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Hernia clinical trials

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NCT ID: NCT00459602 Terminated - Incisional Hernia Clinical Trials

Incisional Hernia Outcomes Study Using Parietex Composite Mesh

Start date: August 2004
Phase: Phase 4
Study type: Observational

The purpose of this study is to describe the outcomes of laparoscopic incisional hernia repair surgery and to record the outcomes of patients after surgery.

NCT ID: NCT00455299 Completed - Clinical trials for Ventral and Ventral Insicional Hernia

LVHR Multicenter Study

Start date: March 2007
Phase: Phase 3
Study type: Interventional

The study aims to prove differences or equalities in outcome for patients operated with laparoscopic ventral hernia repair with different methods of fixation of mesh and with or without approximation of defect prior to meshfixation.

NCT ID: NCT00451893 Active, not recruiting - Inguinal Hernia Clinical Trials

The Significance of the Mesh Thickness in the Operation of Inguinal Hernia

LJUNO
Start date: December 2006
Phase: Phase 2/Phase 3
Study type: Interventional

The trial compares the postoperative complain, pain, quality of life after the implantation of a heavy-weight alternative light-weight mesh, by randomly allocating patients with inguinal hernia disease to two groups of surgeons, each group being trained to operate with one of the above mentioned meshes. Hypothesis: There is less postoperative pain after the implantation of a light-weight mesh.

NCT ID: NCT00444405 Withdrawn - Low Back Pain Clinical Trials

Surgical Treatment Comparison for Recurrent Lumbar Disc Herniation

Start date: March 2007
Phase:
Study type: Observational

The purpose of this study is to compare patients who underwent decompression/discectomy with pedicle screw fusion to patients who received decompression/discectomy without fusion.

NCT ID: NCT00423241 Terminated - Pain Clinical Trials

SEMPERFLO* Pain Management System in Inguinal Hernia Repair

Start date: January 2007
Phase: N/A
Study type: Interventional

This study will compare the clinical performance of the SEMPERFLO* Pain Management System with another commercial pain relief system using 0.5% bupivacaine following unilateral, open, inguinal hernia repair procedures. *Trademark

NCT ID: NCT00416364 Terminated - Inguinal Hernia Clinical Trials

The Economic Impact of Four Varieties of Mesh Inguinal Hernia Repair- a Double-Blinded, Prospective, Randomized Trial

Start date: March 2006
Phase: N/A
Study type: Observational

There are a variety of methods to repair inguinal hernias. Each has its advocate and may confer advantages to individual patients. Postoperative pain, convalescence, recurrence, and economics have all been evaluated however none in a randomized blinded fashion. Recently, investigators have attempted to address some of these concerns with new prosthetic materials. The preferred method of repair currently employs a tension free technique using mesh prosthesis. The approach as advocated by Lichtenstein involves reinforcing the floor of the inquinal canal with an onlay mesh. Newer approaches use a double layer mesh that reinforces the floor in a preperitoneal and onlay technique (Prolene Hernia System) while obliterating the internal inguinal ring or by the Mesh Plug repair (bioresorbable or permanent) which reinforces the inguinal floor with an onlay mesh while obliterating the internal inguinal ring. Currently no study has compared these techniques for ease of performance, postoperative pain, convalescence, quality of life, or cost in a randomized double blinded fashion. NMCP is uniquely qualified to compare these repairs prospectively and blinded to best assess the most cost effective approach which causes the least pain. A prospective double-blinded randomized trial comparing the Lichtenstein onlay mesh technique to Prolene Hernia Sytem (PHS), Mesh Plug Repair (MPR), or Gore Bioresorbable plug for postoperative pain, duration of convalescence, cost, impact on quality of life and ease of performance is proposed. Impact on quality of life will be assessed serially with the SF 12 which is a validated survey used with serial measures in the acute setting.

NCT ID: NCT00393887 Completed - Inguinal Hernia Clinical Trials

Inguinal Hernia Study Using Biodesign IHM

Start date: March 2007
Phase: N/A
Study type: Interventional

Aim is to evaluate outcomes of inguinal hernia repair incorporating the standard Lichtenstein (open) repair using Biodesign IHM in a double blind (physician evaluator and patient will be blinded), randomized, prospective comparative study with polypropylene mesh. Primary outcome is recurrence at 1 year. Hernia recurrence will be confirmed via ultrasound or CT scan.

NCT ID: NCT00384007 Completed - Clinical trials for Disc Herniation With Radiculopathy

A Randomized Trial Comparing SpineJet® Hydrodiscectomy to Open Lumbar Microdiscectomy for Treatment of Lumbar Radiculopathy Due to Disc Herniation

Start date: October 2006
Phase: N/A
Study type: Interventional

The purpose of this study is to compare a standard surgical procedure, open surgical microdiscectomy, used primarily to relieve leg pain and repair disc herniation to a newer surgical procedure, hydrodiscectomy with Spinejet®. The study will examine how well each procedure reduces subject pain and disability over a one-year period. Magnetic resonance imaging (MRI-use of a magnetic field to produce an image) of the lower spinal column taken before and after surgery will also be looked at to determine what physical changes have taken place over the course of a year. Subjects enrolled in this study will also be asked to keep track of their medical expenses related to treating their back pain to see if the surgeries being compared reduce out of pocket expenses.

NCT ID: NCT00373763 Withdrawn - Clinical trials for Diaphragmatic Hernia

Fetoscopic Tracheal Balloon Occlusion in Unborns With Severe Congenital Diaphragmatic Hernia - EUROTRIAL I

Start date: January 2007
Phase: N/A
Study type: Interventional

Diaphragmatic hernia detected in fetal life carries a high risk for postnatal demise due to lung underdevelopment. Clinical experience from prospective controlled non-randomized case series with fetoscopic tracheal balloon occlusion has seen improved survival rates in contrast to untreated controls. Therefore, the purpose of this randomized clinical trial is to provide further evidence about the efficacy and safety of the prenatal interventional approach. Primary outcome measure is postnatal survival to discharge from hospital treatment.

NCT ID: NCT00373438 Recruiting - Clinical trials for Diaphragmatic Hernia

Fetoscopic Tracheal Balloon Occlusion in Left Diaphragmatic Hernia

Start date: January 2009
Phase: Phase 2
Study type: Interventional

Left diaphragmatic hernia detected during fetal life carries a high risk for postnatal lung failure due to lung underdevelopment and pulmonary hypertension. In severe cases, extracorporeal membrane oxygenation (ECMO) is used as a life-saving intensive care means to enable survival of severely affected infants. Clinical experience from prospective controlled non-randomized case series with fetoscopic tracheal balloon occlusion has seen improved survival rates in contrast to untreated controls. Therefore, the purpose of this randomized clinical trial in a less severely affected subgroup of patients is whether by fetoscopic tracheal occlusion, the intensity of postnatal intensive care therapy might be reduced. Primary outcome measure is the need for postnatal ECMO therapy.