Excel database.

NCT ID: NCT02461654 Terminated - Disc Herniations Clinical Trials

EuroPainClinics® Study III (Prospective Observational Study)

EPCSIII
Start date: December 31, 2018
Phase:
Study type: Observational

In this prospective observational trial the effect of the Disc FX microinvasive therapy should be examined in (approximately 150) adult patients with low back pain.

NCT ID: NCT02447965 Terminated - Pain, Postoperative Clinical Trials

Pilot Study: Rectus Sheath Blocks for Improving Abdominal Surgery Conditions

Start date: January 1, 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to show that the use of preoperative rectus sheath blocks can ultimately alleviate the need for using nondepolarizing muscle relaxants during certain abdominal procedures.

NCT ID: NCT02404545 Terminated - Parastomal Hernia Clinical Trials

Prevention of Parastomal Hernia by Mesh Placement

Start date: August 14, 2015
Phase: N/A
Study type: Interventional

Concurrent placement of a mesh during formation of ileal conduit will decrease the incidence of parastomal hernia and associated complications.

NCT ID: NCT02385968 Terminated - Clinical trials for Lumbar Disc Herniations

Detection of Bacteria in Herniated Nucleus Material in Lumbar Disc Herniations by Culture and PCR

Start date: October 2014
Phase: N/A
Study type: Observational

The aim is to investigate if herniated nucleus material in lumbar disc herniations is infected with bacteria, and if so, to determine their prevalence (control group), and to determine if patients with pre-existing Modic changes type 1 have a higher incidence of bacterial growth in relevant lumbar disc samples than patients without Modic changes. A cohort of 15 patients with pre-existing Modic and 15 without-undergoing primary surgery will be examined.